Non surgical therapy for anal fissure

 

Abstract

Background

Because of the disability associated with surgery for anal fissure and the risk of incontinence, medical alternatives for surgery have been sought. Most recently, pharmacologic methods that relax the anal smooth muscle, to accomplish reversibly what occurs in surgery, have been used to obtain fissure healing.

Objectives

To assess the efficacy and morbidity of various medical therapies for anal fissure.

Search methods

Search terms include "anal fissure randomized". Timing from 1966 to May 2006. Further details of the search below.

Selection criteria

Studies in which participants were randomized to a non-surgical therapy for anal fissure. Comparison groups may include an operative procedure, an alternate medical therapy or placebo. Chronic fissure, acute fissure and fissure in children are included in the review. Atypical fissures associated with inflammatory bowel disease or cancer or anal infection are excluded.

Data collection and analysis

Data were abstracted from published reports and meeting abstracts, assessing method of randomization, blinding, "intention to treat" and drop-outs, therapies, supportive measures (applied to both