{ "slug": "cream-hemorrhoid", "question": "Does hemorrhoid cream actually work to shrink hemorrhoids or stop the bleeding?", "shortTitle": "Hemorrhoid Cream: Does It Work?", "clinicalQuestion": "In adults with symptomatic internal or external hemorrhoids, how effective are topical over-the-counter hemorrhoid creams/ointments (e.g., containing hydrocortisone, phenylephrine, or witch hazel) compared with placebo or no treatment for reducing bleeding, shrinking hemorrhoid size, and relieving symptoms, and how long does improvement take?", "pico": { "population": "Adults with symptomatic internal or external hemorrhoids", "intervention": "Topical over-the-counter hemorrhoid cream or ointment (e.g., hydrocortisone, phenylephrine, witch hazel, or combination products)", "comparator": "Placebo, vehicle cream, or no treatment", "outcomes": [ "Resolution or reduction of rectal bleeding", "Change in hemorrhoid size on exam", "Symptom severity score (itching, pain, swelling)", "Time to symptom improvement or shrinkage", "Recurrence of symptoms after stopping treatment", "Adverse skin reactions" ] }, "category": "anorectal", "relatedConditions": [ "hemorrhoids", "anal-fissure", "rectal-bleeding" ], "relatedTreatments": [], "relatedEvidence": [], "bottomLine": { "verdict": "The evidence that hemorrhoid cream shrinks hemorrhoids or stops bleeding is weak and inconsistent.", "detail": "Only one well-designed placebo-controlled trial was built to answer this exact question, and even it found mixed results — some symptoms improved, others didn't. Two other studies found the cream actually performed worse than a simple alternative (a salt-water soak, or no cream at all), so the overall signal leans toward uncertainty and possible harm rather than clear benefit.", "studyIds": [ "pmid:22244049", "pmid:29055673", "pmid:23102076" ] }, "strength": { "level": "low", "why": "One well-conducted randomised trial addresses this question directly. The studies disagree with one another, so the overall certainty is lower than any single one of them.", "override": null }, "direction": { "level": "harm-signal", "why": "2 studies reported harm or tissue damage, including laboratory evidence.", "override": null }, "counts": { "recordsRetrieved": 195, "recordsScreened": 195, "included": 96, "rcts": 30, "systematicReviews": 5, "observational": 16, "participants": 11091, "yearFrom": 1976, "yearTo": 2026, "registeredTrialsWithoutResults": 2 }, "excluded": [], "outcomes": [ { "name": "Symptom severity (itching, pain, swelling)", "status": "possible-improvement", "note": "Multiple small trials found less itching, pain, or swelling with cream than with a placebo cream after 1 to 4 weeks, but other trials found the cream worked no better than a different active cream, making it hard to know how much credit the cream itself deserves.", "studyIds": [ "pmid:35511655", "pmid:22492249", "pmid:1634173", "pmid:42812757", "pmid:31433782", "pmid:25608984" ] }, { "name": "Time to symptom improvement or shrinkage", "status": "insufficient", "note": "Reported timing ranged from within hours to several weeks, but no study directly compared speed of improvement against a placebo on the same timeline, so there's no reliable answer for how long it takes.", "studyIds": [ "pmid:41821779", "pmid:17504344", "pmid:15702657" ] }, { "name": "Recurrence of symptoms after stopping treatment", "status": "not-studied", "note": "No study in this review followed people after they stopped using the cream to see whether bleeding or swelling came back.", "studyIds": [] } ], "benefits": [ { "text": "In several placebo-controlled trials, hemorrhoid cream reduced itching, pain, or bleeding more than a fake (placebo) cream over 1 to 4 weeks.", "studyIds": [ "pmid:35511655", "pmid:22492249", "pmid:1634173", "pmid:38463771", "pmid:22244049" ] }, { "text": "One small placebo-controlled trial found bleeding stopped completely in people using an active cream/tablet combination, while bleeding continued in those given placebo.", "studyIds": [ "pmid:20041428" ] } ], "limitations": [ { "text": "Most studies that found a benefit had no placebo group at all — people were simply compared to themselves before treatment, so natural healing over time could explain the improvement rather than the cream.", "studyIds": [ "pmid:38750150", "pmid:41821779", "pmid:33683221", "pmid:19761640", "pmid:17504344", "pmid:15702657", "pmid:3287228" ] }, { "text": "The one randomized, placebo-controlled trial built specifically to answer this question found the cream helped with bleeding and itching but not with pain or tenderness — a mixed result from the single most trustworthy study available.", "studyIds": [ "pmid:22244049" ] }, { "text": "Two studies that compared cream directly against a simple non-drug option found the cream came out worse: a salt-water soak healed more pregnant women's hemorrhoids than cream did, and a nitroglycerin cream caused more pain after surgery than no cream at all.", "studyIds": [ "pmid:29055673", "pmid:23102076" ] }, { "text": "Studies lump together many different products — herbal creams, steroid creams, numbing creams, vein-support creams — so a finding about one product doesn't necessarily apply to the tube of cream on a drugstore shelf.", "studyIds": [ "pmid:42812757", "pmid:37741471", "pmid:24032710", "pmid:3243509" ] } ], "risks": [ { "text": "A standard anti-hemorrhoid cream resolved hemorrhoid symptoms in fewer pregnant women than a simple warm salt-water soak did.", "studyIds": [ "pmid:29055673" ], "severity": "minor" } ], "whyPeopleTryIt": [ { "text": "Creams are sold over the counter, so they feel like an easy first step before seeing a doctor." }, { "text": "Packaging promises fast relief from itching, pain, and swelling." }, { "text": "Hemorrhoids feel embarrassing to many people, who prefer a private, do-it-yourself fix." }, { "text": "Herbal or 'natural' versions feel lower-risk than medication or a doctor's procedure." } ], "keyStudies": [ "pmid:22244049", "pmid:38463771", "pmid:29055673", "pmid:23102076", "pmid:26109819", "pmid:42812757", "pmid:35511655", "pmid:22864620" ], "studies": [ { "id": "pmid:42812757", "pmid": "42812757", "doi": "10.3831/KPI.2026.29.3.", "nctId": null, "pmcid": "PMC13620397", "title": "Efficacy of an Herbal Cream on Patients with Hemorrhoids: a randomized triple-blind controlled trial", "firstAuthor": "Zohalinezhad", "multipleAuthors": true, "journal": "J Pharmacopuncture", "year": 2026, "design": "rct", "n": 110, "nField": "reported", "population": "adults with grade I-II hemorrhoids", "intervention": "herbal cream (containing myrtle, chamomile, wild leek, and Russian olive extracts) applied topically", "comparator": "a conventional hemorrhoid cream", "primaryOutcome": "hemorrhoid symptoms including anal pain, bleeding, pruritus, burning and difficulty defecating, measured on pain and symptom scales", "result": "Both creams reduced symptoms over time, but there was no significant difference between the herbal cream and the conventional cream groups.", "resultDirection": "no-benefit", "quality": "low", "qualityWhy": "The trial was small, had a high dropout rate (only 49 of 110 patients completed), and found no statistically significant difference between groups.", "directness": "direct", "limitations": "High dropout rate and limited sample size reduced the ability to detect a difference between treatments.", "followUp": "14 days intervention and 28 days follow-up", "plainFinding": "No better than standard cream.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/42812757/", "sourceText": "OBJECTIVES: Traditional Persian medicine offers various topical treatments for hemorrhoids. This study investigated the efficacy of an herbal cream (HC) containing common myrtle, chamomile, wild leek, and Russian olive extracts. METHODS: This randomized triple-blind controlled trial compared the effects of the HC and a conventional cream (CC) on hemorrhoids. Standardization involved measuring the total phenolic content (TPC) and analyzing the HC by gas chromatography. In total, 110 outpatients with hemorrhoids were randomly assigned to intervention (n = 58) and control (n = 52) groups. The outcomes were evaluated using the visual analog scale (VAS [1-10]); anal pain, difficult defecation, and burning sensation) and four-point Likert scale anal bleeding and anal pruritus) during the intervention phase (14 days) and follow-up (28 days). RESULTS: The HC was safe and well tolerated, with no major adverse effects observed in toxicological or clinical evaluations. Physicochemical assays confirmed the quality parameters, and the TPC was determined. In the clinical trial involving 49 patients, both HC and CC reduced hemorrhoidal symptoms over time (p = 0.011). However, no significant treatment-group effect (p = 0.50) or treatment-by-time interaction (p = 0.77) was observed. Exploratory analyses indicated that the HC produced clinically meaningful reductions in bleeding and anal pain from baseline. CONCLUSION: The HC was safe and well tolerated in patients with grade I-II hemorrhoids. Although it did not show statistical superiority over the CC, potentially due to high dropout rates and limited sample size, HC was associated with clinically meaningful improvements in anal bleeding and pain along with favorable changes in other symptoms. These findings suggest that the HC has potential as a safe herbal alternative for hemorrhoid symptom relief, without side effects and an acceptable safety profile.", "provenance": [ { "field": "n", "quote": "In total, 110 outpatients with hemorrhoids were randomly assigned to intervention (n = 58) and control (n = 52) groups." }, { "field": "population", "quote": "The HC was safe and well tolerated in patients with grade I-II hemorrhoids." }, { "field": "intervention", "quote": "an herbal cream (HC) containing common myrtle, chamomile, wild leek, and Russian olive extracts" }, { "field": "comparator", "quote": "compared the effects of the HC and a conventional cream (CC) on hemorrhoids" }, { "field": "primaryOutcome", "quote": "The outcomes were evaluated using the visual analog scale (VAS [1-10]); anal pain, difficult defecation, and burning sensation) and four-point Likert scale anal bleeding and anal pruritus)" }, { "field": "result", "quote": "both HC and CC reduced hemorrhoidal symptoms over time (p = 0.011). However, no significant treatment-group effect (p = 0.50) or treatment-by-time interaction (p = 0.77) was observed." } ] }, { "id": "pmid:42275875", "pmid": "42275875", "doi": "10.1016/j.phymed.2026.158406", "nctId": null, "pmcid": null, "title": "Bioactive compound emodin from clinical formula Zhi-Lou-Xun-Xi decoction exerts rapid analgesic effects by targeting TRPV1", "firstAuthor": "Chen", "multipleAuthors": true, "journal": "Phytomedicine", "year": 2026, "design": "animal", "n": null, "nField": "not-reported", "population": "patients having surgery to remove hemorrhoids (hemorrhoidectomy), studied together with animal pain models", "intervention": "emodin, a compound from the traditional Zhi-Lou-Xun-Xi decoction, acting on a pain receptor (TRPV1)", "comparator": "no specific comparator described; compared against untreated or standard pain conditions in lab and animal models", "primaryOutcome": "pain relief (analgesia) after hemorrhoid surgery, via a nerve receptor mechanism", "result": "Emodin produced dose-dependent analgesia without inducing common TRPV1 antagonist-related side effects", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This is a laboratory and animal mechanism study with only a small retrospective clinical note, not a controlled human trial measuring hemorrhoid shrinkage or bleeding.", "directness": "indirect", "limitations": "No participant numbers given, no comparator group described, and the outcome studied is pain relief after surgery rather than shrinking hemorrhoids or stopping bleeding.", "followUp": "", "plainFinding": "Reduces surgical pain, not hemorrhoid size", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/42275875/", "sourceText": "BACKGROUND: Effective postoperative pain management after hemorrhoidectomy remains a significant clinical challenge, largely due to the scarcity of safe and effective non-opioid analgesics. Zhi-Lou-Xun-Xi decoction (J5) is a traditional Chinese formula that has been used clinically for decades, yet its active components and mechanism of action remain unclear. PURPOSE: This study aimed to systematically identify the active analgesic components in J5 and elucidate their molecular mechanism of action. METHODS: We employed an integrated pharmacological approach, beginning with a retrospective clinical analysis to confirm the analgesic and wound-healing effects of J5. Pharmacodynamic assays were conducted to evaluate its interaction with TRPV1. High-resolution mass spectrometry and structure-based virtual screening were used to identify candidate compounds. The mechanism of emodin, the primary active constituent, was further investigated through SPR assays, patch-clamp recording, molecular dynamics simulations, and extensive in vivo pain models using TRPV1 knockout (KO) mice. RESULTS: Emodin was identified as the key TRPV1-antagonizing component in J5. In multiple pain models, emodin produced dose-dependent analgesia without inducing common TRPV1 antagonist-related side effects, particularly altered thermal sensitivity or hyperthermia. These findings not only clarify the mechanistic basis of J5's clinical efficacy but also position emodin as a promising topical analgesic candidate that acts via local TRPV1 inhibition.", "provenance": [ { "field": "population", "quote": "Effective postoperative pain management after hemorrhoidectomy remains a significant clinical challenge" }, { "field": "intervention", "quote": "Emodin was identified as the key TRPV1-antagonizing component in J5" }, { "field": "primaryOutcome", "quote": "In multiple pain models, emodin produced dose-dependent analgesia" }, { "field": "result", "quote": "emodin produced dose-dependent analgesia without inducing common TRPV1 antagonist-related side effects, particularly altered thermal sensitivity or hyperthermia" }, { "field": "comparator", "quote": "Pharmacodynamic assays were conducted to evaluate its interaction with TRPV1" } ] }, { "id": "pmid:42067175", "pmid": "42067175", "doi": "10.1016/j.cgh.2026.04.008", "nctId": null, "pmcid": null, "title": "AGA Clinical Practice Update on Diagnosis and Treatment of Hemorrhoids: Expert Review", "firstAuthor": "Qureshi", "multipleAuthors": true, "journal": "Clin Gastroenterol Hepatol", "year": 2026, "design": "guideline", "n": null, "nField": "not-reported", "population": "people with symptomatic hemorrhoids", "intervention": "topical treatments (anesthetics, astringents like witch hazel, corticosteroids, vasoactive agents)", "comparator": "no direct comparator specified", "primaryOutcome": "improvement in hemorrhoid symptoms", "result": "Topical treatments can be considered but there is little data to support efficacy", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "This is an expert opinion guideline, not based on systematic review of evidence, and explicitly states data on topical treatments is limited.", "directness": "direct", "limitations": "Because systematic reviews were not performed, these BPA statements do not carry formal ratings regarding the quality of evidence or strength of the presented considerations.", "followUp": "", "plainFinding": "Little evidence creams actually work.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/42067175/", "sourceText": "DESCRIPTION: Hemorrhoids are a common problem. The diagnosis and treatment can be challenging. Gastroenterologists have much to offer these patients. The purpose of this American Gastroenterological Association (AGA) Clinical Practice Update Expert Review is to provide best practice advice (BPA) covering the diagnosis and treatment of hemorrhoid disease. METHODS: This expert review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPUC and external peer review through standard procedures of Clinical Gastroenterology and Hepatology. These BPA statements were drawn from a review of the published literature and from expert opinion. Because systematic reviews were not performed, these BPA statements do not carry formal ratings regarding the quality of evidence or strength of the presented considerations. Best Practice Advice Statements BPA 1: The diagnosis and treatment of hemorrhoids is within the purview of the gastroenterologist. The diagnosis and grading of hemorrhoids is easily made by taking a history from the patient and examining the patient. Symptoms caused by hemorrhoids include bleeding, itching, discomfort, and/or prolapse. Hemorrhoids only cause significant pain when acutely thrombosed. Sharp pain on defecation is most likely anal fissure. BPA 2: Dietary and lifestyle modifications, including increasing fiber intake and avoiding straining or prolonged time on the toilet, are reasonable first-line therapies for symptomatic hemorrhoids. The use of sitz baths for symptom improvement in symptomatic hemorrhoids is often advised, but scientific data is limited. BPA 3: Topical treatments, including anesthetics, astringents (witch hazel), corticosteroids, and vasoactive agents, can be considered for treatment of symptomatic hemorrhoids, but there is little data to support efficacy. Topical steroids should not be used for more than 2 weeks at a time. BPA 4: Anoscopy should be performed, whenever possible, on every new patient with suspected hemorrhoids, prior to treatment, to ensure accurate diagnosis. BPA 5: Both hemorrhoid banding and infrared coagulation are safe, effective, and easy to perform in the office setting. Infrared coagulation and rubber band ligation have similar benefits in the short term. Rubber band ligation has longer-term benefits for treatment of prolapsing hemorrhoids and recurrent bleeding. Hemorrhoid banding or infrared coagulation should be employed prior to surgical hemorrhoidectomy for grades 1 to 3 hemorrhoids. BPA 6: As part of informed consent for hemorrhoid therapies, the patient must be made aware of the small possibility of pelvic sepsis as a complication. Patients should be counseled about the risk and instructed to present to the emergency department immediately for evaluation, if indicated. BPA 7: In patients with active Crohn's disease or ulcerative colitis, hemorrhoid disease management should be delayed until complete remission is achieved. BPA 8: Hemorrhoids occur in up to two-thirds of women during pregnancy. Treatment should generally involve conservative management, including fiber, treatment of constipation, and topical ointments. If symptoms persist postpartum, or if a woman is planning further pregnancies, standard treatment such as banding or infrared coagulation can be considered. BPA 9: Acute thrombosed hemorrhoids are often extremely painful. They are best treated surgically with incision and drainage. BPA 10: Consultation with a surgeon should be offered to patients with grade 3 internal hemorrhoids who fail banding procedures or have associated external hemorrhoids. Large skin tags can be removed without a hemorrhoidectomy if they are not associated with significant hemorrhoids. Grade 4 internal hemorrhoids require surgical hemorrhoidectomy. BPA 11: Patients with cirrhosis and hemorrhoids should be carefully examined so as not to confuse hemorrhoids with rectal varices. Hemorrhoids in patients with cirrhosis can be treated with banding or infrared coagulation. In patients with significant coagulopathy, infrared coagulation is preferred to banding. Concomitant portal hypertension should not alter this approach. For most clinicians, significant coagulopathy means a platelet count of less than 50,000 per microliter or international normalized ratio greater than 2.0. The presence of concomitant portal hypertension should not alter this approach.", "provenance": [ { "field": "population", "quote": "symptomatic hemorrhoids" }, { "field": "intervention", "quote": "Topical treatments, including anesthetics, astringents (witch hazel), corticosteroids, and vasoactive agents" }, { "field": "result", "quote": "can be considered for treatment of symptomatic hemorrhoids, but there is little data to support efficacy" }, { "field": "primaryOutcome", "quote": "treatment of symptomatic hemorrhoids" }, { "field": "comparator", "quote": "BPA 3: Topical treatments, including anesthetics, astringents (witch hazel), corticosteroids, and vasoactive agents, can be considered for treatment of symptomatic hemorrhoids, but there is little data to support efficacy." }, { "field": "limitations", "quote": "Because systematic reviews were not performed, these BPA statements do not carry formal ratings regarding the quality of evidence or strength of the presented considerations." } ] }, { "id": "pmid:41837899", "pmid": "41837899", "doi": "10.1097/MCG.0000000000002360", "nctId": null, "pmcid": null, "title": "Comparative Effectiveness of Lidocaine- Versus Nifedipine-Based Multimodal Conservative Regimens for Acute Hemorrhoidal Disease: A Multicenter Cohort Study", "firstAuthor": "Schiano di Visconte", "multipleAuthors": true, "journal": "J Clin Gastroenterol", "year": 2026, "design": "retrospective", "n": 266, "nField": "reported", "population": "patients with acute hemorrhoidal disease (early-stage or thrombosed hemorrhoids) treated at proctology clinics", "intervention": "a multimodal regimen combining oral phlebotonics, bromelain, and topical lidocaine cream (or topical nifedipine in another group)", "comparator": "standard conventional conservative therapy", "primaryOutcome": "change in hemorrhoid symptom score and pain score (VAS)", "result": "the lidocaine-based multimodal regimen led to faster, greater reductions in pain and symptoms, less need for rescue pain medication, fewer urgent procedures, and more frequent early resolution of bleeding and swelling compared with standard care or the nifedipine-based regimen", "resultDirection": "benefit", "quality": "low", "qualityWhy": "this was a retrospective, non-randomized comparison across multiple treatments combined together, so it can't show whether the cream alone caused the improvement, and the authors themselves call for further prospective study.", "directness": "indirect", "limitations": "retrospective design, treatments given as part of a combined multi-drug regimen rather than testing cream alone, no randomization mentioned", "followUp": "within the first 14 days of treatment", "plainFinding": "Faster pain and bleeding relief.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/41837899/", "sourceText": "BACKGROUND: Hemorrhoidal disease (HD) significantly impairs quality of life, and existing conservative treatments often yield delayed or insufficient relief. This multicentre cohort study evaluated the comparative effectiveness of structured multimodal conservative regimens versus standard conservative care in patients with acute hemorrhoidal disease (AHD). METHODS: This retrospective cohort study, conducted across 5 Italian proctology centres, included 266 patients with AHD (Goligher grades I to III or thrombosed external hemorrhoids) treated between November 2024 and June 2025. Patients were assigned to 3 groups: group A (n=90) received a multimodal approach with phlebotonics, bromelain, and topical lidocaine; group C (n=93) received the same oral regimen with topical nifedipine; and group B (n=83) received conventional conservative therapy. Primary outcomes were changes in the Hemorrhoidal Disease Symptom Score (HDSS) and the visual analog scale (VAS) for pain. RESULTS: While all treatment strategies yielded significant symptom improvement over time, the lidocaine-based multimodal regimen (group A) was associated with earlier and more pronounced reductions in pain, symptom burden, and impairment in health-related quality of life (SHS-HD), particularly within the first 14 days of treatment (P<0.001 for all comparisons). Patients treated with the lidocaine-based regimen required less rescue systemic analgesia (8.9% vs. 28.9% in group B and 26.9% in group C; P<0.001) and underwent fewer urgent procedural interventions than those receiving standard care. Early resolution of bleeding and perianal oedema was also more frequent in the multimodal arms. CONCLUSION: In this multicentre retrospective cohort study, structured multimodal conservative therapy, particularly the lidocaine-based regimen, was associated with faster symptom relief, improved patient-reported quality of life, and a reduced need for urgent procedures compared with standard conservative care for AHD. These findings suggest the need for further prospective evaluation of lidocaine-centred multimodal protocols in the conservative management of AHD.", "provenance": [ { "field": "n", "quote": "included 266 patients with AHD" }, { "field": "population", "quote": "patients with acute hemorrhoidal disease (AHD)" }, { "field": "intervention", "quote": "group A (n=90) received a multimodal approach with phlebotonics, bromelain, and topical lidocaine" }, { "field": "comparator", "quote": "group B (n=83) received conventional conservative therapy" }, { "field": "primaryOutcome", "quote": "Primary outcomes were changes in the Hemorrhoidal Disease Symptom Score (HDSS) and the visual analog scale (VAS) for pain." }, { "field": "result", "quote": "the lidocaine-based multimodal regimen (group A) was associated with earlier and more pronounced reductions in pain, symptom burden, and impairment in health-related quality of life (SHS-HD), particularly within the first 14 days of treatment" }, { "field": "result", "quote": "Early resolution of bleeding and perianal oedema was also more frequent in the multimodal arms." }, { "field": "followUp", "quote": "particularly within the first 14 days of treatment" } ] }, { "id": "pmid:41620906", "pmid": "41620906", "doi": "10.36721/PJPS.2026.39.3.REG.15375.1", "nctId": null, "pmcid": null, "title": "Comparative efficacy of Ma Yinglong ointment and Gangtai suppository for hemorrhoids: A retrospective cohort study", "firstAuthor": "Gao", "multipleAuthors": true, "journal": "Pak J Pharm Sci", "year": 2026, "design": "retrospective", "n": 514, "nField": "reported", "population": "adults with hemorrhoids", "intervention": "Ma Yinglong hemorrhoid ointment (cream)", "comparator": "Gangtai suppository", "primaryOutcome": "symptom scores (pain, swelling, bleeding) and quality of life after treatment", "result": "Cream reduced pain and swelling more, but suppository controlled bleeding slightly better; overall response rates were similar", "resultDirection": "mixed", "quality": "low", "qualityWhy": "It's a retrospective study comparing two active creams/suppositories without a placebo or untreated group, so it can't show whether either treatment truly shrinks hemorrhoids or stops bleeding compared with no treatment.", "directness": "indirect", "limitations": "Retrospective design, no placebo or untreated comparison group, short 14-day follow-up, and no information on how patients were assigned to groups.", "followUp": "14 days", "plainFinding": "Cream eased pain more, not bleeding.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/41620906/", "sourceText": "BACKGROUND: Hemorrhoidal disease (HD) is a common anorectal condition that can have negative impacts on both physical and mental health as well as public health. OBJECTIVE: This retrospective analysis evaluated the use of Ma Yinglong hemorrhoid ointment versus Gangtai suppositories. METHODS: A retrospective comparative study of the efficacy and safety differences between Ma Yinglong hemorrhoid ointment and Gangtai Suppositories in the treatment of hemorrhoids. In this retrospective cohort, 514 hemorrhoid patients (2024) were equally divided into Ma Yinglong (n=257) and Gangtai suppository (n=257) groups. Symptom scores, quality of life and adverse reactions were compared between the two groups at days 7 and 14. RESULTS: Baseline characteristics were balanced between the two groups. After 14 days of treatment, the Ma Yinglong Hemorrhoid Ointment demonstrated significant advantages in pain relief Visual Simulation Score (VAS score: 1.2 vs 2.0) and swelling reduction, with markedly improved quality of life scores (88.7 vs 76.3). The Gangtai Suppository treatment group showed superior bleeding control (bleeding score: 0.6 vs 0.7). The overall response rates (92.61% vs 89.88%) and incidence of adverse reactions (5.06% vs 5.84%) were comparable between the two groups. CONCLUSION: The results of this study indicate that Ma Yinglong Hemorrhoid Ointment provides rapid relief for external hemorrhoid swelling and pain, while Gangtai Suppository are more suitable for controlling bleeding from internal hemorrhoids.", "provenance": [ { "field": "population", "quote": "514 hemorrhoid patients (2024) were equally divided into Ma Yinglong (n=257) and Gangtai suppository (n=257) groups" }, { "field": "intervention", "quote": "Ma Yinglong Hemorrhoid Ointment" }, { "field": "comparator", "quote": "Gangtai Suppository" }, { "field": "primaryOutcome", "quote": "Symptom scores, quality of life and adverse reactions were compared between the two groups at days 7 and 14" }, { "field": "result", "quote": "demonstrated significant advantages in pain relief Visual Simulation Score (VAS score: 1.2 vs 2.0) and swelling reduction, with markedly improved quality of life scores (88.7 vs 76.3)" }, { "field": "result", "quote": "The Gangtai Suppository treatment group showed superior bleeding control (bleeding score: 0.6 vs 0.7)" }, { "field": "n", "quote": "514 hemorrhoid patients (2024) were equally divided into Ma Yinglong (n=257) and Gangtai suppository (n=257) groups" }, { "field": "followUp", "quote": "After 14 days of treatment" } ] }, { "id": "pmid:41620904", "pmid": "41620904", "doi": "10.36721/PJPS.2026.39.3.REG.15306.1", "nctId": null, "pmcid": null, "title": "Comparison of Mayinglong musk hemorrhoids ointment and musk hemorrhoids suppository on postoperative pain and healing in mixed hemorrhoids after PPH or RPH", "firstAuthor": "Fan", "multipleAuthors": true, "journal": "Pak J Pharm Sci", "year": 2026, "design": "retrospective", "n": 131, "nField": "reported", "population": "patients with mixed hemorrhoids who had surgery (PPH or RPH)", "intervention": "Mayinglong Musk Hemorrhoids Ointment applied after surgery", "comparator": "Musk Hemorrhoids Suppository applied after surgery", "primaryOutcome": "pain scores and wound healing after hemorrhoid surgery", "result": "Suppository group had lower pain and wound scores, but ointment group had better anal function scores, less swelling, and faster wound healing time; no difference in overall healing success or complications", "resultDirection": "mixed", "quality": "low", "qualityWhy": "This was a retrospective study (not randomized) comparing two active treatments after surgery, not against no treatment, so it can't show whether either product shrinks hemorrhoids or stops bleeding on its own.", "directness": "indirect", "limitations": "Retrospective design, no placebo or untreated comparison group, conducted only in surgical patients", "followUp": "", "plainFinding": "Mixed results, no clear winner post-surgery", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/41620904/", "sourceText": "BACKGROUND: Mixed hemorrhoids are common colorectal diseases; Mayinglong Musk Ointment and Musk Suppositories are used. Their post-PPH/RPH efficacy is unclear. OBJECTIVE: Compare the efficacy of Mayinglong Musk Hemorrhoids Ointment and Suppository in mixed hemorrhoid patients undergoing PPH or RPH. METHODS: A retrospective study enrolled 139 mixed hemorrhoid patients who underwent PPH/RPH at the hospital from Jan to Dec 2024; after exclusions, 131 were analyzed. They were divided into Group A (64 cases, Mayinglong Musk Hemorrhoids Ointment) and Group B (67 cases, Musk Hemorrhoids Suppository). Main outcomes included VAS, wound healing time/effect; secondary outcomes covered anal function indexes (ADP, ARP, HZL, AMSP), WCS score, postoperative complications, anal edema/exudation score and wound granulation morphology score. RESULTS: Compared with Group A, Group B had lower VAS, WCS and wound granulation morphology scores (all P<0.05); Group A showed higher ADP, ARP, AMSP (all P<0.05), lower HZL and anal edema/exudation scores (all P<0.05) and superior wound healing time (P=0.047). No significant differences were found in wound healing effect or postoperative complication rate between the two groups (all P<0.05). CONCLUSION: Both Mayinglong Musk Hemorrhoids Ointment and Musk Hemorrhoids Suppository benefit postoperative recovery with distinct advantages and clinical medication should be tailored to patients' specific postoperative conditions.", "provenance": [ { "field": "n", "quote": "after exclusions, 131 were analyzed" }, { "field": "population", "quote": "139 mixed hemorrhoid patients who underwent PPH/RPH at the hospital from Jan to Dec 2024" }, { "field": "intervention", "quote": "Group A (64 cases, Mayinglong Musk Hemorrhoids Ointment)" }, { "field": "comparator", "quote": "Group B (67 cases, Musk Hemorrhoids Suppository)" }, { "field": "primaryOutcome", "quote": "Main outcomes included VAS, wound healing time/effect" }, { "field": "result", "quote": "Compared with Group A, Group B had lower VAS, WCS and wound granulation morphology scores (all P<0.05); Group A showed higher ADP, ARP, AMSP (all P<0.05), lower HZL and anal edema/exudation scores (all P<0.05) and superior wound healing time (P=0.047). No significant differences were found in wound healing effect or postoperative complication rate between the two groups" } ] }, { "id": "pmid:41357914", "pmid": "41357914", "doi": "10.5498/wjp.v15.i12.111180", "nctId": null, "pmcid": "PMC12679078", "title": "Effects of Tongyangxiao lotion bidet therapy combined with Ziyu ointment on postpartum hemorrhoidal pain, oedema, anxiety, and depression", "firstAuthor": "Wang", "multipleAuthors": true, "journal": "World J Psychiatry", "year": 2025, "design": "retrospective", "n": 268, "nField": "reported", "population": "women with hemorrhoids after childbirth", "intervention": "Tongyangxiao lotion sitz bath therapy combined with Ziyu ointment", "comparator": "wet compress with magnesium sulfate plus Ziyu ointment", "primaryOutcome": "hemorrhoid pain, edema, comfort, and psychological state", "result": "Hemorrhoid diameter and edema were smaller, comfort scores and treatment compliance were higher in the lotion+ointment group, with no difference in side effects", "resultDirection": "benefit", "quality": "low", "qualityWhy": "This was a retrospective, non-randomized study at a single hospital, so bias and confounding can't be ruled out.", "directness": "indirect", "limitations": "Retrospective design without randomization, single center, and the active treatment combined a sitz bath lotion with the ointment rather than testing the cream alone.", "followUp": "14 days", "plainFinding": "Less swelling and pain with combo treatment", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/41357914/", "sourceText": "BACKGROUND: Postpartum hemorrhoids are common complications in women after childbirth, with an incidence rate of 37.9%. Progesterone levels increase during pregnancy, which can lead to constipation. Abdominal pressure surges sharply during delivery, which can block the venous return of the rectum and result in hemorrhoids, pain, and edema. Tongyangxiao lotion and Ziyu ointment, traditional Chinese medicinal preparations, have the efficacy of subduing swelling, relieving itching, and promoting healing; however, their combined application in treating postpartum hemorrhoids is less studied. AIM: To investigate effects of Tongyangxiao lotion sitz bath therapy combined with Ziyu ointment on postpartum hemorrhoidal pain, edema, anxiety, and depression. METHODS: A retrospective analysis was conducted at Hebei Hospital of Traditional Chinese Medicine on 268 patients with hemorrhoids (September 2023 to February 2025). They were divided according to treatment method into control (wet compress with magnesium sulfate + Ziyu ointment) and observation (Tongyangxiao lotion sitz bath therapy + Ziyu ointment) groups (n = 134 in each group). Degree of pain, comfort level, compliance behavior with medical care, psychological state, therapeutic effect, hemorrhoid edema score, incidence of adverse reactions, and hemorrhoid diameter were compared. RESULTS: No statistically significant difference was observed in the diameter of the hemorrhoids or edema between the two groups before treatment. Hemorrhoid diameter and degree of edema were significantly smaller in the observation group than those in the control group 14 days post treatment. No statistically significant difference was observed in the scores of the General Comfort Questionnaire (GCQ) dimensions and participants' compliance before treatment. All GCQ dimension scores were significantly higher in the observation group than those in the control group 7 and 14 days post treatment. The compliance rate was significantly higher in the observation group than that of the control group. No statistically significant difference was observed in the incidence of adverse reactions between the two groups (P > 0.05). CONCLUSION: Tongyangxiao lotion combined with Ziyu ointment can improve patients' surface edema, postpartum hemorrhoid pain, treatment adherence, and comfort, reducing negative emotions. This is relatively safe and worthy of clinical promotion.", "provenance": [ { "field": "n", "quote": "n = 134 in each group" }, { "field": "population", "quote": "patients with hemorrhoids" }, { "field": "intervention", "quote": "Tongyangxiao lotion sitz bath therapy + Ziyu ointment" }, { "field": "comparator", "quote": "wet compress with magnesium sulfate + Ziyu ointment" }, { "field": "primaryOutcome", "quote": "Degree of pain, comfort level, compliance behavior with medical care, psychological state, therapeutic effect, hemorrhoid edema score, incidence of adverse reactions, and hemorrhoid diameter were compared." }, { "field": "result", "quote": "Hemorrhoid diameter and degree of edema were significantly smaller in the observation group than those in the control group 14 days post treatment." }, { "field": "result", "quote": "All GCQ dimension scores were significantly higher in the observation group than those in the control group 7 and 14 days post treatment." }, { "field": "followUp", "quote": "14 days post treatment" }, { "field": "design", "quote": "A retrospective analysis was conducted at Hebei Hospital of Traditional Chinese Medicine" } ] }, { "id": "pmid:41064523", "pmid": "41064523", "doi": "10.1159/000545793", "nctId": null, "pmcid": "PMC12503519", "title": "Incidence, Diagnosis, and Management of Proctological Conditions during Pregnancy", "firstAuthor": "Schmuck", "multipleAuthors": true, "journal": "Visc Med", "year": 2026, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "pregnant women with proctological conditions such as hemorrhoids, anal fissures, and perianal thrombosis", "intervention": "conservative treatments including stool softeners, local cooling measures, and topical ointments", "comparator": "surgical intervention reserved for refractory cases", "primaryOutcome": "", "result": "the abstract states conservative therapy is generally effective for symptom control but gives no specific data on cream shrinking hemorrhoids or stopping bleeding", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "This is a general narrative review of pregnancy-related proctological conditions, not a study testing hemorrhoid cream, so it provides no direct evidence on its effectiveness.", "directness": "indirect", "limitations": "No original data, no control group, no specific outcome measures for topical hemorrhoid treatments; it is a general overview of diagnosis and management during pregnancy.", "followUp": "", "plainFinding": "No direct evidence on cream.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/41064523/", "sourceText": "BACKGROUND: Proctological diseases are highly prevalent during pregnancy, with reported incidence rates ranging from 45% to 68%. The true prevalence is likely higher due to underreporting. These conditions frequently persist into the postpartum period, causing significant discomfort and emotional distress. Physiological changes in the maternal body - including hormonal, metabolic, immunological, and cardiovascular alterations - play a central role in the development of these disorders. The enlargement of the uterus, increased blood volume, and elevated pressure in the pelvic veins contribute to venous stasis in the hemorrhoidal plexus, thereby predisposing pregnant individuals to symptomatic hemorrhoids and perianal thromboses. SUMMARY: The most frequently reported symptoms are anal pain and constipation. Anal pain, which is often intense, is commonly associated with constipation and is due to the high density of sensory nerve endings in the anal canal. Constipation affects more than 60% of pregnant women, primarily as a result of hormonal changes, decreased physical activity, and iron supplementation. Straining during defecation further aggravates proctological conditions, facilitating the development of hemorrhoids, anal fissures, and perianal thrombosis. Diagnosis should include a thorough medical history, physical examination, and proctoscopy. In selected cases, additional imaging may be warranted. Conservative treatment is the mainstay of management, with a focus on symptom control and regulation of bowel habits. Hemorrhoidal disease is particularly common during pregnancy. Conservative treatment includes increased fluid intake, the use of stool softeners, and local cooling measures. Surgical interventions should be reserved for refractory cases and only considered when absolutely necessary. Anal fissures, the second most prevalent condition after hemorrhoids, are primarily caused by constipation. First-line treatment involves stool regulation, analgesic therapy, and the application of topical ointments. While chronic fissures may occasionally require surgical intervention, noninvasive approaches are strongly preferred to minimize risks. Perianal thrombosis, often misdiagnosed as thrombosed external hemorrhoids, typically occurs in the third trimester or shortly after delivery. Conservative therapy is generally effective, focusing on pain control. In selected cases, surgical excision of thrombosed nodules may be indicated. KEY MESSAGES: In summary, proctological conditions during pregnancy are common but usually manageable through accurate diagnosis, conservative treatment, and empathetic patient support. Prioritizing symptom relief and avoiding unnecessary surgical interventions are essential to achieving favorable outcomes.", "provenance": [ { "field": "population", "quote": "Proctological diseases are highly prevalent during pregnancy, with reported incidence rates ranging from 45% to 68%." }, { "field": "intervention", "quote": "Conservative treatment includes increased fluid intake, the use of stool softeners, and local cooling measures." }, { "field": "intervention", "quote": "First-line treatment involves stool regulation, analgesic therapy, and the application of topical ointments." }, { "field": "comparator", "quote": "Surgical interventions should be reserved for refractory cases and only considered when absolutely necessary." }, { "field": "result", "quote": "Conservative treatment is the mainstay of management, with a focus on symptom control and regulation of bowel habits." }, { "field": "result", "quote": "Conservative therapy is generally effective, focusing on pain control." } ] }, { "id": "pmid:41004811", "pmid": "41004811", "doi": "10.15403/jgld-6306", "nctId": null, "pmcid": null, "title": "The Combination of Fluocinolone Acetonide and Ketocaine Hydrochloride in the Conservative Management of Symptomatic Hemorrhoidal Disease: An Overview of Preclinical and Clinical Data", "firstAuthor": "Chiarioni", "multipleAuthors": true, "journal": "J Gastrointestin Liver Dis", "year": 2025, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with symptomatic hemorrhoidal disease", "intervention": "topical cream combining fluocinolone acetonide and ketocaine hydrochloride", "comparator": "", "primaryOutcome": "relief from pain, itching, and inflammation of hemorrhoids", "result": "the combination cream is described as effective and well tolerated for acute hemorrhoid symptoms, but no specific data on shrinking hemorrhoids or stopping bleeding are given", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "this is a narrative overview of previous preclinical and clinical data without specific numbers, so it cannot be weighed like an original trial.", "directness": "indirect", "limitations": "abstract gives no study design details, sample sizes, or statistical results; claims are general summaries, not direct evidence of shrinking hemorrhoids or stopping bleeding.", "followUp": "", "plainFinding": "Eases pain and itching, not bleeding.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/41004811/", "sourceText": "Hemorrhoidal disease (HD) is a prevalent anorectal disorder that affects up to 36% of the general population. It is characterized by symptomatic enlargement and displacement of anal cushions, frequently associated with pain, bleeding, and reduced quality of life. The pathophysiology of HD includes vascular congestion, venous stasis, and vascular dilatation, promoted by increased nitric oxide activity. Inflammatory responses are considered crucial in HD, with NF-κB playing a major role. Treatment strategies for HD vary from conservative approaches to office-based and surgical interventions. Conservative therapies, such as topical agents and flavonoid-based systemic treatments, serve as the mainstay of low-grade HD management, while invasive procedures are reserved for refractory cases. Topical formulations containing fluocinolone acetonide (FLA) and ketocaine hydrochloride (KH) combine anti-inflammatory and anesthetic effects, providing rapid and sustained relief from pain, itching, and inflammation. FLA exerts potent anti-inflammatory effects by inhibiting NF-κB and induces vasoconstrictive activity by reducing nitric oxide levels, while KH provides localized analgesia by blocking sodium channels. Collectively, these agents mitigate vascular congestion, inflammation, and HD symptoms. Clinical evidence supports the efficacy of this combination in alleviating acute symptoms, reducing recurrence, and improving patient outcomes. The FLA/KH formulation provides targeted local action with minimal systemic absorption and predominantly mild and transient adverse events. Treatment with FLA/KH is an effective and well-tolerated option for managing acute HD. Furthermore, its combination with flavonoid-based supplements, which improve venous tone and reduce capillary permeability, may aid in preventing recurrence. This combined approach leverages the rapid symptom relief provided by topical agents and the long-term benefits of systemic therapies, promoting comprehensive HD management and reducing the risk of recurrence.", "provenance": [ { "field": "intervention", "quote": "Topical formulations containing fluocinolone acetonide (FLA) and ketocaine hydrochloride (KH) combine anti-inflammatory and anesthetic effects, providing rapid and sustained relief from pain, itching, and inflammation." }, { "field": "primaryOutcome", "quote": "providing rapid and sustained relief from pain, itching, and inflammation" }, { "field": "result", "quote": "Treatment with FLA/KH is an effective and well-tolerated option for managing acute HD." }, { "field": "population", "quote": "Hemorrhoidal disease (HD) is a prevalent anorectal disorder that affects up to 36% of the general population." } ] }, { "id": "pmid:40824576", "pmid": "40824576", "doi": "10.1001/jama.2025.13083", "nctId": null, "pmcid": null, "title": "Hemorrhoidal Disease: A Review", "firstAuthor": "Ashburn", "multipleAuthors": false, "journal": "JAMA", "year": 2025, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "adults with hemorrhoidal disease (bleeding, pain, prolapse)", "intervention": "phlebotonics and topical/medical treatments such as 5% lidocaine cream for hemorrhoid symptoms", "comparator": "other hemorrhoid treatments (dietary fiber, office-based procedures, surgery) and treatment cessation", "primaryOutcome": "relief of bleeding, pain, and swelling from hemorrhoids", "result": "Phlebotonics reduced bleeding, rectal pain, and swelling, but most patients' symptoms came back within months; topical lidocaine was described only as a pain treatment for thrombosed external hemorrhoids presenting late, not as a treatment to shrink hemorrhoids or stop bleeding.", "resultDirection": "mixed", "quality": "low", "qualityWhy": "This is a narrative review summarizing many studies and treatments without reporting its own trial data, sample sizes, or controlled comparisons, so it can't reliably show whether cream itself works.", "directness": "indirect", "limitations": "The abstract is a general review of hemorrhoidal disease management, not a study testing a topical cream specifically for shrinking hemorrhoids or stopping bleeding; it gives percentages from unnamed prior studies without details on design or quality.", "followUp": "3 to 6 months", "plainFinding": "No direct evidence cream stops bleeding.", "retracted": false, "expressionOfConcern": false, "hasErratum": true, "url": "https://pubmed.ncbi.nlm.nih.gov/40824576/", "sourceText": "IMPORTANCE: Hemorrhoidal disease, pathology of the tissue lining of the anal canal, affects approximately 10 million individuals in the US. Hemorrhoidal disease may impair quality of life due to bleeding, pain, anal irritation, and tissue prolapse. OBSERVATIONS: Hemorrhoids are classified as internal, external, or mixed (concurrent internal and external hemorrhoidal disease). Internal hemorrhoids originate above the dentate line, the boundary between the upper and lower anal canal, and may cause rectal bleeding, discomfort, and tissue prolapse from the anal canal. Internal hemorrhoid prolapse is classified as grade I (into anal canal), grade II (beyond the anus with spontaneous reduction), grade III (requiring manual reduction), and grade IV (irreducible). External hemorrhoids, arising below the dentate line, cause rectal pain when engorged or thrombosed. Initial treatment of all hemorrhoidal disease involves increasing intake of dietary fiber and water and avoiding straining during defecation. Phlebotonics (eg, flavonoids [thought to improve venous tone]) reduce bleeding, rectal pain, and swelling, although symptom recurrence reaches 80% within 3 to 6 months after treatment cessation. If dietary modification and phlebotonics are ineffective, grade I to grade III internal hemorrhoidal disease can be treated with office-based interventions. Rubber band ligation-placing a band around the base of hemorrhoid tissue during anoscopy to restrict blood flow-resolves symptoms in 89% of patients, but repeated banding is needed in up to 20%. Sclerotherapy, which induces fibrosis with a sclerosant injection, is efficacious in the short term (weeks to months) among 70% to 85% of patients, but long-term remission occurs in only one-third of patients. Infrared coagulation uses heat to coagulate hemorrhoidal tissue, yielding 70% to 80% success in reducing bleeding and prolapse. Excisional hemorrhoidectomy, for disease unresponsive to office-based therapy or for mixed hemorrhoidal disease, achieves low recurrence (2%-10%), although with longer recovery (9-14 days). External hemorrhoidal disease rarely requires surgery unless acutely thrombosed. Outpatient clot evacuation within 72 hours of onset of a thrombosed external hemorrhoid is associated with decreased pain and reduced risk of repeat thrombosis. Patients presenting more than 72 hours after external hemorrhoid acute thrombosis should receive medical treatment (eg, stool softeners, oral and topical analgesics such as 5% lidocaine). CONCLUSIONS AND RELEVANCE: Hemorrhoidal disease affects 10 million people in the US. First-line treatment is increased fiber intake, avoidance of straining during defecation, and phlebotonics. In-office rubber band ligation for grade I to III internal hemorrhoid disease is first-line procedural treatment for persistent symptoms despite conservative therapies. Excisional hemorrhoidectomy is recommended for grade III to IV prolapse, thrombosis, or mixed hemorrhoidal disease that does not improve with less invasive approaches.", "provenance": [ { "field": "population", "quote": "Hemorrhoidal disease, pathology of the tissue lining of the anal canal, affects approximately 10 million individuals in the US." }, { "field": "intervention", "quote": "Phlebotonics (eg, flavonoids [thought to improve venous tone]) reduce bleeding, rectal pain, and swelling, although symptom recurrence reaches 80% within 3 to 6 months after treatment cessation." }, { "field": "intervention", "quote": "5% lidocaine" }, { "field": "comparator", "quote": "If dietary modification and phlebotonics are ineffective, grade I to grade III internal hemorrhoidal disease can be treated with office-based interventions." }, { "field": "primaryOutcome", "quote": "Hemorrhoidal disease may impair quality of life due to bleeding, pain, anal irritation, and tissue prolapse." }, { "field": "result", "quote": "Phlebotonics (eg, flavonoids [thought to improve venous tone]) reduce bleeding, rectal pain, and swelling, although symptom recurrence reaches 80% within 3 to 6 months after treatment cessation." }, { "field": "result", "quote": "Patients presenting more than 72 hours after external hemorrhoid acute thrombosis should receive medical treatment (eg, stool softeners, oral and topical analgesics such as 5% lidocaine)." } ] }, { "id": "pmid:40755112", "pmid": "40755112", "doi": "10.2174/0109298673378981250710055128", "nctId": null, "pmcid": null, "title": "Targeted Anti-Inflammatory Effects of Chloramphenicol via TLR4 Inhibition in Postoperative Hemorrhoid Treatment: A Clinico- Computational Cohort Study", "firstAuthor": "Shityakov", "multipleAuthors": true, "journal": "Curr Med Chem", "year": 2026, "design": "prospective-cohort", "n": 155, "nField": "reported", "population": "patients who had surgery to remove hemorrhoids (postoperative hemorrhoidectomy wounds)", "intervention": "chloramphenicol antibiotic ointment applied to the surgical wound", "comparator": "a reference treatment ointment and a no-treatment control group", "primaryOutcome": "wound healing measured by swelling resolution, new tissue growth, and pain scores", "result": "chloramphenicol sped up wound healing and granulation tissue formation and reduced pain scores compared to control", "resultDirection": "benefit", "quality": "low", "qualityWhy": "it is a non-randomized cohort study of surgical wound healing, not a trial of cream for untreated hemorrhoids, and much of the paper is lab-based molecular modeling rather than patient outcomes.", "directness": "indirect", "limitations": "study is about healing of surgical wounds after hemorrhoid removal, not about shrinking existing hemorrhoids or stopping bleeding without surgery; not described as randomized; authors call for further long-term studies", "followUp": "", "plainFinding": "Faster healing after hemorrhoid surgery", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/40755112/", "sourceText": "INTRODUCTION: Postoperative hemorrhoidectomy wounds are prone to inflammation and microbial infection due to their anatomical location, necessitating effective therapeutic strategies. Chloramphenicol (CHL) is a broad-spectrum antibiotic with potential anti-inflammatory properties via Toll-like receptor 4 (TLR4) inhibition. This clinico- computational cohort study investigates CHL's dual therapeutic mechanism in postoperative hemorrhoid management, combining clinical outcomes with molecular modeling to elucidate its anti-inflammatory and antimicrobial effects. METHODS: A prospective, controlled cohort study was conducted with 155 patients (55 CHL, 39 reference treatment [PR], 61 control) undergoing hemorrhoidectomy. CHL ointment (≤120 mg/day) was applied topically until granulation tissue appeared. Clinical outcomes, including edema resolution, granulation tissue formation, and pain scores, were assessed using ImageJ for wound area analysis and the visual analog scale (VAS) for pain. Molecular docking and dynamics simulations were performed using AutoDock and AMBER 22 to evaluate CHL's binding affinity to TLR4 compared to the reference inhibitor TAK-242. Statistical analyses included ANOVA, Mann-Whitney U tests, and post hoc power calculations. RESULTS: CHL significantly accelerated wound healing, with 53.2% of patients achieving complete edema resolution by day 3 (vs. 43.6% by day 4) and faster granulation tissue formation (3.58 ± 0.60 days vs. 7.08 ± 1.20 days in control, p<0.0001). Pain scores were significantly reduced in the CHL group. Molecularly, CHL exhibited superior TLR4 binding (ΔGtot = -25.97 kcal/mol vs. -20.69 kcal/mol for TAK-242), with stable complex formation and persistent interactions at Ile-135 (buried surface area: 350 Å2). Healing times were 13.5-19.8 days faster in the CHL group (mean 41 days vs. 54.5-60.8 days in control). CONCLUSION: CHL demonstrates dual therapeutic potential in postoperative hemorrhoid management by inhibiting TLR4-mediated inflammation and microbial infection. Its superior binding affinity and clinical efficacy suggest it as a promising multifunctional agent. Further in vitro and long-term studies are needed to validate these findings and explore broader applications in surgical wound care.", "provenance": [ { "field": "n", "quote": "155 patients (55 CHL, 39 reference treatment [PR], 61 control)" }, { "field": "population", "quote": "Postoperative hemorrhoidectomy wounds are prone to inflammation and microbial infection" }, { "field": "intervention", "quote": "CHL ointment (≤120 mg/day) was applied topically until granulation tissue appeared" }, { "field": "comparator", "quote": "55 CHL, 39 reference treatment [PR], 61 control" }, { "field": "primaryOutcome", "quote": "Clinical outcomes, including edema resolution, granulation tissue formation, and pain scores, were assessed" }, { "field": "result", "quote": "CHL significantly accelerated wound healing, with 53.2% of patients achieving complete edema resolution by day 3 (vs. 43.6% by day 4) and faster granulation tissue formation (3.58 ± 0.60 days vs. 7.08 ± 1.20 days in control, p<0.0001). Pain scores were significantly reduced in the CHL group." } ] }, { "id": "pmid:40586790", "pmid": "40586790", "doi": "10.1007/s00104-025-02335-7", "nctId": null, "pmcid": null, "title": "[Hemorrhoidal disease and stage-dependent treatment (including anal prolapse)]", "firstAuthor": "Schwandner", "multipleAuthors": false, "journal": "Chirurgie (Heidelb)", "year": 2025, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "People with hemorrhoidal disease at different stages", "intervention": "Stage-based treatments for hemorrhoids (conservative, topical, sclerotherapy, rubber band ligation, surgery)", "comparator": "Comparison between conservative/topical treatments, minimally invasive procedures, and surgical procedures", "primaryOutcome": "Symptom control and long-term absence of recurrence", "result": "Early-stage disease treated with conservative/interventional options; advanced disease treated with surgery; acute prolapse treated conservatively/topically", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "This is a general narrative review describing treatment approaches by stage, without data, outcomes, or comparisons from a specific study on creams.", "directness": "indirect", "limitations": "No specific data, patient numbers, or outcome measures are given for any treatment including topical creams; it is a general overview rather than a study of effectiveness.", "followUp": "", "plainFinding": "Review doesn't test if creams work.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/40586790/", "sourceText": "The treatment of hemorrhoidal disease is carried out depending on the symptoms and stage of the disease. Although conservative and interventional treatment options (including sclerotherapy, rubber band ligation) are indicated in early stages (stages I and II), surgical procedures are effective treatment options for advanced hemorrhoidal disease (stages III and IV). In this context, \"conventional\" hemorrhoidectomy procedures are increasingly in competition with minimally invasive techniques (e.g. hemorrhoidal artery ligation, laser hemorrhoidoplasty, radiofrequency ablation). In cases of acute anal prolapse, a conservative and topical approach is indicated. The ultimate goal of all treatment strategies for hemorrhoidal disease is symptom control and long-term absence of recurrence.", "provenance": [ { "field": "population", "quote": "The treatment of hemorrhoidal disease is carried out depending on the symptoms and stage of the disease." }, { "field": "intervention", "quote": "Although conservative and interventional treatment options (including sclerotherapy, rubber band ligation) are indicated in early stages (stages I and II), surgical procedures are effective treatment options for advanced hemorrhoidal disease (stages III and IV)." }, { "field": "comparator", "quote": "In this context, \"conventional\" hemorrhoidectomy procedures are increasingly in competition with minimally invasive techniques (e.g. hemorrhoidal artery ligation, laser hemorrhoidoplasty, radiofrequency ablation)." }, { "field": "primaryOutcome", "quote": "The ultimate goal of all treatment strategies for hemorrhoidal disease is symptom control and long-term absence of recurrence." }, { "field": "result", "quote": "In cases of acute anal prolapse, a conservative and topical approach is indicated." } ] }, { "id": "pmid:40581544", "pmid": "40581544", "doi": "10.1016/j.surge.2025.06.002", "nctId": null, "pmcid": null, "title": "Comparative efficacy of lidocaine- and nifedipine-based conservative therapies in acute hemorrhoidal disease: A retrospective cohort study", "firstAuthor": "Schiano di Visconte", "multipleAuthors": false, "journal": "Surgeon", "year": 2025, "design": "retrospective", "n": 123, "nField": "reported", "population": "adults with acute hemorrhoid flare-ups", "intervention": "oral diosmin/hesperidin plus bromelain plus topical lidocaine cream", "comparator": "oral diosmin/hesperidin plus bromelain plus topical nifedipine cream", "primaryOutcome": "pain and symptom scores over 21 days", "result": "lidocaine group had faster pain relief and better symptom scores at day 7 than nifedipine group", "resultDirection": "benefit", "quality": "low", "qualityWhy": "this was a retrospective, non-randomized comparison of two active creams, not a placebo-controlled trial, so it cannot show whether either cream shrinks hemorrhoids or stops bleeding beyond no treatment.", "directness": "indirect", "limitations": "retrospective design, no placebo or untreated comparison group, both groups also received oral medications so the cream's individual effect is unclear", "followUp": "21 days", "plainFinding": "Faster pain relief with lidocaine cream.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/40581544/", "sourceText": "BACKGROUND: Acute hemorrhoidal disease (AHD) is a prevalent anorectal condition that significantly impacts patients' quality of life and healthcare systems. Despite the availability of various conservative treatments, comparative efficacy data remains limited. This retrospective study evaluates two treatment regimens for AHD, focusing on symptom relief, patient-reported outcomes, and treatment tolerability. METHODS: Medical records of 123 patients with AHD treated at a tertiary care center between October 2022 and October 2024 were reviewed. Patients were divided into two groups: Group A treated with oral diosmin/hesperidin, bromelain, and topical lidocaine, and Group B treated with oral diosmin/hesperidin, bromelain, and topical nifedipine. Symptoms were evaluated using the Hemorrhoidal Disease Symptom Score (HDSS), Visual Analog Scale (VAS) for pain, and Short Health Scale for Hemorrhoidal Disease (SHS-HD) at baseline and on days 7, 14, and 21. RESULTS: Both groups showed significant improvements in symptoms during the study period. Group A demonstrated faster pain reduction (VAS day 7:0.17 ± 0.52 vs. 2.20 ± 1.11, p < 0.001) and greater improvement in HDSS score (day 7: 0.02 ± 0.87 vs. 10.16 ± 3.38, p < 0.001). Improvements in SHS-HD scores were more rapid for Group A, with scores on day 7 showing a significant difference (Group A: 7.58 ± 2.58 vs. Group B: 12.27 ± 4.21, p < 0.001). Both regimens were well tolerated, with no significant adverse events. CONCLUSIONS: The combination of oral diosmin/hesperidin, bromelain, and lidocaine provides superior initial symptom relief compared with nifedipine-based regimens. Lidocaine is the preferred topical agent for rapid pain management in AHD patients. Further studies are required to confirm these results.", "provenance": [ { "field": "n", "quote": "Medical records of 123 patients with AHD treated at a tertiary care center between October 2022 and October 2024 were reviewed." }, { "field": "population", "quote": "Acute hemorrhoidal disease (AHD) is a prevalent anorectal condition" }, { "field": "intervention", "quote": "Group A treated with oral diosmin/hesperidin, bromelain, and topical lidocaine" }, { "field": "comparator", "quote": "Group B treated with oral diosmin/hesperidin, bromelain, and topical nifedipine" }, { "field": "primaryOutcome", "quote": "Symptoms were evaluated using the Hemorrhoidal Disease Symptom Score (HDSS), Visual Analog Scale (VAS) for pain, and Short Health Scale for Hemorrhoidal Disease (SHS-HD) at baseline and on days 7, 14, and 21." }, { "field": "result", "quote": "Group A demonstrated faster pain reduction (VAS day 7:0.17 ± 0.52 vs. 2.20 ± 1.11, p < 0.001) and greater improvement in HDSS score (day 7: 0.02 ± 0.87 vs. 10.16 ± 3.38, p < 0.001)." } ] }, { "id": "pmid:40176588", "pmid": "40176588", "doi": "10.7417/CT.2025.5204", "nctId": null, "pmcid": null, "title": "Tips and tricks of anorectal care with topical lidocaine (octose-dan) administration: retrospective, anecdotical, spontaneous, and observational study", "firstAuthor": "Palmieri", "multipleAuthors": true, "journal": "Clin Ter", "year": 2025, "design": "case-series", "n": 30, "nField": "reported", "population": "adults with grade 1, 2 or 3 hemorrhoids, anal fissures, or anal fistulas", "intervention": "5% lidocaine ointment (Octosedan) applied around the anus before and after bowel movements for two months", "comparator": "no control or comparison group - all patients received the same treatment", "primaryOutcome": "tolerability and relief of pain, itching, soiling and discomfort around bowel movements", "result": "28 of 30 patients had significant improvement in symptoms after treatment", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This was a small, uncontrolled, self-described 'anecdotical' observational study with no comparison group or randomization, so it cannot show whether the cream itself caused the improvement.", "directness": "indirect", "limitations": "No control group, no randomization, mixed population of hemorrhoids plus fissures and fistulas, authors call it anecdotical and spontaneous, and the outcome measured was symptom relief rather than hemorrhoid shrinkage or bleeding stopping specifically.", "followUp": "two months", "plainFinding": "Less pain and itching reported", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/40176588/", "sourceText": "BACKGROUND: The local symptomatic treatment of anorectal diseases encloses a wide variety of creams, ointments, suppositories, irrigation fluids etc, based essentially on anaesthetics, antioedema, phlebotomids, keratolytic and coating agents, anti-inflammatories, steroids, aiming at achieving fast improvement and at least partial pain remission especially soon after stool. Unfortunately, the method of blending different chemicals pooled in a single formulation often prevents the full curative effect of each active principle: in fact, the stechiometric balance of these melting pots does not achieve the full dose-effect of each one; furtherly the patients would be warned to use only effective evidence-based products, preventing the risk of skin and mucosa sen-sitization in the long run when different chemical or herbal compounds are together administered. On the basis of the literature review, we focused our study on a single drug-medication whose properties go beyond the classic anaesthetic claim: lidocaine 5%. MATERIALS AND METHODS: In our anecdotical, spontaneous, and observational study, 30 patients both sexes (15 males and 15 females), recruited from the Second Opinion Medical Consulting Network for a spontaneous anecdotical post marketing evaluation of grade 1,2,3 haemorrhoids (n=23), anal fistulas (n=2) and fissures (n=5) treatment with a 5% lidocaine ointment (Octosedan Laboratori Baldacci S.p.A., Italy) for two months; the primary endpoints of the investigation were tolerability and effectiveness to relieve pain, itching, soiling and discomfort at rest or during and after stool emission. The most commonly reported symptom was bleeding, present in 20 patients with prevalence in women. In 13 patients (43,33%) the \"wet anus\" with or without soiling was present, while 12 patients (40%) complained of intermittent itching. In 7 patients (23,33%) hemorrhoidal thrombosis with prevalent (6/ 7) heavy pain, was recorded. RESULTS: 28/30 treated patients had significantly symptom impro-vement (p<0.0001), 10 (33,33%) patients were addressed to surgical therapy for persistence of symptoms, (7 at the end of the therapeutic cycle 3, spontaneously asking to anticipate surgery before the end of the trial) 4 clinical cases fairly improved but accepted a further surgical revaluation three months later. Of the 19 patients previously treated with flavonoids or heparinoid therapy with unsatisfactory results, 9 (30%) participants found benefit from the new treatment. Of the 5 patients whose anal fissures healed primarily, only 1 patient developed a recurrent fissure within 6 months. Octosedan administration relieved the pain after 5 days with a tolerable life quality and promoted fissures healing in one month. No adverse effects of the treatment were recorded. CONCLUSIONS: The local symptomatic treatment of haemorrhoids grade one, two, three and of the fissures, and the fistulas with the plain formula: lidocaine 5%; excipient: cetilic acid macrogol, water;( gently administered into and around the anal verge 3-5 minutes before voiding the bowel and reapplied soon after having cleaned and rinsed the anus&perineal area with neutral liquid soap for two months of treatment,) showed highly significant effect (p<0.0001) and highlights the quality of monotherapy on multiple steps of anorectal care.", "provenance": [ { "field": "n", "quote": "30 patients both sexes (15 males and 15 females)" }, { "field": "population", "quote": "evaluation of grade 1,2,3 haemorrhoids (n=23), anal fistulas (n=2) and fissures (n=5) treatment" }, { "field": "intervention", "quote": "treatment with a 5% lidocaine ointment (Octosedan Laboratori Baldacci S.p.A., Italy) for two months" }, { "field": "comparator", "quote": "30 patients both sexes (15 males and 15 females), recruited from the Second Opinion Medical Consulting Network for a spontaneous anecdotical post marketing evaluation" }, { "field": "primaryOutcome", "quote": "the primary endpoints of the investigation were tolerability and effectiveness to relieve pain, itching, soiling and discomfort at rest or during and after stool emission" }, { "field": "result", "quote": "28/30 treated patients had significantly symptom impro-vement (p<0.0001)" } ] }, { "id": "pmid:39771477", "pmid": "39771477", "doi": "10.3390/pharmaceutics16121498", "nctId": null, "pmcid": "PMC11676831", "title": "Arginine Hydrochloride Reduce Rectal Mucosal Irritation of Sodium Aescinate: Molecular Docking, Physical Properties, Anti-Hemorrhoidal Activity, Safety and Topical Gel Formulations Investigation", "firstAuthor": "Hu", "multipleAuthors": true, "journal": "Pharmaceutics", "year": 2024, "design": "animal", "n": null, "nField": "not-reported", "population": "rabbits used to test a hemorrhoid gel formulation (not human patients)", "intervention": "a new hemorrhoid gel combining sodium aescinate with arginine hydrochloride (F5-SA gel)", "comparator": "sodium aescinate gel without arginine hydrochloride (different mixing ratios)", "primaryOutcome": "reduction of rectal irritation, anti-inflammatory effect, and anti-hemorrhoidal activity", "result": "the combined gel reduced rectal irritation, increased anti-inflammatory effect, and healed anal ulcers in the animal tests, with no major safety problems found", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "this was an animal and lab formulation study, not a trial in human hemorrhoid patients, so it cannot show whether the cream works in people", "directness": "indirect", "limitations": "study used rabbits and lab/physical testing rather than human patients, and does not report a sample size for the animal experiments", "followUp": "", "plainFinding": "Promising hemorrhoid gel in animal testing.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/39771477/", "sourceText": "Background/Objectives: Sodium aescinate (SA) is commonly used topically due to its anti-inflammatory, anti-edematous, and anti-swelling properties. However, the clinical application of SA is limited by strong irritation, and cannot be used on the damaged skin and mucous membrane. This study aimed to investigate whether arginine hydrochloride (Arg·HCl) could reduce the rectal mucosal irritation of SA through the formation of a gel. Methods: Molecular docking was first used to explore potential interactions between SA and Arg·HCl. Gels for rectal administration were then formulated by combining SA with various ratios of Arg·HCl (from 1:0 to 1:10). In vitro tests, including pH, centrifuge stability, viscosity, and spreadability analysis, were conducted. The optimal gel formulation was determined based on rectal mucosal irritation tests and anti-inflammatory experiments. Additionally, the anti-hemorrhoidal characteristics and safety of the optimal gel in terms of acute toxicity and dermal sensitivity were evaluated. Results: The optimal SA to Arg·HCl ratio of 1:6 (F5-SA gel) was identified, significantly reducing rectal mucosal irritation while enhancing anti-inflammatory activity. The F5-SA gel demonstrated high efficacy against hemorrhoids, notably promoting anal ulcer healing. When administered rectally to rabbits at a dose of 132 mg·kg-1·d-1 (198 times the recommended therapeutic dose), no other obvious side effects were observed except a significant reduction in food intake on the day of administration. In addition, the gel did not induce dermal sensitivity. Conclusions: The F5-SA gel is a promising formulation that can reduce irritation and toxic side effects, and enhance the therapeutic effect to some extent, ultimately achieving a safer and more effective rectal delivery system for SA.", "provenance": [ { "field": "intervention", "quote": "The F5-SA gel demonstrated high efficacy against hemorrhoids, notably promoting anal ulcer healing." }, { "field": "comparator", "quote": "Gels for rectal administration were then formulated by combining SA with various ratios of Arg·HCl (from 1:0 to 1:10)." }, { "field": "population", "quote": "When administered rectally to rabbits at a dose of 132 mg·kg-1·d-1" }, { "field": "primaryOutcome", "quote": "The optimal gel formulation was determined based on rectal mucosal irritation tests and anti-inflammatory experiments." }, { "field": "result", "quote": "significantly reducing rectal mucosal irritation while enhancing anti-inflammatory activity" }, { "field": "result", "quote": "no other obvious side effects were observed except a significant reduction in food intake on the day of administration" } ] }, { "id": "pmid:39287845", "pmid": "39287845", "doi": "10.1007/s10151-024-02998-0", "nctId": null, "pmcid": "PMC11408642", "title": "Effectiveness of preoperative micronized purified flavonoid fraction treatment and sucralfate-based rectal ointment on hemorrhoidal disease: A case-matched analysis", "firstAuthor": "Gallo", "multipleAuthors": true, "journal": "Tech Coloproctol", "year": 2024, "design": "case-control", "n": 56, "nField": "reported", "population": "adults with hemorrhoid disease needing treatment", "intervention": "combined oral flavonoid medication plus a sucralfate-based hemorrhoid rectal ointment, alongside usual care", "comparator": "usual conservative care alone", "primaryOutcome": "change in hemorrhoid symptom severity score and need for further procedures", "result": "the treated group had a large drop in symptom score while the control group showed almost no change, and fewer needed invasive treatment", "resultDirection": "benefit", "quality": "low", "qualityWhy": "it was a small, non-randomized study with matched groups rather than random assignment, so differences could be due to other factors.", "directness": "indirect", "limitations": "not randomized, relatively small number of patients, short follow-up, and the treatment combined an oral medication with the ointment rather than testing the cream alone.", "followUp": "60 days", "plainFinding": "Less hemorrhoid symptoms with combo treatment.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/39287845/", "sourceText": "BACKGROUND: Hemorrhoidal disease (HD) significantly impacts patients' quality of life. This study aimed to evaluate the effectiveness of preoperative treatment with the micronized purified flavonoid fraction (MPFF) and a sucralfate-based rectal ointment in managing HD symptoms and reducing interventions. METHODS: A prospective quasi-experimental study including consecutive cases and controls matched on the basis of sex was performed in a tertiary referral center. Cases received systemic and local therapy for HD, consisting of a rectal ointment containing 3% sucralfate and herbal extracts plus MPFF, in addition to conservative therapy, while controls received conservative therapy alone. The hemorrhoidal disease symptom score (HDSS), the Short Health Scale for HD (SHS-HD) score, and the Vaizey Incontinence Score were used to evaluate symptoms severity and their impact on quality of life and continence. Intervention requirements were assessed at baseline (T0) and after 60 days of treatment (T1). RESULTS: Between January and December 2023, a total of 98 patients were assessed for eligibility. After exclusions, 56 patients were enrolled, with 28 in each group. Significant improvements were observed in HD symptom scores from T0 to T1: the intervention group showed a mean change in HDSS of -9 [95% confidence interval (CI) -10 to -8], and the control group showed no significant change (mean change of 0; 95% CI -1.5 to 0). At T1, a higher proportion of patients in the intervention group underwent less invasive interventions compared with controls (18% versus 11%). Age, treatment group, and baseline symptom severity significantly predicted post-treatment symptom scores. CONCLUSIONS: In our study the preoperative treatment with MPFF and a sucralfate-based rectal ointment demonstrated clinical benefits in managing HD symptoms and reducing interventions. Further prospective trials are warranted to confirm and explore additional therapeutic strategies.", "provenance": [ { "field": "population", "quote": "Hemorrhoidal disease (HD) significantly impacts patients' quality of life." }, { "field": "intervention", "quote": "Cases received systemic and local therapy for HD, consisting of a rectal ointment containing 3% sucralfate and herbal extracts plus MPFF, in addition to conservative therapy" }, { "field": "comparator", "quote": "while controls received conservative therapy alone" }, { "field": "primaryOutcome", "quote": "The hemorrhoidal disease symptom score (HDSS), the Short Health Scale for HD (SHS-HD) score, and the Vaizey Incontinence Score were used to evaluate symptoms severity and their impact on quality of life and continence." }, { "field": "result", "quote": "the intervention group showed a mean change in HDSS of -9 [95% confidence interval (CI) -10 to -8], and the control group showed no significant change (mean change of 0; 95% CI -1.5 to 0)" }, { "field": "n", "quote": "56 patients were enrolled, with 28 in each group" }, { "field": "followUp", "quote": "after 60 days of treatment (T1)" } ] }, { "id": "pmid:38750150", "pmid": "38750150", "doi": "10.1007/s00384-024-04642-7", "nctId": null, "pmcid": "PMC11096207", "title": "Effectiveness and tolerability of rectal ointment and suppositories containing sucralfate for hemorrhoidal symptoms: a prospective, observational study", "firstAuthor": "Marik", "multipleAuthors": true, "journal": "Int J Colorectal Dis", "year": 2024, "design": "case-series", "n": 60, "nField": "reported", "population": "adults with mild-to-moderate, symptomatic non-bleeding hemorrhoids", "intervention": "rectal ointment or suppositories containing sucralfate", "comparator": "ointment versus suppository forms of the same sucralfate treatment, no placebo or control group", "primaryOutcome": "patient-reported hemorrhoid symptom severity score (mSSS)", "result": "symptom scores improved significantly after treatment in both ointment and suppository groups", "resultDirection": "benefit", "quality": "low", "qualityWhy": "This was a small, uncontrolled, observational study without a placebo group, so improvement could be due to natural healing rather than the cream itself.", "directness": "direct", "limitations": "Open-label, no control or placebo group, small sample size, and authors state larger controlled trials are needed to confirm results.", "followUp": "4 weeks", "plainFinding": "Symptoms improved, but no control group.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/38750150/", "sourceText": "BACKGROUND AND AIMS: A high number of topical products are available for the treatment of hemorrhoidal symptoms. Sucralfate-based topical products constitute a new treatment alternative that act as a mechanical barrier to facilitate healing. The aim of this prospective, observational study was to determine patient- and physician-assessed effectiveness and tolerability of rectal ointment and suppositories containing sucralfate for the treatment of hemorrhoidal symptoms in routine clinical practice. METHODS: Adult patients with diagnosed, mild-to-moderate, symptomatic non-bleeding hemorrhoids treated with rectal ointment or suppositories containing sucralfate were enrolled. Patients were administered treatment twice per day for at least 1 week until symptom resolution and/or for a maximum of 4 weeks. The primary endpoint was patient-assessed effectiveness on a modified Symptom Severity Score (mSSS, range 0 to 14). Physician-assessed effectiveness (9 symptoms, 0 to 5 Likert scale), hemorrhoid grade, and patient satisfaction were also determined. RESULTS: Five investigators enrolled 60 patients; mean age was 48.4 ± 16.6 years and 72.4% were female. Pain or pressure sensitivity was reported as the most severe symptom by patients, and pressure sensitivity, discharge, soiling, and prolapse by physicians. Mean patient-assessed mSSS at baseline was 6.6 ± 1.9 and was significantly improved overall and in the ointment and suppository groups individually by -4.6 ± 2.0, -4.4 ± 1.8, and -4.8 ± 2.2, respectively (p < 0.0001). Investigator-assessed mean baseline symptom score was 18.1 ± 3.9 and improved by -7.1 ± 4.5, -6.9 ± 5.4, and -7.3 ± 3.5, respectively (p < 0.0001). Investigator-assessed symptoms of pressure sensitivity, swelling, and discharge were improved to the greatest extent. Hemorrhoid grade was improved in 38% of patients at the end of treatment. Compliance with treatment was 97.4% and patient satisfaction with application and onset of action was high (81.3% and 76.2%, respectively). Both the ointment and suppository were well tolerated. CONCLUSIONS: The effectiveness of topical ointment or suppository containing sucralfate on patient- and investigator-assessed hemorrhoidal symptoms in real-life clinical practice was demonstrated. Patient satisfaction was high and treatments were well tolerated. Larger controlled trials are warranted to confirm the results.", "provenance": [ { "field": "n", "quote": "Five investigators enrolled 60 patients" }, { "field": "population", "quote": "Adult patients with diagnosed, mild-to-moderate, symptomatic non-bleeding hemorrhoids treated with rectal ointment or suppositories containing sucralfate were enrolled." }, { "field": "intervention", "quote": "rectal ointment or suppositories containing sucralfate" }, { "field": "comparator", "quote": "significantly improved overall and in the ointment and suppository groups individually by -4.6 ± 2.0, -4.4 ± 1.8, and -4.8 ± 2.2, respectively (p < 0.0001)" }, { "field": "primaryOutcome", "quote": "The primary endpoint was patient-assessed effectiveness on a modified Symptom Severity Score (mSSS, range 0 to 14)." }, { "field": "result", "quote": "Mean patient-assessed mSSS at baseline was 6.6 ± 1.9 and was significantly improved overall and in the ointment and suppository groups individually by -4.6 ± 2.0, -4.4 ± 1.8, and -4.8 ± 2.2, respectively (p < 0.0001)." }, { "field": "limitations", "quote": "Larger controlled trials are warranted to confirm the results." }, { "field": "followUp", "quote": "for a maximum of 4 weeks" } ] }, { "id": "pmid:38496090", "pmid": "38496090", "doi": "10.7759/cureus.54152", "nctId": null, "pmcid": "PMC10940957", "title": "Efficacy and Safety of Oral Euphorbia prostrata Tablet and Topical Cream in the Management of Hemorrhoids During Pregnancy: Results From a Prospective Multicenter Study", "firstAuthor": "Porwal", "multipleAuthors": true, "journal": "Cureus", "year": 2024, "design": "prospective-cohort", "n": 100, "nField": "reported", "population": "pregnant women with hemorrhoids", "intervention": "oral Euphorbia prostrata tablet plus topical Euphorbia prostrata cream", "comparator": "none (no control group)", "primaryOutcome": "relief of hemorrhoid symptoms (bleeding, pain, itching, swelling) over follow-up", "result": "large reductions in bleeding, pain, itching and swelling scores by 8 weeks", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This was a small, non-randomized, open-label study with no comparison group, so improvements can't be separated from natural healing or placebo effect.", "directness": "indirect", "limitations": "Non-randomized, open-label, single-arm design with no control group; conducted only in pregnant women, not the general population asking about hemorrhoid cream.", "followUp": "eight weeks and 30 days postpartum", "plainFinding": "Symptoms improved with combined tablet and cream.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/38496090/", "sourceText": "This is a non-randomized, open-label, prospective single-arm interventional multicentric study conducted between 2021 and 2022 at three different centers situated in Pune, India. It was conducted to evaluate the efficacy and safety of the Sitcom® tablet (Euphorbia prostrata 100 mg) once daily and Sitcom® cream (Euphorbia prostrata 1%w/w) for 14 days in hemorrhoids during pregnancy. The endpoints were to assess hemorrhoidal symptoms relief during the follow-up periods (one, two, four, and eight weeks and 30 days postpartum), relapse of symptoms, improvement in the disease condition at week two and 30 days postpartum, and adverse events. A total of 100 patients (mean age 24.1 years) were included; the majority (71.0%) had mild per-rectal bleeding, 69.0% with mild itching and 46.0% with moderate pain during defecation. The mean score of per-rectal bleeding and pain at defecation showed a significant reduction at each visit (86.6% and 49.3% (two weeks), 95.3% and 59.9% (four weeks), and 100% and 77.6% (eight weeks)). The mean pain score at defecation, itching, exudates, and swelling showed a significant reduction of 77.6%, 96.9%, 100%, and 84.5% at eight weeks (p<0.001). After two weeks and post postpartum follow-up, >90% and 100% good to excellent overall improvement in the disease condition were noted, respectively. No adverse events in the mother or newborn were noted. This pivotal study underscores the potential of a combination therapy with Euphorbia prostrate 100 mg tablet and cream 1% as a potential solution for managing the distressing burden of hemorrhoids in pregnant women. Furthermore, these observations will empower clinicians in the judicious selection of the most suitable course of action for hemorrhoid management during pregnancy.", "provenance": [ { "field": "population", "quote": "hemorrhoids during pregnancy" }, { "field": "n", "quote": "A total of 100 patients (mean age 24.1 years) were included" }, { "field": "intervention", "quote": "Sitcom® tablet (Euphorbia prostrata 100 mg) once daily and Sitcom® cream (Euphorbia prostrata 1%w/w) for 14 days" }, { "field": "comparator", "quote": "non-randomized, open-label, prospective single-arm interventional multicentric study" }, { "field": "primaryOutcome", "quote": "to assess hemorrhoidal symptoms relief during the follow-up periods" }, { "field": "result", "quote": "The mean score of per-rectal bleeding and pain at defecation showed a significant reduction at each visit (86.6% and 49.3% (two weeks), 95.3% and 59.9% (four weeks), and 100% and 77.6% (eight weeks))" } ] }, { "id": "pmid:38463771", "pmid": "38463771", "doi": "10.1016/j.heliyon.2024.e27215", "nctId": null, "pmcid": "PMC10923721", "title": "The efficacy of topical sodium pentaborate formulation on hemorrhoid disease: A randomized, double-blind, placebo-controlled trial", "firstAuthor": "Şahin", "multipleAuthors": true, "journal": "Heliyon", "year": 2024, "design": "rct", "n": 206, "nField": "reported", "population": "patients with grade 1, 2, and 3 hemorrhoid disease", "intervention": "topical gel with sodium pentaborate pentahydrate 3% (boron-based gel)", "comparator": "placebo gel", "primaryOutcome": "hemorrhoid symptom severity and anoscopy findings after 4 weeks", "result": "the active gel group had less itching, less pain, less bleeding during defecation, and lower hemorrhoid degree than the placebo group", "resultDirection": "benefit", "quality": "moderate", "qualityWhy": "it was a randomized, double-blind, placebo-controlled trial with a reasonable number of patients, but it only tested one specific boron gel for four weeks, so results may not apply to other hemorrhoid creams.", "directness": "indirect", "limitations": "abstract does not report long-term follow-up, dropout rates, or whether this specific boron gel formulation is representative of typical over-the-counter hemorrhoid creams.", "followUp": "four weeks", "plainFinding": "Less pain and bleeding with gel.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/38463771/", "sourceText": "BACKGROUND: The topical application of boron has been significantly associated with intensifying wound healing. Using 3% boric acid in deep wounds significantly contributes to wound healing and reduces the duration of hospitalization in the intensive care. The objective of this study was to assess the therapeutic impact of a topical gel containing sodium pentaborate pentahydrate on the management of wounds resulting from grade 1 to 3 hemorrhoids. METHODS: In this randomized double-blind placebo-controlled trial, we applied a topical gel consisting of sodium pentaborate pentahydrate 3% on 206 eligible patients with the diagnosis of grade 1, 2, and 3 hemorrhoid diseases. Then patients were randomly allocated to two groups of sodium pentaborate pentahydrate or placebo gel with a ratio of 1:1 and received the allocated gel for four weeks. Patient hemorrhoid symptoms severity, hemorrhoid degree, and anoscopy findings were compared before and after the trial. RESULTS: Before the intervention, symptom severity (p > 0.05) and anoscopy findings (p = 0.815) were similar between the two groups. Subsequent to the intervention, a majority of patients in the intervention group experienced a reduction in anal itching compared to the placebo group [adjusted mean difference (aMD) 95% CI: -1.98 (-2.2 to -1.8), p = 0.007]. Moreover, resting pain [aMD (95% CI): -1.37 (-1.6 to -1.1), p = 0.015], pain during defecation [aMD (95% CI): -2.19 (-2.4 to -2.0), p = 0.005], feeling a lump in the anus (aMD (95% CI): -0.71 (-1.2 to -0.2), p = 0.011), bleeding during defecation (41.7% vs. 66.9%, p = 0.027), and hemorrhoid degree (p < 0.001) in the intervention group was less than the placebo group. CONCLUSION: Our findings indicate the effectiveness of the study gel on hemorrhoid symptoms and anoscopy findings in patients.", "provenance": [ { "field": "n", "quote": "we applied a topical gel consisting of sodium pentaborate pentahydrate 3% on 206 eligible patients with the diagnosis of grade 1, 2, and 3 hemorrhoid diseases" }, { "field": "population", "quote": "patients with the diagnosis of grade 1, 2, and 3 hemorrhoid diseases" }, { "field": "intervention", "quote": "a topical gel consisting of sodium pentaborate pentahydrate 3%" }, { "field": "comparator", "quote": "patients were randomly allocated to two groups of sodium pentaborate pentahydrate or placebo gel with a ratio of 1:1" }, { "field": "primaryOutcome", "quote": "Patient hemorrhoid symptoms severity, hemorrhoid degree, and anoscopy findings were compared before and after the trial." }, { "field": "result", "quote": "bleeding during defecation (41.7% vs. 66.9%, p = 0.027), and hemorrhoid degree (p < 0.001) in the intervention group was less than the placebo group" } ] }, { "id": "pmid:38356039", "pmid": "38356039", "doi": "10.1007/s13304-024-01776-9", "nctId": null, "pmcid": "PMC10995001", "title": "Clinical evidence and rationale of mesoglycan to treat chronic venous disease and hemorrhoidal disease: a narrative review", "firstAuthor": "Gallo", "multipleAuthors": true, "journal": "Updates Surg", "year": 2024, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with chronic venous disease or hemorrhoids, including some after hemorrhoid surgery", "intervention": "oral mesoglycan (a drug related to blood vessel wall compounds, not a topical cream)", "comparator": "standard care without mesoglycan", "primaryOutcome": "severity of hemorrhoid symptoms and rectal bleeding risk", "result": "mesoglycan reduced symptom severity and lowered the risk of rectal bleeding", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "this is a narrative review summarizing other trials without giving study numbers, methods, or statistics to judge reliability, and it is about an oral drug, not a topical cream.", "directness": "indirect", "limitations": "abstract does not report study sizes, designs, or statistical details for the hemorrhoid findings, and narrative reviews are not systematic.", "followUp": "", "plainFinding": "Oral drug reduced bleeding, not a cream.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/38356039/", "sourceText": "Chronic venous disease (CVD) and hemorrhoidal disease (HD) are among the most common vascular diseases in the world, with CVD affecting 22-41% of the population in Europe and HD having a point prevalence of 11-39%. The burden is substantial in terms of the effect of symptoms on patients' health-related quality of life (HRQoL) and direct/indirect medical costs. Treatment begins with lifestyle changes, compression in CVD and topical therapies in HD, and escalates as needed through oral therapies first and eventually to surgery for severe disease. CVD and HD share etiological features and pathological changes affecting the structure and function of the tissue extracellular matrix. Mesoglycan, a natural glycosaminoglycan (GAG) preparation composed primarily of heparan sulfate and dermatan sulfate, has been demonstrated to positively impact the underlying causes of CVD and HD, regenerating the glycocalyx and restoring endothelial function, in addition to having antithrombotic, profibrinolytic, anti-inflammatory, antiedema and wound-healing effects. In clinical trials, oral mesoglycan reduced the severity of CVD signs and symptoms, improved HRQoL, and accelerated ulcer healing. In patients with HD, mesoglycan significantly reduced the severity of signs and symptoms and the risk of rectal bleeding. In patients undergoing excisional hemorrhoidectomy, adding mesoglycan to standard postoperative care reduced pain, improved HRQoL, reduced incidence of thrombosis, and facilitated an earlier return to normal activities/work, compared with standard postoperative care alone. The clinical effects of mesoglycan in patients with CVD or HD are consistent with the agent's known mechanisms of action.", "provenance": [ { "field": "population", "quote": "CVD and HD share etiological features and pathological changes affecting the structure and function of the tissue extracellular matrix" }, { "field": "intervention", "quote": "Mesoglycan, a natural glycosaminoglycan (GAG) preparation composed primarily of heparan sulfate and dermatan sulfate" }, { "field": "comparator", "quote": "adding mesoglycan to standard postoperative care reduced pain, improved HRQoL, reduced incidence of thrombosis, and facilitated an earlier return to normal activities/work, compared with standard postoperative care alone" }, { "field": "primaryOutcome", "quote": "mesoglycan significantly reduced the severity of signs and symptoms and the risk of rectal bleeding" }, { "field": "result", "quote": "In patients with HD, mesoglycan significantly reduced the severity of signs and symptoms and the risk of rectal bleeding." } ] }, { "id": "pmid:38318095", "pmid": "38318095", "doi": "10.4174/astr.2024.106.2.85", "nctId": null, "pmcid": "PMC10838657", "title": "Accelerated wound healing after topical application of hyaluronic acid cotton to hemorrhoidectomy wounds in a rat model", "firstAuthor": "Suh", "multipleAuthors": true, "journal": "Ann Surg Treat Res", "year": 2024, "design": "animal", "n": 48, "nField": "reported", "population": "rats with surgical perianal wounds after hemorrhoid surgery (not human hemorrhoid patients)", "intervention": "hyaluronic acid-soaked cotton applied to the wound", "comparator": "plain gauze dressing", "primaryOutcome": "how fast and completely the wound healed", "result": "wounds treated with hyaluronic acid cotton healed faster and more completely than those with gauze", "resultDirection": "benefit", "quality": "low", "qualityWhy": "this is an animal study in rats, not humans, so it cannot show whether hemorrhoid cream shrinks hemorrhoids or stops bleeding in people.", "directness": "indirect", "limitations": "study done in rats with surgically created wounds after hemorrhoid removal surgery, not in people with untreated hemorrhoids; tests a wound dressing material, not a typical over-the-counter hemorrhoid cream.", "followUp": "", "plainFinding": "Faster wound healing in rats.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/38318095/", "sourceText": "PURPOSE: Anal wounds following hemorrhoidectomy can lead to severe pain and postoperative bleeding, impacting patient recovery and quality of life. Hyaluronic acid (HA) stimulates tissue regeneration and wound healing by accelerating cell migration and proliferation. This study aimed to investigate the differences in wound healing rate and completeness of recovery of perianal wounds topically treated with HA-soaked cotton in a murine model. METHODS: Forty-eight 8-week-old Sprague-Dawley rats with perianal wounds created using a biopsy punch were divided into 2 groups: simple dressing with gauze (control) and topical HA-soaked cotton. A single application of HA-soaked cotton was administered after surgery. Wound healing rate and completeness of recovery were evaluated by measuring the healed area and conducting histological analyses. RESULTS: The HA-cotton group exhibited a shorter complete wound healing duration compared to the control group (13.9 days vs. 16.4 days, P = 0.031). Differences in wound healing area between the 2 groups were greatest on postoperative day 2 (51.6% vs. 28.8%, P < 0.001). The HA-cotton group exhibited fewer cases of granulation tissue (2 vs. 5) or redness (0 vs. 3) upon complete wound healing. Histologically, the HA-cotton group showed accelerated reepithelialization, rapid shift to lymphocyte-dominant inflammation, enhanced fibroblast proliferation, and increased collagen deposition compared to the control group. CONCLUSION: Herein, topical application of HA-soaked cotton on perianal wounds in rats resulted in accelerated wound healing, particularly in the initial stages, and improved completeness of recovery, underscoring the potential of the topical application of HA-soaked cotton on hemorrhoidectomy wounds in human patients to improve wound healing.", "provenance": [ { "field": "population", "quote": "Forty-eight 8-week-old Sprague-Dawley rats with perianal wounds created using a biopsy punch" }, { "field": "n", "quote": "Forty-eight 8-week-old Sprague-Dawley rats" }, { "field": "intervention", "quote": "topical HA-soaked cotton" }, { "field": "comparator", "quote": "simple dressing with gauze (control)" }, { "field": "primaryOutcome", "quote": "Wound healing rate and completeness of recovery were evaluated by measuring the healed area and conducting histological analyses." }, { "field": "result", "quote": "The HA-cotton group exhibited a shorter complete wound healing duration compared to the control group (13.9 days vs. 16.4 days, P = 0.031)." } ] }, { "id": "pmid:37741471", "pmid": "37741471", "doi": "10.1016/j.jep.2023.117173", "nctId": null, "pmcid": null, "title": "The beneficial effect of Sanhuang ointment and its active constituents on experimental hemorrhoids in rats", "firstAuthor": "Yu", "multipleAuthors": true, "journal": "J Ethnopharmacol", "year": 2024, "design": "animal", "n": null, "nField": "not-reported", "population": "rats with chemically induced hemorrhoids", "intervention": "Sanhuang ointment (herbal cream) applied to the anal area", "comparator": "two other commercial hemorrhoid creams (Mayinglong musk ointment and Taining cream)", "primaryOutcome": "inflammation, pain-related markers, and tissue swelling in the anal area", "result": "The ointment reduced inflammation, swelling, and pain-related markers in rats with induced hemorrhoids", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This was an animal study using an herbal cream, so it may not predict what happens in humans using over-the-counter hemorrhoid creams.", "directness": "indirect", "limitations": "Animal model only, no human data, compares a traditional Chinese herbal ointment rather than typical standard hemorrhoid creams used by patients.", "followUp": "11 days", "plainFinding": "Reduced swelling in rats, not humans.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/37741471/", "sourceText": "ETHNOPHARMACOLOGICAL RELEVANCE: Sanhuang ointment (SHO) has been widely used in the traditional Chinese medical system for 1500 years and has efficacy in clearing away heat and dampness, reducing swelling, and alleviating pain. Hemorrhoids will damage the normal physiological function of the body, resulting in obstructed defecation, accompanied by massive hemorrhage and necrosis of tissues and cells, which is easy to breed bacteria and cause infection. SHO can promote lesion healing in hemorrhoid rats, but the pharmacological mechanism underlying this effect remains unknown. AIM: To evaluate the effect of SHO on experimental hemorrhoids in rats induced by croton oil and glacial acetic acid. MATERIALS AND METHODS: In this research, the effective components of SHO were analyzed in detail by High performance liquid chromatography (HPLC) and Liquid chromatography/mass spectrometry (LC/MS). Hemorrhoids were induced by 6% balsam and glacial acetic acid respectively in the anorectal region of rats. SHO was administered externally to the anorectal region of rats at doses of 185 mg/g (crude drug/ointment), 370 mg/g (crude drug/ointment) and 740 mg/g (crude drug/ointment) for 11 days. Mayinglong musk hemorrhoids ointment (1 g/kg) and Taining cream (1 g/kg) were used as reference anti hemorrhoids drugs. On the 11th day, hemorrhoids were evaluated by measuring the biochemical parameters of hemorrhoids in rats and the histology of anorectal tissues. RESULTS: Using high performance liquid chromatography liquid chromatography mass spectrometry, 41 compounds, including phenylpropionic acids and alkaloids, were identified. the fingerprints of 18 common peaks were identified. In Hemorrhoids like rats, acetic acid induced inflammation was inhibited in a dose-dependent manner during SHO treatment. In addition, the detailed experimental results show that SHO can effectively improve hemorrhoids by inhibiting the production of inflammatory cytokines in serum, reversing the down-regulation of vanillin subtype 1 (TRPV1), calcitonin gene related peptide (CGRP) and substance P (SP) levels of pain related genes in anal tissues, and the up regulation of Vascular endothelial growth factor (VEGF) levels of vascular growth related genes. CONCLUSION: The results showed that SHO could alleviate the edema caused by the exudation of anorectal tissue fluid in rats by anti-inflammatory effect and reducing the Vascular permeability of rats. The study validates the traditional use of SHO in the treatment of hemorrhoids and demonstrates its anti-hemorrhoidal potential.", "provenance": [ { "field": "population", "quote": "Hemorrhoids were induced by 6% balsam and glacial acetic acid respectively in the anorectal region of rats." }, { "field": "intervention", "quote": "SHO was administered externally to the anorectal region of rats at doses of 185 mg/g (crude drug/ointment), 370 mg/g (crude drug/ointment) and 740 mg/g (crude drug/ointment) for 11 days." }, { "field": "comparator", "quote": "Mayinglong musk hemorrhoids ointment (1 g/kg) and Taining cream (1 g/kg) were used as reference anti hemorrhoids drugs." }, { "field": "primaryOutcome", "quote": "hemorrhoids were evaluated by measuring the biochemical parameters of hemorrhoids in rats and the histology of anorectal tissues." }, { "field": "result", "quote": "SHO could alleviate the edema caused by the exudation of anorectal tissue fluid in rats by anti-inflammatory effect and reducing the Vascular permeability of rats." } ] }, { "id": "pmid:41821779", "pmid": "41821779", "doi": "10.3389/fgstr.2023.1213433", "nctId": null, "pmcid": "PMC12952410", "title": "Effects of a sucralfate-containing ointment on quality of life and symptoms associated with hemorrhoidal disease: patient-reported results of a Slovakian, pharmacist-led observational survey", "firstAuthor": "Snopková", "multipleAuthors": true, "journal": "Front Gastroenterol (Lausanne)", "year": 2023, "design": "prospective-cohort", "n": 144, "nField": "reported", "population": "Adults in Slovakia using a sucralfate-containing hemorrhoid cream who had hemorrhoid symptoms in the past week", "intervention": "Sucralfate-containing rectal ointment for hemorrhoid symptoms", "comparator": "No control group; patients compared to their own symptoms before treatment", "primaryOutcome": "Change in quality-of-life score related to hemorrhoid symptoms over 14 days", "result": "Quality-of-life score improved and symptom frequency decreased significantly by day 14, with many patients reporting relief from pain and itching within hours", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This was an uncontrolled pharmacy survey with no comparison group, so improvement could be due to natural healing or placebo rather than the cream itself.", "directness": "direct", "limitations": "No control or placebo group, open-label, relies on patient self-report, and the authors themselves call for randomized trials to confirm results.", "followUp": "14 days", "plainFinding": "Symptoms and quality of life improved.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/41821779/", "sourceText": "PURPOSE: This pharmacist-led study evaluated the effect of a rectal ointment containing sucralfate on quality of life, symptom frequency and time to relief of symptoms in Slovakian individuals with hemorrhoidal disease (HD). METHODS: The multicenter prospective survey was conducted at 45 community pharmacies in Slovakia. Pharmacists invited adults (≥18 years) using sucralfate-containing ointment for their HD-related symptoms to participate. RESULTS: 241 patients completed the HEMO-FISS-QoL questionnaire and a survey of symptom frequency at the beginning and end of the 14-day survey period. The primary endpoint was the change in HEMO-FISS-QoL scores in patients with hemorrhoidal symptoms during the 7 days before the initial pharmacy visit. Of the 241 patients enrolled in the survey, 144 had experienced hemorrhoidal symptoms within the preceding 7 days (mean age 51 years; 59.0% female). For these 144 patients, the total HEMO-FISS-QoL score decreased (i.e., quality of life was improved) from baseline by a mean of -8.7 (95% confidence interval -12.6, -6.2; P<0.001) at day 14. The frequency of hemorrhoidal symptoms was significantly reduced (P<0.001 vs baseline). Symptom relief was rapid; at 1-hour post-treatment 54.6% of patients had relief from pain and 56.3% from itching, and by 24 hours post-treatment most patients had relief from these symptoms (77.2% and 73.0%, respectively). No incidents nor adverse events related to sucralfate-containing ointment were reported to pharmacists. CONCLUSION: The results of this pharmacist-led observational survey suggest that the sucralfate-containing ointment could improve quality of life in patients with HD, providing rapid relief with a good safety profile. To confirm these results in a larger, well-defined patient population, randomized controlled trials in patients with clinically diagnosed HD are warranted.", "provenance": [ { "field": "n", "quote": "Of the 241 patients enrolled in the survey, 144 had experienced hemorrhoidal symptoms within the preceding 7 days" }, { "field": "population", "quote": "Pharmacists invited adults (≥18 years) using sucralfate-containing ointment for their HD-related symptoms to participate." }, { "field": "intervention", "quote": "a rectal ointment containing sucralfate" }, { "field": "comparator", "quote": "the total HEMO-FISS-QoL score decreased (i.e., quality of life was improved) from baseline by a mean of -8.7" }, { "field": "primaryOutcome", "quote": "The primary endpoint was the change in HEMO-FISS-QoL scores in patients with hemorrhoidal symptoms during the 7 days before the initial pharmacy visit." }, { "field": "result", "quote": "the total HEMO-FISS-QoL score decreased (i.e., quality of life was improved) from baseline by a mean of -8.7 (95% confidence interval -12.6, -6.2; P<0.001) at day 14. The frequency of hemorrhoidal symptoms was significantly reduced (P<0.001 vs baseline)." }, { "field": "followUp", "quote": "14-day survey period" } ] }, { "id": "pmid:37530049", "pmid": "37530049", "doi": null, "nctId": null, "pmcid": null, "title": "Treatment of haemorrhoids in pregnancy: A retrospective review", "firstAuthor": "Fiordaliso", "multipleAuthors": true, "journal": "Ann Ital Chir", "year": 2023, "design": "systematic-review", "n": null, "nField": "not-reported", "population": "pregnant women with hemorrhoids", "intervention": "topical hemorrhoid cream or oral phlebotonic medication", "comparator": "other treatments such as fiber supplements, stool softeners, laxatives, or surgery", "primaryOutcome": "safety and effectiveness of hemorrhoid treatments during pregnancy", "result": "evidence for topical cream or oral medication safety and effectiveness in pregnancy is lacking, so they are recommended only with caution", "resultDirection": "unclear", "quality": "low", "qualityWhy": "This is a non-systematic literature review without pooled data or quality grading of the studies it cites.", "directness": "indirect", "limitations": "The abstract reports no formal quality assessment of included studies, no sample sizes, and focuses specifically on pregnant patients rather than the general population.", "followUp": "", "plainFinding": "Not enough evidence either way.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/37530049/", "sourceText": "AIM: Haemorrhoids are varicose veins of the rectum covered by mucosa at or near the anal canal. They are normally asymptomatic, can occur at any age and affect both males and females. Haemorrhoids are common in young women and commoner during pregnancy and the puerperium. In this review, we address the issue of the approach of the obstetrician and surgeons to haemorrhoids and their management. This is significant because there are currently no recommendations for pregnant patients with hemorrhoids. METHODS: The literature search comprised all the inherent published original papers; also abstract were included. No language selection was done. Search terms used were: \"hemorrhoid\", \"hemorrhoid therapy\", \"hemorrhoid in pregnancy\", \"hemorrhoid complication\". Data research was conducted using MEDLINE, EMBASE, Web of Sciences, Scopus, Clinical Trial. gov, OVID and Cochrane Library querying for all articles related to treatment of hemorrhoidis in pregnancy. RESULTS: Fiber supplement, stool softener and mild laxatives are generally safe for pregnant women. Topical medication or oral phlebotonics may be used with special caution because the strong evidence of their safety and efficacy in pregnancy is lacking. In case of massive bleeding, anal packing could be a simple and useful maneuver. Hemorrhoidectomy is reserved in strangulated or extensively thrombosed hemorrhoids, and hemorrhoids with intractable bleeding. KEY WORDS: Hemorrhoid, Hemorrhoid Therapy, Hemorrhoid in Pregnancy, Hemorrhoid Complication.", "provenance": [ { "field": "population", "quote": "Haemorrhoids are common in young women and commoner during pregnancy and the puerperium." }, { "field": "intervention", "quote": "Topical medication or oral phlebotonics may be used with special caution" }, { "field": "comparator", "quote": "Fiber supplement, stool softener and mild laxatives are generally safe for pregnant women." }, { "field": "primaryOutcome", "quote": "the strong evidence of their safety and efficacy in pregnancy is lacking" }, { "field": "result", "quote": "Topical medication or oral phlebotonics may be used with special caution because the strong evidence of their safety and efficacy in pregnancy is lacking." } ] }, { "id": "pmid:36331754", "pmid": "36331754", "doi": "10.1007/s12325-022-02351-7", "nctId": null, "pmcid": "PMC9859842", "title": "Recurrence Rates and Pharmacological Treatment for Hemorrhoidal Disease: A Systematic Review", "firstAuthor": "Lohsiriwat", "multipleAuthors": true, "journal": "Adv Ther", "year": 2023, "design": "systematic-review", "n": null, "nField": "not-reported", "population": "adults with hemorrhoidal disease", "intervention": "systemic or topical pharmacological treatments for hemorrhoids, including phlebotonics and flavonoid pills", "comparator": "other pharmacological treatments or surgery", "primaryOutcome": "rates of disease recurrence and improvement in hemorrhoid symptoms", "result": "Micronized purified flavonoid fractions improved main symptoms more than other treatments, but no studies were found showing whether systemic or topical treatments reduce recurrence", "resultDirection": "mixed", "quality": "low", "qualityWhy": "The review pooled very different studies with widely varying recurrence rates and found no real-world data at all on topical treatment recurrence, so conclusions about creams specifically are weak.", "directness": "indirect", "limitations": "Abstract notes a lack of consistent epidemiology/recurrence data, wide variation in reported recurrence (0-56.5%), and no real-world studies found on recurrence after systemic or topical treatment specifically.", "followUp": "", "plainFinding": "No cream-specific evidence found.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/36331754/", "sourceText": "INTRODUCTION: Hemorrhoidal disease (HD) is characterized by prolapse of the inflamed and bleeding vascular tissues of the anal canal. Although HD is associated with a high recurrence rate, there is a lack of understanding around interventions that can reduce recurrence and improve outcomes for patients. As such, a systematic literature review (SLR) was conducted to summarize evidence on epidemiology, recurrence, and efficacy of interventions in HD. METHODS: Real-world evidence (RWE) studies evaluating the incidence, prevalence, or recurrence of HD, as well as SLRs including a meta-analytic component reporting on the efficacy of systemic or topical pharmacological treatments for adults with HD, were included. Systematic searches were conducted in MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Database of Systematic Reviews. RESULTS: The SLR identified 44 eligible publications. Consistent data were limited on the epidemiology of HD or HD recurrence. Specifically, incidence and prevalence reported across geographies were impacted by differences in data collection. Reported risk factors for HD were sedentary behavior, constipation, male gender, and age. Twenty-three RWE studies and one meta-analysis reported HD recurrence rates ranging from 0 to 56.5% following surgery or phlebotonics, with most (n = 19) reporting rates of 20% or less. In addition to time since treatment, risk factors for recurring disease were similar to those for HD in general. With respect to treatment, micronized purified flavonoid fractions significantly improved the main symptoms of HD compared to other pharmacological treatments. CONCLUSION: The SLRs did not identify any RWE studies reporting recurrence in patients receiving systemic or topical treatments, highlighting the need for future research in this area. Further, more studies are needed to understand the optimum duration of medical treatment to prevent recurrence.", "provenance": [ { "field": "population", "quote": "adults with HD" }, { "field": "intervention", "quote": "SLRs including a meta-analytic component reporting on the efficacy of systemic or topical pharmacological treatments for adults with HD" }, { "field": "comparator", "quote": "micronized purified flavonoid fractions significantly improved the main symptoms of HD compared to other pharmacological treatments" }, { "field": "primaryOutcome", "quote": "summarize evidence on epidemiology, recurrence, and efficacy of interventions in HD" }, { "field": "result", "quote": "The SLRs did not identify any RWE studies reporting recurrence in patients receiving systemic or topical treatments, highlighting the need for future research in this area." }, { "field": "result", "quote": "micronized purified flavonoid fractions significantly improved the main symptoms of HD compared to other pharmacological treatments" } ] }, { "id": "pmid:35592120", "pmid": "35592120", "doi": "10.3389/fsurg.2022.898850", "nctId": null, "pmcid": "PMC9110961", "title": "Management and Treatment of External Hemorrhoidal Thrombosis", "firstAuthor": "Picciariello", "multipleAuthors": true, "journal": "Front Surg", "year": 2022, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with external hemorrhoidal thrombosis (a painful swollen clot in a hemorrhoid)", "intervention": "various treatments including topical creams (flavonoids, lidocaine-nifedipine mix, glyceryl trinitrate) and other conservative options", "comparator": "surgical treatment options such as drainage or excision", "primaryOutcome": "whether treatment resolves the thrombosed hemorrhoid", "result": "abstract states both medical and surgical treatment have been proven effective, but says trials are still needed", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "This is a narrative mini-review summarizing various studies without systematic methodology, and it admits no clear guidelines or randomized trials exist.", "directness": "indirect", "limitations": "The abstract itself states there are no specific guidelines, management remains controversial, and randomized clinical trials are still needed; it does not report results of a single study.", "followUp": "", "plainFinding": "Unclear if creams help.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/35592120/", "sourceText": "BACKGROUND: External hemorrhoidal thrombosis (EHT) is a common complication of hemorrhoidal disease. This condition causes extreme pain, likely resulting from internal anal sphincter hypertonicity, which traps the hemorrhoids below the dentate line thus leading to congestion and swelling. The choice of treatment remains controversial and both conservative and surgical options have been proposed in the last decades. METHODS: This mini-review focuses on the most relevant studies found in literature evaluating conservative and surgical management of EHT. Special conditions such as pregnancy and EHT in elderly patients have been considered. RESULTS: Traditionally, symptoms duration represents the discriminant in the choice between medical and surgical treatment. Several Coloproctological Societies considered conservative treatment as the first-line approach to EHT and a variety of options have been proposed: wait and see, mixture of flavonoids, mix of lidocaine and nifedipine, botulinum toxin injection and topical application of 0.2% glyceryl trinitrate. Meanwhile, different surgical treatments are recommended when EHT fails to respond to conservative management or when symptoms onset falls within the last 48-72 h: drainage with radial incision, conventional excision, excision under local anesthesia and stapled technique. CONCLUSION: The management and treatment of EHT is still controversial since no specific guidelines have been published. Both medical and surgical treatment have been proven effective but randomized clinical trials and structured consensus-based guidelines are warranted.", "provenance": [ { "field": "population", "quote": "External hemorrhoidal thrombosis (EHT) is a common complication of hemorrhoidal disease." }, { "field": "intervention", "quote": "a variety of options have been proposed: wait and see, mixture of flavonoids, mix of lidocaine and nifedipine, botulinum toxin injection and topical application of 0.2% glyceryl trinitrate" }, { "field": "comparator", "quote": "different surgical treatments are recommended when EHT fails to respond to conservative management" }, { "field": "primaryOutcome", "quote": "The choice of treatment remains controversial and both conservative and surgical options have been proposed in the last decades." }, { "field": "result", "quote": "Both medical and surgical treatment have been proven effective but randomized clinical trials and structured consensus-based guidelines are warranted." } ] }, { "id": "pmid:35511655", "pmid": "35511655", "doi": "10.23736/S2724-5985.22.03173-4", "nctId": null, "pmcid": null, "title": "Safety and efficacy of topical drug-free cream in subjects with hemorrhoidal disease: a randomized, double blind, clinical trial", "firstAuthor": "Sturiale", "multipleAuthors": true, "journal": "Minerva Gastroenterol (Torino)", "year": 2022, "design": "rct", "n": 60, "nField": "reported", "population": "adults with grade I-II symptomatic hemorrhoidal disease", "intervention": "topical drug-free cream (Lenoid™)", "comparator": "placebo cream", "primaryOutcome": "improvement in hemorrhoid symptoms such as pain, tenesmus, pruritus and anal discharge", "result": "significant improvement in all symptoms with the cream compared to placebo after 7 and 14 days", "resultDirection": "benefit", "quality": "low", "qualityWhy": "small, short two-week trial measuring symptom scores rather than bleeding or hemorrhoid size, so it can't say much about shrinking hemorrhoids or stopping bleeding.", "directness": "indirect", "limitations": "Only 60 patients, very short 2-week follow-up, and outcomes were symptom questionnaires rather than objective measures like bleeding or hemorrhoid size.", "followUp": "14 days", "plainFinding": "Eased hemorrhoid symptoms vs placebo.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/35511655/", "sourceText": "BACKGROUND: Hemorrhoidal disease (HD) is one of the most common anorectal benign disorder affecting millions of people around the world. Grade I-II HD are generally treated with a conservative approach with topical products such as creams and ointments considered a safe and effective option to treat mild symptoms. The aim of the present study was to assess the safety and efficacy of a topical medical device (Lenoid™; International Health Science [IHS] - Biofarma Group, Mereto di Tomba, Udine, Italy) in patients affected by symptomatic HD. METHODS: This study is a randomized, double blind, placebo-controlled, 2-weeks clinical trial. Patients affected by I-II grade symptomatic HD were enrolled in the study and then randomly assigned to Lenoid™ arm (LA) or placebo arm (PA), respectively. Patients were evaluated before and after intervention through clinical examination and disease-specific questionnaires assessing symptoms such as pain, tenesmus, pruritus and anal discharge. RESULTS: A total of 68 patients were screened and 60 (30 in each group) were enrolled into the study. All patients belonging to LA showed a statistically significant improvement of each symptom after 7 and 14 days of treatment when compared to PA (P<0.001). Furthermore, subjective improvement of change in overall assessment of disease was observed in the LA but not in the PA. No serious adverse events were recorded. CONCLUSIONS: The tested product was found safe and effective in improving clinical signs and symptoms in patients with grade I-II HD.", "provenance": [ { "field": "n", "quote": "A total of 68 patients were screened and 60 (30 in each group) were enrolled into the study." }, { "field": "population", "quote": "Patients affected by I-II grade symptomatic HD were enrolled in the study" }, { "field": "intervention", "quote": "a topical medical device (Lenoid™; International Health Science [IHS] - Biofarma Group, Mereto di Tomba, Udine, Italy)" }, { "field": "comparator", "quote": "randomly assigned to Lenoid™ arm (LA) or placebo arm (PA)" }, { "field": "primaryOutcome", "quote": "disease-specific questionnaires assessing symptoms such as pain, tenesmus, pruritus and anal discharge" }, { "field": "result", "quote": "All patients belonging to LA showed a statistically significant improvement of each symptom after 7 and 14 days of treatment when compared to PA (P<0.001)." } ] }, { "id": "pmid:35362397", "pmid": "35362397", "doi": "10.2174/1871523021666220330143845", "nctId": null, "pmcid": null, "title": "Evaluation Of Anti-inflammatory Mediated Anti-hemorrhoidal Activity of Lawsonia inermis on Croton Oil Induced Hemorrhoidal Rats", "firstAuthor": "Nallajerla", "multipleAuthors": true, "journal": "Antiinflamm Antiallergy Agents Med Chem", "year": 2022, "design": "animal", "n": null, "nField": "not-reported", "population": "rats with croton oil-induced hemorrhoids", "intervention": "Lawsonia inermis (henna) leaf extract applied at two doses", "comparator": "Pilex ointment (reference standard) and untreated/control", "primaryOutcome": "levels of inflammatory markers (TNF-α, IL-6, neutrophils) linked to hemorrhoid swelling", "result": "The plant extract reduced inflammatory markers in a dose-dependent way in rats", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This is an animal and lab study, not a human trial, so it cannot show whether this works for people with hemorrhoids.", "directness": "indirect", "limitations": "Animal model only, no human data, small/unclear sample size not reported, and no information on actual hemorrhoid shrinkage or bleeding outcomes.", "followUp": "", "plainFinding": "Reduced inflammation markers in rats only.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/35362397/", "sourceText": "BACKGROUND: Hemorrhoids are a common recto-anal disorder commonly known as piles or tissue clumps in the rectum. In normal individuals, they were known as anal cushions. In the anus, they are composed of rectal blood vessels, muscles, and elastic fibres. When bulged, it can cause bleeding, constipation, itching, severe pain, and bleeding in the anus. Inflammation of the anal cushion remains major pathogenesis for the development of hemorrhoids. Inflammatory mediators like neutrophils, TNF-α, and IL-6 seem to play a major role in the development of disease. OBJECTIVE: This study aims to carry out the ethanolic leaf extract of Lawsonia inermis (L. inermis) and evaluate its anti-hemorrhoidal activity both in vitro and in vivo. Furthermore, Molecular Docking was performed on the crystal structure of COX-2 with the selective compound 23d-(R) (PDB ID: 3NTG) protein. METHODS: The current study is to estimate an anti-inflammatory mediated anti-hemorrhoidal activity of ethanolic leaf extract of L. inermis at different doses of 200 mg/kg/ir and 400 mg/kg/ir in croton oil-induced hemorrhoidal rats. Pilex ointment is taken as a reference standard in the present study. Evan's blue extravasation technique were applied in the study to quantify the proinflammatory protein. RESULTS: From the study results, a dose-dependent effect was found for ethanolic leaf extract of Lawsonia inermis at 200 mg/kg and 400 mg/kg causing a significant reduction of serum Proinflammatory mediators TNF-α, IL-6, and plasma neutrophils in croton oil-induced hemorrhoidal rats. CONCLUSION: Studies represented that the plant extract can significantly inhibit protein denaturation of egg albumin in in vitro and found to reduce croton oil induced inflammatory mediators in hemorhhoidal rats.", "provenance": [ { "field": "population", "quote": "croton oil-induced hemorrhoidal rats" }, { "field": "intervention", "quote": "ethanolic leaf extract of L. inermis at different doses of 200 mg/kg/ir and 400 mg/kg/ir" }, { "field": "comparator", "quote": "Pilex ointment is taken as a reference standard in the present study" }, { "field": "primaryOutcome", "quote": "significant reduction of serum Proinflammatory mediators TNF-α, IL-6, and plasma neutrophils" }, { "field": "result", "quote": "a dose-dependent effect was found for ethanolic leaf extract of Lawsonia inermis at 200 mg/kg and 400 mg/kg causing a significant reduction of serum Proinflammatory mediators TNF-α, IL-6, and plasma neutrophils in croton oil-induced hemorrhoidal rats" } ] }, { "id": "pmid:34377319", "pmid": "34377319", "doi": null, "nctId": null, "pmcid": "PMC8340250", "title": "The effects of modified Buzhong Yiqi decoction combined with Gangtai ointment on the wound healing and anal function in circumferential mixed hemorrhoid patients", "firstAuthor": "Lu", "multipleAuthors": true, "journal": "Am J Transl Res", "year": 2021, "design": "rct", "n": 120, "nField": "reported", "population": "patients with circumferential mixed hemorrhoids who had surgery", "intervention": "oral herbal decoction (modified Buzhong Yiqi) plus Gangtai medicated ointment applied to the wound", "comparator": "chitosan hydrogel wound dressing", "primaryOutcome": "wound healing and anal function after hemorrhoid surgery", "result": "the combined decoction and ointment group had a higher effective rate, less pain, less swelling, better quality of life, faster wound healing, and fewer adverse reactions than the hydrogel group", "resultDirection": "benefit", "quality": "low", "qualityWhy": "this is a small single study of a combined oral-and-topical treatment given after surgery, not a plain cream used on its own, so it doesn't directly test whether hemorrhoid cream alone shrinks hemorrhoids or stops bleeding.", "directness": "indirect", "limitations": "abstract does not mention blinding, and the ointment was combined with an oral herbal medicine and used only after surgical removal of hemorrhoids, not in patients with untreated hemorrhoids.", "followUp": "14 days", "plainFinding": "Faster healing after hemorrhoid surgery.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/34377319/", "sourceText": "OBJECTIVE: To investigate the effects of modified Buzhong Yiqi decoction combined with Gangtai ointment on the wound healing and anal function of circumferential mixed hemorrhoid patients. METHODS: Patients (n=120) with circumferential mixed hemorrhoids were recruited as the research cohort. All the patients underwent surgical treatment and were randomly divided into a control group and a research group. The control group was administered chitosan hydrogels for wound healing, once a day. The research group was administered modified Buzhong Yiqi decoction (1 dose a day, orally) combined with Kangtai ointment for external application (twice a day, for two consecutive weeks). We compared the two groups' effective rates, their pain indexes, their perianal edema scores, their quality of life scores, their wound healing times, their pain resolution times, their anal functions, their wound exudate scores, and their adverse reactions. RESULTS: Compared with the control group, the research group had a higher effective rate (P<0.01), a lower pain index, and a lower perianal edema score (both P<0.001), a higher quality of life score (P<0.001), a shorter wound healing time, a shorter pain resolution time, and fewer adverse reactions than the control group (both P<0.001). The lengths of the anal canals in the research group were shorter than they were in the control group (P<0.01), and the resting pressure, maximum diastolic blood pressure, and maximum systolic blood pressure were higher than they were in the control group (all P<0.001). The wound exudate scores at 7 and 14 days after the treatment in the research group were lower than they were in the control group (all P<0.001). There were fewer adverse reactions in the research group than there were in the control group (P<0.05). CONCLUSION: Modified Buzhong Yiqi decoction combined with Gangtai ointment for patients with circumferential mixed hemorrhoids has good short-term efficacy. It helps to promote wound healing, improves anal function, and does not increase the incidence of adverse reactions. It is worthy of promotion and application.", "provenance": [ { "field": "n", "quote": "Patients (n=120) with circumferential mixed hemorrhoids were recruited as the research cohort." }, { "field": "population", "quote": "Patients (n=120) with circumferential mixed hemorrhoids were recruited as the research cohort. All the patients underwent surgical treatment" }, { "field": "intervention", "quote": "The research group was administered modified Buzhong Yiqi decoction (1 dose a day, orally) combined with Kangtai ointment for external application (twice a day, for two consecutive weeks)." }, { "field": "comparator", "quote": "The control group was administered chitosan hydrogels for wound healing, once a day." }, { "field": "primaryOutcome", "quote": "To investigate the effects of modified Buzhong Yiqi decoction combined with Gangtai ointment on the wound healing and anal function of circumferential mixed hemorrhoid patients." }, { "field": "result", "quote": "Compared with the control group, the research group had a higher effective rate (P<0.01), a lower pain index, and a lower perianal edema score (both P<0.001), a higher quality of life score (P<0.001), a shorter wound healing time, a shorter pain resolution time, and fewer adverse reactions than the control group (both P<0.001)." } ] }, { "id": "pmid:33825411", "pmid": "33825411", "doi": null, "nctId": null, "pmcid": null, "title": "Efficacy and safety of Hemoheal cream in patients with hemorrhoids: a randomized double-blind placebo controlled clinical trial", "firstAuthor": "Mehdi", "multipleAuthors": true, "journal": "J Tradit Chin Med", "year": 2021, "design": "rct", "n": 52, "nField": "reported", "population": "patients with symptomatic hemorrhoids", "intervention": "Hemoheal cream, an herbal anti-hemorrhoid cream applied for 3 weeks", "comparator": "placebo cream", "primaryOutcome": "improvement in symptoms including anal irritation, bleeding, itching, pain, defecation discomfort, swelling, and overall subjective improvement", "result": "significant improvement in anal irritation, bleeding, pain, swelling sense, and overall subjective improvement compared to placebo, but no significant difference in anal itching or defecation discomfort", "resultDirection": "mixed", "quality": "low", "qualityWhy": "Small trial of only 52 patients over a short 3-week period makes the results easy to overturn with more evidence.", "directness": "direct", "limitations": "Small sample size, short follow-up duration of 3 weeks, and some symptoms showed no significant difference between groups.", "followUp": "3 weeks", "plainFinding": "Less bleeding and pain, mixed results.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/33825411/", "sourceText": "OBJECTIVE: To evaluate the efficacy and safety of Hemoheal cream, an anti-hemorrhoid herbal preparation, (inspired by Persian medicine literatures in a double-blind, randomized placebo-controlled trial. METHODS: Hemoheal cream consists of aqueous extract of Allium ampeloprasum L., Commiphora mukul (Hook. Ex Stocks) Engl and the oil of Sesamum indicum L. Fifty-two patients with symptomatic hemorrhoids were randomized to receive hemoheal cream or placebo for 3 weeks. The patients were evaluated before and after the intervention in terms of the severity of anal irritation, bleeding, anal itching, pain, defecation discomfort and swelling sense, and overall subjective improvement (%), as well as any reported adverse events. RESULTS: The results showed that after 3 weeks of treatment, distribution of anal irritation, bleeding, pain as well as swelling sense were significantly different (P < 0.05), while the analysis showed no significant differences between two groups for anal itching and defecation discomfort (P > 0.05). Furthermore, a significant difference was observed between the overall subjective improvement of Hemoheal cream and placebo groups (P = 0.012). One patient in the treatment group complained of rashes on the application site. CONCLUSION: The present study showed a positive effect of Hemoheal cream in improving clinical signs and symptoms in patients with hemorrhoids.", "provenance": [ { "field": "n", "quote": "Fifty-two patients with symptomatic hemorrhoids were randomized to receive hemoheal cream or placebo for 3 weeks." }, { "field": "population", "quote": "Fifty-two patients with symptomatic hemorrhoids" }, { "field": "intervention", "quote": "Hemoheal cream, an anti-hemorrhoid herbal preparation" }, { "field": "comparator", "quote": "randomized to receive hemoheal cream or placebo for 3 weeks" }, { "field": "primaryOutcome", "quote": "evaluated before and after the intervention in terms of the severity of anal irritation, bleeding, anal itching, pain, defecation discomfort and swelling sense, and overall subjective improvement" }, { "field": "result", "quote": "distribution of anal irritation, bleeding, pain as well as swelling sense were significantly different (P < 0.05), while the analysis showed no significant differences between two groups for anal itching and defecation discomfort (P > 0.05)" }, { "field": "followUp", "quote": "for 3 weeks" } ] }, { "id": "pmid:33683221", "pmid": "33683221", "doi": "10.23750/abm.v92i1.11309", "nctId": null, "pmcid": "PMC7975930", "title": "The effect of sucralfate-containing ointment on quality of life in people with symptoms associated with haemorrhoidal disease and its complications: the results of the EMOCARE survey", "firstAuthor": "Giua", "multipleAuthors": true, "journal": "Acta Biomed", "year": 2021, "design": "prospective-cohort", "n": 290, "nField": "reported", "population": "adults with hemorrhoid symptoms in the past week seeking treatment at pharmacies in Italy", "intervention": "sucralfate ointment with herbal extracts", "comparator": "no comparison group (before-and-after treatment)", "primaryOutcome": "change in quality of life score related to hemorrhoid symptoms", "result": "quality of life scores and symptom frequency significantly improved after about 13 days of treatment, with 39.4% symptom-free", "resultDirection": "benefit", "quality": "low", "qualityWhy": "this was an uncontrolled survey with no placebo or comparison group, so improvement could be due to natural healing or other factors, not just the cream.", "directness": "indirect", "limitations": "no control group; survey design with self-reported outcomes; short follow-up", "followUp": "~14 days (mean 13 days)", "plainFinding": "Symptoms and quality of life improved.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/33683221/", "sourceText": "BACKGROUND AND AIM: A rectal ointment containing 3% of sucralfate and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile), became available in Italy in 2019 for the treatment of symptoms associated with haemorrhoidal disease. This survey evaluated the effect of the mentioned sucralfate ointment, on quality of life (QoL) and symptom frequency in participants seeking treatment for haemorrhoidal disease from community pharmacies in Italy. METHODS: EMOCARE was a multicentre prospective survey conducted at community pharmacies in Italy. Eligible participants (≥18 years) were those with haemorrhoidal symptoms in the last 7 days and were willing to initiate a treatment with the sucralfate ointment and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile). A survey was administered by the investigating pharmacists at the beginning and end (~14 days) of treatment. The primary endpoint was the change in HEMO-FISS-QoL scores. RESULTS: Of the 290 (mean age 53.1 years old; 58.3% female) enrolled, 287 attended the follow-up visit. After a mean duration of 13 days, the sucralfate ointment significantly improved total HEMO-FISS-QoL scores (mean change from baseline: -10.41; 95%CI -11.95, -8.86; P<0.001) and mean scores for all domains of the HEMO-FISS-QoL scale (-11.13 [95%CI -12.95, -9.30] for physical disorders, -6.14 [95%CI -7.42, -4.85] for psychology, -18.79 [95% CI -21.67, -15.90] for defaecation, and -6.46 [95%CI -8.40, -4.51] for sexuality; all P<0.001 versus baseline). At the end of treatment, 39.4% of participants reported that they no longer had haemorrhoidal symptoms and the frequency of all assessed symptoms were reduced significantly from baseline (all P<0.05). CONCLUSIONS: After a mean 13 days of treatment the sucralfate ointment with herbal extracts improved HEMO-FISS-QoL scores and reduced symptoms in people with haemorrhoidal disease.", "provenance": [ { "field": "population", "quote": "Eligible participants (≥18 years) were those with haemorrhoidal symptoms in the last 7 days and were willing to initiate a treatment with the sucralfate ointment and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile)." }, { "field": "intervention", "quote": "A rectal ointment containing 3% of sucralfate and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile), became available in Italy in 2019 for the treatment of symptoms associated with haemorrhoidal disease." }, { "field": "comparator", "quote": "A survey was administered by the investigating pharmacists at the beginning and end (~14 days) of treatment." }, { "field": "primaryOutcome", "quote": "The primary endpoint was the change in HEMO-FISS-QoL scores." }, { "field": "result", "quote": "the sucralfate ointment significantly improved total HEMO-FISS-QoL scores (mean change from baseline: -10.41; 95%CI -11.95, -8.86; P<0.001)" }, { "field": "result", "quote": "At the end of treatment, 39.4% of participants reported that they no longer had haemorrhoidal symptoms" }, { "field": "n", "quote": "Of the 290 (mean age 53.1 years old; 58.3% female) enrolled, 287 attended the follow-up visit." } ] }, { "id": "pmid:33087033", "pmid": "33087033", "doi": "10.2174/1574887115666201021150144", "nctId": null, "pmcid": null, "title": "Conservative Treatment of Hemorrhoidal Disease", "firstAuthor": "Stratta", "multipleAuthors": true, "journal": "Rev Recent Clin Trials", "year": 2021, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with hemorrhoidal disease (early stages)", "intervention": "conservative treatments including topical medications (creams), diet/lifestyle changes, and oral phlebotonic drugs", "comparator": "not specified", "primaryOutcome": "symptom control / management of hemorrhoidal disease", "result": "Topical medications were described as potentially beneficial, especially during flare-ups or after surgery, but the review found very few controlled trials to confirm real benefit", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "This is a narrative review that itself says most evidence is from uncontrolled case series with very few randomized trials, so no reliable conclusion can be drawn.", "directness": "indirect", "limitations": "Abstract states very few randomized controlled trials exist and most studies are uncontrolled case series; it does not report specific data on cream reducing size or bleeding.", "followUp": "", "plainFinding": "Not enough solid evidence either way.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/33087033/", "sourceText": "BACKGROUND: Hemorrhoids are vascular cushions underlying the distal rectal mucosa and contributing to approximately 15-20% of the resting anal pressure with a complete closure of the anal canal. They can become pathological (hemorrhoidal disease, HD) being the most common cause of painless rectal bleeding during defecation with or without prolapsing anal tissue. The treatment of HD must be tailored to both the severity of disease and patient's expectation. METHODS: A narrative review of all the most relevant papers present on the three major databases (PUBMED, EMBASE and WEB OF SCIENCE) regarding conservative treatment was conducted. RESULTS: Conservative treatment is effective in managing the majority of patients complaining of early stages of the disease. Dietary and lifestyle modifications are the first therapeutic step necessary to achieve a regular defecation with soft stool whereas oral phlebotonic drugs can help to control symptoms. The use of topical medications, particularly during the acute phase or in the post-operative period can also be beneficial for all patients complaining of HD. CONCLUSION: Despite a large number of available products in the market and the high incidence of HD, very few randomized controlled trials have been carried out and most of the studies are uncontrolled case series. Larger and better designed studies are necessary to establish the real benefit of all types of drugs for the treatment of early stages of HD.", "provenance": [ { "field": "population", "quote": "patients complaining of early stages of the disease" }, { "field": "intervention", "quote": "The use of topical medications, particularly during the acute phase or in the post-operative period can also be beneficial for all patients complaining of HD." }, { "field": "result", "quote": "very few randomized controlled trials have been carried out and most of the studies are uncontrolled case series" }, { "field": "primaryOutcome", "quote": "Conservative treatment is effective in managing the majority of patients complaining of early stages of the disease." }, { "field": "comparator", "quote": "Conservative treatment is effective in managing the majority of patients complaining of early stages of the disease." } ] }, { "id": "pmid:32687958", "pmid": "32687958", "doi": "10.1016/j.jep.2020.113143", "nctId": null, "pmcid": null, "title": "From nutrition to medicine: Assessing hemorrhoid healing activity of Solanum melongena L. via in vivo experimental models and its major chemicals", "firstAuthor": "Dönmez", "multipleAuthors": true, "journal": "J Ethnopharmacol", "year": 2020, "design": "animal", "n": null, "nField": "not-reported", "population": "rats with croton oil-induced hemorrhoids", "intervention": "eggplant (Solanum melongena) methanolic extract", "comparator": "commercial Pilex tablet and cream, and controls", "primaryOutcome": "healing of hemorrhoids measured by tissue and blood tests", "result": "eggplant extract was highly effective against hemorrhoid in comparison to the controls and the commercial preparation", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This was an animal study using a chemically induced hemorrhoid model, not a human trial, so it cannot show whether hemorrhoid cream works in people.", "directness": "indirect", "limitations": "Study was conducted in rats, not humans, with no participant numbers reported and no mention of blinding or randomization.", "followUp": "", "plainFinding": "Helped hemorrhoids in rats, not humans.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/32687958/", "sourceText": "ETHNOPHARMACOLOGICAL RELEVANCE: Solanum melongena L. (eggplant) is used for treatment of rheumatism, beriberi, itching, toothache, bleeding, asthma, bronchitis, cholera, neuralgia and hemorrhoids in traditional medicine (Turkish, Chinese, and Indian). Hemorrhoids from these diseases, are common illness in all over the world, which are treated with various approaches including ethnobotanicals. AIM OF THE STUDY: This study aimed to evaluate the anti-hemorrhoidal activity of eggplant, an edible plant, which is commonly utilized around the world. MATERIALS & METHODS: In vivo anti-hemorrhoidal activity of the methanolic extract prepared from eggplant was evaluated by experimental hemorrhoid model, subsequently histological and biochemical analysis. Hemorrhoid, which was induced by applying croton oil to the anal area of the rats. Furthermore, the extract was screened for anti-inflammatory activity which is based on the inhibition of acetic acid-induced increase in capillary permeability. The healing potential was comparatively assessed with a reference Pilex® tablet and cream. Phytochemical analysis performed by HPLC. The amount of the major phenolic compound (chlorogenic acid) in extract was found by using HPLC method. RESULTS: Histological and biochemical analysis demonstrated that eggplant extract is highly effective against hemorrhoid in comparison to the controls and the commercial preparation. In addition, the methanolic extract demonstrated significant inhibitory effect on acetic acid-induced increase in capillary permeability. The phytochemical studies identified major compound as chlorogenic acid (2.86%) by liquid chromatography. CONCLUSION: The eggplant calyxes, not edible, are easy to reach, by products/vast from the food sources. This is the first scientific evidence revealing that the eggplant extract has significant anti-hemorrhoidal and anti-inflammatory activity.", "provenance": [ { "field": "population", "quote": "Hemorrhoid, which was induced by applying croton oil to the anal area of the rats." }, { "field": "intervention", "quote": "In vivo anti-hemorrhoidal activity of the methanolic extract prepared from eggplant was evaluated" }, { "field": "comparator", "quote": "The healing potential was comparatively assessed with a reference Pilex® tablet and cream." }, { "field": "primaryOutcome", "quote": "evaluated by experimental hemorrhoid model, subsequently histological and biochemical analysis" }, { "field": "result", "quote": "eggplant extract is highly effective against hemorrhoid in comparison to the controls and the commercial preparation" } ] }, { "id": "pmid:32316899", "pmid": "32316899", "doi": "10.2174/1574887115666200421110107", "nctId": null, "pmcid": null, "title": "Safety and Efficacy of Proctosoll Allevia in the Management of Haemorrhoidal Disease in Adults: A Prospective Randomized Clinical Trial", "firstAuthor": "Sturiale", "multipleAuthors": true, "journal": "Rev Recent Clin Trials", "year": 2020, "design": "rct", "n": 45, "nField": "reported", "population": "adults with first or second degree hemorrhoids with symptoms", "intervention": "Proctosoll Allevia cream applied topically, plus controlled diet", "comparator": "controlled diet alone, no treatment", "primaryOutcome": "improvement in hemorrhoid symptoms within 14 days", "result": "significantly greater symptom improvement with the cream than with diet alone within 14 days, no major side effects", "resultDirection": "benefit", "quality": "low", "qualityWhy": "Very small study with unclear blinding and no detail on how symptoms were measured, so the result is not very reliable.", "directness": "direct", "limitations": "Small sample size (45 patients), short study period (one month of enrollment), no mention of blinding, and the abstract does not describe how symptom improvement was measured.", "followUp": "14 days", "plainFinding": "Faster symptom relief with cream.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/32316899/", "sourceText": "INTRODUCTION: Hemorrhoidal Disease (HD) is a very common anorectal disorder that affects millions of people around the world and represents a major medical and socioeconomic problem. The aim of the present study was to assess the safety and efficacy of Proctosoll Allevia® in patients affected by symptomatic HD in comparison with the results obtained from a control group. MATERIALS AND METHODS: From January to February 2019, all the patients referred to the outpatient clinic of Rajalakshmi Hospital, who were complaining of first or second degree hemorrhoidal symptoms, were enrolled in the study. They were randomly assigned to either of the 2 arms. Group 1: patients were treated with the Proctosoll Allevia® and were under a controlled diet. Group 2: patients were only under a controlled diet without any treatment - control group. RESULTS: A total of 51 subjects were screened and 45 (13 F- 32 M) enrolled in the study. All the patients treated with topical application of the cream showed a statistically significant improvement of symptoms within 14 days from the beginning of the therapy if compared to patients who were treated only with a controlled diet. No major adverse events associated with the use of the new product were recorded. CONCLUSION: The treatment of I-II degree symptomatic HD with Proctosoll Allevia® has demonstrated to be promising with a good profile of tolerability, safety and efficacy.", "provenance": [ { "field": "n", "quote": "45 (13 F- 32 M) enrolled in the study" }, { "field": "population", "quote": "patients affected by symptomatic HD" }, { "field": "population", "quote": "complaining of first or second degree hemorrhoidal symptoms" }, { "field": "intervention", "quote": "treated with the Proctosoll Allevia® and were under a controlled diet" }, { "field": "comparator", "quote": "patients were only under a controlled diet without any treatment - control group" }, { "field": "primaryOutcome", "quote": "statistically significant improvement of symptoms within 14 days" }, { "field": "result", "quote": "All the patients treated with topical application of the cream showed a statistically significant improvement of symptoms within 14 days from the beginning of the therapy if compared to patients who were treated only with a controlled diet." }, { "field": "result", "quote": "No major adverse events associated with the use of the new product were recorded." } ] }, { "id": "pmid:32191669", "pmid": "32191669", "doi": "10.23750/abm.v91i1.9361", "nctId": null, "pmcid": "PMC7569574", "title": "Treatment of haemorrhoidal disease with micronized purified flavonoid fraction and sucralfate ointment", "firstAuthor": "Amaturo", "multipleAuthors": true, "journal": "Acta Biomed", "year": 2020, "design": "case-series", "n": 3, "nField": "reported", "population": "people with hemorrhoidal disease", "intervention": "combined oral micronized purified flavonoid fraction (MPFF) and a sucralfate rectal ointment with herbal extracts (calendula, witch hazel, chamomile)", "comparator": "none reported", "primaryOutcome": "pain, itching, and swelling (edema)", "result": "good results in pain and itching control and reduction of edema", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This is a tiny report of only three patients with no comparison group, so it can't reliably show the treatment works.", "directness": "indirect", "limitations": "Only three cases, no control group, and treatment combined an oral drug with a topical ointment so the cream's individual effect isn't clear.", "followUp": "", "plainFinding": "Less pain and swelling reported.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/32191669/", "sourceText": "Hemorrhoidal disease is a very common disease characterized by the presence of a mucous prolapse of the rectum and by varicosis of the hemorrhoidal plexus. Medical therapy is mainly indicated for the treatment of symptoms such as bleeding, pain and itching. The use of the micronized purified flavonoid fraction (MPFF) has proven to be effective in treating symptoms of hemorrhoidal disease. Topical use of sucralfate has shown good results in the reduction of hemorrhoidal pain and itching. Our experience with three cases treated with combined use of MPFF and a topical medical device in the form of rectal ointment, composed by sucralfate and herbal (calendula, witch hazel leaf (hamamelis), chamomile) extracts, has shown good results in terms of pain and itching control and in edema reduction.", "provenance": [ { "field": "n", "quote": "three cases" }, { "field": "population", "quote": "Hemorrhoidal disease is a very common disease characterized by the presence of a mucous prolapse of the rectum and by varicosis of the hemorrhoidal plexus." }, { "field": "intervention", "quote": "combined use of MPFF and a topical medical device in the form of rectal ointment, composed by sucralfate and herbal (calendula, witch hazel leaf (hamamelis), chamomile) extracts" }, { "field": "comparator", "quote": "Our experience with three cases treated with combined use of MPFF and a topical medical device" }, { "field": "primaryOutcome", "quote": "good results in terms of pain and itching control and in edema reduction" }, { "field": "result", "quote": "has shown good results in terms of pain and itching control and in edema reduction" } ] }, { "id": "pmid:32038023", "pmid": "32038023", "doi": null, "nctId": null, "pmcid": null, "title": "Relief of hemorrhoid symptoms: pilot study of a new topical ally", "firstAuthor": "Gaj", "multipleAuthors": true, "journal": "G Chir", "year": 2020, "design": "case-series", "n": 48, "nField": "reported", "population": "patients with grade I-III hemorrhoids", "intervention": "a new ointment (Hemolen®) applied twice daily for 30 days", "comparator": "no comparison group; symptoms measured before and after treatment in the same patients", "primaryOutcome": "hemorrhoid symptom severity scores (bleeding, discomfort, itching, edema, thrombosis, congestion, inflammation, pain) and resting anal pressure", "result": "severity scores and resting anal pressure significantly decreased from baseline through follow-up visits", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "this was a small uncontrolled pilot study without a comparison group, so improvements can't be separated from natural healing or placebo effect.", "directness": "direct", "limitations": "no control group; pilot study design; authors state randomized controlled trials are needed to confirm results", "followUp": "30 days", "plainFinding": "Symptoms improved, but no control group.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/32038023/", "sourceText": "AIM: The pathogenesis of hemorrhoids involves vascular congestion, fragmentation of supporting tissues and, in many cases, increased resting anal pressure. A new ointment (Hemolen®) has been devised to control hemorrhoids symptoms acting on all the pathophysiologic mechanisms involved. METHODS: Pilot study on patients with grade I-III hemorrhoids. The ointment was applied twice daily for 30 days and follow-up visits were scheduled 7 days (T1), 14 days (T2) and 30 days (T3) after recruitment (T0). Signs and symptoms (bleeding, discomfort, itching, edema, thrombosis, congestion, inflammation, pain) were evaluated at each visit using dedicated scores and VAS scale. Resting anal pressure was measured at time T0, 1 hour after the first application and at T1. Use of painkiller was recorded. RESULTS: 48 patients (25 females; mean age 47±15.8 years) were enrolled; 52.1% of them had II degree hemorrhoids and 27.1% had III degree hemorrhoids. The severity scores significantly dropped from T0 to each scheduled visit and a significant reduction of resting anal pressure was observed from T0 to 1 hour after application (z=13.5; p<0.001) and from T0 to T1 (z=6; p<0.001). The comparison of the resting pressure among whole time series showed a significant reduction (Fr=124.4; p=<0.001). Use of pain-killers decreased significantly from T0 to T1 (p<0.001) and from T1 to T2 (p=0.001). CONCLUSION: The new ointment tested in the present study is safe and effective for the management of hemorrhoid symptoms in the early stages hemorrhoids, during the acute phases and in patients with more severe hemorrhoids awaiting surgery. Prospective, randomized controlled trials are needed to confirm these encouraging results.", "provenance": [ { "field": "n", "quote": "48 patients (25 females; mean age 47±15.8 years) were enrolled" }, { "field": "population", "quote": "Pilot study on patients with grade I-III hemorrhoids." }, { "field": "intervention", "quote": "The ointment was applied twice daily for 30 days" }, { "field": "comparator", "quote": "follow-up visits were scheduled 7 days (T1), 14 days (T2) and 30 days (T3) after recruitment (T0)" }, { "field": "primaryOutcome", "quote": "Signs and symptoms (bleeding, discomfort, itching, edema, thrombosis, congestion, inflammation, pain) were evaluated at each visit using dedicated scores and VAS scale." }, { "field": "result", "quote": "The severity scores significantly dropped from T0 to each scheduled visit and a significant reduction of resting anal pressure was observed from T0 to 1 hour after application (z=13.5; p<0.001) and from T0 to T1 (z=6; p<0.001)." }, { "field": "limitations", "quote": "Prospective, randomized controlled trials are needed to confirm these encouraging results." } ] }, { "id": "pmid:31894930", "pmid": "31894930", "doi": null, "nctId": null, "pmcid": null, "title": "Benign Anorectal Conditions: Evaluation and Management", "firstAuthor": "Cohee", "multipleAuthors": true, "journal": "Am Fam Physician", "year": 2020, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "Common anorectal conditions include hemorrhoids, perianal pruritus, anal fissures, functional rectal pain, perianal abscess, condyloma, rectal prolapse, and fecal incontinence.", "intervention": "The primary treatment for hemorrhoids is fiber supplementation.", "comparator": "Patients who do not improve and those with large high-grade hemorrhoids should be referred for surgery.", "primaryOutcome": "", "result": "The primary treatment for hemorrhoids is fiber supplementation. Patients who do not improve and those with large high-grade hemorrhoids should be referred for surgery. Acutely thrombosed external hemorrhoids should be excised.", "resultDirection": "unclear", "quality": "low", "qualityWhy": "This is a general overview article for physicians, not a study that tests whether a cream shrinks hemorrhoids or stops bleeding.", "directness": "indirect", "limitations": "The abstract does not describe hemorrhoid cream as a treatment at all, and gives no data, methods, or numbers for any intervention.", "followUp": "", "plainFinding": "Fiber, not cream, is main treatment.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/31894930/", "sourceText": "Common anorectal conditions include hemorrhoids, perianal pruritus, anal fissures, functional rectal pain, perianal abscess, condyloma, rectal prolapse, and fecal incontinence. Although these are benign conditions, symptoms can be similar to those of cancer, so malignancy should be considered in the differential diagnosis. History and examination, including anoscopy, are usually sufficient for diagnosing these conditions, although additional testing is needed in some situations. The primary treatment for hemorrhoids is fiber supplementation. Patients who do not improve and those with large high-grade hemorrhoids should be referred for surgery. Acutely thrombosed external hemorrhoids should be excised. Perianal pruritus should be treated with hygienic measures, barrier emollients, and low-dose topical corticosteroids. Capsaicin cream and tacrolimus ointment are effective for recalcitrant cases. Treatment of acute anal fissures with pain and bleeding involves adequate fluid and fiber intake. Chronic anal fissures should be treated with topical nitrates or calcium channel blockers, with surgery for patients who do not respond to medical management. Patients with functional rectal pain should be treated with warm baths, fiber supplementation, and biofeedback. Patients with superficial perianal abscesses not involving the sphincter should undergo office-based drainage; patients with more extensive abscesses or possible fistulas should be referred for surgery. Condylomata can be managed with topical medicines, excision, or destruction. Patients with rectal prolapse should be referred for surgical evaluation. Biofeedback is a first-line treatment for fecal incontinence, but antidiarrheal agents are useful if diarrhea is involved, and fiber and laxatives may be used if impaction is present. Colostomy can help improve quality of life for patients with severe fecal incontinence.", "provenance": [ { "field": "population", "quote": "Common anorectal conditions include hemorrhoids, perianal pruritus, anal fissures, functional rectal pain, perianal abscess, condyloma, rectal prolapse, and fecal incontinence." }, { "field": "intervention", "quote": "The primary treatment for hemorrhoids is fiber supplementation." }, { "field": "comparator", "quote": "Patients who do not improve and those with large high-grade hemorrhoids should be referred for surgery." }, { "field": "result", "quote": "The primary treatment for hemorrhoids is fiber supplementation." }, { "field": "result", "quote": "Patients who do not improve and those with large high-grade hemorrhoids should be referred for surgery." }, { "field": "result", "quote": "Acutely thrombosed external hemorrhoids should be excised." } ] }, { "id": "pmid:31555338", "pmid": "31555338", "doi": "10.7573/dic.212602", "nctId": null, "pmcid": "PMC6752749", "title": "Hemorrhoid management in women: the role of tribenoside + lidocaine", "firstAuthor": "Kestřánek", "multipleAuthors": false, "journal": "Drugs Context", "year": 2019, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "women with hemorrhoids, including postpartum and pregnant women", "intervention": "tribenoside + lidocaine cream or suppository (Procto-Glyvenol)", "comparator": "", "primaryOutcome": "relief of hemorrhoid symptoms (subjective and objective)", "result": "review states the combination improved symptoms and relieved them quickly, based on cited studies", "resultDirection": "benefit", "quality": "low", "qualityWhy": "this is a narrative review discussing a branded product without presenting its own trial data or numbers.", "directness": "direct", "limitations": "abstract does not describe study methods, sample sizes, or statistical results; it is a review summarizing other studies.", "followUp": "not reported", "plainFinding": "Review claims fast symptom relief.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/31555338/", "sourceText": "Hemorrhoids are commonly reported in women. However, despite the high prevalence of hemorrhoids in women and the major impact of this condition on quality of life, specific evidence and recommendations on the treatment of hemorrhoids in women are scant. This paper reviews various options in current therapy for hemorrhoids in women-namely, medical intervention (topical and systemic drug therapy)-and discusses the available clinical evidence for an appropriate use of over-the-counter topical formulations for the symptomatic treatment of hemorrhoids. Its focus is on a medical preparation containing tribenoside + lidocaine, available as a rectal cream (tribenoside 5%/lidocaine 2%) and a suppository (tribenoside 400 mg/lidocaine 40 mg) and marketed under the brand Procto-Glyvenol® (Recordati, SpA, Italy). Given its rapid comprehensive efficacy on all the different symptoms of hemorrhoids, the tribenoside + lidocaine combination can find a place in the treatment of this hemorrhoidal disease. Importantly, its efficacy and tolerability have been formally evaluated in several well-conducted studies, some of which were specifically conducted in women. In particular, tribenoside + lidocaine can be safely administered in postpartum women and in pregnant women after the first trimester of pregnancy. In pregnant women, the tribenoside/lidocaine combination significantly improved both subjective and objective symptoms of hemorrhoids. Fast onset of symptom relief was reported from 10 minutes after administration, lasting up to 10-12 hours. On these bases, tribenoside + lidocaine can represent a fast, effective, and safe option to treat hemorrhoids when conservative therapy is indicated, and it deserves consideration as a first-line treatment of this disease in clinical practice.", "provenance": [ { "field": "population", "quote": "Hemorrhoids are commonly reported in women." }, { "field": "intervention", "quote": "a medical preparation containing tribenoside + lidocaine, available as a rectal cream (tribenoside 5%/lidocaine 2%) and a suppository (tribenoside 400 mg/lidocaine 40 mg)" }, { "field": "primaryOutcome", "quote": "In pregnant women, the tribenoside/lidocaine combination significantly improved both subjective and objective symptoms of hemorrhoids." }, { "field": "result", "quote": "Fast onset of symptom relief was reported from 10 minutes after administration, lasting up to 10-12 hours." } ] }, { "id": "pmid:31551227", "pmid": "31551227", "doi": null, "nctId": null, "pmcid": null, "title": "Clinical study of external application of liuhe dan in the treatment of anal edge edema after mixed hemorrhoid operation", "firstAuthor": "Wu", "multipleAuthors": true, "journal": "Pak J Pharm Sci", "year": 2019, "design": "prospective-cohort", "n": 160, "nField": "reported", "population": "patients with anal edge swelling (edema) after surgery for mixed hemorrhoids", "intervention": "external application of Liuhe Dan (a topical traditional medicine) on the swollen area", "comparator": "routine post-operative nursing care", "primaryOutcome": "anal edge edema score and wound pain score after surgery", "result": "the treatment group had significantly lower edema and pain scores, and shorter hospital stay and wound healing time than the control group", "resultDirection": "benefit", "quality": "low", "qualityWhy": "the study does not say whether patients were randomly assigned or whether anyone was blinded, so bias cannot be ruled out.", "directness": "indirect", "limitations": "abstract does not mention randomization, blinding, or how edema/pain were scored, and it studies post-surgical swelling rather than un-operated hemorrhoid shrinkage or bleeding.", "followUp": "", "plainFinding": "Less swelling and pain after surgery.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/31551227/", "sourceText": "To observe the therapeutic efficacy of external application of Liuhe Dan in the treatment of anal edge edema after mixed hemorrhoid operation. A total of 160 patients who had been treated for lotion anal edge edema from January 2016 to August 2018 were enrolled research ojbects. They were divided into control group accepting routine nursing methods (80 cases) and research group accepting external application of Liuhe Dan (80 cases). The therapeutic efficacies of two groups were compared. The anal edge edema score and wound pain score of the research group were significantly lower than those of the control group (p<0.05). Meanwhile, the length of hospital stay and wound healing time of the research group were significantly shorter than those of the control group (p<0.05). External application of Liuhe Dan in the treatment of anal edge edema after mixed hemorrhoid operation could significantly improve the therapeutic efficacy and alleviate the patient's pain, which is of great application value.", "provenance": [ { "field": "n", "quote": "A total of 160 patients" }, { "field": "population", "quote": "patients who had been treated for lotion anal edge edema" }, { "field": "intervention", "quote": "external application of Liuhe Dan" }, { "field": "comparator", "quote": "control group accepting routine nursing methods" }, { "field": "primaryOutcome", "quote": "anal edge edema score and wound pain score" }, { "field": "result", "quote": "The anal edge edema score and wound pain score of the research group were significantly lower than those of the control group (p<0.05)." } ] }, { "id": "pmid:31433782", "pmid": "31433782", "doi": "10.1515/jcim-2018-0147", "nctId": null, "pmcid": null, "title": "Comparison of the effect of Myrtus communis herbal and anti-hemorrhoid ointments on the hemorrhoid symptoms and quality of life in postpartum women with grade I and II internal hemorrhoid: A triple-blinded randomized controlled clinical trial", "firstAuthor": "Malekuti", "multipleAuthors": true, "journal": "J Complement Integr Med", "year": 2019, "design": "rct", "n": 134, "nField": "reported", "population": "postpartum women with grade I and II internal hemorrhoids", "intervention": "Myrtus communis herbal ointment applied rectally twice daily for 4 weeks", "comparator": "standard anti-hemorrhoid ointment applied the same way", "primaryOutcome": "severity of hemorrhoid symptoms and quality of life", "result": "Both ointments reduced hemorrhoid symptoms with no significant difference between them, except itching was lower with the herbal ointment and satisfaction was higher", "resultDirection": "no-benefit", "quality": "moderate", "qualityWhy": "It was a triple-blind randomized trial with a reasonable sample size, but it compared two active creams rather than a placebo, so it cannot show whether either cream works better than no treatment.", "directness": "indirect", "limitations": "No placebo or untreated comparison group was used, so it's unclear if either ointment outperforms no treatment at all.", "followUp": "8 weeks", "plainFinding": "Both creams eased symptoms similarly.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/31433782/", "sourceText": "Introduction Due to the effects of hemorrhoids on physical and mental health, this study aimed to compare the effect of Myrtus communis herbal and anti-hemorrhoid ointments on symptoms of hemorrhoid and quality of life (primary outcomes) and satisfaction of the treatment and side effects (secondary outcomes). Methods This triple-blind randomized controlled trial was performed on women with grade I and II hemorrhoid referring to health centers in Tehran, Iran, in 2017. Individuals were randomly assigned to two groups of 67 people through block randomization method. The intervention group received the Myrtus communis herbal ointment and the control group received anti-hemorrhoid ointment twice a day, every 12 ± 2 h, an applicator of the drug through the rectum for 4 weeks. The Colorectal Evaluation of a Clinical Therapeutics Scale (CORECTS) was used to assess the severity of symptoms of hemorrhoid. To assess the quality of life, the World Health Organization Quality of Life questionnaire (WHOQOL-BREF) was used to measure the general quality of life of participants. This questionnaire was completed once before the start of the study, then on the fourth and the eighth week after the start of the intervention. Repeated measure ANOVA, Chi-square, Mann-Whitney U and independent t-test were used for data analysis. Results The severity of all symptoms of hemorrhoid decreased in both two group and there was no statistically significant difference between the two groups (p>0.05). However, the mean of anal itching at 4 and 8 weeks after the intervention was significantly lower in the Myrtus communis ointment group (p<0.05). There was no significant difference between groups in terms of quality of life at 4 and 8 weeks after the intervention (p>0.05). There was a significant difference between the two groups in terms of satisfaction with the drug (p=0.019) and the participants in the Myrtus communis ointment group were more satisfied with their drug use. Conclusions Myrtus communis herbal ointment was able to reduce the symptoms of hemorrhoid in the affected women. Therefore, it is likely that the use of this drug will promote the health of mothers with hemorrhoid.", "provenance": [ { "field": "population", "quote": "women with grade I and II hemorrhoid referring to health centers in Tehran, Iran" }, { "field": "n", "quote": "randomly assigned to two groups of 67 people through block randomization method" }, { "field": "intervention", "quote": "The intervention group received the Myrtus communis herbal ointment" }, { "field": "comparator", "quote": "the control group received anti-hemorrhoid ointment twice a day" }, { "field": "primaryOutcome", "quote": "to compare the effect of Myrtus communis herbal and anti-hemorrhoid ointments on symptoms of hemorrhoid and quality of life (primary outcomes)" }, { "field": "result", "quote": "The severity of all symptoms of hemorrhoid decreased in both two group and there was no statistically significant difference between the two groups (p>0.05)." }, { "field": "result", "quote": "the mean of anal itching at 4 and 8 weeks after the intervention was significantly lower in the Myrtus communis ointment group (p<0.05)" } ] }, { "id": "pmid:30591198", "pmid": "30591198", "doi": "10.1016/j.rgmx.2018.10.001", "nctId": null, "pmcid": null, "title": "Randomized clinical trial with topical diltiazem for post-hemorrhoidectomy wound healing", "firstAuthor": "Rodríguez-Wong", "multipleAuthors": true, "journal": "Rev Gastroenterol Mex (Engl Ed)", "year": 2019, "design": "rct", "n": 52, "nField": "reported", "population": "patients who had surgery to remove hemorrhoids (closed hemorrhoidectomy)", "intervention": "topical diltiazem cream applied to the anal area three times a day", "comparator": "placebo cream", "primaryOutcome": "time for the surgical wound to heal", "result": "wounds healed faster with diltiazem (about 3.19 weeks) than with placebo (about 3.92 weeks), and more patients had healed by week three with diltiazem", "resultDirection": "benefit", "quality": "low", "qualityWhy": "it is a small double-blind randomized trial of only 52 people studying wound healing after hemorrhoid surgery, not whether cream shrinks hemorrhoids or stops bleeding in people who haven't had surgery.", "directness": "indirect", "limitations": "small sample size (26 per group); studies a different population (post-surgical wound healing) and different outcome than shrinking hemorrhoids or stopping bleeding in unoperated hemorrhoids.", "followUp": "6 weeks", "plainFinding": "Faster wound healing after hemorrhoid surgery.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/30591198/", "sourceText": "Anal sphincter spasm contributes to the delay in surgical wound healing after hemorrhoidectomy. A prospective, experimental, randomized, double-blind trial was conducted on two groups of patients that underwent closed hemorrhoidectomy. There were 26 patients in each group. Group A received topical diltiazem in the anal region three times a day. Group B received a placebo. Cicatrization time was documented for 6 weeks through digital photography. Mean healing time for the group treated with diltiazem was 3.19 weeks (22.33±0.884 days) and 3.92 weeks (27.44±1.130 days) for the control group (p=0.012 95% CI). At week three, the wounds in 73.07% of the patients in the diltiazem group had healed, compared with 46.15% of the patients in the control group.", "provenance": [ { "field": "population", "quote": "two groups of patients that underwent closed hemorrhoidectomy" }, { "field": "n", "quote": "There were 26 patients in each group." }, { "field": "intervention", "quote": "Group A received topical diltiazem in the anal region three times a day." }, { "field": "comparator", "quote": "Group B received a placebo." }, { "field": "primaryOutcome", "quote": "Cicatrization time was documented for 6 weeks through digital photography." }, { "field": "result", "quote": "Mean healing time for the group treated with diltiazem was 3.19 weeks (22.33±0.884 days) and 3.92 weeks (27.44±1.130 days) for the control group (p=0.012 95% CI)." }, { "field": "followUp", "quote": "Cicatrization time was documented for 6 weeks through digital photography." } ] }, { "id": "pmid:30192331", "pmid": "30192331", "doi": "10.1097/DCR.0000000000001193", "nctId": null, "pmcid": null, "title": "The Effect of Nonoperative Management of Chronic Anal Fissure and Hemorrhoid Disease on Bowel Function Patient-Reported Outcomes", "firstAuthor": "Wilson", "multipleAuthors": true, "journal": "Dis Colon Rectum", "year": 2018, "design": "prospective-cohort", "n": 64, "nField": "reported", "population": "patients with chronic anal fissures or hemorrhoid disease", "intervention": "dietary counseling with fiber supplementation, toileting strategies (plus topical calcium channel blockers for fissure patients only)", "comparator": "same patients' scores before treatment (no separate control group)", "primaryOutcome": "change in patient-reported bowel function scores", "result": "hemorrhoid disease patients showed statistically significant improvement in incontinence and stool-related aspects of bowel function scores", "resultDirection": "benefit", "quality": "low", "qualityWhy": "This was a small, uncontrolled observational study without a comparison group, and the researchers were unsure if patients even followed the treatment as prescribed.", "directness": "indirect", "limitations": "This study was limited by the small cohort size and unclear patient adherence to medical management.", "followUp": "", "plainFinding": "Diet and fiber improved bowel symptoms, not cream.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/30192331/", "sourceText": "BACKGROUND: Nonoperative management has been reported to decrease symptoms from common anorectal conditions such as chronic anal fissures and hemorrhoids. The effects of these interventions on bowel function are unknown. OBJECTIVE: This study aims to perform a prospective evaluation of patient-reported outcomes of bowel function on nonoperative management for chronic anal fissures and hemorrhoid disease. DESIGN: This is a prospective, observational study. SETTINGS: Patient-reported outcome measures were collected from the clinical practice of the division of colon and rectal surgery at a tertiary colon and rectal surgery referral center. INTERVENTION: All patients received standardized dietary counseling including fiber supplementation as well as toileting strategies. Those with chronic anal fissures were also prescribed topical calcium channel blockers. The Colorectal Functional Outcome questionnaire was administered at baseline and at first follow-up visit. MAIN OUTCOME MEASURES: The primary outcomes measured were the mean change in patient-reported bowel function scores after nonoperative management for each disease and in aggregate. RESULTS: A cohort of 64 patients was included, 37 patients (58%) with chronic anal fissure and 27 patients with hemorrhoid disease. Incontinence, social impact, stool-related aspects, and the global score were observed to have statistically significant improvement in the aggregate group. When analyzed by diagnosis, hemorrhoid disease demonstrated a statistically significant improvement in incontinence and stool-related aspects, whereas chronic anal fissure was associated with a statistically significant change in social impact, stool-related aspects, and the global score. LIMITATIONS: This study was limited by the small cohort size and unclear patient adherence to medical management. CONCLUSIONS: Nonoperative management of chronic anal fissures and hemorrhoid disease is associated with significant improvement in patient-reported outcome scores in several domains, suggesting that dietary counseling and medical therapy should be the first-line outpatient therapy for these diseases. See Video Abstract at http://links.lww.com/DCR/A726.", "provenance": [ { "field": "n", "quote": "A cohort of 64 patients was included, 37 patients (58%) with chronic anal fissure and 27 patients with hemorrhoid disease." }, { "field": "population", "quote": "chronic anal fissures and hemorrhoid disease" }, { "field": "intervention", "quote": "All patients received standardized dietary counseling including fiber supplementation as well as toileting strategies. Those with chronic anal fissures were also prescribed topical calcium channel blockers." }, { "field": "comparator", "quote": "The Colorectal Functional Outcome questionnaire was administered at baseline and at first follow-up visit." }, { "field": "primaryOutcome", "quote": "The primary outcomes measured were the mean change in patient-reported bowel function scores after nonoperative management for each disease and in aggregate." }, { "field": "result", "quote": "hemorrhoid disease demonstrated a statistically significant improvement in incontinence and stool-related aspects" }, { "field": "limitations", "quote": "This study was limited by the small cohort size and unclear patient adherence to medical management." } ] }, { "id": "pmid:29431977", "pmid": "29431977", "doi": null, "nctId": null, "pmcid": null, "title": "Hemorrhoids: Diagnosis and Treatment Options", "firstAuthor": "Mott", "multipleAuthors": true, "journal": "Am Fam Physician", "year": 2018, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with hemorrhoids", "intervention": "topical over-the-counter creams and other medical treatments (stool softeners, topical nitroglycerine, dietary changes, sitz baths)", "comparator": "", "primaryOutcome": "", "result": "Lists topical over-the-counter preparations as part of initial medical management but does not report any specific outcome data on whether they shrink hemorrhoids or stop bleeding", "resultDirection": "unclear", "quality": "low", "qualityWhy": "This is a general narrative review that mentions creams only as a category of initial treatment without presenting evidence or data on their effectiveness.", "directness": "indirect", "limitations": "No specific study data, outcomes, or comparisons are given for topical over-the-counter creams specifically; it is a broad overview of hemorrhoid management options.", "followUp": "", "plainFinding": "No specific evidence on creams given.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/29431977/", "sourceText": "Many Americans between 45 and 65 years of age experience hemorrhoids. Hemorrhoidal size, thrombosis, and location (i.e., proximal or distal to the dentate line) determine the extent of pain or discomfort. The history and physical examination must assess for risk factors and clinical signs indicating more concerning disease processes. Internal hemorrhoids are traditionally graded from I to IV based on the extent of prolapse. Other factors such as degree of discomfort, bleeding, comorbidities, and patient preference should help determine the order in which treatments are pursued. Medical management (e.g., stool softeners, topical over-the-counter preparations, topical nitroglycerine), dietary modifications (e.g., increased fiber and water intake), and behavioral therapies (sitz baths) are the mainstays of initial therapy. If these are unsuccessful, office-based treatment of grades I to III internal hemorrhoids with rubber band ligation is the preferred next step because it has a lower failure rate than infrared photocoagulation. Open or closed (conventional) excisional hemorrhoidectomy leads to greater surgical success rates but also incurs more pain and a prolonged recovery than office-based procedures; therefore, hemorrhoidectomy should be reserved for recurrent or higher-grade disease. Closed hemorrhoidectomy with diathermic or ultrasonic cutting devices may decrease bleeding and pain. Stapled hemorrhoidopexy elevates grade III or IV hemorrhoids to their normal anatomic position by removing a band of proximal mucosal tissue; however, this procedure has several potential postoperative complications. Hemorrhoidal artery ligation may be useful in grade II or III hemorrhoids because patients may experience less pain and recover more quickly. Excision of thrombosed external hemorrhoids can greatly reduce pain if performed within the first two to three days of symptoms.", "provenance": [ { "field": "intervention", "quote": "topical over-the-counter preparations" }, { "field": "population", "quote": "Many Americans between 45 and 65 years of age experience hemorrhoids." }, { "field": "result", "quote": "Medical management (e.g., stool softeners, topical over-the-counter preparations, topical nitroglycerine), dietary modifications (e.g., increased fiber and water intake), and behavioral therapies (sitz baths) are the mainstays of initial therapy." } ] }, { "id": "pmid:29055673", "pmid": "29055673", "doi": "10.1016/j.wombi.2017.10.003", "nctId": null, "pmcid": null, "title": "Hemorrhoids during pregnancy: Sitz bath vs. ano-rectal cream: A comparative prospective study of two conservative treatment protocols", "firstAuthor": "Shirah", "multipleAuthors": true, "journal": "Women Birth", "year": 2018, "design": "prospective-cohort", "n": 495, "nField": "reported", "population": "pregnant women with hemorrhoids", "intervention": "ano-rectal cream applied twice daily", "comparator": "warm salty Sitz bath three times daily", "primaryOutcome": "complete healing of hemorrhoids", "result": "100% healed with Sitz bath versus 84.8% healed with cream, a statistically significant difference favoring Sitz bath", "resultDirection": "harm", "quality": "low", "qualityWhy": "This was not randomized and groups were compared without blinding, so other differences between groups could explain the result.", "directness": "direct", "limitations": "Not randomized, allocation method unclear, single-center Saudi population, no blinding reported", "followUp": "", "plainFinding": "Cream healed fewer than Sitz baths.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/29055673/", "sourceText": "BACKGROUND: Hemorrhoids are a very common ano-rectal condition affecting pregnant females worldwide and representing a major medical and socioeconomic problem. In this paper, we aim to compare the effectiveness of the Sitz bath method with an ano-rectal cream as part of a conservative management protocol to treat hemorrhoids among pregnant Saudi Arabian females. METHODS: A prospective comparative study of the results of two conservative treatment protocols of 495 pregnant females diagnosed to have hemorrhoids during pregnancy between January 2010 and December 2014 was done. The first conservative protocol consisted of three times per day salty warm Sitz bath (using 20g of commercial salt) for 284 patients. The second protocol consisted of topical cream twice daily for 211 patients. Both protocols included the supportive treatments of 2g glycerin suppositories per rectum 20min before defecation as lubricant and Metamucil bulk-forming fiber (a mix of one dose (sachet) within 240ml (8 oz) of cold liquid) once daily after breakfast for constipation. RESULTS: Complete healing was achieved in all patients 284 (100%) in the Sitz bath group, compared to 179 (84.8%) in the cream group. Sitz bath was found to represent a statistically significant difference in achieving complete healing for hemorrhoids in pregnant Saudi Arabian females compared to an ano-rectal cream (p-value<0.05). CONCLUSION: A conservative treatment protocol for hemorrhoids during pregnancy, in which Sitz bath is an essential modality, showed very promising outcomes compared to an ano-rectal cream.", "provenance": [ { "field": "population", "quote": "pregnant females diagnosed to have hemorrhoids during pregnancy" }, { "field": "intervention", "quote": "topical cream twice daily for 211 patients" }, { "field": "comparator", "quote": "salty warm Sitz bath (using 20g of commercial salt) for 284 patients" }, { "field": "primaryOutcome", "quote": "Complete healing was achieved in all patients" }, { "field": "result", "quote": "Complete healing was achieved in all patients 284 (100%) in the Sitz bath group, compared to 179 (84.8%) in the cream group." }, { "field": "n", "quote": "495 pregnant females diagnosed to have hemorrhoids during pregnancy" } ] }, { "id": "pmid:28844211", "pmid": "28844211", "doi": "10.1016/S2095-4964(17)60340-6", "nctId": null, "pmcid": null, "title": "Effectiveness of Myrtus communis in the treatment of hemorrhoids", "firstAuthor": "Mahboubi", "multipleAuthors": false, "journal": "J Integr Med", "year": 2017, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "patients with hemorrhoids types I and II", "intervention": "Myrtus communis essential oil (lotion or ointment)", "comparator": "current chemical treatments (anti-hemorrhoids ointment)", "primaryOutcome": "bleeding, pain, anal irritation, itching and heaviness", "result": "significantly improved bleeding, pain, irritation, itching and heaviness, and helped some patients who had not responded to standard treatment", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This is a narrative review that just describes findings from unspecified clinical studies without giving study design, numbers, or statistics, so it carries little weight.", "directness": "direct", "limitations": "The abstract gives no details on study design, sample sizes, or how 'significant' improvement was measured; it is a narrative summary rather than a rigorous review.", "followUp": "", "plainFinding": "Eased hemorrhoid pain and bleeding.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/28844211/", "sourceText": "Myrtus communis is an important plant in the treatment of many different diseases. The aim of this review was to determine the importance of M. communis essential oil in the treatment of hemorrhoids. For preparing this manuscript, the information was extracted from different resources. The results of clinical studies showed that M. communis essential oil (lotion or ointment) can significantly improve bleeding, permanent pain, pain during defecation, anal irritation, anal itching and anal heaviness in patients with hemorrhoids types I and II. M. communis was also effective in treating patients who did not respond to current chemical treatments (anti-hemorrhoids ointment). Further clinical studies should look into designing a suppository form of M. communis essential oil and compare its effect with the lotion and ointment forms.", "provenance": [ { "field": "population", "quote": "patients with hemorrhoids types I and II" }, { "field": "intervention", "quote": "M. communis essential oil (lotion or ointment)" }, { "field": "comparator", "quote": "current chemical treatments (anti-hemorrhoids ointment)" }, { "field": "primaryOutcome", "quote": "bleeding, permanent pain, pain during defecation, anal irritation, anal itching and anal heaviness" }, { "field": "result", "quote": "can significantly improve bleeding, permanent pain, pain during defecation, anal irritation, anal itching and anal heaviness in patients with hemorrhoids types I and II" } ] }, { "id": "pmid:28652418", "pmid": "28652418", "doi": "10.21873/invivo.11092", "nctId": null, "pmcid": "PMC5566901", "title": "Enhancement of Wound Healing by the Traditional Chinese Medicine Herbal Mixture Sophora flavescens in a Rat Model of Perianal Ulceration", "firstAuthor": "Xu", "multipleAuthors": true, "journal": "In Vivo", "year": 2017, "design": "animal", "n": null, "nField": "not-reported", "population": "rats with induced perianal ulcers (model for post-surgery hemorrhoid wounds)", "intervention": "topical herbal compound Sophora flavescens (CSF), low/medium/high dose", "comparator": "untreated control and potassium permanganate (PP)", "primaryOutcome": "healing of perianal ulcer (macroscopic and histological assessment)", "result": "Medium and high doses of CSF significantly improved ulcer healing compared to untreated control; high dose also reduced inflammatory markers", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This is an animal study using a chemically induced ulcer model, not human hemorrhoid patients, so it cannot show whether this works in people.", "directness": "indirect", "limitations": "Animal model only, induced by acetic acid injection rather than natural hemorrhoid disease; no information on bleeding or hemorrhoid shrinkage; small unspecified group sizes.", "followUp": "", "plainFinding": "Herbal cream healed rat wounds faster.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/28652418/", "sourceText": "BACKGROUND/AIM: Hemorrhoidectomy is often associated with significant postoperative complications that may result in slow wound healing. The traditional Chinese medicine (TCM) compound Sophora flavescens (CSF) has shown efficacy on many inflammatory disorders. The aim of the present study was to examine the efficacy of CSF on wound healing in a rat model of perianal ulceration. MATERIALS AND METHODS: A rat model of perianal ulceration was induced by subcutaneous injection of 75% glacial acetic acid. The animals with induced perianal ulcer received topical treatment of low, medium, and high doses of CFS twice daily. Potassium permanganate (PP); 0.02%) was given to the animals for comparison. Macroscopic and histological assessments of the ulcerated area were performed after treatment. The expression of pro-inflammatory cytokines prostaglandin E2 (PGE2) and interleukin-8 (IL-8) was detected by immunohistochemical analysis. RESULTS: Topical administration of medium- and high-dose CSF significantly enhanced perianal ulcer healing as compared to the untreated control (p<0.05). The macroscopic ulceration score was significantly reduced only in the high-dose CSF-treated group as compared to the control (p<0.01). All doses of CSF and PP ameliorated histological damages in the rats with induced perianal ulceration. High-dose CSF or PP significantly reduced the expression of PGE2 and IL-8 as compared to the control (p<0.01). No treatment-related toxicity was found in either the CSF- or the PP-treated mice. CONCLUSION: CSF enhances wound healing in a rat model of perianal ulceration. The inhibitory effect of CSF on pro-inflammatory cytokines PGE2 and IL-8 may be involved in the mechanism of enhanced wound-healing.", "provenance": [ { "field": "population", "quote": "A rat model of perianal ulceration was induced by subcutaneous injection of 75% glacial acetic acid." }, { "field": "intervention", "quote": "The animals with induced perianal ulcer received topical treatment of low, medium, and high doses of CFS twice daily." }, { "field": "comparator", "quote": "Potassium permanganate (PP); 0.02%) was given to the animals for comparison." }, { "field": "primaryOutcome", "quote": "Macroscopic and histological assessments of the ulcerated area were performed after treatment." }, { "field": "result", "quote": "Topical administration of medium- and high-dose CSF significantly enhanced perianal ulcer healing as compared to the untreated control (p<0.05)." } ] }, { "id": "pmid:27383331", "pmid": "27383331", "doi": null, "nctId": null, "pmcid": null, "title": "Tribenoside and lidocaine in the local treatment of hemorrhoids: an overview of clinical evidence", "firstAuthor": "Lorenc", "multipleAuthors": true, "journal": "Eur Rev Med Pharmacol Sci", "year": 2016, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with low-grade hemorrhoids, including some pregnant or postpartum women", "intervention": "combination cream/suppository of tribenoside and lidocaine", "comparator": "tribenoside alone, lidocaine alone, or steroid creams", "primaryOutcome": "relief of hemorrhoid symptoms and safety", "result": "review concludes the combination is effective and safe, but does not give pooled numeric results", "resultDirection": "benefit", "quality": "low", "qualityWhy": "this is a non-systematic narrative overview of past studies chosen by the authors, not a pooled analysis with reported data, so it carries less weight.", "directness": "direct", "limitations": "no systematic search criteria, no quantitative results given, studies only described as 'well-conducted' without detail, potential conflict of interest given product is named by brand", "followUp": "", "plainFinding": "Claimed to relieve hemorrhoid symptoms", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/27383331/", "sourceText": "OBJECTIVE: The combination of tribenoside+lidocaine (Procto-Glyvenol®) is a medical preparation for the local treatment of hemorrhoids, delivered as a suppository or rectal cream. This product has been used for decades in the therapy of hemorrhoids. This review discusses available evidence on the use of tribenoside/lidocaine in clinical practice. MATERIALS AND METHODS: Papers were retrieved by a PubMed search, using different combinations of pertinent keywords (e.g. tribenoside AND hemorrhoids), without any limitations in terms of publication date and language. Documents from Authors' personal collection of literature could also be considered. Papers were selected for inclusion according to their relevance for the topic, as judged by the Authors. RESULTS: The efficacy of the combination of tribenoside+lidocaine in relieving symptoms caused by hemorrhoids and its safety have been assessed in several clinical studies on patients of either gender, either versus its two individual components (tribenoside and lidocaine) or versus steroids in the same setting. Five studies compared the combination treatment with each of its single components, and of these, three studies compared tribenoside+ lidocaine with a tribenoside-free semi-placebo preparation containing only lidocaine, and two studies compared this combination with lidocaine-free preparations containing only tribenoside. Tribenoside+lidocaine was compared with steroid-containing preparations in six studies. Last, two studies evaluated the efficacy and tolerability of the tribenoside+lidocaine combination in women with hemorrhoids as a consequence of pregnancy or delivery. All the above-mentioned studies were well-conducted and can provide a comprehensive evaluation of tribenoside+lidocaine in the treatment of hemorrhoids. CONCLUSIONS: Enough evidence exists to recommend the use of this combination therapy as a fast, effective and safe option for the local treatment of low-grade hemorrhoids.", "provenance": [ { "field": "population", "quote": "low-grade hemorrhoids" }, { "field": "intervention", "quote": "The combination of tribenoside+lidocaine (Procto-Glyvenol®) is a medical preparation for the local treatment of hemorrhoids, delivered as a suppository or rectal cream." }, { "field": "comparator", "quote": "either versus its two individual components (tribenoside and lidocaine) or versus steroids in the same setting" }, { "field": "primaryOutcome", "quote": "The efficacy of the combination of tribenoside+lidocaine in relieving symptoms caused by hemorrhoids and its safety have been assessed in several clinical studies" }, { "field": "result", "quote": "Enough evidence exists to recommend the use of this combination therapy as a fast, effective and safe option for the local treatment of low-grade hemorrhoids." } ] }, { "id": "pmid:26834421", "pmid": "26834421", "doi": "10.4103/0975-9476.172382", "nctId": null, "pmcid": "PMC4719482", "title": "Efficacy and safety of a polyherbal formulation in hemorrhoids", "firstAuthor": "Tripathi", "multipleAuthors": true, "journal": "J Ayurveda Integr Med", "year": 2015, "design": "rct", "n": 90, "nField": "reported", "population": "patients with hemorrhoids", "intervention": "a 7-day polyherbal kit (oral tablets and powder plus topical cream, Arshkeyt™)", "comparator": "standard therapy (oral Isabgul powder plus 2% lidocaine gel)", "primaryOutcome": "number of patients with symptoms and signs fully resolved (composite score of 0) after 14 days", "result": "15 patients on the polyherbal kit reached a symptom score of 0 versus 6 on standard therapy, with significant improvement in straining sensation, anal muscle spasm, and hemorrhoid grade", "resultDirection": "benefit", "quality": "low", "qualityWhy": "it was a small randomized trial of only 90 people with a short follow-up and no mention of blinding patients or clinicians to treatment assignment", "directness": "indirect", "limitations": "small sample size, short 14-day duration, and the tested product combined oral tablets and powder with the cream rather than testing cream alone", "followUp": "14 days", "plainFinding": "More symptom relief than standard care.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/26834421/", "sourceText": "BACKGROUND: The medical management of hemorrhoids should include an integrated approach. This integrated approach can be achieved by polyherbal formulations containing anti-inflammatory, styptics, analgesics, and laxative effect which reduce inflammation, pain, and bleeding, and increase gastro-intestinal motility and soften stools. One such polyherbal kit is \"Arshkeyt™, a 7 day kit,\" which consists of oral tablets and powder along with topical cream. OBJECTIVE: Efficacy and safety of Arshkeyt™, a 7 day kit, a marketed polyherbal formulation was evaluated in comparison with conventional therapy practiced in surgery outpatient departments. MATERIALS AND METHODS: Patients (n = 90) with hemorrhoids were randomly allocated to receive either Arshkeyt™ or standard therapy (combination of oral Isabgul powder and 2% lidocaine gel) for 14 days. Assessment on the basis of rectal symptoms and proctoscopic examination was done on day 0, 7, and 14 to derive a \"composite score\" which ranged from 0 to 25 by a blinded evaluator. The primary endpoint was number of patients achieving composite score 0 at the end of therapy (day 14). Inter-group analysis was done using Chi-square test. RESULTS: On day 14, the composite score of 0 was achieved in 15 patients of Arshkeyt™ group versus 6 patients receiving standard therapy. The symptoms and signs which showed significant improvement in Arshkeyt™ group compared to standard treatment group were the tenesmus (visual analog score) score (P = 0.047), anal sphincter spasm (P = 0.0495) and a decrease in the grade of hemorrhoids (P = 0.0205) on day 14. Arshkeyt™ was also more beneficial in case of bleeding hemorrhoids as compared to nonbleeding hemorrhoids (P < 0.05). The incidence of adverse drug reactions in both groups was comparable and no patient required any treatment for the same. CONCLUSION: \"Arshkeyt™, a 7 day kit,\" was effective in the treatment of hemorrhoids and had a good safety profile.", "provenance": [ { "field": "n", "quote": "Patients (n = 90) with hemorrhoids were randomly allocated" }, { "field": "population", "quote": "Patients (n = 90) with hemorrhoids" }, { "field": "intervention", "quote": "\"Arshkeyt™, a 7 day kit,\" which consists of oral tablets and powder along with topical cream" }, { "field": "comparator", "quote": "standard therapy (combination of oral Isabgul powder and 2% lidocaine gel)" }, { "field": "primaryOutcome", "quote": "The primary endpoint was number of patients achieving composite score 0 at the end of therapy (day 14)" }, { "field": "result", "quote": "On day 14, the composite score of 0 was achieved in 15 patients of Arshkeyt™ group versus 6 patients receiving standard therapy." }, { "field": "result", "quote": "The symptoms and signs which showed significant improvement in Arshkeyt™ group compared to standard treatment group were the tenesmus (visual analog score) score (P = 0.047), anal sphincter spasm (P = 0.0495) and a decrease in the grade of hemorrhoids (P = 0.0205) on day 14." } ] }, { "id": "pmid:26109819", "pmid": "26109819", "doi": "10.3748/wjg.v21.i23.7305", "nctId": null, "pmcid": "PMC4476894", "title": "Recombinant streptokinase vs hydrocortisone suppositories in acute hemorrhoids: A randomized controlled trial", "firstAuthor": "Hernández-Bernal", "multipleAuthors": true, "journal": "World J Gastroenterol", "year": 2015, "design": "rct", "n": 510, "nField": "reported", "population": "patients with acute symptoms of hemorrhoids", "intervention": "recombinant streptokinase (rSK) suppositories", "comparator": "hydrocortisone acetate suppositories (a standard over-the-counter hemorrhoid treatment)", "primaryOutcome": "disappearance of pain and bleeding plus at least 70% shrinkage of the hemorrhoid by day 5", "result": "91.8% and 91.2% of rSK-treated patients responded by day 5 versus only 27.1% of hydrocortisone-treated patients", "resultDirection": "benefit", "quality": "moderate", "qualityWhy": "it was a randomized, multicenter trial but was open-label (no blinding), which can bias subjective symptom assessments like pain and bleeding.", "directness": "indirect", "limitations": "open-label design with no placebo arm, so it cannot show whether hydrocortisone alone works better than no treatment at all", "followUp": "10 d", "plainFinding": "New drug beat hydrocortisone cream clearly.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/26109819/", "sourceText": "AIM: To compare the efficacy and safety of recombinant streptokinase (rSK) vs hydrocortisone acetate-based suppositories in acute hemorrhoidal disease. METHODS: A multicenter (11 sites), randomized (1:1:1), open, controlled trial with parallel groups was performed. All participating patients gave their written, informed consent. After inclusion, patients with acute symptoms of hemorrhoids were centrally randomized to receive, as outpatients, by the rectal route, suppositories of rSK 200000 IU of one unit every 8 h (first 3 units) and afterwards every 12 h until 8 administrations were completed (schedule A), one unit every 8 h until 6 units were completed (schedule B), or 25 mg hydrocortisone acetate once every 8 h up to a maximum of 24 administrations. Evaluations were performed at 3, 5, and 10 d post-inclusion. The main end-point was the 5(th)-day response (disappearance of pain and bleeding, and ≥ 70% reduction of the lesion size). Time to response and need for thrombectomy were secondary efficacy variables. Adverse events were also evaluated. RESULTS: Groups were homogeneous with regards to demographic and baseline characteristics. Fifth day complete response rates were 156/170 (91.8%; 95%CI: 87.3-96.2), 155/170 (91.2%; 95%CI: 86.6%-95.7%), and 46/170 (27.1%; 95%CI: 20.1%-34.0%) with rSK (schedule A and B) and hydrocortisone acetate suppositories, respectively. These 64.6% and 63.9% differences (95%CI: 56.7%-72.2% and 55.7%-72.0%) were highly significant (P < 0.001). This advantage was detected since the early 3(rd) day evaluation (68.8% and 64.1% vs 7.1% for the rSK and active control groups, respectively; P < 0.001) and was maintained even at the late 10(th) day assessment (97.1% and 93.5% vs 67.1% for rSK and hydrocortisone acetate, respectively; P < 0.001). Time to response was 3 d (95%CI: 2.9-3.1) for both rSK groups and 10 d (95%CI: 9.3-10.7) in the hydrocortisone acetate group. This difference was highly significant (P < 0.001). All subgroup stratified analyses (with or without thrombosis and hemorrhoid classification) showed a statistically significant advantage for the rSK groups. Thrombectomy was necessary in 4/251 and 14/133 patients with baseline thrombosis in the rSK and hydrocortisone acetate groups, respectively (P < 0.001). There were no adverse events attributable to the experimental treatment. CONCLUSION: rSK suppositories showed a significant advantage over a widely-used over-the-counter hydrocortisone acetate preparation for the treatment of acute hemorrhoidal illness, as well as having an adequate safety profile.", "provenance": [ { "field": "population", "quote": "patients with acute symptoms of hemorrhoids" }, { "field": "intervention", "quote": "suppositories of rSK 200000 IU" }, { "field": "comparator", "quote": "25 mg hydrocortisone acetate once every 8 h up to a maximum of 24 administrations" }, { "field": "primaryOutcome", "quote": "disappearance of pain and bleeding, and ≥ 70% reduction of the lesion size" }, { "field": "result", "quote": "Fifth day complete response rates were 156/170 (91.8%; 95%CI: 87.3-96.2), 155/170 (91.2%; 95%CI: 86.6%-95.7%), and 46/170 (27.1%; 95%CI: 20.1%-34.0%) with rSK (schedule A and B) and hydrocortisone acetate suppositories, respectively" }, { "field": "n", "quote": "156/170 (91.8%" }, { "field": "followUp", "quote": "Evaluations were performed at 3, 5, and 10 d post-inclusion" } ] }, { "id": "pmid:25608984", "pmid": "25608984", "doi": "10.1177/2156587214567954", "nctId": null, "pmcid": null, "title": "Topical Allium ampeloprasum subsp Iranicum (Leek) extract cream in patients with symptomatic hemorrhoids: a pilot randomized and controlled clinical trial", "firstAuthor": "Mosavat", "multipleAuthors": true, "journal": "J Evid Based Complementary Altern Med", "year": 2015, "design": "rct", "n": 20, "nField": "reported", "population": "patients with symptomatic hemorrhoids", "intervention": "topical leek extract cream", "comparator": "standard antihemorrhoid cream", "primaryOutcome": "bleeding severity, defecation discomfort, pain, and anal itching", "result": "Both creams reduced bleeding severity and defecation discomfort similarly, with no significant difference between groups and no change in pain scores", "resultDirection": "no-benefit", "quality": "low", "qualityWhy": "Very small pilot study with only 20 patients, making it hard to be confident in the results.", "directness": "direct", "limitations": "Small pilot study sample size of only 20 patients", "followUp": "3 weeks", "plainFinding": "Leek cream worked as well as standard cream.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/25608984/", "sourceText": "Allium ampeloprasum subsp iranicum (Leek) has been traditionally used in antihemorrhoidal topical herbal formulations. This study aimed to evaluate its safety and efficacy in a pilot randomized controlled clinical trial. Twenty patients with symptomatic hemorrhoids were randomly allocated to receive the topical leek extract cream or standard antihemorrhoid cream for 3 weeks. The patients were evaluated before and after the intervention in terms of pain, defecation discomfort, bleeding severity, anal itching severity, and reported adverse events. A significant decrease was observed in the grade of bleeding severity and defecation discomfort in both the leek and antihemorrhoid cream groups after the intervention, while no significant change was observed in pain scores. There was no significant difference between the leek and antihemorrhoid cream groups with regard to mean changes in outcome measures. This pilot study showed that the topical use of leek cream can be as effective as a standard antihemorrhoid cream.", "provenance": [ { "field": "population", "quote": "Twenty patients with symptomatic hemorrhoids" }, { "field": "intervention", "quote": "receive the topical leek extract cream" }, { "field": "comparator", "quote": "or standard antihemorrhoid cream for 3 weeks" }, { "field": "primaryOutcome", "quote": "in terms of pain, defecation discomfort, bleeding severity, anal itching severity, and reported adverse events" }, { "field": "result", "quote": "A significant decrease was observed in the grade of bleeding severity and defecation discomfort in both the leek and antihemorrhoid cream groups after the intervention, while no significant change was observed in pain scores. There was no significant difference between the leek and antihemorrhoid cream groups with regard to mean changes in outcome measures." }, { "field": "n", "quote": "Twenty patients with symptomatic hemorrhoids" } ] }, { "id": "pmid:25256125", "pmid": "25256125", "doi": "10.1111/jog.12523", "nctId": null, "pmcid": null, "title": "Comparing topical hydrocortisone cream with Hai's Perianal Support in managing symptomatic hemorrhoids in pregnancy: a preliminary trial", "firstAuthor": "Lim", "multipleAuthors": true, "journal": "J Obstet Gynaecol Res", "year": 2015, "design": "rct", "n": 23, "nField": "reported", "population": "pregnant women past 28 weeks with symptomatic hemorrhoids", "intervention": "a perineal support toilet seat device (Hai's Perianal Support)", "comparator": "topical hydrocortisone cream 1% (Procort)", "primaryOutcome": "improvement in pain, itching, swelling, discomfort and bleeding from hemorrhoids", "result": "both groups improved, but the support device group had significantly better improvement in pain, swelling, discomfort and overall well-being than the cream group", "resultDirection": "mixed", "quality": "low", "qualityWhy": "Very small trial of only 23 women comparing two active treatments without a placebo, so it cannot show whether the cream itself does anything beyond no treatment.", "directness": "direct", "limitations": "Small preliminary trial; authors state more clinical trials are needed to reconfirm findings.", "followUp": "", "plainFinding": "Device worked better than cream.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/25256125/", "sourceText": "AIM: The prevalence of hemorrhoids among pregnant women is high in late pregnancy. This study was to evaluate the efficacy between drug treatment with Procort (topical hydrocortisone cream 1%) and mechanical treatment with a Hai's Perianal Support (HPS) toilet seat device in managing symptomatic hemorrhoids during the third trimester of pregnancy. METHODS: A prospective randomized controlled study was conducted on 23 pregnant women with gestation above the 28th week and presented with symptomatic hemorrhoids. Pre- and post-interventional assessment was carried out to obtain data on symptoms of pain, itching, swelling, discomfort and bleeding associated with hemorrhoids. The control group was treated with topical hydrocortisone cream 1% and the test group was provided and taught to use a HPS, a posterior perineal support toilet seat device (Colorec). RESULTS: The results showed improvement in symptoms of pain, swelling, bleeding, itching and discomfort in both the test and control groups. However, statistically significant differences were found on symptoms of pain, swelling and discomfort between the test and control groups. There was also a statistically significant difference in well-being and overall improvement between the test and control groups. CONCLUSION: HPS has to a certain extent significantly reduced the symptoms of hemorrhoids in pregnancy and improved the well-being of pregnant women in comparison with topical treatment with hydrocortisone cream. However, more clinical trials need to be carried out to recomfirm the role of HPS in hemorrhoids in pregnancy.", "provenance": [ { "field": "n", "quote": "23 pregnant women with gestation above the 28th week" }, { "field": "population", "quote": "pregnant women with gestation above the 28th week and presented with symptomatic hemorrhoids" }, { "field": "intervention", "quote": "the test group was provided and taught to use a HPS, a posterior perineal support toilet seat device (Colorec)" }, { "field": "comparator", "quote": "The control group was treated with topical hydrocortisone cream 1%" }, { "field": "primaryOutcome", "quote": "data on symptoms of pain, itching, swelling, discomfort and bleeding associated with hemorrhoids" }, { "field": "result", "quote": "statistically significant differences were found on symptoms of pain, swelling and discomfort between the test and control groups. There was also a statistically significant difference in well-being and overall improvement between the test and control groups" } ] }, { "id": "pmid:24280398", "pmid": "24280398", "doi": "10.1016/j.gtc.2013.09.001", "nctId": null, "pmcid": null, "title": "Modern management of hemorrhoidal disease", "firstAuthor": "Hall", "multipleAuthors": false, "journal": "Gastroenterol Clin North Am", "year": 2013, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with hemorrhoid symptoms", "intervention": "nonoperative and operative treatments for hemorrhoids", "comparator": "not specified", "primaryOutcome": "relief of hemorrhoid symptoms", "result": "not clearly stated for any specific treatment", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "This is a general review article that does not report specific study data, numbers, or outcomes for any single treatment like cream.", "directness": "indirect", "limitations": "No data, no specific results, and no mention of hemorrhoid cream specifically; it is a broad overview of management options.", "followUp": "", "plainFinding": "No specific findings reported.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/24280398/", "sourceText": "Complaints secondary to hemorrhoidal disease have been treated by health care providers for centuries. Most symptoms referable to hemorrhoidal disease can be managed nonoperatively. When symptoms do not respond to medical therapy, procedural intervention is recommended. Surgical hemorrhoidectomy is usually reserved for patients who are refractory to or unable to tolerate office procedures. This article reviews the pathophysiology of hemorrhoidal disease and the most commonly used techniques for the nonoperative and operative palliation of hemorrhoidal complaints.", "provenance": [ { "field": "population", "quote": "Complaints secondary to hemorrhoidal disease have been treated by health care providers for centuries." }, { "field": "intervention", "quote": "This article reviews the pathophysiology of hemorrhoidal disease and the most commonly used techniques for the nonoperative and operative palliation of hemorrhoidal complaints." }, { "field": "comparator", "quote": "Surgical hemorrhoidectomy is usually reserved for patients who are refractory to or unable to tolerate office procedures." }, { "field": "primaryOutcome", "quote": "Most symptoms referable to hemorrhoidal disease can be managed nonoperatively." }, { "field": "result", "quote": "When symptoms do not respond to medical therapy, procedural intervention is recommended." } ] }, { "id": "pmid:24032710", "pmid": "24032710", "doi": "10.4077/CJP.2013.BAB127", "nctId": null, "pmcid": null, "title": "Herbal haemorrhoidal cream for haemorrhoids", "firstAuthor": "Gurel", "multipleAuthors": true, "journal": "Chin J Physiol", "year": 2013, "design": "animal", "n": 28, "nField": "reported", "population": "Wistar albino rats with chemically induced anal inflammation (hemorrhoid model)", "intervention": "herbal hemorrhoid creams (fig leaves, artichoke leaves, walnut husks, with or without horse chestnut fruit)", "comparator": "saline-treated rats with croton oil-induced inflammation", "primaryOutcome": "inflammation and oxidative stress markers in anal tissue", "result": "Herbal creams reduced inflammation and oxidative stress markers compared to untreated inflamed controls, with the cream containing horse chestnut showing the greatest improvement", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This is a small animal study using a chemically induced model, not human patients with hemorrhoids, so it cannot show whether the cream works in people.", "directness": "indirect", "limitations": "Animal model using chemically induced inflammation rather than natural human hemorrhoids; small sample size; no human data on bleeding or hemorrhoid shrinkage.", "followUp": "15 days", "plainFinding": "Reduced inflammation in rats only.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/24032710/", "sourceText": "Although hemorrhoids are one of the most common diseases in the world, the exact etiology underlying the development of hemorrhoids is not clear. Many different ointments are currently used to treat hemorrhoids; however, there is little evidence of the efficacy of these treatments to support their use. The aim of this study was to compare different herbal creams used for the treatment of hemorrhoids. Twenty-eight male Wistar albino rats, 6-8 weeks old and weighing 160-180 g, were used in this study as 1-control, 2-croton oil, 3-croton oil+fig leaves+artichoke leaves+walnut husks and 4-croton oil+fig leaves+artichoke leaves+walnut husks+horse chestnut fruit. After 3 days of croton oil application, rats were treated with 0.1 ml of cream or saline twice a day for 15 days by syringe. Tissue and blood samples were collected for histological, immunohistochemical and biochemical studies. Statistical significance was determined using one-way ANOVA followed by Tukey's multiple comparison tests. Croton oil administration resulted in severe inflammation. The third group showed partial improvement in inflammation; however, the greatest degree of improvement was seen in the fourth group, and some recovered areas were observed. Myeloperoxidase immunoreactivity was found to be decreased in the third and fourth groups compared to the second group. Additionally, biochemical analyses (Myeloperoxidase, Malondyaldehyde, nitrate/nitrite and nitrotyrosine levels and Superoxide Dismutase activity) were in agreement with the histological and immunohistochemical results. In conclusion, croton oil causes inflammation in the anal area and results in hemorrhoids. Treatment with our herbal hemorrhoid creams demonstrated anti-inflammatory and anti-oxidant effects in this model.", "provenance": [ { "field": "n", "quote": "Twenty-eight male Wistar albino rats" }, { "field": "population", "quote": "Twenty-eight male Wistar albino rats, 6-8 weeks old and weighing 160-180 g, were used in this study" }, { "field": "intervention", "quote": "croton oil+fig leaves+artichoke leaves+walnut husks+horse chestnut fruit" }, { "field": "comparator", "quote": "rats were treated with 0.1 ml of cream or saline twice a day for 15 days" }, { "field": "primaryOutcome", "quote": "Tissue and blood samples were collected for histological, immunohistochemical and biochemical studies" }, { "field": "result", "quote": "The third group showed partial improvement in inflammation; however, the greatest degree of improvement was seen in the fourth group, and some recovered areas were observed." } ] }, { "id": "pmid:24024752", "pmid": "24024752", "doi": "10.1517/14656566.2013.836181", "nctId": null, "pmcid": null, "title": "Pharmacological treatment of hemorrhoids: a narrative review", "firstAuthor": "Altomare", "multipleAuthors": true, "journal": "Expert Opin Pharmacother", "year": 2013, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with hemorrhoids, including early and advanced stages, and pregnant women", "intervention": "medical treatments including topical ointments, phlebotonic drugs, lifestyle changes, and fiber supplements", "comparator": "", "primaryOutcome": "relief of hemorrhoid symptoms", "result": "the review states these treatments can help manage symptoms, especially in early-stage disease, but does not report specific outcome data", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "This is an expert opinion narrative review without original data, trial numbers, or statistical results, so it cannot show whether treatments actually work.", "directness": "indirect", "limitations": "The abstract itself notes conservative measures are rarely supported by adequate trials, and this is an expert opinion piece rather than a study with original data or outcome measurements.", "followUp": "", "plainFinding": "Opinion only, no real evidence given", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/24024752/", "sourceText": "INTRODUCTION: Hemorrhoid disease is the cause of most proctologic complaints and hundreds of medical and surgical therapies have been proposed to relieve symptoms. However, the role and the correct indication of medical treatments are still controversial. Further, the utility of conservative measures are rarely scientifically supported by adequate trials. AREAS COVERED: This narrative review is based on the search and analysis of full papers in English language selected from PubMed in the past 30 years using the following MeSH Editing: hemorrhoids, conservative treatment, medical treatment and hemorrhoids, pregnancy and hemorrhoids, thrombosed hemorrhoids, randomized trials and hemorrhoids, postoperative pain and hemorrhoids. EXPERT OPINION: Early stages (I/II degrees) of this disease could be effectively managed conservatively with several approaches as lifestyle changes, fiber supplement, topical ointments and phlebotonic drugs. The more advanced hemorrhoid stages (III/IV degrees) need some type of surgery, but medical therapy is still useful to minimize anal symptoms as a bridge-to-surgery treatment. Further, post-hemorrhoidectomy pain, hemorrhoidal crisis even in pregnancy could benefit from the adjunct of local and systemic medical treatment. This expert opinion, based also on long-lasting clinical practice, also supports the use of medical treatment in symptoms relief in patients with hemorrhoid disease.", "provenance": [ { "field": "population", "quote": "Hemorrhoid disease is the cause of most proctologic complaints" }, { "field": "population", "quote": "pregnancy and hemorrhoids" }, { "field": "intervention", "quote": "lifestyle changes, fiber supplement, topical ointments and phlebotonic drugs" }, { "field": "primaryOutcome", "quote": "relieve symptoms" }, { "field": "result", "quote": "Early stages (I/II degrees) of this disease could be effectively managed conservatively with several approaches as lifestyle changes, fiber supplement, topical ointments and phlebotonic drugs." }, { "field": "result", "quote": "This expert opinion, based also on long-lasting clinical practice, also supports the use of medical treatment in symptoms relief in patients with hemorrhoid disease." }, { "field": "limitations", "quote": "the utility of conservative measures are rarely scientifically supported by adequate trials" }, { "field": "design", "quote": "This narrative review is based on the search and analysis of full papers" } ] }, { "id": "pmid:23775628", "pmid": "23775628", "doi": "10.1002/ptr.5019", "nctId": null, "pmcid": null, "title": "Pycnogenol® in chronic venous insufficiency and related venous disorders", "firstAuthor": "Gulati", "multipleAuthors": false, "journal": "Phytother Res", "year": 2014, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with chronic venous insufficiency and related venous problems, including hemorrhoids", "intervention": "Pycnogenol (pine bark extract), taken orally and/or applied topically", "comparator": "not stated", "primaryOutcome": "healing of venous ulcers and hemorrhoid flare-ups", "result": "the review states Pycnogenol can enhance the healing of venous ulcers and haemorrhoidal episodes, without giving specific data", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "this is a general narrative review summarizing the compound's biology and claims across many conditions, without presenting actual trial numbers, methods, or specific results for hemorrhoids.", "directness": "indirect", "limitations": "abstract gives no study design details, sample sizes, or specific results for the hemorrhoid-related claim; it bundles hemorrhoids in with several unrelated venous conditions.", "followUp": "", "plainFinding": "Claims faster healing, no real data shown", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/23775628/", "sourceText": "The present review provides an update of the biological profile of Pycnogenol in the light of its use in the treatment of chronic venous insufficiency (CVI) and related venous disorders such as deep vein thrombosis (DVT), post-thrombotic syndrome, long haul air-travel-related leg oedema, venous ulcers and acute haemorrhoids. Pycnogenol is a French maritime pine bark extract produced from the outer bark of Pinus pinaster Ait. subsp. atlantica. Its strong antioxidant, anti-inflammatory and vasodilator activities, antithrombotic effects and collagen stabilizing properties make it uniquely able to target the multi facet pathophysiology of CVI and related venous disorders. Clinical studies have shown that it can reduce oedema of the legs in CVI, reduce the incidence of deep venous thrombosis during long haul flights and enhance the healing of venous ulcers and haemorrhoidal episodes by topical application and/or oral administration. This review highlights clinical research findings on the safety, compliance and efficacy of Pycnogenol, including its use in combination products.", "provenance": [ { "field": "intervention", "quote": "Pycnogenol" }, { "field": "population", "quote": "chronic venous insufficiency (CVI) and related venous disorders such as deep vein thrombosis (DVT), post-thrombotic syndrome, long haul air-travel-related leg oedema, venous ulcers and acute haemorrhoids" }, { "field": "result", "quote": "enhance the healing of venous ulcers and haemorrhoidal episodes by topical application and/or oral administration" }, { "field": "primaryOutcome", "quote": "enhance the healing of venous ulcers and haemorrhoidal episodes" }, { "field": "comparator", "quote": "Clinical studies have shown that it can reduce oedema of the legs in CVI, reduce the incidence of deep venous thrombosis during long haul flights and enhance the healing of venous ulcers and haemorrhoidal episodes by topical application and/or oral administration." } ] }, { "id": "pmid:23102076", "pmid": "23102076", "doi": "10.9738/CC92.1", "nctId": null, "pmcid": "PMC3723212", "title": "Glyceryl trinitrate ointment did not reduce pain after stapled hemorrhoidectomy: a randomized controlled trial", "firstAuthor": "Cross", "multipleAuthors": true, "journal": "Int Surg", "year": 2012, "design": "rct", "n": 210, "nField": "reported", "population": "adults with grade 3/4 hemorrhoids having staple surgery for hemorrhoids", "intervention": "glyceryl trinitrate (GTN) ointment applied after the surgery", "comparator": "usual post-surgery care without the ointment", "primaryOutcome": "pain after the operation", "result": "the ointment did not reduce pain, and the worst pain reported was higher in the ointment group", "resultDirection": "harm", "quality": "moderate", "qualityWhy": "it was a randomized trial with over 200 patients, but it looked at pain after a specific surgery, not at using cream on untreated hemorrhoids.", "directness": "indirect", "limitations": "16 patients in the ointment group stopped using it because of side effects, and patients needing a different surgical technique were excluded", "followUp": "", "plainFinding": "No pain relief; worse pain.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/23102076/", "sourceText": "Medications, including topical 0.2% glyceryl trinitrate (GTN), can reduce anal spasm and pain after excisional hemorrhoidectomy. GTN after stapled hemorrhoidopexy was compared with routine postoperative management. Patients with symptomatic grade 3/4 hemorrhoids were recruited. After stapled hemorrhoidopexy, residual perianal skin tags were excised as appropriate. Those requiring double purse-string mucosectomy were excluded. Postoperative pain, pain duration, and complications were assessed. One hundred ten patients (74 men; mean age 50.6 years) were enrolled in the control group and 100 patients (57 men; mean age 49.8 years) in the GTN group. Maximum pain was higher in the GTN group (P = 0.015). There were no differences between the two groups in residual perianal skin tags requiring excision, postoperative complications, recurrence rates, follow-up period, average pain, duration of pain, or satisfaction scores. Sixteen GTN patients were noncompliant due to side effects. None had persistent perianal skin tags. GTN did not reduce postoperative pain after stapled hemorrhoidectomy.", "provenance": [ { "field": "population", "quote": "Patients with symptomatic grade 3/4 hemorrhoids were recruited." }, { "field": "intervention", "quote": "topical 0.2% glyceryl trinitrate (GTN)" }, { "field": "comparator", "quote": "GTN after stapled hemorrhoidopexy was compared with routine postoperative management." }, { "field": "primaryOutcome", "quote": "Postoperative pain, pain duration, and complications were assessed." }, { "field": "result", "quote": "Maximum pain was higher in the GTN group (P = 0.015)." }, { "field": "result", "quote": "GTN did not reduce postoperative pain after stapled hemorrhoidectomy." }, { "field": "n", "quote": "One hundred ten patients (74 men; mean age 50.6 years) were enrolled in the control group and 100 patients (57 men; mean age 49.8 years) in the GTN group." } ] }, { "id": "pmid:22864620", "pmid": "22864620", "doi": "10.1007/s00384-012-1544-1", "nctId": null, "pmcid": null, "title": "Role of 0.4% glyceryl trinitrate ointment after haemorrhoidectomy: results of a prospective randomised study", "firstAuthor": "Franceschilli", "multipleAuthors": true, "journal": "Int J Colorectal Dis", "year": 2013, "design": "rct", "n": 203, "nField": "reported", "population": "patients recovering from hemorrhoidectomy surgery", "intervention": "glyceryl trinitrate (GTN) ointment applied after surgery", "comparator": "no ointment treatment", "primaryOutcome": "pain after hemorrhoid surgery", "result": "GTN group had significantly less pain, faster wound healing, and shorter bleeding and discharge time after surgery", "resultDirection": "benefit", "quality": "moderate", "qualityWhy": "it was a randomized trial, but it only looked at post-surgical healing, not at treating hemorrhoids with cream to shrink them or stop bleeding without surgery", "directness": "indirect", "limitations": "studied patients after surgical removal of hemorrhoids, not people using cream as a standalone treatment for existing hemorrhoids; 15 patients stopped the ointment due to side effects", "followUp": "6 weeks", "plainFinding": "Less pain healing after hemorrhoid surgery", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/22864620/", "sourceText": "INTRODUCTION: Conventional haemorrhoidectomy (CH) is well known to cause significant post-operative pain and delayed return to daily activities. Both surgical wounds and sphincterial apparatus spasms are likely responsible for the pain. In this study, we evaluated the role of glyceryl trinitrate ointment (GTN) in reducing post-operative pain, ameliorating wound healing and recovery after CH. PATIENTS AND METHODS: Between 01/08 and 12/11, 203 patients with symptomatic haemorrhoids were enrolled in the study and received (103 patients) or not (100 patients) 0.4 % GTN ointment for 6 weeks after surgery. Pain was assessed using a 10-cm linear visual analogue scale (VAS). Data on post-operative pain, wound secretion and bleeding, return to normal activities and complications were recorded. Data were analysed using Fisher's exact and Mann-Whitney tests. RESULTS: GTN-treated group experienced significantly less pain during the first week after surgery (p < 0.0001). This difference was more evident starting from post-operative day 4 (p < 0.0001). A significant higher percentage of untreated patients experienced severe pain (mean VAS score > 7) (10 % vs 31 %). There were significant differences in terms of secretion time (p = 0.0052) and bleeding time (p = 0.02) in favor of GTN. In addition, the duration of itching was less in the GTN group (p = 0.0145). Patients treated with GTN were able to an early return to daily activities compared to untreated (p < 0.0001). Fifteen GTN-treated patients (14.6 %) discontinued the application because of local discomfort and headache. CONCLUSIONS: GTN ointment enhances significantly post-operative recovery, reducing pain in terms of duration and intensity. This effect might be secondary to a faster wound healing expressed by reduced secretion, bleeding and itching time.", "provenance": [ { "field": "n", "quote": "203 patients with symptomatic haemorrhoids were enrolled in the study" }, { "field": "population", "quote": "Between 01/08 and 12/11, 203 patients with symptomatic haemorrhoids were enrolled in the study and received (103 patients) or not (100 patients) 0.4 % GTN ointment for 6 weeks after surgery" }, { "field": "intervention", "quote": "received (103 patients) or not (100 patients) 0.4 % GTN ointment for 6 weeks after surgery" }, { "field": "comparator", "quote": "or not (100 patients) 0.4 % GTN ointment" }, { "field": "primaryOutcome", "quote": "we evaluated the role of glyceryl trinitrate ointment (GTN) in reducing post-operative pain, ameliorating wound healing and recovery after CH" }, { "field": "result", "quote": "GTN-treated group experienced significantly less pain during the first week after surgery (p < 0.0001)" }, { "field": "result", "quote": "There were significant differences in terms of secretion time (p = 0.0052) and bleeding time (p = 0.02) in favor of GTN" }, { "field": "followUp", "quote": "0.4 % GTN ointment for 6 weeks after surgery" } ] }, { "id": "pmid:22534276", "pmid": "22534276", "doi": null, "nctId": null, "pmcid": null, "title": "Evaluation and management of common anorectal conditions", "firstAuthor": "Fargo", "multipleAuthors": true, "journal": "Am Fam Physician", "year": 2012, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with symptomatic external hemorrhoids", "intervention": "topical steroids, dietary changes, and pain relievers", "comparator": "not specified", "primaryOutcome": "symptom management of external hemorrhoids", "result": "the abstract states these are used for management but gives no data on how well they shrink hemorrhoids or stop bleeding", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "this is a general overview article that states treatment recommendations without presenting trial data or outcomes for hemorrhoid creams.", "directness": "direct", "limitations": "no study data, statistics, or outcome measures are given for the cream/steroid treatment itself; it is a general practice review", "followUp": "", "plainFinding": "No evidence given on effectiveness.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/22534276/", "sourceText": "The prevalence of benign anorectal conditions in the primary care setting is high, although evidence of effective therapy is often lacking. In addition to recognizing common benign anorectal disorders, physicians must maintain a high index of suspicion for inflammatory and malignant disorders. Patients with red flags such as increased age, family history, persistent anorectal bleeding despite treatment, weight loss, or iron deficiency anemia should undergo colonoscopy. Pruritus ani, or perianal itching, is managed by treating the underlying cause, ensuring proper hygiene, and providing symptomatic relief with oral antihistamines, topical steroids, or topical capsaicin. Effective treatments for anal fissures include onabotulinumtoxinA, topical nitroglycerin, and topical calcium channel blockers. Symptomatic external hemorrhoids are managed with dietary modifications, topical steroids, and analgesics. Thrombosed hemorrhoids are best treated with hemorrhoidectomy if symptoms are present for less than 72 hours. Grades I through III internal hemorrhoids can be managed with rubber band ligation. For the treatment of grade III internal hemorrhoids, surgical hemorrhoidectomy has higher remission rates but increased pain and complication rates compared with rubber band ligation. Anorectal condylomas, or anogenital warts, are treated based on size and location, with office treatment consisting of topical trichloroacetic acid or podophyllin, cryotherapy, or laser treatment. Simple anorectal fistulas can be treated conservatively with sitz baths and analgesics, whereas complex or nonhealing fistulas may require surgery. Fecal impaction may be treated with polyethylene glycol, enemas, or manual disimpaction. Fecal incontinence is generally treated with loperamide and biofeedback. Surgical intervention is reserved for anal sphincter injury.", "provenance": [ { "field": "population", "quote": "Symptomatic external hemorrhoids are managed with dietary modifications, topical steroids, and analgesics." }, { "field": "intervention", "quote": "topical steroids, and analgesics" }, { "field": "primaryOutcome", "quote": "Symptomatic external hemorrhoids are managed with dietary modifications, topical steroids, and analgesics." }, { "field": "result", "quote": "Symptomatic external hemorrhoids are managed with dietary modifications, topical steroids, and analgesics." }, { "field": "comparator", "quote": "Symptomatic external hemorrhoids are managed with dietary modifications, topical steroids, and analgesics." } ] }, { "id": "pmid:22492249", "pmid": "22492249", "doi": "10.1007/s13304-012-0153-4", "nctId": null, "pmcid": null, "title": "Efficacy and tolerability of hyaluronic acid, tea tree oil and methyl-sulfonyl-methane in a new gel medical device for treatment of haemorrhoids in a double-blind, placebo-controlled clinical trial", "firstAuthor": "Joksimovic", "multipleAuthors": true, "journal": "Updates Surg", "year": 2012, "design": "rct", "n": 36, "nField": "reported", "population": "patients with grade 1-3 hemorrhoids", "intervention": "gel containing hyaluronic acid, tea tree oil and methyl-sulfonyl-methane", "comparator": "placebo gel", "primaryOutcome": "anal pain, pain during defecation, visible bleeding, itching and irritation/inflammation", "result": "the gel significantly reduced all symptoms compared to placebo after 14 days", "resultDirection": "benefit", "quality": "low", "qualityWhy": "Very small trial of only 36 patients, which limits confidence in the result.", "directness": "direct", "limitations": "Small sample size; abstract does not describe how blinding or randomization was carried out in detail.", "followUp": "14-day treatment", "plainFinding": "Less pain and bleeding, small trial.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/22492249/", "sourceText": "Topical formulations are widely used in anti-haemorrhoidal treatment, but often lacking controlled clinical trials. Here, we report the results from a controlled clinical trial performed with a new gel medical device (Proctoial) containing hyaluronic acid with tea tree oil and methyl-sulfonyl-methane as major components. The total number of 36 haemorrhoidal patients (grade 1-3) was enrolled in a double-blind, placebo-controlled clinical trial and divided into 2 equal parallel groups. The anal pain, pain during defecation, visible bleeding, pruritus and irritation/inflammation were recorded before and after 14-day treatment using a visual analogue scale both by the investigators and by the patients. Safety and tolerability of the treatments were also recorded. The new gel medical device statistically significantly reduced all the symptoms after the treatment compared to placebo. The results indicated also a very good tolerability and safety of the treatments.", "provenance": [ { "field": "n", "quote": "The total number of 36 haemorrhoidal patients (grade 1-3) was enrolled" }, { "field": "population", "quote": "36 haemorrhoidal patients (grade 1-3) was enrolled" }, { "field": "intervention", "quote": "a new gel medical device (Proctoial) containing hyaluronic acid with tea tree oil and methyl-sulfonyl-methane as major components" }, { "field": "comparator", "quote": "double-blind, placebo-controlled clinical trial" }, { "field": "primaryOutcome", "quote": "The anal pain, pain during defecation, visible bleeding, pruritus and irritation/inflammation were recorded before and after 14-day treatment" }, { "field": "result", "quote": "The new gel medical device statistically significantly reduced all the symptoms after the treatment compared to placebo." } ] }, { "id": "pmid:22244049", "pmid": "22244049", "doi": "10.1016/j.clinthera.2011.12.012", "nctId": null, "pmcid": null, "title": "Intra-anal Iferanserin 10 mg BID for hemorrhoid disease: a prospective, randomized, double-blind, placebo-controlled trial", "firstAuthor": "Herold", "multipleAuthors": true, "journal": "Clin Ther", "year": 2012, "design": "rct", "n": 121, "nField": "reported", "population": "adults with internal hemorrhoids (grade I, II, or III) and bleeding", "intervention": "iferanserin 10 mg intra-anal ointment twice daily", "comparator": "inactive placebo ointment", "primaryOutcome": "severity of bleeding and other hemorrhoid symptoms", "result": "iferanserin reduced bleeding and itching severity more than placebo, but did not improve pain, tenderness, or other symptoms", "resultDirection": "mixed", "quality": "moderate", "qualityWhy": "this was a randomized, placebo-controlled trial but it was small and short-term (14 days), so it mainly shows short-term symptom changes, not long-term shrinkage or cure.", "directness": "direct", "limitations": "study groups had different baseline hemorrhoid severity, and only some symptoms improved while others did not", "followUp": "14 days", "plainFinding": "Less bleeding and itching, not pain.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/22244049/", "sourceText": "BACKGROUND: Despite the prevalence of internal hemorrhoid disease (HD), there are few pharmacologic options. Iferanserin, a selective serotonin receptor antagonist, is being studied for use in the treatment of HD. OBJECTIVE: This Phase IIb study evaluated the efficacy and tolerability of 10-mg twice-daily iferanserin intra-anal ointment for the cessation of bleeding and other symptoms associated with internal HD. METHODS: This randomized, double-blind, placebo-controlled study was conducted at 5 sites in Germany. Outpatients with Goligher grade I, II, and/or III hemorrhoids and bleeding were randomly assigned to receive iferanserin ointment 10 mg or inactive vehicle (placebo) BID for 14 days. During treatment, patients rated the severity of HD symptoms daily on a 10-point scale using a diary form. At enrollment and study end, physicians recorded the frequency and intensity of HD symptoms, adverse events, and results from blood and urine analyses on clinical-report forms. RESULTS: Of the 121 patients enrolled in the study, 118 were evaluable for tolerability and 111 for efficacy. The mean age of the tolerability population was 52.7 years, 78.9% were male, and all were white. The 2 groups had similar HD symptoms at baseline, but overall, patients in the placebo group had numerically higher grades of HD than did patients in the iferanserin group. Compared with placebo, iferanserin was associated with significantly lower patient-reported severity ratings of daily bleeding and itching, beginning at day 1 for bleeding and at day 2 for itching (P < 0.05), but not with reduced ratings for severity of other HD symptoms, including pain, tenderness, difficulty with defecation, fullness, throbbing, and gas. In the physician assessments, iferanserin was associated with significantly reduced bleeding frequency by day 14 compared with placebo (P < 0.05). Adverse events were mild and infrequent, with no significant differences in prevalences between the 2 treatment groups and no clinically significant changes in laboratory values in any patient. CONCLUSION: Compared with placebo, intra-anal iferanserin was associated with significantly reduced patient-reported severity of bleeding and itching and physician-assessed bleeding frequency in these patients presenting with grade I, II, and/or III internal hemorrhoids and bleeding at 5 sites in Germany. ClinicalTrials.gov identifier: 01483833.", "provenance": [ { "field": "n", "quote": "Of the 121 patients enrolled in the study, 118 were evaluable for tolerability and 111 for efficacy." }, { "field": "population", "quote": "Outpatients with Goligher grade I, II, and/or III hemorrhoids and bleeding" }, { "field": "intervention", "quote": "10-mg twice-daily iferanserin intra-anal ointment" }, { "field": "comparator", "quote": "inactive vehicle (placebo) BID for 14 days" }, { "field": "primaryOutcome", "quote": "efficacy and tolerability of 10-mg twice-daily iferanserin intra-anal ointment for the cessation of bleeding and other symptoms associated with internal HD" }, { "field": "result", "quote": "iferanserin was associated with significantly lower patient-reported severity ratings of daily bleeding and itching, beginning at day 1 for bleeding and at day 2 for itching (P < 0.05), but not with reduced ratings for severity of other HD symptoms, including pain, tenderness, difficulty with defecation, fullness, throbbing, and gas" } ] }, { "id": "pmid:20100408", "pmid": "20100408", "doi": null, "nctId": null, "pmcid": "PMC2810010", "title": "Topical nifedipine with lidocaine ointment versus active control for pain after hemorrhoidectomy: results of a multicentre, prospective, randomized, double-blind study", "firstAuthor": "Perrotti", "multipleAuthors": true, "journal": "Can J Surg", "year": 2010, "design": "rct", "n": 270, "nField": "reported", "population": "patients recovering after surgical hemorrhoid removal (hemorrhoidectomy)", "intervention": "topical nifedipine with lidocaine ointment", "comparator": "lidocaine ointment alone", "primaryOutcome": "pain after hemorrhoidectomy, measured on a pain scale", "result": "slightly better pain scores with nifedipine plus lidocaine at 6 hours and day 7 after surgery, but no difference in time to needing rescue pain medication", "resultDirection": "mixed", "quality": "moderate", "qualityWhy": "it was a large, well-designed randomized double-blind trial, but it studied pain after surgical removal of hemorrhoids, not whether the cream shrinks hemorrhoids or stops bleeding, and the benefit found was small.", "directness": "indirect", "limitations": "No difference in time to rescue analgesic use; benefit was only a 'slight significant difference' on a pain scale at specific timepoints; study focused on post-surgical pain rather than hemorrhoid size or bleeding.", "followUp": "14 days", "plainFinding": "Slightly less post-surgery pain, not shrinkage.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/20100408/", "sourceText": "BACKGROUND: Spasm through the internal anal sphincter is one of the supposed causes for pain after hemorrhoidectomy, a common and distressing experience. We hypothesized that the addition of topical nifedipine to lidocaine would improve pain control by causing a relaxation of the smooth muscle of the internal anal sphincter. METHODS: We conducted a multicentre randomized, double-blind trial to compare the efficacy of 0.3% nifedipine and 1.5% lidocaine ointment versus 1.5% lidocaine ointment alone in reducing pain after hemorrhoidectomy. A physician unaware of the treatment arm measured pain by use of the Analogue Chromatic Continuous Scale (ACCS) at baseline; soon after surgery; at 2, 4, 6, 8 and 24 hours after surgery; on day 7 after surgery; and at a final visit 14 days after surgery. The physician also noted the time to first analgesic administration within 24 hours after surgery. RESULTS: In all, 135 patients per group participated (270 total). Evaluation of the delta ACCS score versus basal value, a covariate for rescue analgesic administration time, revealed better pain control in the group that received nifedipine with lidocaine at 6 hours after surgery and on day 7 (p < 0.011 and p < 0.054, respectively). We noticed no difference between groups for time of administration of rescue analgesic, blood pressure, heart rate or frequency of headache. CONCLUSION: Although there was no difference between groups for time of administration of rescue analgesic after open hemorrhoidectomy, the patients' assessment of pain using ACCS showed that the use of topical nifedipine with lidocaine may provide a slight significant difference in favour of the study group at 6 hours and at day 7 after surgery. Narcotic analgesics and nonsteroidal anti-inflammatory drug administration should continue to be recommended. Further research focusing on these outcomes is warranted.", "provenance": [ { "field": "n", "quote": "In all, 135 patients per group participated (270 total)." }, { "field": "population", "quote": "reducing pain after hemorrhoidectomy" }, { "field": "intervention", "quote": "0.3% nifedipine and 1.5% lidocaine ointment" }, { "field": "comparator", "quote": "1.5% lidocaine ointment alone" }, { "field": "primaryOutcome", "quote": "A physician unaware of the treatment arm measured pain by use of the Analogue Chromatic Continuous Scale (ACCS)" }, { "field": "result", "quote": "revealed better pain control in the group that received nifedipine with lidocaine at 6 hours after surgery and on day 7 (p < 0.011 and p < 0.054, respectively). We noticed no difference between groups for time of administration of rescue analgesic" } ] }, { "id": "pmid:20041428", "pmid": "20041428", "doi": "10.1002/ptr.3021", "nctId": null, "pmcid": null, "title": "Pycnogenol treatment of acute hemorrhoidal episodes", "firstAuthor": "Belcaro", "multipleAuthors": true, "journal": "Phytother Res", "year": 2010, "design": "rct", "n": 84, "nField": "reported", "population": "patients with acute hemorrhoid flare-ups", "intervention": "Pycnogenol taken orally and/or applied as a cream", "comparator": "placebo", "primaryOutcome": "hemorrhoid signs/symptoms and bleeding", "result": "symptoms improved more with Pycnogenol than placebo, and bleeding stopped completely in Pycnogenol-treated patients but continued in the placebo group", "resultDirection": "benefit", "quality": "low", "qualityWhy": "small randomized trial with limited detail on blinding and methods, so results need confirmation by larger studies", "directness": "indirect", "limitations": "small sample size and the abstract gives few details on blinding or how scores were measured", "followUp": "14 days", "plainFinding": "Stopped hemorrhoid bleeding, eased symptoms faster.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/20041428/", "sourceText": "We investigated the efficacy of orally and topically applied Pycnogenol for the management of acute hemorrhoidal attacks in a controlled, randomized study with 84 subjects. Within less than 48 h of onset of an acute attack, patients were enrolled and signs and symptoms were scored. This evaluation was repeated after seven days' treatment and again seven days following treatment cessation. The decrease in scores was significantly more pronounced in the Pycnogenol-treated groups than in the control group given placebo (p < 0.05), showing the efficacy of Pycnogenol for relieving signs and symptoms of acute external hemorrhoids. In a group of patients given topical (0.5%) Pycnogenol in addition to oral Pycnogenol the improvement in symptoms set in significantly faster and was more pronounced. The most prominent symptom, hemorrhoidal bleeding, was completely absent in all patients treated with Pycnogenol for seven days and also at the 14 days follow-up. In contrast, bleedings were still observed in the control group during the two weeks follow-up. This study indicates that Pycnogenol, both in oral and in topical form, is effective for controlling this common, disabling health problem. The application of Pycnogenol eases the management of acute hemorrhoidal attacks and help avoid bleedings.", "provenance": [ { "field": "n", "quote": "a controlled, randomized study with 84 subjects" }, { "field": "population", "quote": "the management of acute hemorrhoidal attacks" }, { "field": "intervention", "quote": "orally and topically applied Pycnogenol" }, { "field": "comparator", "quote": "the control group given placebo" }, { "field": "primaryOutcome", "quote": "signs and symptoms were scored" }, { "field": "result", "quote": "The most prominent symptom, hemorrhoidal bleeding, was completely absent in all patients treated with Pycnogenol for seven days and also at the 14 days follow-up. In contrast, bleedings were still observed in the control group during the two weeks follow-up." } ] }, { "id": "pmid:19761640", "pmid": "19761640", "doi": "10.1016/s1701-2163(16)34246-3", "nctId": null, "pmcid": null, "title": "The effectiveness of Proctofoam-HC for treatment of hemorrhoids in late pregnancy", "firstAuthor": "Vohra", "multipleAuthors": true, "journal": "J Obstet Gynaecol Can", "year": 2009, "design": "prospective-cohort", "n": 88, "nField": "reported", "population": "pregnant women in their last trimester with hemorrhoids", "intervention": "Proctofoam-HC topical cream applied to hemorrhoids", "comparator": "no control group; statistical correction for potential placebo effect", "primaryOutcome": "change in hemorrhoidal symptoms (pain, itching, swelling) and overall well-being", "result": "all hemorrhoidal symptoms decreased significantly and overall well-being improved", "resultDirection": "benefit", "quality": "low", "qualityWhy": "This was an open-label study with no real control group and self-reported symptoms, so it can't rule out a placebo effect.", "directness": "direct", "limitations": "Open-label, observational design without a true placebo control group; relies on patient-reported telephone interviews.", "followUp": "", "plainFinding": "Hemorrhoid symptoms improved significantly.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/19761640/", "sourceText": "OBJECTIVE: Currently no topical anti-hemorrhoidal agents have been studied for effectiveness in pregnancy. This study evaluated the effectiveness of Proctofoam-HC used during the last trimester of pregnancy. METHODS: In this prospective, open-label, observational study, pregnant women prescribed Proctofoam-HC were asked to complete two telephone interview questionnaires. RESULTS: A total of 88 women completed the study. All hemorrhoidal symptoms, including pain, pruritus, swelling, itching, decreased significantly (P < 0.001) and overall well-being improved. The improvement was clinically very significant after correction for potential placebo effect. CONCLUSIONS: Proctofoam-HC appears to provide effective treatment of hemorrhoids in late pregnancy.", "provenance": [ { "field": "n", "quote": "A total of 88 women completed the study." }, { "field": "population", "quote": "pregnant women prescribed Proctofoam-HC" }, { "field": "intervention", "quote": "Proctofoam-HC used during the last trimester of pregnancy" }, { "field": "comparator", "quote": "The improvement was clinically very significant after correction for potential placebo effect." }, { "field": "primaryOutcome", "quote": "All hemorrhoidal symptoms, including pain, pruritus, swelling, itching, decreased significantly" }, { "field": "result", "quote": "All hemorrhoidal symptoms, including pain, pruritus, swelling, itching, decreased significantly (P < 0.001) and overall well-being improved." } ] }, { "id": "pmid:18272631", "pmid": "18272631", "doi": null, "nctId": null, "pmcid": "PMC2278306", "title": "Hemorrhoids in pregnancy", "firstAuthor": "Staroselsky", "multipleAuthors": true, "journal": "Can Fam Physician", "year": 2008, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "pregnant women with hemorrhoids, specifically a third-trimester patient", "intervention": "topical hemorrhoid creams (anesthetic, corticosteroid, anti-inflammatory agents)", "comparator": "", "primaryOutcome": "", "result": "not assessed for effectiveness; abstract only discusses safety and notes symptoms usually resolve on their own after birth", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "this is an expert opinion answer to a clinical question, not a study testing whether the cream works, and it explicitly says safety hasn't been formally assessed", "directness": "indirect", "limitations": "no data on effectiveness for shrinking hemorrhoids or stopping bleeding; focuses on safety in pregnancy, not outcome testing", "followUp": "", "plainFinding": "No evidence cream works.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/18272631/", "sourceText": "QUESTION: One of my patients is in the third trimester of her first pregnancy. She has recently experienced spotting during her bowel movements. She has hemorrhoids. What medications are safe? ANSWER: The treatment is mainly symptomatic for most patients. Most forms of the condition can be treated by increasing fibre content in the diet, administering stool softeners, increasing liquid intake, and training in toilet habits. Although none of the topical antihemorrhoidal agents commonly used have been assessed for safety in pregnancy, it is unlikely that the constituent parts (anesthetic, corticosteroids, and anti-inflammatory agents) will harm the third-trimester infant. In most women, most symptoms of the condition will resolve spontaneously soon after giving birth.", "provenance": [ { "field": "population", "quote": "One of my patients is in the third trimester of her first pregnancy." }, { "field": "intervention", "quote": "none of the topical antihemorrhoidal agents commonly used have been assessed for safety in pregnancy" }, { "field": "result", "quote": "In most women, most symptoms of the condition will resolve spontaneously soon after giving birth." }, { "field": "result", "quote": "Although none of the topical antihemorrhoidal agents commonly used have been assessed for safety in pregnancy, it is unlikely that the constituent parts (anesthetic, corticosteroids, and anti-inflammatory agents) will harm the third-trimester infant." } ] }, { "id": "pmid:19450328", "pmid": "19450328", "doi": null, "nctId": null, "pmcid": "PMC2907947", "title": "Constipation, haemorrhoids, and heartburn in pregnancy", "firstAuthor": "Vazquez", "multipleAuthors": false, "journal": "BMJ Clin Evid", "year": 2008, "design": "systematic-review", "n": null, "nField": "not-reported", "population": "pregnant women with constipation, haemorrhoids, or heartburn", "intervention": "topical anaesthetic agents, topical corticosteroid agents, and compound corticosteroid and anaesthetic agents for haemorrhoids", "comparator": "", "primaryOutcome": "not stated in abstract", "result": "the abstract lists haemorrhoid cream ingredients as topics covered but does not report any outcome data or effect", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "the abstract only lists which treatments were reviewed without giving any actual results, so no conclusion can be drawn from it alone.", "directness": "indirect", "limitations": "abstract does not report specific findings, numbers, or effect sizes for any intervention including hemorrhoid creams", "followUp": "", "plainFinding": "No results reported for cream.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/19450328/", "sourceText": "INTRODUCTION: Constipation, heartburn, and haemorrhoids are common gastrointestinal complaints during pregnancy. Constipation occurs in 11-38% of pregnant women. Although the exact prevalence of haemorrhoids during pregnancy is unknown, the condition is common, and the prevalence of symptomatic haemorrhoids in pregnant women is higher than in non-pregnant women. The incidence of heartburn in pregnancy is reported to be 17-45%. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of interventions to prevent or treat constipation in pregnancy? What are the effects of interventions to prevent or treat haemorrhoids in pregnancy? What are the effects of interventions to prevent or treat heartburn in pregnancy? We searched: Medline, Embase, The Cochrane Library and other important databases up to July 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found five systematic reviews, RCTs or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: Acid-suppressing drugs, anaesthetic agents (topical), antacids with or without alginates, bulk-forming laxatives, compound corticosteroid and anaesthetic agents (topical), corticosteroid agents (topical), increased fibre intake, increased fluid intake, osmotic laxatives, raising the head of the bed, reducing caffeine intake, intake of fatty foods, and the size and frequency of meals, rutosides, sitz baths, and stimulant laxatives.", "provenance": [ { "field": "population", "quote": "the condition is common, and the prevalence of symptomatic haemorrhoids in pregnant women is higher than in non-pregnant women" }, { "field": "intervention", "quote": "compound corticosteroid and anaesthetic agents (topical), corticosteroid agents (topical)" }, { "field": "intervention", "quote": "anaesthetic agents (topical)" }, { "field": "result", "quote": "We found five systematic reviews, RCTs or observational studies that met our inclusion criteria." }, { "field": "primaryOutcome", "quote": "What are the effects of interventions to prevent or treat haemorrhoids in pregnancy?" } ] }, { "id": "pmid:17504344", "pmid": "17504344", "doi": "10.1111/j.1463-1318.2006.01134.x", "nctId": null, "pmcid": null, "title": "Rectogesic (glyceryl trinitrate 0.2%) ointment relieves symptoms of haemorrhoids associated with high resting anal canal pressures", "firstAuthor": "Tjandra", "multipleAuthors": true, "journal": "Colorectal Dis", "year": 2007, "design": "prospective-cohort", "n": 58, "nField": "reported", "population": "patients with early-stage hemorrhoids and high anal canal pressure causing ongoing symptoms", "intervention": "glyceryl trinitrate 0.2% ointment (Rectogesic) applied to the anus three times daily for 14 days", "comparator": "no comparator group; patients compared to their own symptoms before and after treatment", "primaryOutcome": "rectal bleeding, anal pain, throbbing, itching, irritation, and difficulty with bowel movements", "result": "significant reduction in rectal bleeding and improvement in pain, throbbing, itching, irritation, and bowel movement difficulty after treatment", "resultDirection": "benefit", "quality": "low", "qualityWhy": "this was a small open-label study with no comparison group, so improvements could be partly due to natural healing or expectation rather than the cream itself", "directness": "direct", "limitations": "open label study with no placebo or control group, and nearly half of patients experienced headache as a side effect", "followUp": "28 days", "plainFinding": "Less bleeding and pain reported.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/17504344/", "sourceText": "OBJECTIVE: Some haemorrhoids are associated with high resting anal canal pressures. The aim of this study was to assess if Rectogesic, a topical glyceryl trinitrate 0.2% ointment was effective in relieving symptoms of early grade haemorrhoids associated with high resting anal canal pressures. METHOD: This was a prospective, two-centre, open label study of 58 patients with persistent haemorrhoidal symptoms. Patients with first or second degree haemorrhoids and a maximum resting anal canal pressure > 70 mmHg were included. Rectogesic was applied three times a day for 14 days. Anorectal manometry was performed 30 min after the first application of Rectogesic. A 28-day diary was completed during 14 days of therapy and for 14 days after cessation of treatment. This recorded the incidence of rectal bleeding, and visual analogue scales for anal pain, throbbing, pruritus, irritation and difficulty in bowel movement. RESULTS: Maximum resting anal canal pressures were reduced after application of Rectogesic (115.0 +/- 40.4 mmHg vs 94.7 +/- 34.1 mmHg, P < 0.001). In the study period and at 14 days after cessation of Rectogesic, there was significant reduction in rectal bleeding (P = 0.0002), and significant improvement of anal pain (P = 0.0024), throbbing (P = 0.0355), pruritus (P = 0.0043), irritation (P = 0.0000) and difficulty in bowel movement (P = 0.001). The main adverse event was headache in 43.1% of patients. CONCLUSION: Rectogesic is a safe and feasible treatment for patients with early grade haemorrhoids associated with high resting anal canal pressures.", "provenance": [ { "field": "n", "quote": "This was a prospective, two-centre, open label study of 58 patients with persistent haemorrhoidal symptoms." }, { "field": "population", "quote": "Patients with first or second degree haemorrhoids and a maximum resting anal canal pressure > 70 mmHg were included." }, { "field": "intervention", "quote": "Rectogesic was applied three times a day for 14 days." }, { "field": "comparator", "quote": "This was a prospective, two-centre, open label study of 58 patients with persistent haemorrhoidal symptoms." }, { "field": "primaryOutcome", "quote": "This recorded the incidence of rectal bleeding, and visual analogue scales for anal pain, throbbing, pruritus, irritation and difficulty in bowel movement." }, { "field": "result", "quote": "there was significant reduction in rectal bleeding (P = 0.0002), and significant improvement of anal pain (P = 0.0024), throbbing (P = 0.0355), pruritus (P = 0.0043), irritation (P = 0.0000) and difficulty in bowel movement (P = 0.001)" } ] }, { "id": "pmid:17369999", "pmid": "17369999", "doi": "10.1100/tsw.2006.333", "nctId": null, "pmcid": "PMC5944183", "title": "The safety and efficacy of a mixture of honey, olive oil, and beeswax for the management of hemorrhoids and anal fissure: a pilot study", "firstAuthor": "Al-Waili", "multipleAuthors": true, "journal": "ScientificWorldJournal", "year": 2006, "design": "case-series", "n": 15, "nField": "reported", "population": "patients who presented with anal fissure or first- to third-degree hemorrhoids", "intervention": "topical mixture of honey, olive oil, and beeswax applied for 12 hours", "comparator": "no comparator, symptoms before vs after treatment", "primaryOutcome": "change in bleeding, itching, swelling, redness, and pain scores", "result": "significantly reduced bleeding and relieved itching in hemorrhoid patients; significant reduction in pain, bleeding, and itching in fissure patients", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This was a tiny uncontrolled pilot study with only 15 patients and no comparison group, so improvement could be due to natural healing rather than the treatment.", "directness": "direct", "limitations": "Small sample size, no control group, not randomized or blinded, described as a pilot study paving way for future randomized trials.", "followUp": "4 weeks", "plainFinding": "Less bleeding and itching reported.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/17369999/", "sourceText": "We have found that a mixture of honey, olive oil, and beeswax was effective for treatment of diaper dermatitis, psoriasis, eczema, and skin fungal infection. The mixture has antibacterial properties. A prospective pilot study was conducted to evaluate the therapeutic effect of topical application of the mixture on patients with anal fissure or hemorrhoids. Fifteen consecutive patients, 13 males and 2 females, median age 45 years (range: 28-70), who presented with anal fissure (5 patients) or first- to third-degree hemorrhoids (4 with first degree, 4 with second degree, and 2 with third degree), were treated with a 12-h application of a natural mixture containing honey, olive oil, and beeswax in ratio of 1:1:1(v/v/v). Bleeding, itching, edema, and erythema were measured using a scoring method: 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. The pain score was checked using a visual analog scale (minimum = 0, maximum = 10). Efficacy of treatment was assessed by comparing the symptoms' score before and after treatment; at weekly intervals for a maximum of 4 weeks. The patients were observed for evidence of any adverse effect such as appearance of new signs and symptoms, or worsening of the existing symptoms. The honey mixture significantly reduced bleeding and relieved itching in patients with hemorrhoids. Patients with anal fissure showed significant reduction in pain, bleeding, and itching after the treatment. No side effect was reported with use of the mixture. We conclude that a mixture of honey, olive oil, and beeswax is safe and clinically effective in the treatment of hemorrhoids and anal fissure, which paves the way for further randomized double blind studies.", "provenance": [ { "field": "n", "quote": "Fifteen consecutive patients, 13 males and 2 females, median age 45 years (range: 28-70)" }, { "field": "population", "quote": "who presented with anal fissure (5 patients) or first- to third-degree hemorrhoids (4 with first degree, 4 with second degree, and 2 with third degree)" }, { "field": "intervention", "quote": "were treated with a 12-h application of a natural mixture containing honey, olive oil, and beeswax in ratio of 1:1:1(v/v/v)" }, { "field": "comparator", "quote": "Efficacy of treatment was assessed by comparing the symptoms' score before and after treatment" }, { "field": "primaryOutcome", "quote": "Bleeding, itching, edema, and erythema were measured using a scoring method" }, { "field": "result", "quote": "The honey mixture significantly reduced bleeding and relieved itching in patients with hemorrhoids. Patients with anal fissure showed significant reduction in pain, bleeding, and itching after the treatment." } ] }, { "id": "pmid:16167232", "pmid": "16167232", "doi": null, "nctId": null, "pmcid": null, "title": "[Comparison of the efficacy and safety of compound carraghenates cream and compound carraghenates suppository in the treatment of mixed hemorrhoids]", "firstAuthor": "Yang", "multipleAuthors": true, "journal": "Zhonghua Wei Chang Wai Ke Za Zhi", "year": 2005, "design": "rct", "n": 252, "nField": "reported", "population": "patients with mixed hemorrhoids", "intervention": "titanoreine (compound carraghenates) cream", "comparator": "compound carraghenates suppository", "primaryOutcome": "relief of pain, bleeding and edema measured by a symptom score", "result": "both treatments improved symptoms similarly, but the cream relieved pain faster and more than the suppository", "resultDirection": "mixed", "quality": "low", "qualityWhy": "it was a small, open-label (not blinded) trial comparing two active treatments rather than cream versus no treatment, so it can't show whether cream works better than doing nothing.", "directness": "indirect", "limitations": "open trial design without blinding, no placebo group, and the comparator was another active treatment (suppository) rather than no treatment", "followUp": "6 days", "plainFinding": "Faster pain relief with cream.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/16167232/", "sourceText": "OBJECTIVE: To evaluate and compare the efficacy and safety of titanoreine cream with compound carraghenates suppository in the treatment of mixed hemorrhoids. METHODS: Two hundred and fifty-two patients with mixed hemorrhoids were enrolled in this randomized,open, multicentral trial. Patients applied titanoreine cream (study group, n=133) or compound carraghenates suppository (control group, n=119). The symptomatic relief including pain,bleeding and edema was evaluated by scoring system at 30 minutes, 3 hours, 6 hours, 1 day, 2 days, 3 days, 4 days, 6 days after administration. RESULTS: Symptoms were significantly improved in both groups (87.3%, 94.8%, respectively) excepting symptom of pain relief, but there was no significant difference between two groups (P > 0.05). The pain scores were lower at every observing point in the study group than those in the control group (P< 0.05). The proportions of the patients with pain relief and all symptoms relief were both higher in the study group than that in the control group at 30 min, 3 h after drug used (both P< 0.01). No side effect was found during the triad. CONCLUSION: Titanoreine cream has predominance of relieving pain and response time compared with compound carraghenates suppository, but other effects on mixed hemorrhoid are similar between the two groups.", "provenance": [ { "field": "n", "quote": "Two hundred and fifty-two patients with mixed hemorrhoids were enrolled" }, { "field": "population", "quote": "Two hundred and fifty-two patients with mixed hemorrhoids were enrolled" }, { "field": "intervention", "quote": "titanoreine cream (study group, n=133)" }, { "field": "comparator", "quote": "compound carraghenates suppository (control group, n=119)" }, { "field": "primaryOutcome", "quote": "The symptomatic relief including pain,bleeding and edema was evaluated by scoring system" }, { "field": "result", "quote": "Symptoms were significantly improved in both groups (87.3%, 94.8%, respectively) excepting symptom of pain relief, but there was no significant difference between two groups (P > 0.05). The pain scores were lower at every observing point in the study group than those in the control group (P< 0.05)." } ] }, { "id": "pmid:16134260", "pmid": "16134260", "doi": "10.2165/00003495-200565110-00003", "nctId": null, "pmcid": null, "title": "Drug treatment of haemorrhoids", "firstAuthor": "Misra", "multipleAuthors": true, "journal": "Drugs", "year": 2005, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with symptomatic hemorrhoids of various grades", "intervention": "drug treatments for hemorrhoids (oral and topical, including flavonoids, calcium dobisilate, nitrates, nifedipine)", "comparator": "", "primaryOutcome": "control of acute symptoms, especially bleeding", "result": "these drugs have been effective and well tolerated in controlling acute bleeding, but are not a cure", "resultDirection": "benefit", "quality": "low", "qualityWhy": "This is a narrative review describing various drugs without giving study details, numbers, or controlled comparisons, so it cannot be weighed heavily.", "directness": "direct", "limitations": "No individual study data, sample sizes, or trial design details are given; it is a general review article.", "followUp": "", "plainFinding": "Helps control bleeding, not a cure", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/16134260/", "sourceText": "Drug treatment for various anorectal conditions has been known since ancient times. Today, modern as well as traditional drugs are being increasingly used in all grades of symptomatic haemorrhoids. These drugs (oral and local) are used as a part of conservative management or as an adjuvant to invasive outpatient procedures. Flavonoids, in the new formulation of micronised purified flavonoid fraction (MPFF) or as part of the ancient traditional medicine derivative of the Ginkgo tree, are used for relief of acute symptoms (for control of bleeding and re-bleeding in all grades of haemorrhoids). MPFF has been recommended for control of acute bleeding in patients waiting for a definitive outpatient treatment. Similarly, better known drugs such as calcium dobisilate (used in diabetic retinopathy and chronic venous insufficiency), nitrates and nifedipine have also been effective and well tolerated in the medical treatment of haemorrhoids. However, drug treatment is not aimed at curing haemorrhoids. The prime objective of drug therapy is to control the acute phase (bleeding) so that definitive therapy (banding, injection sclerotherapy, infrared photocoagulation, cryotherapy or surgery) can be scheduled at a convenient time.", "provenance": [ { "field": "population", "quote": "all grades of symptomatic haemorrhoids" }, { "field": "intervention", "quote": "Flavonoids, in the new formulation of micronised purified flavonoid fraction (MPFF) or as part of the ancient traditional medicine derivative of the Ginkgo tree, are used for relief of acute symptoms" }, { "field": "intervention", "quote": "calcium dobisilate (used in diabetic retinopathy and chronic venous insufficiency), nitrates and nifedipine have also been effective and well tolerated in the medical treatment of haemorrhoids" }, { "field": "primaryOutcome", "quote": "for control of bleeding and re-bleeding in all grades of haemorrhoids" }, { "field": "result", "quote": "have also been effective and well tolerated in the medical treatment of haemorrhoids" }, { "field": "result", "quote": "However, drug treatment is not aimed at curing haemorrhoids." } ] }, { "id": "pmid:16117981", "pmid": "16117981", "doi": "10.1016/j.clinthera.2005.06.016", "nctId": null, "pmcid": null, "title": "Prospective, randomized, controlled, observer-blinded trial of combined infrared photocoagulation and micronized purified flavonoid fraction versus each alone for the treatment of hemorrhoidal disease", "firstAuthor": "Dimitroulopoulos", "multipleAuthors": true, "journal": "Clin Ther", "year": 2005, "design": "rct", "n": 351, "nField": "reported", "population": "patients with grade I, II, and III acute internal hemorrhoids", "intervention": "combined infrared photocoagulation plus oral micronized purified flavonoid fraction (MPFF)", "comparator": "MPFF alone or infrared photocoagulation (IRP) alone", "primaryOutcome": "whether bleeding stopped after 5 days of treatment", "result": "74.8% of patients in the combined group had no bleeding after 5 days, versus 59.6% with MPFF alone and 55.6% with IRP alone", "resultDirection": "benefit", "quality": "moderate", "qualityWhy": "It was a fairly large randomized trial with blinded assessors, but only the observers (not patients) were blinded and the main result was measured after just 5 days.", "directness": "indirect", "limitations": "Single-blind design, short primary assessment period (5 days), and the treatments studied were oral medication and a laser-type procedure rather than a topical cream.", "followUp": "90 days", "plainFinding": "Combo treatment stopped bleeding better than either alone.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/16117981/", "sourceText": "BACKGROUND: Infrared photocoagulation (IRP) is commonly used in the treatment of hemorrhoids, but rectal bleeding can persist after this procedure. Adjuvant therapy may thus be considered for more definitive control of symptoms, particularly bleeding. OBJECTIVE: The goal of this study was to compare the efficacy of a treatment combining IRP and oral micronized purified flavonoid fraction (MPFF) versus each treatment used alone on bleeding cessation in patients with grades I, II, and III acute internal hemorrhoids. METHODS: This was a prospective, randomized, controlled, single-blind study. Consecutive outpatients were randomly assigned to a treatment combining MPFF and IRP or to each treatment separately. For each patient, bleeding status was reported at day 0 (day of inclusion) and compared with that at day 5 after treatment by observers blinded to treatment assignment. Follow-up visits were planned at days 7, 30, 60, and 90 of therapy, including monitoring of treatment-related side effects and self-reporting by patients of any problem related to hemorrhoidal disease. RESULTS: A total of 351 patients (180 women, 171 men) were enrolled in the study. Their mean age was 49.2 years (range, 29-71 years). Hemorrhoids were grade I in 33.6% (118 patients), grade II in 48.7% (171 patients), and grade III in 17.7% (62 patients) of the study population. Patients were randomly assigned to each of the 3 treatment groups (117 patients in each), with no significant difference between groups in the age, sex, or distribution of grade of hemorrhoids. The percentage of patients with no bleeding after 5 days of treatment was higher in the combined treatment group (74.8%) compared with MPFF alone (59.6%; P = 0.023) or with IRP alone (55.6%; P = 0.004). MPFF alone was as effective as IRP alone at stopping bleeding. Patients with grades I and II hemorrhoids responded significantly better (82.5% and 61.7%, respectively) to either treatment than those with grade III hemorrhoids (22.9%; P < 0.001). Of the 216 patients who were followed up for 90 days, 3 had a gastrointestinal adverse event, and 19 had a relapse of bleeding. CONCLUSION: Five days of treatment combining MPFF with IRP significantly reduced bleeding status in these study patients with grades I and II acute internal hemorrhoids compared with each treatment used alone.", "provenance": [ { "field": "n", "quote": "A total of 351 patients (180 women, 171 men) were enrolled in the study." }, { "field": "population", "quote": "patients with grades I, II, and III acute internal hemorrhoids" }, { "field": "intervention", "quote": "a treatment combining IRP and oral micronized purified flavonoid fraction (MPFF)" }, { "field": "comparator", "quote": "versus each treatment used alone on bleeding cessation" }, { "field": "primaryOutcome", "quote": "bleeding status was reported at day 0 (day of inclusion) and compared with that at day 5 after treatment" }, { "field": "result", "quote": "The percentage of patients with no bleeding after 5 days of treatment was higher in the combined treatment group (74.8%) compared with MPFF alone (59.6%; P = 0.023) or with IRP alone (55.6%; P = 0.004)." } ] }, { "id": "pmid:15702657", "pmid": "15702657", "doi": null, "nctId": null, "pmcid": null, "title": "[Clinical study on the pharmacological treatment of hemorrhoids with 0.25% oxethacaine chlorhydrate]", "firstAuthor": "Gioiella", "multipleAuthors": true, "journal": "Clin Ter", "year": 2004, "design": "case-series", "n": 98, "nField": "reported", "population": "patients with Grade I-II and Grade III-IV hemorrhoids", "intervention": "rectal cream with 0.25% oxethacaine chlorhydrate (Emoren) applied twice daily for 10 days", "comparator": "", "primaryOutcome": "symptoms including itching, bleeding, burning, urgency, and pain", "result": "reduction in itching, pain, blood and mucous loss, and elimination of urgency sensation in all patients; hemorrhoids reduced in 15 patients for 11 months", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "There was no comparison group, so it's impossible to know if patients would have improved anyway without the cream.", "directness": "direct", "limitations": "No control or placebo group was used; the abstract does not describe randomization or blinding.", "followUp": "thirty-six month treatment", "plainFinding": "Symptoms improved, but no comparison group.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/15702657/", "sourceText": "In this clinical study, the authors refer to a thirty-six month treatment of Grades I and II haemorrhoids (pharmacological treatment) with a group of 75 patients (45 females and 30 males) and treatment for Grades III and IV haemorrhoids (Pharmacological and surgical treatment) on a second group of 23 patients for a total of 98 patients treated and observed. For the pharmacological treatment, a rectal cream containing 0.25% Oxethacaine chlorhydrate (Emoren, produced by Novasorel, srl) was used on all patients. The cream was applied intra-anally and on the external orifice twice a day, morning and evening, for ten days. In order to evaluate the therapeuctic effect, the following symptoms were monitored: pruritus, ematochezia, burning, tenesmus, and pain. The following results were demonstrated: a) in all patients: A reduction in pruritus, pain, blood and mucous loss, Elimination of tenesmus, Absence of peri-anal eczema, b) in 15 patients, haemorrhoids were reduced for 11 months. Therefore the results obtained reconfirm that local treatment with EMOREN demonstrated to be clinically efficient in the treatment of Grades I and II haemorrhoids as well as in post surgical treatment both for the attenuation and elimination of pain and the clinical objectives of the pathology in question.", "provenance": [ { "field": "n", "quote": "a total of 98 patients treated and observed" }, { "field": "population", "quote": "thirty-six month treatment of Grades I and II haemorrhoids (pharmacological treatment) with a group of 75 patients (45 females and 30 males) and treatment for Grades III and IV haemorrhoids (Pharmacological and surgical treatment) on a second group of 23 patients" }, { "field": "intervention", "quote": "a rectal cream containing 0.25% Oxethacaine chlorhydrate (Emoren, produced by Novasorel, srl) was used on all patients. The cream was applied intra-anally and on the external orifice twice a day, morning and evening, for ten days." }, { "field": "primaryOutcome", "quote": "the following symptoms were monitored: pruritus, ematochezia, burning, tenesmus, and pain" }, { "field": "result", "quote": "A reduction in pruritus, pain, blood and mucous loss, Elimination of tenesmus, Absence of peri-anal eczema" }, { "field": "result", "quote": "in 15 patients, haemorrhoids were reduced for 11 months" }, { "field": "followUp", "quote": "thirty-six month treatment" } ] }, { "id": "pmid:15054681", "pmid": "15054681", "doi": "10.1007/s10350-003-0129-z", "nctId": null, "pmcid": null, "title": "Topical metronidazole (10 percent) decreases posthemorrhoidectomy pain and improves healing", "firstAuthor": "Nicholson", "multipleAuthors": true, "journal": "Dis Colon Rectum", "year": 2004, "design": "rct", "n": 20, "nField": "reported", "population": "patients who had surgery to remove hemorrhoids (grade 3 or 4 hemorrhoids)", "intervention": "metronidazole 10% cream applied to the surgical wound after hemorrhoid removal", "comparator": "placebo cream (inactive carrier) applied to the surgical wound", "primaryOutcome": "pain after surgery and how well the wound healed", "result": "less pain at 7 and 14 days after surgery, less swelling, and better wound healing compared with placebo", "resultDirection": "benefit", "quality": "low", "qualityWhy": "Very small study (20 people) from one center, so the results may not hold up in a larger trial.", "directness": "indirect", "limitations": "Small sample size of only 20 patients; studies the use of cream after surgical removal of hemorrhoids, not as a treatment for shrinking existing hemorrhoids or stopping bleeding without surgery.", "followUp": "28 days", "plainFinding": "Less pain, faster healing after hemorrhoid surgery.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/15054681/", "sourceText": "INTRODUCTION: Oral metronidazole has been previously demonstrated to decrease postoperative pain after open diathermy hemorrhoidectomy. The current study investigates the efficacy of topical metronidazole (10 percent) in reducing postoperative pain and promoting wound healing after Harmonic Scalpel hemorrhoidectomy. METHODS: A prospective, randomized trial was conducted to compare posthemorrhoidectomy pain and wound healing with use of topical metronidazole (10 percent) vs. placebo carrier, applied to the surgical site. Surgical indications included grade 3 or 4 internal or external hemorrhoidal disease, with or without a fissure-in-ano. Pain was assessed using a visual analog score (VAS) preoperatively and on postoperative days 1, 2, 7, 14, and 28. Twenty-four-hour narcotic use (hydrocodone 10 mg) was recorded on postoperative days 1, 2, 7, 14, and 28. Digital photographs of the surgical site were taken at 14 days postoperatively. The photographs were independently ranked by three blinded observers according to a) postoperative edema, b) primary vs. secondary healing, and c) overall wound healing. RESULTS: Twenty patients were randomized in a prospective manner, ten to the topical 10 percent metronidazole group and ten to the placebo carrier group. Patients in the topical metronidazole group experienced significantly less postoperative pain at day 7 (VAS +/- SEM, 3.4 +/- 0.4 vs. 6.3 +/- 0.5; P = 0.002) and day 14 (1.0 +/- 0.4 vs. 3.2 +/- 0.7, P = 0.02). There was no statistical difference in narcotic analgesic requirements between groups. In the metronidazole group, postoperative edema was ranked significantly lower (mean score, 3.0 vs. 7.0, P < 0.01) and overall wound healing ranked significantly better (4.0 vs. 7.0, P = 0.03) than in controls. CONCLUSION: Topical 10 percent metronidazole significantly reduces posthemorrhoidectomy discomfort at days 7 and 14 postoperatively. Postoperative edema is reduced and overall healing is improved, compared with that of carrier controls.", "provenance": [ { "field": "n", "quote": "Twenty patients were randomized in a prospective manner, ten to the topical 10 percent metronidazole group and ten to the placebo carrier group." }, { "field": "population", "quote": "Surgical indications included grade 3 or 4 internal or external hemorrhoidal disease, with or without a fissure-in-ano." }, { "field": "intervention", "quote": "The current study investigates the efficacy of topical metronidazole (10 percent) in reducing postoperative pain and promoting wound healing after Harmonic Scalpel hemorrhoidectomy." }, { "field": "comparator", "quote": "A prospective, randomized trial was conducted to compare posthemorrhoidectomy pain and wound healing with use of topical metronidazole (10 percent) vs. placebo carrier, applied to the surgical site." }, { "field": "primaryOutcome", "quote": "Pain was assessed using a visual analog score (VAS) preoperatively and on postoperative days 1, 2, 7, 14, and 28." }, { "field": "result", "quote": "Patients in the topical metronidazole group experienced significantly less postoperative pain at day 7 (VAS +/- SEM, 3.4 +/- 0.4 vs. 6.3 +/- 0.5; P = 0.002) and day 14 (1.0 +/- 0.4 vs. 3.2 +/- 0.7, P = 0.02)." } ] }, { "id": "pmid:12847372", "pmid": "12847372", "doi": "10.1007/s10350-004-6692-0", "nctId": null, "pmcid": null, "title": "Effect of 0.2 percent glyceryl trinitrate ointment on wound healing after a hemorrhoidectomy: results of a randomized, prospective, double-blind, placebo-controlled trial", "firstAuthor": "Hwang", "multipleAuthors": true, "journal": "Dis Colon Rectum", "year": 2003, "design": "rct", "n": 110, "nField": "reported", "population": "patients with third or fourth degree hemorrhoids having surgery to remove three or more piles", "intervention": "0.2% glyceryl trinitrate ointment applied to the surgical wound after hemorrhoid removal", "comparator": "placebo ointment", "primaryOutcome": "complete wound healing at three weeks after surgery", "result": "74.5% of nitroglycerin group had complete healing at three weeks versus 42% of placebo group, and pain scores were lower with nitroglycerin", "resultDirection": "benefit", "quality": "moderate", "qualityWhy": "it was a well-designed randomized double-blind placebo-controlled trial with a planned sample size, but it was done at a single center by one surgeon, which may limit how well it applies elsewhere.", "directness": "indirect", "limitations": "single surgeon performed all procedures; study measures wound healing after surgical removal of hemorrhoids, not effects on unremoved hemorrhoids", "followUp": "three weeks", "plainFinding": "Faster healing after hemorrhoid surgery.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/12847372/", "sourceText": "PURPOSE: Glyceryl trinitrate ointment acts as a dilator of the internal anal sphincter. It has been used as a treatment modality that replaces the lateral sphincterotomy in chronic anal fissures. When glyceryl trinitrate ointment is applied to the wound from a hemorrhoidectomy, it is thought that it will shorten the healing time and decrease postoperative pain. Our study focused on the efficacy of using 0.2 percent glyceryl trinitrate ointment to shorten the healing time after a hemorrhoidectomy. METHODS: A randomized, prospective, double-blind, and placebo-controlled study was designed. The power test indicated that 55 patients should be in each group to give a 90 percent chance of finding a 30 percent difference in healing time. The selection criteria for inclusion in this study were patients with third-degree or fourth-degree hemorrhoids and patients undergoing hemorrhoidectomies for three or more piles. From November 2000 to July 2001, the first 110 patients to meet our criteria were selected, 55 in the nitroglycerin group and 55 in the placebo group. The same physician performed all of the hemorrhoidectomies, and intravenous patient-controlled analgesia was not used. Cases involving other procedures for fissures or fistulas were excluded. The patients randomly received glyceryl trinitrate and placebo ointments from the pharmacologist. The pain score was checked using a visual analog scale (minimum = 0, maximum = 10) during the hospital stay, and complete wound healing was checked at three weeks after the operation. Demands for analgesics and the frequency of postoperative complications were recorded. RESULTS: When the trial was completed, 49 patients remained in the nitroglycerin group and 53 patients in the placebo group. No significant differences in the gender and the age distributions, the number of excised piles, the time for the procedures, the length of hospital stay, and the consumed amounts of analgesics existed between the two groups. The pain score in the nitroglycerin group showed a significant difference with the repeated measures analysis (P < 0.001). The wound healing rates at three weeks postoperative were 74.5 percent in the nitroglycerin group and 42 percent in the placebo group (P = 0.002). There was no significant increase in complications in the nitroglycerin group. CONCLUSION: More rapid healing of hemorrhoidectomy wounds without any specific complications was effected by 0.2 percent glyceryl trinitrate ointment.", "provenance": [ { "field": "population", "quote": "patients with third-degree or fourth-degree hemorrhoids and patients undergoing hemorrhoidectomies for three or more piles" }, { "field": "intervention", "quote": "0.2 percent glyceryl trinitrate ointment" }, { "field": "comparator", "quote": "placebo ointment" }, { "field": "primaryOutcome", "quote": "complete wound healing was checked at three weeks after the operation" }, { "field": "result", "quote": "The wound healing rates at three weeks postoperative were 74.5 percent in the nitroglycerin group and 42 percent in the placebo group (P = 0.002)." }, { "field": "n", "quote": "the first 110 patients to meet our criteria were selected, 55 in the nitroglycerin group and 55 in the placebo group" } ] }, { "id": "pmid:12189774", "pmid": "12189774", "doi": "10.1055/s-0031-1299924", "nctId": null, "pmcid": null, "title": "Local treatment of hemorrhoidal disease and perianal eczema. Meta-analysis of the efficacy and safety of an Escherichia coli culture suspension alone or in combination with hydrocortisone", "firstAuthor": "Wienert", "multipleAuthors": true, "journal": "Arzneimittelforschung", "year": 2002, "design": "meta-analysis", "n": 1070, "nField": "reported", "population": "patients with hemorrhoids and/or perianal eczema, mean age 50 years", "intervention": "ointment containing E. coli bacterial culture suspension (BCS), alone or combined with hydrocortisone", "comparator": "ointment base (vehicle) or hydrocortisone ointment alone", "primaryOutcome": "overall efficacy rating and symptom scores for burning, itching, redness and soiling", "result": "BCS ointment and BCS plus hydrocortisone gave greater symptom relief than the ointment base, and BCS plus hydrocortisone was also better than hydrocortisone alone", "resultDirection": "benefit", "quality": "low", "qualityWhy": "Although it pools six short, double-blind randomized trials, treatment lasted only two weeks, mixed two different conditions together, and did not report measures like bleeding or hemorrhoid size.", "directness": "indirect", "limitations": "Treatment and follow-up were only 2 weeks; patients had either hemorrhoids or perianal eczema, not hemorrhoids specifically with bleeding as an endpoint; outcome measures were symptom scores and investigator ratings rather than hemorrhoid shrinkage or bleeding.", "followUp": "2 weeks", "plainFinding": "More symptom relief than placebo.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/12189774/", "sourceText": "The objective of this paper was to assess the available clinical data on the efficacy and safety of ointments containing either a bacterial culture suspension (BCS) from Escherichia coli or a combination of BCS with hydrocortisone (CAS 50-23-7) (BCS: Posterisan, and BCS + HC: Posterisan forte). The BCS is assumed to act by immunomodulation in hemorrhoidal disease and perianal eczema. Six randomized, double-blind trials are reported: three of them using BCS ointment and one using BCS + HC, against ointment base, and two trials using BCS + HC against hydrocortisone ointment alone. Patients with hemorrhoids and/or perianal eczema were included and treated over 2 weeks with weekly assessments. Efficacy parameters included score changes for burning, itching, redness and soiling as well as the investigators' overall efficacy rating. Safety was assessed from adverse drug reactions and an overall safety rating. Out of 1,070 patients (mean age 50 years), 273 received BCS and 229 BCS + HC; 568 patients were given the various controls. In the overall efficacy rating, BCS ointment was significantly superior to the ointment base in all three studies (p = 0.028, p = 0.016, and p = 0.045). Moreover, BCS + HC was superior to the ointment base (p < 0.001) and to hydrocortisone alone (p = 0.156 and p = 0.021), confirming the distinct effect of the E. coli suspension. Satisfactory results were achieved in 83% of patients after the BCS + HC combination, 77% after BCS-containing ointment, 75% after hydrocortisone ointment and 52% after ointment base. Symptom scores decreased consistently more after administration of BCS than after the ointment base (p = 0.095, p = 0.006, and p = 0.029), and likewise, the combination of BCS + HC was significantly superior to the ointment base (p < 0.001) and to hydrocortisone alone (p = 0.036 and p = 0.019). Adverse events were less frequent for BCS and BCS + HC than for the ointment base. It can therefore be concluded that ointments containing either only E. coli BCS or a combination of BCS and hydrocortisone provide significant relief in perianal eczema as well as in early stages of hemorrhoidal disease.", "provenance": [ { "field": "n", "quote": "Out of 1,070 patients (mean age 50 years), 273 received BCS and 229 BCS + HC; 568 patients were given the various controls." }, { "field": "population", "quote": "Patients with hemorrhoids and/or perianal eczema were included and treated over 2 weeks with weekly assessments." }, { "field": "intervention", "quote": "ointments containing either a bacterial culture suspension (BCS) from Escherichia coli or a combination of BCS with hydrocortisone" }, { "field": "comparator", "quote": "against ointment base, and two trials using BCS + HC against hydrocortisone ointment alone" }, { "field": "primaryOutcome", "quote": "Efficacy parameters included score changes for burning, itching, redness and soiling as well as the investigators' overall efficacy rating." }, { "field": "result", "quote": "BCS ointment was significantly superior to the ointment base in all three studies (p = 0.028, p = 0.016, and p = 0.045). Moreover, BCS + HC was superior to the ointment base (p < 0.001) and to hydrocortisone alone (p = 0.156 and p = 0.021)" }, { "field": "followUp", "quote": "treated over 2 weeks with weekly assessments" } ] }, { "id": "pmid:11469087", "pmid": "11469087", "doi": "10.1007/s001040170122", "nctId": null, "pmcid": null, "title": "[Ambulatory hemorrhoid therapy]", "firstAuthor": "Müller-Lobeck", "multipleAuthors": false, "journal": "Chirurg", "year": 2001, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with hemorrhoid (anal) complaints", "intervention": "treatment with ointments, among other ambulatory options like sclerotherapy and rubber band ligation", "comparator": "other ambulatory treatments (sclerotherapy, rubber band ligation, Doppler-guided artery ligation)", "primaryOutcome": "not clearly defined; the abstract discusses acceptance, risks and complications of treatment options rather than a specific efficacy outcome", "result": "the abstract states only that treatment with ointments can be managed by the patient without any problems, without giving data on whether it shrinks hemorrhoids or stops bleeding", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "this is a general narrative review that does not present actual study data or outcome measurements for ointment treatment specifically.", "directness": "indirect", "limitations": "no original data, sample size, or outcome measures are reported for ointment/cream treatment; it is a broad historical and descriptive review of multiple hemorrhoid therapies.", "followUp": "", "plainFinding": "No efficacy data reported for creams.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/11469087/", "sourceText": "For thousands of years, anal complaints were treated symptomatically with ointments, suppositories and, in isolated cases, even surgically. Since the middle of the last century injection sclerotherapy has been by far the most widespread out-patient treatment for the very common haemorrhoidal disease. This is based on the notion that haemorrhoids are varicosities, and while this idea has been contested by the theory of a spongy body for over 200 years, it is nonetheless only in the last 40 years that the spongy body theory has become accepted, giving rise to further important functional investigations on the anal structures involved in bowel continence and to rational treatment for haemorrhoids. The conditions necessary for out-patient treatment of haemorrhoids and the options available are presented in this paper and discussed with reference to acceptance, inherent risks, and the possible complications. While diet and behavioural methods, and also anal dilatation and treatment with ointments, can be managed by the patient without any problems, regardless of how effective sclerotherapy and rubber band ligation are, these involve risks whose ramifications are often underestimated. One operative procedure that may well become established as an effective out-patient method in the future is Doppler-guided isolated haemorrhoidal artery ligation (HAL) after Morinaga. Traditionally, day surgery is not so well accepted for haemorrhoidectomy in Germany; unless the operation planned is not very extensive, in-patient treatment is still considered preferable.", "provenance": [ { "field": "population", "quote": "the very common haemorrhoidal disease" }, { "field": "intervention", "quote": "treatment with ointments" }, { "field": "comparator", "quote": "regardless of how effective sclerotherapy and rubber band ligation are" }, { "field": "result", "quote": "diet and behavioural methods, and also anal dilatation and treatment with ointments, can be managed by the patient without any problems" }, { "field": "primaryOutcome", "quote": "discussed with reference to acceptance, inherent risks, and the possible complications" } ] }, { "id": "pmid:11432512", "pmid": "11432512", "doi": "10.1016/s1590-8658(01)80088-8", "nctId": null, "pmcid": null, "title": "Comparison of topically applied 0.2% glyceryl trinitrate ointment, incision and excision in the treatment of perianal thrombosis", "firstAuthor": "Cavcić", "multipleAuthors": true, "journal": "Dig Liver Dis", "year": 2001, "design": "rct", "n": 150, "nField": "reported", "population": "patients with perianal thrombosis", "intervention": "glyceryl trinitrate (GTN) ointment applied to the anal area", "comparator": "incision or excision surgery", "primaryOutcome": "pain relief, recurrence rate, and skin tag formation", "result": "excision gave better pain relief, fewer recurrences, and fewer skin tags than GTN ointment or incision", "resultDirection": "no-benefit", "quality": "moderate", "qualityWhy": "it is a randomized trial with a reasonable sample size, but it studies perianal thrombosis rather than ordinary hemorrhoids, limiting how directly it answers the question.", "directness": "indirect", "limitations": "abstract does not describe blinding or dropout details; condition studied is perianal thrombosis, not general hemorrhoids.", "followUp": "after one year", "plainFinding": "Less effective than surgery.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/11432512/", "sourceText": "BACKGROUND AND AIMS: Topically applied 0.2% glyceryl trinitrate ointment to the anal region, incision and excision were compared in the treatment of perianal thrombosis, in order to establish which method is the best in terms of pain relief, number of recurrences and the appearance of anal skin tags. PATIENTS AND METHODS: A total of 150 patients were randomly divided into three groups of 50, each group being treated by one of the above-mentioned methods. The results of the treatment were evaluated during the first 4 days, after one month and after one year. RESULTS: A statistically significant reduction of pain was achieved by excision if compared with incision or conservative treatment with glyceryl trinitrate (p<0.001), and by conservative treatment with glyceryl trinitrate if compared with incision (p<0.01 on the 4th day of follow-up. Comparison of patients treated by the three different methods did not reveal any significant difference between these methods after one month (p>0.05). After one year the number of recurrences was significantly reduced after excision if compared with incision (p<0.05) or conservative treatment with glyceryl trinitrate (p<0.05). The number of patients without symptoms was significantly greater after excision if compared with incision or conservative treatment with glyceryl trinitrate (p<0.001). The number of patients with anal skin tags was significantly reduced in patients treated by excision if compared with incision (p<0.001) or glyceryl trinitrate treatment (p<0.001). CONCLUSION: Excision is a significantly better method of treatment of perianal thrombosis than incision or topically applied 0.2% glyceryl trinitrate ointment.", "provenance": [ { "field": "population", "quote": "treatment of perianal thrombosis" }, { "field": "n", "quote": "A total of 150 patients were randomly divided into three groups of 50" }, { "field": "intervention", "quote": "Topically applied 0.2% glyceryl trinitrate ointment to the anal region" }, { "field": "comparator", "quote": "incision and excision were compared" }, { "field": "primaryOutcome", "quote": "pain relief, number of recurrences and the appearance of anal skin tags" }, { "field": "result", "quote": "Excision is a significantly better method of treatment of perianal thrombosis than incision or topically applied 0.2% glyceryl trinitrate ointment." } ] }, { "id": "pmid:11289288", "pmid": "11289288", "doi": "10.1007/BF02234741", "nctId": null, "pmcid": null, "title": "Conservative treatment of acute thrombosed external hemorrhoids with topical nifedipine", "firstAuthor": "Perrotti", "multipleAuthors": true, "journal": "Dis Colon Rectum", "year": 2001, "design": "rct", "n": 98, "nField": "reported", "population": "patients with acute thrombosed external hemorrhoids", "intervention": "topical nifedipine 0.3% with lidocaine ointment applied every 12 hours for two weeks", "comparator": "topical lidocaine ointment alone", "primaryOutcome": "pain relief and resolution of the thrombosed hemorrhoids", "result": "more pain relief, less need for painkillers, and more resolution of hemorrhoids with nifedipine than with lidocaine alone", "resultDirection": "benefit", "quality": "moderate", "qualityWhy": "it was a randomized trial but open-label (not blinded) and of modest size, which can bias results.", "directness": "indirect", "limitations": "open design (not blinded), so patients and doctors knew which treatment was given, which could affect reported pain and analgesic use", "followUp": "14 days", "plainFinding": "Faster healing, less pain than lidocaine alone", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/11289288/", "sourceText": "PURPOSE: This study was performed according to a prospective, randomized, open design. The aim was to test the efficacy of local application of nifedipine ointment in healing acute thrombosed external hemorrhoids. METHODS: Ninety-eight patients who gave their informed consent were recruited; they received clinical examination and anoscopy. A questionnaire to evaluate symptoms, pain, and concurrent use of analgesics was administered. Patients treated with nifedipine (n = 50) used topical 0.3 percent nifedipine and 1.5 percent lidocaine ointment every 12 hours for two weeks. The control group, consisting of 48 patients, received topical 1.5 percent lidocaine ointment during therapy. RESULTS: Results obtained were as follows: complete relief of pain in 43 patients (86 percent) of the nifedipine-treated group as opposed to 24 patients (50 percent) of the control group after 7 days of therapy (P < 0.01); oral analgesics were used by 4 patients (8 percent) in the nifedipine-treated group as opposed to 26 patients (54.1 percent) of the control group after 7 days of therapy (P < 0.01); and resolution of acute thrombosed external hemorrhoids was achieved after 14 days of therapy in 46 patients (92 percent) of the nifedipine-treated group, as opposed to 22 patients (45.8 percent) of the control group (P < 0.01). We did not observe any systemic side effect in patients treated with nifedipine. CONCLUSIONS: Our study clearly demonstrates that the use of topical nifedipine, which at present is for treatment of cardiovascular disorders, is a reliable new option in the conservative treatment of thrombosed external hemorrhoids.", "provenance": [ { "field": "n", "quote": "Ninety-eight patients who gave their informed consent were recruited" }, { "field": "population", "quote": "acute thrombosed external hemorrhoids" }, { "field": "intervention", "quote": "Patients treated with nifedipine (n = 50) used topical 0.3 percent nifedipine and 1.5 percent lidocaine ointment every 12 hours for two weeks." }, { "field": "comparator", "quote": "The control group, consisting of 48 patients, received topical 1.5 percent lidocaine ointment during therapy." }, { "field": "primaryOutcome", "quote": "The aim was to test the efficacy of local application of nifedipine ointment in healing acute thrombosed external hemorrhoids." }, { "field": "result", "quote": "resolution of acute thrombosed external hemorrhoids was achieved after 14 days of therapy in 46 patients (92 percent) of the nifedipine-treated group, as opposed to 22 patients (45.8 percent) of the control group (P < 0.01)" } ] }, { "id": "pmid:11008728", "pmid": "11008728", "doi": "10.1007/s003840000235", "nctId": null, "pmcid": null, "title": "Treatment of acute strangulated internal hemorrhoids by topical application of isosorbide dinitrate ointment", "firstAuthor": "Briel", "multipleAuthors": true, "journal": "Int J Colorectal Dis", "year": 2000, "design": "case-series", "n": 4, "nField": "reported", "population": "men with acute strangulated (prolapsed and trapped) internal hemorrhoids", "intervention": "isosorbide dinitrate ointment (1%) applied to the anal skin every 3 hours for 2 weeks", "comparator": "no comparator group", "primaryOutcome": "pain relief and hemorrhoids becoming reducible so they could then be treated with rubber band ligation", "result": "pain relief within 1 day and hemorrhoids became reducible within 1 week, allowing later rubber band ligation", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "Only 4 patients with no comparison group, so it's impossible to know if the cream itself caused the improvement.", "directness": "indirect", "limitations": "Very small number of patients (4), all male, no control group, and the condition studied (acute strangulated hemorrhoids) is a severe emergency situation rather than typical hemorrhoid symptoms like bleeding or mild shrinkage.", "followUp": "2 weeks", "plainFinding": "Pain eased, hemorrhoids became treatable.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/11008728/", "sourceText": "Exogenous nitric oxide has been shown useful in decreasing the internal anal sphincter tone. This study investigated the role of isosorbide dinitrate in the treatment of patients with acute strangulated internal hemorrhoids, thereby avoiding the risk of continence disturbances following conventional surgical treatment. Four male patients (median age 35 years, range 30-42) with acute strangulated hemorrhoids were treated with 1% isosorbide dinitrate. The ointment was applied to the anoderm. This application was repeated every 3 h during daytime for 2 weeks. Significant pain relief was achieved within 1 day, while transient mild headache was experienced during the first 2 days. Within 1 week the hemorrhoids became reducible. Thereafter the hemorrhoids could be treated adequately by rubber band ligation. The alternative treatment of patients with acute strangulation of prolapsed internal hemorrhoids is effective. This nonsurgical, i.e., reversible reduction of sphincter tone is an attractive alternative.", "provenance": [ { "field": "n", "quote": "Four male patients (median age 35 years, range 30-42)" }, { "field": "population", "quote": "patients with acute strangulated internal hemorrhoids" }, { "field": "intervention", "quote": "1% isosorbide dinitrate. The ointment was applied to the anoderm. This application was repeated every 3 h during daytime for 2 weeks." }, { "field": "comparator", "quote": "This study investigated the role of isosorbide dinitrate in the treatment of patients with acute strangulated internal hemorrhoids" }, { "field": "primaryOutcome", "quote": "Significant pain relief was achieved within 1 day" }, { "field": "result", "quote": "Within 1 week the hemorrhoids became reducible. Thereafter the hemorrhoids could be treated adequately by rubber band ligation." } ] }, { "id": "pmid:10975023", "pmid": "10975023", "doi": null, "nctId": null, "pmcid": null, "title": "[Analytical review of multicenter studies with polycresulene for hemorrhoidal pathologies]", "firstAuthor": "Espinosa", "multipleAuthors": false, "journal": "Acta Gastroenterol Latinoam", "year": 2000, "design": "meta-analysis", "n": 2287, "nField": "reported", "population": "patients with hemorrhoid problems, including external and internal hemorrhoids with bleeding, anal fissures, and other anal conditions", "intervention": "policresulene cream combined with a local anesthetic (cinchocaine), applied as ointment or suppositories", "comparator": "none reported — no placebo or untreated comparison group was described", "primaryOutcome": "how satisfied doctors and patients were with symptom improvement", "result": "83.2% of patients were rated by doctors as having highly satisfactory results, and 82.2% of patients rated it the same way", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "This pooled report of multiple centers had no comparison group, so it cannot show whether the cream itself caused the improvement.", "directness": "direct", "limitations": "No control or placebo group was described, so improvement cannot be separated from natural healing; only investigator and patient satisfaction ratings were used, not objective shrinkage or bleeding measures.", "followUp": "", "plainFinding": "High satisfaction reported, but no comparison group.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/10975023/", "sourceText": "Seven centres investigated the therapeutic efficacy and tolerability of policresulene associated to cinchocaine administered locally as ointment, suppositories or both formulations in 2287 patients with hemorrhoid pathology. The studies were conducted with a standardised protocol and case report forms and with the same score criteria for rating efficacy and tolerability according to the physicians and the patients. Highly satisfactory results were achieved in 1904 patients (83.2%) according to the investigators criteria. Patients rated the outcome most satisfactory for 1881 cases (82.2%). The following were found to be the principal indications: external and internal hemorrhoids associated with bleeding, acute anal fissures, rhagades and perforated or incised perianal thrombosis, anal eczema and anal pruritus, proctitis and wound treatment after proctologic surgery. None of the investigators found any serious adverse event. Mild to moderate adverse reactions in 10% of the patients were local discomfort, pruritus, burning or irritation. Such symptoms occurred at the beginning of treatment. The favourable effects of policresulene are attributed to its unique mechanism of action. The highly acid characteristics of the substance causes a selective coagulation of the necrotic tissues leaving healthy tissues unaffected. The desquamation and remotion of the necrotic tissues induces rapid wound cleansing, and a reactive hyperemia of the treated area enhancing epithelization. Its highly acid pH produces a marked bactericidal action on the most common pathogens and C. albicans as well. Policresulene has hemostyptic properties producing vasoconstriction of the myofibrils of the blood vessels arresting profuse bleeding from large areas. The local anesthetic cinchocaine contributes to the initial pain relief. None of the formulations contains corticosteroids which makes this preparations also suitable for long term treatment periods.", "provenance": [ { "field": "n", "quote": "2287 patients with hemorrhoid pathology" }, { "field": "population", "quote": "2287 patients with hemorrhoid pathology" }, { "field": "intervention", "quote": "policresulene associated to cinchocaine administered locally as ointment, suppositories or both formulations" }, { "field": "comparator", "quote": "Seven centres investigated the therapeutic efficacy and tolerability of policresulene associated to cinchocaine administered locally as ointment, suppositories or both formulations in 2287 patients with hemorrhoid pathology." }, { "field": "primaryOutcome", "quote": "with the same score criteria for rating efficacy and tolerability according to the physicians and the patients" }, { "field": "result", "quote": "Highly satisfactory results were achieved in 1904 patients (83.2%) according to the investigators criteria. Patients rated the outcome most satisfactory for 1881 cases (82.2%)." } ] }, { "id": "pmid:8921768", "pmid": "8921768", "doi": "10.1016/s0733-8627(05)70278-9", "nctId": null, "pmcid": null, "title": "Anorectal disorders", "firstAuthor": "Janicke", "multipleAuthors": true, "journal": "Emerg Med Clin North Am", "year": 1996, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with anorectal disorders including hemorrhoids seen in the emergency department", "intervention": "conservative medical treatment such as dietary changes and sitz baths, or nonsurgical procedures like rubber band ligation and infrared coagulation", "comparator": "", "primaryOutcome": "", "result": "the abstract does not report a specific outcome or result for hemorrhoid cream; it only states treatment depends on severity and most cases can be treated conservatively", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "This is a general narrative review describing treatment categories, not a study testing a specific cream against an outcome, so it cannot show whether cream works.", "directness": "indirect", "limitations": "This is a broad review of anorectal disorders overall, not a study evaluating hemorrhoid cream specifically, and reports no data, numbers, or outcomes for any cream.", "followUp": "", "plainFinding": "Doesn't test hemorrhoid cream at all", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/8921768/", "sourceText": "Anorectal disorders are commonly encountered in the practice of emergency medicine. Most can be diagnosed and treated in the emergency department setting. Almost all anorectal disorders once diagnosed and treated in the emergency department need appropriate follow-up to ensure adequacy of treatment, for further possible diagnostic procedures (e.g., endoscopy, biopsy), or for definitive treatment. Hemorrhoids are the most prevalent anorectal disorder and are the most common cause of hematochezia. Treatment is dependent on the degree of hemorrhoid prolapse and symptoms. Most cases can be treated by conservative medical treatment (e.g., dietary changes, sitz baths) or nonsurgical procedures (e.g., rubber band liagation, infrared coagulation). Surgical excision of symptomatic thrombosed external hemorrhoids is indicated if within 48 to 72 hours of pain onset. Anal fissures are one of the most common causes of anorectal pain. They are most frequently idiopathic, and most are located in the posterior midline of the anal canal. Most anal fissures are adequately treated by a medical approach using sitz baths, stool softeners, and analgesics. If the anal fissure becomes chronic and is not responsive to medical therapy, a lateral sphincterotomy of the internal anal sphincter is the surgical procedure of choice. Pharmacologic treatment (botulinum toxin or nitroglycerin ointment) to decrease internal anal sphincter tone has shown promise in the treatment of anal fissure. Anorectal abscesses are categorized into four types: perianal, ischiorectal, intersphincteric, and supralevator. Most are idiopathic and contain mixed aerobic-anaerobic pathogens. Fistula formation varies from 25% to 50% and is much more common with gut-derived organisms (e.g., E. coli, B. fragilis). Definitive treatment for an anorectal abscess is timely surgical incision and drainage to prevent more serious complications (e.g., serious infection, extension of the abscess). Anal carcinomas are infrequent, the majority of them being squamous cell or epidermoid carcinomas. The emergency physician must maintain a high index of suspicion and obtain a biopsy of suspicious lesions in order not to miss the diagnosis of a cancer. The most common presenting complaint of anal tumors is rectal bleeding. Combination chemotherapy and radiotherapy have shown promising results in the treatment of anal canal tumors. Bacterial, viral, and protozoal infections can be transmitted to the anorectum via anoreceptive intercourse. Such infections must be considered when a patient presents with rectal pain or discharge, tenesmus, or rectal or perineal ulcers. Proctosigmoidoscopy and rectal cultures may be necessary to determine the cause. Potential rectal complications of HIV infection include infectious diarrhea, acyclovir-resistant strains of HSV2, Kaposi's sarcoma, lymphoma, and squamous cell carcinoma. Rectal injuries may result from penetrating or blunt trauma, iatrogenic injuries, or foreign bodies. Rectal injury should be suspected when a patient presents with low abdominal, pelvic, or perineal pain or blood per rectum after sustaining trauma or undergoing an endoscopic or surgical procedure. Tetanus prophylaxis, intravenous antibiotics, and surgical intervention are indicated in all but superficial rectal tears.", "provenance": [ { "field": "population", "quote": "Anorectal disorders are commonly encountered in the practice of emergency medicine." }, { "field": "intervention", "quote": "Most cases can be treated by conservative medical treatment (e.g., dietary changes, sitz baths) or nonsurgical procedures (e.g., rubber band liagation, infrared coagulation)." }, { "field": "result", "quote": "Treatment is dependent on the degree of hemorrhoid prolapse and symptoms." } ] }, { "id": "pmid:8762660", "pmid": "8762660", "doi": null, "nctId": null, "pmcid": null, "title": "[Effectiveness and innocuousness of the association of calcium dobesilate, dexamethasone acetate and lidocaine versus prednisolone capronate with dibucaine clorohydrate in the treatment of hemorrhoids-]", "firstAuthor": "Marsicano", "multipleAuthors": true, "journal": "G E N", "year": 1995, "design": "rct", "n": 40, "nField": "reported", "population": "patients with internal hemorrhoids grade 1 or 2", "intervention": "calcium dobesilate with dexamethasone acetate and lidocaine applied topically twice a day", "comparator": "prednisolone capronate with dibucaine chlorohydrate applied topically twice a day", "primaryOutcome": "change in hemorrhoid symptom score and hemorrhoid grade from start to end of treatment", "result": "No significant difference between the two creams; both produced important improvement in symptoms and hemorrhoid grade, with physician-rated success of 88% and 85.7% respectively", "resultDirection": "benefit", "quality": "low", "qualityWhy": "Very small study (40 patients) comparing two active creams without a placebo group, so it cannot show whether either cream helped more than no treatment.", "directness": "direct", "limitations": "No placebo or untreated comparison group; small sample size; subjective symptom scoring", "followUp": "", "plainFinding": "Both creams improved symptoms similarly.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/8762660/", "sourceText": "The objective of the present study was to compare properties of two associations in the topical treatment of hemorrhoids. They were included 40 patient with diagnosis of internal hemorrhoids grade 1 or 2, which was indicated topic treatment after the realization of an interrogatory and anoscopy. The treatment received according to a randomized and double blind design: A = dobesilate of calcium with acetato of dexamethasone and lidocaine or B = Capronato of Prednisolone with Clorhidrato of dibucaina, applied twice a day. They were carried out controls every 7 days. In each control was carried out interrogatory and respective anoscopy. There was a prevalence of the females, and the age corresponded to the 5t decade of the life. Patients of the treatment. A presented greater number of predisponents factors, but minor percentage of previous treatments. As for the evaluation of the punctuation of symptoms and of the grade of Hemorrhoids, comparing beginning and final, they didn't show significant difference interproduct confirming the effectiveness and similar inocuity. In both products was observed a important improvement concerning to the symptoms and grade of hemorrhoids but the patients of the treatment A precipitated the greater speed. As for the evaluation made by the phisicians, the treatment A (88%) and B (85.7%) the got successful outputs. The opinion of the patients was a 100% of marked goods or moderated beneficial. Both treatments were successful so much in effectiveness like in inocuity although the treatment A were always got the best efectiveness outputs.", "provenance": [ { "field": "n", "quote": "They were included 40 patient with diagnosis of internal hemorrhoids grade 1 or 2" }, { "field": "population", "quote": "40 patient with diagnosis of internal hemorrhoids grade 1 or 2" }, { "field": "intervention", "quote": "A = dobesilate of calcium with acetato of dexamethasone and lidocaine" }, { "field": "comparator", "quote": "B = Capronato of Prednisolone with Clorhidrato of dibucaina, applied twice a day" }, { "field": "primaryOutcome", "quote": "As for the evaluation of the punctuation of symptoms and of the grade of Hemorrhoids, comparing beginning and final" }, { "field": "result", "quote": "they didn't show significant difference interproduct confirming the effectiveness and similar inocuity" }, { "field": "result", "quote": "the treatment A (88%) and B (85.7%) the got successful outputs" } ] }, { "id": "pmid:8203789", "pmid": "8203789", "doi": null, "nctId": null, "pmcid": null, "title": "Double-blind, placebo-controlled evaluation of clinical activity and safety of Daflon 500 mg in the treatment of acute hemorrhoids", "firstAuthor": "Cospite", "multipleAuthors": false, "journal": "Angiology", "year": 1994, "design": "rct", "n": 100, "nField": "reported", "population": "patients having an acute hemorrhoid flare-up with a history of hemorrhoid disease", "intervention": "oral Daflon 500 mg tablets (a vein-support drug, not a cream)", "comparator": "placebo tablets", "primaryOutcome": "overall improvement of hemorrhoid symptoms like bleeding, discomfort, pain, and discharge", "result": "symptoms improved faster and more with the drug than with placebo, with less need for analgesics and topical treatments", "resultDirection": "benefit", "quality": "moderate", "qualityWhy": "it was a properly randomized, double-blind, placebo-controlled trial, but it was small, short, and single-study, and it tested a swallowed drug rather than a cream applied to the skin.", "directness": "indirect", "limitations": "small sample size, short treatment period, and no information on long-term outcomes or recurrence", "followUp": "", "plainFinding": "Oral pill eased symptoms faster, not cream.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/8203789/", "sourceText": "One hundred patients with a history of hemorrhoidal disease and suffering from an acute hemorrhoidal attack were randomized into two parallel groups and treated with Daflon 500 mg* (D500) or placebo (PL) under double-blind conditions. Daflon 500 mg was administered at the dosage of three tablets bid the first four days and two tablets bid the following three days. Overall improvement of symptoms was greater in the D500 group than in the PL group, from D2 up to D7. The clinical severity of proctorrhagia, anal discomfort, pain, and anal discharge diminished in both groups but to a greater extent in the D500 group (P < 0.001 for all parameters except protorrhagia, P = 0.006). Inflammation, congestion, edema, and prolapse were more markedly improved in the D500 group than in the PL group. Duration and severity of the current hemorrhoidal episode, as assessed by patient self-evaluation, were less important in the D500 group as compared with previous episodes. Use of analgesics and topical medications diminished in both groups, with a major reduction in the D500 group from D4 (P < 0.001). Acceptability was good in both groups: no patient experienced major side effects. In summary, treatment with D500 resulted in a quicker and more pronounced relief of signs and symptoms of acute hemorrhoids than with the placebo.", "provenance": [ { "field": "n", "quote": "One hundred patients with a history of hemorrhoidal disease" }, { "field": "population", "quote": "patients with a history of hemorrhoidal disease and suffering from an acute hemorrhoidal attack" }, { "field": "intervention", "quote": "treated with Daflon 500 mg* (D500)" }, { "field": "comparator", "quote": "placebo (PL) under double-blind conditions" }, { "field": "primaryOutcome", "quote": "Overall improvement of symptoms was greater in the D500 group than in the PL group" }, { "field": "result", "quote": "treatment with D500 resulted in a quicker and more pronounced relief of signs and symptoms of acute hemorrhoids than with the placebo" } ] }, { "id": "pmid:1634173", "pmid": "1634173", "doi": null, "nctId": null, "pmcid": null, "title": "[Local therapy of grade 1 and 2 hemorrhoids. Effectiveness of a combination preparation with standardized blood leech extract]", "firstAuthor": "Dressler", "multipleAuthors": true, "journal": "Fortschr Med", "year": 1992, "design": "rct", "n": 80, "nField": "reported", "population": "patients with first and second degree hemorrhoids", "intervention": "topical combination preparation containing standardized leech extract, polidocanol and allantoin", "comparator": "placebo cream", "primaryOutcome": "improvement in subjective and objective symptoms and signs of hemorrhoids", "result": "symptoms and signs improved significantly more rapidly with the active cream than placebo", "resultDirection": "benefit", "quality": "low", "qualityWhy": "small, short one-week trial with few details on how symptoms were measured or on long-term outcomes like bleeding or shrinkage", "directness": "direct", "limitations": "Only 80 patients, one week duration, abstract gives no numeric effect sizes and does not report bleeding or hemorrhoid size specifically.", "followUp": "one week", "plainFinding": "Faster symptom relief than placebo", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/1634173/", "sourceText": "AIMS: Testing the effectiveness of a topical combination preparation containing standardized leech extract, polidocanol and allantoin. STUDY DESIGN: Placebo-controlled, double-blind study in 80 patients with first and second degree hemorrhoids; duration of treatment one week; examinations performed on admission and on days 3, 4, 5 and 8. RESULTS: Both the subjective and objective symptoms and signs improved during the one week of treatment statistically significantly more rapidly under the test preparation as compared with placebo. Histologically demonstrable signs of inflammation were more clearly improved in the preparation group than in the placebo group. No side effects were observed. CONCLUSIONS: The good efficacy and tolerability of a topical therapeutic preparation in first and second degree hemorrhoids have been convincingly demonstrated.", "provenance": [ { "field": "n", "quote": "double-blind study in 80 patients with first and second degree hemorrhoids" }, { "field": "population", "quote": "80 patients with first and second degree hemorrhoids" }, { "field": "intervention", "quote": "a topical combination preparation containing standardized leech extract, polidocanol and allantoin" }, { "field": "comparator", "quote": "Placebo-controlled, double-blind study" }, { "field": "primaryOutcome", "quote": "Both the subjective and objective symptoms and signs improved during the one week of treatment" }, { "field": "result", "quote": "improved during the one week of treatment statistically significantly more rapidly under the test preparation as compared with placebo" } ] }, { "id": "pmid:1582642", "pmid": "1582642", "doi": null, "nctId": null, "pmcid": null, "title": "[Ointment treatment of 1st degree hemorrhoids. Comparison of the effectiveness of a phytogenic preparation with two new ointments containing synthetic drugs]", "firstAuthor": "Knoch", "multipleAuthors": true, "journal": "Fortschr Med", "year": 1992, "design": "rct", "n": 90, "nField": "reported", "population": "patients with first-degree hemorrhoids", "intervention": "plant-based (herbal) hemorrhoid ointment", "comparator": "two synthetic ointments, one containing a corticoid", "primaryOutcome": "symptom improvement: itching, bleeding, burning, soreness", "result": "all three ointments worked well with no major differences between groups, slight trend favoring the herbal one", "resultDirection": "no-benefit", "quality": "low", "qualityWhy": "small three-armed trial of only 90 patients over three weeks, limiting confidence in finding true differences between treatments.", "directness": "direct", "limitations": "Small sample size split across three groups and short 21-day duration.", "followUp": "21 days", "plainFinding": "All creams worked equally well.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/1582642/", "sourceText": "OBJECTIVES: Investigation of the usefulness of a vegetable-based hemorrhoid ointment in comparison with two other ointments containing synthetic substances, one of which additionally contained corticoid. STUDY DESIGN: Treatment of 90 patients with first-degree hemorrhoids in the surgical department of a University Polyclinic, within the framework of a double-blind three-limb study of 21 days duration. Follow-up examinations on the third, seventh, fourteenth and twenty-first day of treatment. TARGET CRITERIA: Four typical symptoms--pruritus, bleeding, burning sensation, sore sensation--graded by both physician and patient. RESULTS: All three ointments proved highly effective. Both during the course of treatment and at the final examination carried out on the 21st day, no major differences were to be found between the three treatment groups. In the case of some of the test parameters, a positive tendency in favor of the herbal ointment was observed.", "provenance": [ { "field": "n", "quote": "Treatment of 90 patients with first-degree hemorrhoids" }, { "field": "population", "quote": "patients with first-degree hemorrhoids" }, { "field": "intervention", "quote": "a vegetable-based hemorrhoid ointment" }, { "field": "comparator", "quote": "two other ointments containing synthetic substances, one of which additionally contained corticoid" }, { "field": "primaryOutcome", "quote": "Four typical symptoms--pruritus, bleeding, burning sensation, sore sensation--graded by both physician and patient" }, { "field": "result", "quote": "All three ointments proved highly effective. Both during the course of treatment and at the final examination carried out on the 21st day, no major differences were to be found between the three treatment groups." } ] }, { "id": "pmid:1732110", "pmid": "1732110", "doi": "10.1016/0016-5085(92)90082-a", "nctId": null, "pmcid": null, "title": "Effects of 2-camphanone on canine portal vein blood flow and rat smooth muscle", "firstAuthor": "Xie", "multipleAuthors": true, "journal": "Gastroenterology", "year": 1992, "design": "animal", "n": null, "nField": "not-reported", "population": "anesthetized dogs and rats used to test portal vein blood flow", "intervention": "2-camphanone applied transdermally or intravenously", "comparator": "vehicle-treated animals", "primaryOutcome": "portal venous blood flow velocity and vein muscle contractions", "result": "2-camphanone increased blood flow velocity and reduced vein muscle contractions in animals", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This was an animal and isolated-tissue experiment, not a study of people with hemorrhoids, so it cannot show whether hemorrhoids actually shrink or stop bleeding.", "directness": "indirect", "limitations": "Study was conducted in dogs and rats, not in humans with hemorrhoids, and did not measure hemorrhoid symptoms directly.", "followUp": "", "plainFinding": "Increased vein blood flow in animals.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/1732110/", "sourceText": "2-Camphanone is under clinical evaluation for alleviation of hemorrhoidal bleeding and inflammation. Reduced portal venous blood flow may distend, whereas improved portal venous blood flow may alleviate, hemorrhoidal vein distention. The effects of 2-camphanone on canine portal venous blood flow were investigated using pulsed Doppler flow techniques and on the spontaneous contractions of the isolated rat portal vein. Both intravenous (0.06, 0.2, and 0.6 mg/kg) and transdermal (6 mg/dog on the thigh) administration of 2-camphanone to dogs anesthetized with pentobarbital sodium increased portal venous flow velocity by 20%-30% without affecting femoral arterial blood flow, heart rate, or arterial blood pressure compared with vehicle-treated animals. Transdermal administration of 0.6, 2, and 6 mg of 2-camphanone, in a volume of 0.1 mL, to rats decreased the spontaneous contractions of the isolated rat portal vein in vitro. The data suggest that 2-camphanone exhibits a relatively selective effect on portal venous smooth muscle to reduce venous congestion and increase blood flow velocity. 2-Camphanone may be useful in the treatment not only of hemorrhoids, but also of esophageal reflux and portal hypertension.", "provenance": [ { "field": "population", "quote": "administration of 2-camphanone to dogs anesthetized with pentobarbital sodium" }, { "field": "intervention", "quote": "Both intravenous (0.06, 0.2, and 0.6 mg/kg) and transdermal (6 mg/dog on the thigh) administration of 2-camphanone" }, { "field": "comparator", "quote": "compared with vehicle-treated animals" }, { "field": "primaryOutcome", "quote": "The effects of 2-camphanone on canine portal venous blood flow were investigated using pulsed Doppler flow techniques and on the spontaneous contractions of the isolated rat portal vein." }, { "field": "result", "quote": "increased portal venous flow velocity by 20%-30% without affecting femoral arterial blood flow, heart rate, or arterial blood pressure" } ] }, { "id": "pmid:1567701", "pmid": "1567701", "doi": null, "nctId": null, "pmcid": null, "title": "[Pressure of the anal canal in patients with hemorrhoids or with anal fissure. Effect of the topical application of an anesthetic gel]", "firstAuthor": "Mínguez", "multipleAuthors": true, "journal": "Rev Esp Enferm Dig", "year": 1992, "design": "prospective-cohort", "n": 19, "nField": "reported", "population": "patients with hemorrhoids or with posterior anal fissure", "intervention": "anesthetic gel containing tetracaine applied inside the anal canal", "comparator": "measurements before gel application and a healthy control group of same age and sex", "primaryOutcome": "anal canal pressure and pain sensation", "result": "gel lowered anal pressure in hemorrhoid patients and eased pain in some patients, but pain relief did not match pressure changes", "resultDirection": "mixed", "quality": "very-low", "qualityWhy": "Very small, uncontrolled study measuring pressure and pain, not actual hemorrhoid size or bleeding.", "directness": "indirect", "limitations": "Very small sample, no blinding or placebo comparison, measures pressure/pain rather than bleeding or hemorrhoid size.", "followUp": "", "plainFinding": "Eased pain, lowered canal pressure.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/1567701/", "sourceText": "The pressure measurements and clinical sensation of 11 patients with hemorrhoids and 8 patients with posterior and fissure were analyzed before and after the topical administration of an anesthetic gel containing tetracaine in the anal canal. A significant increase of the maximal basal pressure (p less than 0.01) was observed in comparison with a control group of the same age and sex. No differences in the maximal pressure of voluntary contractions. The anesthetic gel produced a significant decrease of the maximal basal pressure in subjects with hemorrhoids, as well as a lessening of pain in 37% of patients with anal fissure and in 55% of those with hemorrhoids. This symptomatic improvement was not correlated with changes in pressure. Therefore we conclude that the hypertonicity of the anal canal is not secondary to pain and must be evaluated as a disturbance related to the subjacent lesion.", "provenance": [ { "field": "n", "quote": "11 patients with hemorrhoids and 8 patients with posterior and fissure" }, { "field": "population", "quote": "11 patients with hemorrhoids and 8 patients with posterior and fissure" }, { "field": "intervention", "quote": "topical administration of an anesthetic gel containing tetracaine in the anal canal" }, { "field": "comparator", "quote": "comparison with a control group of the same age and sex" }, { "field": "primaryOutcome", "quote": "pressure measurements and clinical sensation" }, { "field": "result", "quote": "The anesthetic gel produced a significant decrease of the maximal basal pressure in subjects with hemorrhoids, as well as a lessening of pain in 37% of patients with anal fissure and in 55% of those with hemorrhoids. This symptomatic improvement was not correlated with changes in pressure." } ] }, { "id": "pmid:1661696", "pmid": "1661696", "doi": "10.1016/s0016-5107(91)70867-5", "nctId": null, "pmcid": null, "title": "A prospective crossover trial of direct current electrotherapy in symptomatic hemorrhoidal disease", "firstAuthor": "Wright", "multipleAuthors": true, "journal": "Gastrointest Endosc", "year": 1991, "design": "rct", "n": 16, "nField": "reported", "population": "patients referred for treatment of symptomatic hemorrhoids", "intervention": "direct current electrotherapy plus standard medical therapy (sitz baths, hydrocortisone suppositories, topical preparations, high fiber diet)", "comparator": "sham electrotherapy plus the same standard medical therapy", "primaryOutcome": "improvement in hemorrhoid symptoms", "result": "no statistically significant difference in symptom improvement between direct current electrotherapy and sham therapy", "resultDirection": "no-benefit", "quality": "low", "qualityWhy": "Very small crossover trial of only 16 patients comparing an electrical device, not the cream itself, to a sham version with both arms also receiving topical treatment.", "directness": "indirect", "limitations": "Only 16 patients; both groups received topical/medical therapy so the cream's own effect is not isolated; crossover design; no mention of blinding success.", "followUp": "16 weeks", "plainFinding": "No added benefit from electrotherapy device.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/1661696/", "sourceText": "Many new modalities have been developed to treat symptomatic hemorrhoidal disease. In order to determine whether direct current electrotherapy therapy is effective, a prospective, crossover study was done. Sixteen patients referred for treatment of symptomatic hemorrhoids underwent a 16-week treatment protocol. Patients were randomized to receive either medical therapy with a sham therapy, or medical therapy with active direct current electrotherapy at 4-week intervals. All patients were instructed in medical therapy including sitz baths, hydrocortisone suppositories, topical preparations, and a high fiber diet with an educational booklet. Patients who did not respond to initial therapy were crossed over at 8 weeks, receiving alternate therapy twice. Improvement in symptoms, or lack thereof, was not statistically different between the two treatment groups. Comparisons of the internal sphincter pressure, external sphincter pressure, maximum squeeze pressure, and rectal sensitivity to balloon insufflation (volume) were not statistically different before, during, or after any treatment modality (p = 0.46, 0.60, 0.33). The size and grade of hemorrhoids on entry into the study had no bearing on the outcome. In a prospective crossover trial, no difference could be found between standard medical therapy and direct current electrotherapy in the treatment of symptomatic-hemorrhoidal disease.", "provenance": [ { "field": "n", "quote": "Sixteen patients referred for treatment of symptomatic hemorrhoids underwent a 16-week treatment protocol." }, { "field": "population", "quote": "Sixteen patients referred for treatment of symptomatic hemorrhoids underwent a 16-week treatment protocol." }, { "field": "intervention", "quote": "medical therapy with active direct current electrotherapy at 4-week intervals" }, { "field": "comparator", "quote": "medical therapy with a sham therapy" }, { "field": "primaryOutcome", "quote": "Improvement in symptoms, or lack thereof, was not statistically different between the two treatment groups." }, { "field": "result", "quote": "Improvement in symptoms, or lack thereof, was not statistically different between the two treatment groups." } ] }, { "id": "pmid:2392628", "pmid": "2392628", "doi": null, "nctId": null, "pmcid": null, "title": "[The symptomatic therapy of hemorrhoids and anal eczema--a report of experiences from proctology practice]", "firstAuthor": "Neiger", "multipleAuthors": true, "journal": "Schweiz Rundsch Med Prax", "year": 1990, "design": "case-series", "n": 92, "nField": "reported", "population": "patients with hemorrhoid disease and related conditions", "intervention": "suppositories or cream containing a steroid (fluocortolone pivalate), local anesthetic (lidocaine), and in the cream also an antiseptic (chlorquinaldol)", "comparator": "no comparison group", "primaryOutcome": "how well the treatment worked, judged by doctors/patients", "result": "treatment judged good or very good in 92% of cases, well tolerated in all cases", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This was an uncontrolled study of patients all given the treatment, with no placebo or comparison group, so it can't show whether the cream itself caused the improvement.", "directness": "indirect", "limitations": "No control group, no blinding, and outcome judged subjectively as 'good or very good' without objective measures of hemorrhoid size or bleeding.", "followUp": "", "plainFinding": "Mostly rated effective, but no control group.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/2392628/", "sourceText": "Besides the various operative procedures, which nowadays have come into use in hemorrhoidal disorders, drug therapy as well continues to keep an important place. Its main conditions of application are inflammatory processes before, between and after hemorrhoidal sclerosis or proctological operations. In a clinical study suppositories with the corticoid fluocortolone-21-pivalate and the local anesthetic lidocaine hydrochloride as well as a cream with the same substances and in addition, chlorquinaldol were tested in 92 patients with hemorrhoidal diseases and their concomitant conditions. In 92% of the cases efficacy of the preparations proved to be good or very good, and in all cases they were well tolerated.", "provenance": [ { "field": "n", "quote": "were tested in 92 patients with hemorrhoidal diseases" }, { "field": "population", "quote": "92 patients with hemorrhoidal diseases and their concomitant conditions" }, { "field": "intervention", "quote": "suppositories with the corticoid fluocortolone-21-pivalate and the local anesthetic lidocaine hydrochloride as well as a cream with the same substances and in addition, chlorquinaldol" }, { "field": "comparator", "quote": "were tested in 92 patients with hemorrhoidal diseases and their concomitant conditions" }, { "field": "primaryOutcome", "quote": "efficacy of the preparations proved to be good or very good" }, { "field": "result", "quote": "In 92% of the cases efficacy of the preparations proved to be good or very good, and in all cases they were well tolerated." } ] }, { "id": "pmid:3243509", "pmid": "3243509", "doi": "10.1254/fpj.92.227", "nctId": null, "pmcid": null, "title": "[Neriproct: its anti-inflammatory effect on an experimentally induced hemorrhoid model in the rat]", "firstAuthor": "Nishiki", "multipleAuthors": true, "journal": "Nihon Yakurigaku Zasshi", "year": 1988, "design": "animal", "n": null, "nField": "not-reported", "population": "rats with chemically induced hemorrhoids (croton-oil or abrasive irritation models)", "intervention": "Neriproct cream (steroid diflucortolone valerate combined with lidocaine)", "comparator": "other anti-hemorrhoid creams (Scheriproct, Proctosedyl, Posterisan forte, Borraginol N, Posterisan, Borraza G) and other steroids (prednisolone, hydrocortisone caproate, hydrocortisone)", "primaryOutcome": "reduction of inflammation and tissue damage in the hemorrhoid model", "result": "Neriproct reduced inflammation, tissue destruction and swelling more effectively than the other tested anti-hemorrhoid drugs in rats", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This is an animal study using artificially induced hemorrhoids in rats, not a human trial, so it cannot show whether the cream works for people.", "directness": "indirect", "limitations": "Animal model only, no human data, and higher doses of the steroid suppressed wound healing.", "followUp": "", "plainFinding": "Reduced inflammation in rat hemorrhoids.", "retracted": false, "expressionOfConcern": false, "hasErratum": true, "url": "https://pubmed.ncbi.nlm.nih.gov/3243509/", "sourceText": "Several glucocorticoids as a cream formulation were applied to the recto-anus of the croton-oil-induced hemorrhoid rat. Among the steroids tested, i.e. diflucortolone valerate (DFV), prednisolone (PS), hydrocortisone caproate (HC), and hydrocortisone (H), DFV was found to suppress inflammation most effectively. The effect of DFV was not affected by combination with lidocaine. In this model, the analgesic effect of lidocaine was apparently prolonged by an increase of the threshold for pain by the anti-inflammatory effect of DFV. This additive effect is regarded as a merit of the combination in Neriproct. Therapeutic effects of Neriproct and several anti-hemorrhoid drugs were also examined by using a hemorrhoid model with abrasive irritation compared to those obtained by the croton-oil model. In both models, efficacy of Neriproct was superior to that of the other drugs such as Scheriproct, Proctosedyl, Posterisan forte, Borraginol N, Posterisan and Borraza G. Microscopic observation showed that destruction of the mucus epithelium, necrosis of the mucus layer, infiltration of inflammatory cells and vasodilatation in the croton-oil model were also suppressed markedly by Neriproct application. No difference was observed in the efficacy between the cream and suppository formulation of Neriproct. Suppression of wound healing was found with a dosage of DFV lower than those of PS, HC and H. However, the efficacy ratio of the wound-healing suppression and anti-inflammation of DFV was the largest among the steroids tested.", "provenance": [ { "field": "population", "quote": "croton-oil-induced hemorrhoid rat" }, { "field": "intervention", "quote": "The effect of DFV was not affected by combination with lidocaine." }, { "field": "comparator", "quote": "efficacy of Neriproct was superior to that of the other drugs such as Scheriproct, Proctosedyl, Posterisan forte, Borraginol N, Posterisan and Borraza G" }, { "field": "primaryOutcome", "quote": "DFV was found to suppress inflammation most effectively" }, { "field": "result", "quote": "In both models, efficacy of Neriproct was superior to that of the other drugs such as Scheriproct, Proctosedyl, Posterisan forte, Borraginol N, Posterisan and Borraza G." } ] }, { "id": "pmid:3287228", "pmid": "3287228", "doi": null, "nctId": null, "pmcid": null, "title": "[Results of the use of topical diosmin (venosmine) in the treatment of acute hemorrhoid pathology]", "firstAuthor": "Tajana", "multipleAuthors": true, "journal": "Minerva Med", "year": 1988, "design": "case-series", "n": 50, "nField": "reported", "population": "patients with grade 1-4 hemorrhoids with strangulation and thrombosis", "intervention": "topical diosmin (venosmine) cream", "comparator": "none (no control group)", "primaryOutcome": "severity of hemorrhoid symptoms (bleeding, swelling, redness, pain, itching) scored over visits", "result": "swelling and redness improved by about 75% and 73% over three weekly visits", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This was a small uncontrolled study with no comparison group, so improvement cannot be separated from natural healing over time.", "directness": "direct", "limitations": "No control group; patients who had prior treatment were excluded, and the study was not randomized or blinded.", "followUp": "three consecutive weekly visits", "plainFinding": "Less swelling and redness, uncontrolled study.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/3287228/", "sourceText": "There is still much discussion about the pharmacological treatment of certain symptoms caused by haemorrhoids and their complications. In 1986 topical treatment with Diosmina ointment was used on 50 patients (33 males, 17 females) with grade 1, 2, 3 or 4 haemorrhoids featuring strangulation and thrombosis. Patients who had previously been given other treatment were excluded from the study. The efficacy of the treatment was assessed by a simple method previously used by others which involves scoring (0-3) the major symptoms of the condition (bleeding, oedema, erythema, pain, itching) according to severity. The drug was most effective on oedema and erythema, producing 75% and 73% improvements as assessed in three consecutive weekly visits. These results confirm the value of Diosmina in the topical treatment of acute haemorrhoids. In particular the treatment is very well tolerated and produces no unwanted side effects if properly used.", "provenance": [ { "field": "n", "quote": "topical treatment with Diosmina ointment was used on 50 patients (33 males, 17 females)" }, { "field": "population", "quote": "50 patients (33 males, 17 females) with grade 1, 2, 3 or 4 haemorrhoids featuring strangulation and thrombosis" }, { "field": "intervention", "quote": "topical treatment with Diosmina ointment" }, { "field": "comparator", "quote": "Patients who had previously been given other treatment were excluded from the study." }, { "field": "primaryOutcome", "quote": "scoring (0-3) the major symptoms of the condition (bleeding, oedema, erythema, pain, itching) according to severity" }, { "field": "result", "quote": "The drug was most effective on oedema and erythema, producing 75% and 73% improvements as assessed in three consecutive weekly visits." } ] }, { "id": "pmid:2838221", "pmid": "2838221", "doi": "10.1185/03007998809111128", "nctId": null, "pmcid": null, "title": "Comparative efficacy and tolerability of two ointment and suppository preparations ('Uniroid' and 'Proctosedyl') in the treatment of second degree haemorrhoids in general practice", "firstAuthor": "Smith", "multipleAuthors": true, "journal": "Curr Med Res Opin", "year": 1988, "design": "rct", "n": 89, "nField": "reported", "population": "patients with second degree hemorrhoids in general practice", "intervention": "antibiotic-corticosteroid ointment or suppository ('Uniroid' or 'Proctosedyl')", "comparator": "the other antibiotic-corticosteroid formulation (ointment vs suppository, Uniroid vs Proctosedyl)", "primaryOutcome": "control of symptoms including pain, itching, bleeding, and anal discharge", "result": "symptoms improved in all groups, with over 90% control after 3 weeks and no significant differences between treatments", "resultDirection": "benefit", "quality": "low", "qualityWhy": "this was an open (not blinded) study comparing two active treatments without a placebo group, so it cannot show whether the creams work better than no treatment at all.", "directness": "indirect", "limitations": "open study design (not blinded), no placebo or untreated comparison group, so benefit could be due to natural resolution over time.", "followUp": "3 weeks", "plainFinding": "Symptoms improved, but no placebo comparison.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/2838221/", "sourceText": "A multi-centre general practice, open study was carried out in 89 patients with second degree haemorrhoids to compare the efficacy and tolerability of two antibiotic-corticosteroid combinations ('Uniroid' and 'Proctosedyl') in ointment and suppository formulations. Patients were allocated at random into 4 groups and received treatment with one of the trial preparations for 1, 2 or 3 weeks, as required, with weekly assessments of response. There were no significant differences between the various groups at the start of treatment. Significant improvement occurred in all groups during treatment. Both suppository and ointment formulations were broadly comparable and control of symptoms was achieved from Week 2 onwards, building up to levels in excess of 90% after 3 weeks of therapy. With regard to the symptoms of pain and itching, suppositories gave marginally greater relief in the early stages of treatment, while both ointment and suppositories were associated with similar reduction in bleeding from haemorrhoids. Whereas both suppository formulations were about equal in reducing anal discharge, 'Uniroid' ointment was clinically superior to 'Proctosedyl' ointment in controlling this symptom over the 3-week trial period. No unwanted effects were experienced attributable to treatment. No statistically significant differences between the two ointment and the two suppository formulations were identified in this study and all four preparations were found to be efficacious in the majority of patients studied.", "provenance": [ { "field": "n", "quote": "89 patients with second degree haemorrhoids" }, { "field": "population", "quote": "89 patients with second degree haemorrhoids" }, { "field": "intervention", "quote": "two antibiotic-corticosteroid combinations ('Uniroid' and 'Proctosedyl') in ointment and suppository formulations" }, { "field": "comparator", "quote": "Patients were allocated at random into 4 groups and received treatment with one of the trial preparations for 1, 2 or 3 weeks" }, { "field": "primaryOutcome", "quote": "control of symptoms was achieved from Week 2 onwards" }, { "field": "result", "quote": "Significant improvement occurred in all groups during treatment." }, { "field": "result", "quote": "building up to levels in excess of 90% after 3 weeks of therapy" }, { "field": "result", "quote": "No statistically significant differences between the two ointment and the two suppository formulations were identified in this study" } ] }, { "id": "pmid:3662418", "pmid": "3662418", "doi": null, "nctId": null, "pmcid": null, "title": "[Non-surgical treatment of hemorrhoids]", "firstAuthor": "Libeskind", "multipleAuthors": false, "journal": "Ann Gastroenterol Hepatol (Paris)", "year": 1987, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with hemorrhoids", "intervention": "non-surgical treatments (creams, medications, and office procedures)", "comparator": "surgery or no treatment", "primaryOutcome": "symptom relief from hemorrhoids", "result": "The abstract says these treatments often give interesting results but does not provide data on effectiveness", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "This is a general narrative overview describing available treatments without presenting any study data or outcomes to judge effectiveness.", "directness": "indirect", "limitations": "No data, numbers, or specific outcomes are given; it is a descriptive overview of available treatment options, not a study of effectiveness.", "followUp": "", "plainFinding": "No real evidence given either way.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/3662418/", "sourceText": "The treatment of hemorrhoids includes a vast array of medical and instrumental means. If there is no true medical treatment, there are numerous products in order to act on the symptoms or one of the factors of the hemorrhoidal complex. Thus, phlebotonics, local topical agents, anti-infectious and anti-inflammatory agents, myorelaxants, transit regulators. Instrumental means are essentially represented by sclerosing injections, infra-red photocoagulation, cryotherapy, and mainly elastic rubber bands. All these treatments, some of which were offered as a substitute to surgery, often give interesting results, but are not devoid of danger. The attitude of the medico-surgical proctologist is then to find a happy medium between a procedure which is insufficient and one which may become unnecessarily aggressive.", "provenance": [ { "field": "population", "quote": "The treatment of hemorrhoids includes a vast array of medical and instrumental means." }, { "field": "intervention", "quote": "phlebotonics, local topical agents, anti-infectious and anti-inflammatory agents, myorelaxants, transit regulators" }, { "field": "comparator", "quote": "some of which were offered as a substitute to surgery" }, { "field": "primaryOutcome", "quote": "there are numerous products in order to act on the symptoms or one of the factors of the hemorrhoidal complex" }, { "field": "result", "quote": "All these treatments, some of which were offered as a substitute to surgery, often give interesting results, but are not devoid of danger." } ] }, { "id": "pmid:3538088", "pmid": "3538088", "doi": null, "nctId": null, "pmcid": null, "title": "Outpatient management of hemorrhoids", "firstAuthor": "Schussman", "multipleAuthors": true, "journal": "Prim Care", "year": 1986, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with hemorrhoids", "intervention": "dietary changes, stool softeners, and local hydrocortisone creams", "comparator": "", "primaryOutcome": "", "result": "", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "This is a general review article with no study data, just recommendations, so it cannot show whether the cream works.", "directness": "indirect", "limitations": "No data, outcomes, or comparisons are reported; it is a general management review, not a study of cream effectiveness.", "followUp": "", "plainFinding": "No evidence reported either way.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/3538088/", "sourceText": "Hemorrhoids are a common medical problem that usually can be managed conservatively with dietary changes, stool softeners, and local hydrocortisone creams. Acutely thrombosed external hemorrhoids require excision of the entire hemorrhoidal mass and the overlying skin. Persistently bleeding or painful internal hemorrhoids are best managed by the technique of band ligation.", "provenance": [ { "field": "population", "quote": "Hemorrhoids are a common medical problem" }, { "field": "intervention", "quote": "managed conservatively with dietary changes, stool softeners, and local hydrocortisone creams" } ] }, { "id": "pmid:7423174", "pmid": "7423174", "doi": null, "nctId": null, "pmcid": null, "title": "[Pathogenesis, clinical aspects and conservative therapy of hemorrhoids]", "firstAuthor": "Neiger", "multipleAuthors": false, "journal": "Schweiz Med Wochenschr", "year": 1980, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people diagnosed with hemorrhoids after examination", "intervention": "ointments and suppositories applied to the anal area", "comparator": "other treatments such as sclerosing injections, infrared coagulation, and rubber band ligation", "primaryOutcome": "whether symptomatic treatment relieved hemorrhoid symptoms", "result": "the abstract states ointments/suppositories are tried first, with no data on how well they worked, and that sclerosing injections, infrared coagulation or banding were used if this failed", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "This is a general overview of hemorrhoid treatments with no study data, numbers, or comparison results reported for creams.", "directness": "indirect", "limitations": "No patient numbers, no measured outcomes, no comparison data for ointment/suppository treatment specifically; it is a descriptive overview rather than a study.", "followUp": "", "plainFinding": "No efficacy data for creams.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/7423174/", "sourceText": "Hemorrhoids are readily diagnosed by proctoscopy. They should not be treated without thorough examination, as carcinoma of the rectum or sigmoid may cause similar symptoms. The examination should include careful inspection of the anal region, digital palpation, proctoscopy and sigmoidoscopy. Once the diagnosis is established, instruction in anal hygiene should first be given. Local use of ointment and suppositories follows. If this symptomatic treatment fails, sclerosing injections are recommended. For this purpose various irritant solutions are used which may on occasion lead to complications such as local and, in rare cases, extensive necrosis of the rectal mucosa. In the search for a method which avoids any type of irritant substance, coagulation by infrared radiation using a special probe has been developed and found to be at least as successful as injection treatment. For prolapsing piles, however, rubber band ligature appears to be the most effective method.", "provenance": [ { "field": "intervention", "quote": "Local use of ointment and suppositories follows." }, { "field": "comparator", "quote": "If this symptomatic treatment fails, sclerosing injections are recommended." }, { "field": "comparator", "quote": "coagulation by infrared radiation using a special probe has been developed and found to be at least as successful as injection treatment" }, { "field": "comparator", "quote": "For prolapsing piles, however, rubber band ligature appears to be the most effective method." }, { "field": "population", "quote": "Hemorrhoids are readily diagnosed by proctoscopy." }, { "field": "primaryOutcome", "quote": "Once the diagnosis is established, instruction in anal hygiene should first be given." }, { "field": "result", "quote": "Local use of ointment and suppositories follows. If this symptomatic treatment fails, sclerosing injections are recommended." } ] }, { "id": "pmid:345437", "pmid": "345437", "doi": null, "nctId": null, "pmcid": null, "title": "[Hemorrhoids: recognition and current therapeutic possibilities]", "firstAuthor": "Neiger", "multipleAuthors": false, "journal": "Schweiz Med Wochenschr", "year": 1978, "design": "narrative-review", "n": null, "nField": "not-reported", "population": "people with hemorrhoids or anal/rectal complaints seen by a general practitioner", "intervention": "creams or suppositories applied symptomatically", "comparator": "anal hygiene instruction alone, or other treatments like injections, infrared coagulation, or banding", "primaryOutcome": "symptom relief and resolution of hemorrhoids", "result": "the abstract does not report any outcome data for creams or suppositories, only that they are used after hygiene advice and before injection treatment if hygiene fails", "resultDirection": "unclear", "quality": "very-low", "qualityWhy": "this is a general narrative review describing treatment approaches without presenting any study data or outcomes for creams specifically.", "directness": "direct", "limitations": "no numerical data, no comparison groups, no outcome measures reported for cream/suppository treatment; purely descriptive review of management strategies", "followUp": "", "plainFinding": "No evidence reported either way.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/345437/", "sourceText": "Up to 5% of the patients of a general practitioner have terminal bowel disease, most frequently hemorrhoids. Any patient who presents with ano-rectal discomfort or anal blood losses should undergo thorough proctologic examination including rectoscopy. Digital palpation is insufficient as only 10% of rectal carcinomas can be reached. The treatment of hemorrhoids should be started by instructing the patient on anal hygiene, to be followed only then by symptomatic application of creams or suppositories. If these symptomatic measures fail, treatment by injections is indicated. This method may be complicated by localized or extensive necrosis of the rectal mucosa, the cause of which is assumed to be an immunologic event resembling the Arthus phenomenon in which bacterial or possibly pharmacologic substances may act as antigens. Therefore, a method of provoking coagulation without using foreign substances was sought. Thermocoagulation by the infrared coagulator appears to be a suitable method: first experience tends show equal efficacy with coagulation by injection treatment. Prolapsing hemorrhoids are still treated by barron ligation. The precise management of each therapeutic approach is described.", "provenance": [ { "field": "intervention", "quote": "symptomatic application of creams or suppositories" }, { "field": "population", "quote": "Up to 5% of the patients of a general practitioner have terminal bowel disease, most frequently hemorrhoids." }, { "field": "comparator", "quote": "If these symptomatic measures fail, treatment by injections is indicated." }, { "field": "result", "quote": "The treatment of hemorrhoids should be started by instructing the patient on anal hygiene, to be followed only then by symptomatic application of creams or suppositories." }, { "field": "primaryOutcome", "quote": "The treatment of hemorrhoids should be started by instructing the patient on anal hygiene, to be followed only then by symptomatic application of creams or suppositories." } ] }, { "id": "pmid:132941", "pmid": "132941", "doi": null, "nctId": null, "pmcid": null, "title": "[Multicenter clinical study of a novel steroid-free preparation in proctology]", "firstAuthor": "Arnold", "multipleAuthors": true, "journal": "Arzneimittelforschung", "year": 1976, "design": "case-series", "n": 585, "nField": "reported", "population": "patients with various anal and rectal (proctological) conditions, including bleeding internal hemorrhoids", "intervention": "Faktu suppositories and ointment (containing Albothyl, a steroid-free acidic compound)", "comparator": "none reported", "primaryOutcome": "therapeutic efficacy and tolerance as judged by treating physicians", "result": "Highly satisfactory results were achieved in 486 patients (83.1%)", "resultDirection": "benefit", "quality": "very-low", "qualityWhy": "This was an uncontrolled multicenter observation with no comparison group or randomization, so improvement can't be separated from natural healing or placebo effect.", "directness": "indirect", "limitations": "No control group, no randomization, outcome based on physician-judged satisfaction rather than objective measures, and population included many different anal conditions beyond hemorrhoids.", "followUp": "", "plainFinding": "Most patients improved, but no control group.", "retracted": false, "expressionOfConcern": false, "hasErratum": false, "url": "https://pubmed.ncbi.nlm.nih.gov/132941/", "sourceText": "In a multicentre study 15 physicians investigated the therapeutic efficacy and tolerance of Faktu suppositories and ointment (containing the active principle of Albothyl, a condensation product of m-cresolsulfonic acid and formaldehyde) in 585 patients with proctological affections. Highly satisfactory results were achieved in 486 patients (83.1%). The following were found to be the main indications: -treatment of wounds after proctological operations, -fresh and fissures, -bleeding internal haemorrhoids, -anal eczema and anal pruritus, -rhagades and perforated or prolapsed external haemorrhoids (perianal thrombosis). None of the investigators reported any persisting adverse side-effects. 16% of the patients complained of local discomfort of varying intensity such as pruritus, burning or irritation. The symptoms mostly appeared on commencement of the treatment and necessitated discontinuation of therapy in 5.3% only. The extremely favourable effect of Albothyl - the active principle of Faktu - is due to its unique mechanism of action: the markedly acid milieu of the substance. Furthermore the Faktu preparations do not contain any steroids and consequently they can be used without any misgivings over prolonged periods.", "provenance": [ { "field": "n", "quote": "585 patients with proctological affections" }, { "field": "population", "quote": "585 patients with proctological affections" }, { "field": "intervention", "quote": "Faktu suppositories and ointment (containing the active principle of Albothyl, a condensation product of m-cresolsulfonic acid and formaldehyde)" }, { "field": "comparator", "quote": "15 physicians investigated the therapeutic efficacy and tolerance of Faktu suppositories and ointment" }, { "field": "primaryOutcome", "quote": "the therapeutic efficacy and tolerance of Faktu suppositories and ointment" }, { "field": "result", "quote": "Highly satisfactory results were achieved in 486 patients (83.1%)." } ] } ], "faqs": [ { "q": "Should I stop using hemorrhoid cream?", "a": "You don't have to. No study found serious injury from typical over-the-counter hemorrhoid cream, and some trials found it eased itching, pain, or bleeding for a few weeks. Just don't expect it to shrink hemorrhoids or stop bleeding for good, and see a doctor if bleeding doesn't settle quickly." }, { "q": "Will hemorrhoid cream make my hemorrhoids go away?", "a": "The studies don't show this clearly. Most trials measured symptom relief, not whether the hemorrhoid itself shrank, and the few that did look at hemorrhoid size gave mixed or low-quality results." }, { "q": "What worked better than cream in these studies?", "a": "A warm salt-water soak healed more pregnant women's hemorrhoids than cream did, and an injectable clot-dissolving suppository stopped bleeding and shrank hemorrhoids better than a standard hydrocortisone suppository. If bleeding continues, ask a doctor about these or office procedures." }, { "q": "Is it safe to use hemorrhoid cream during pregnancy?", "a": "Several small studies in pregnant women used topical creams without reporting serious problems, but the quality of this evidence is very low. Check with your obstetrician before starting any cream." }, { "q": "How long should I try cream before seeing a doctor?", "a": "Studies that found a benefit usually saw it within 1 to 4 weeks. If your symptoms — especially bleeding — haven't improved by then, or if bleeding is new or heavy, see a doctor instead of continuing on your own." } ], "patientTakeaway": "Hemorrhoid cream probably won't hurt you, but it also probably won't shrink your hemorrhoids or reliably stop bleeding — the proof just isn't there, and a couple of studies even found it did worse than simple alternatives. If you're bleeding, try proven basics like more fiber and water, warm sitz baths, and avoiding straining; if bleeding doesn't stop within a week or two, or comes back, see a doctor to check the cause and discuss in-office treatment.", "methodology": { "databases": [ "PubMed", "ClinicalTrials.gov", "Crossref" ], "searchStrings": { "pubmed": "(\"Hemorrhoids/drug therapy\"[Mesh] OR hemorrhoid*[tiab]) AND (cream*[tiab] OR ointment*[tiab] OR topical[tiab] OR \"Administration, Topical\"[Mesh]) AND (bleeding[tiab] OR shrink*[tiab] OR symptom*[tiab] OR efficacy[tiab] OR \"treatment outcome\"[Mesh])" }, "pubmedQueryTranslation": "(\"hemorrhoids/drug therapy\"[MeSH Terms] OR \"hemorrhoid*\"[Title/Abstract]) AND (\"cream*\"[Title/Abstract] OR \"ointment*\"[Title/Abstract] OR \"topical\"[Title/Abstract] OR \"administration, topical\"[MeSH Terms]) AND (\"bleeding\"[Title/Abstract] OR \"shrink*\"[Title/Abstract] OR \"symptom*\"[Title/Abstract] OR \"efficacy\"[Title/Abstract] OR \"treatment outcome\"[MeSH Terms])", "searchedOn": "2026-10-05", "inclusion": [ "Human, animal or laboratory studies reporting an outcome relevant to the question" ], "exclusion": [ "Records about a different condition or intervention", "Records reporting no outcome", "Retracted publications, which are listed but excluded from every count" ], "extractionLevel": "abstract", "gradingNote": "Evidence strength is adapted from the GRADE framework. It is not a GRADE assessment and was not produced by a GRADE panel.", "limits": [ "Fields were read from abstracts, not full text, so detail reported only in a paper's methods section is not captured." ] }, "seo": { "title": "Does Hemorrhoid Cream Actually Work?", "description": "Review of 30 trials (11,091 people) finds weak, mixed evidence that hemorrhoid cream shrinks hemorrhoids or stops bleeding; 2 studies suggest harm." }, "lastChecked": "2026-10-05", "lastChanged": "2026-10-05", "nextCheckDue": "2026-11-05", "history": [], "pipeline": { "screenModel": "claude-haiku-4-5", "extractModel": "claude-sonnet-5", "composeModel": "claude-sonnet-5", "promptVersion": "ev-1", "ranOn": "2026-10-05" }, "status": "published" }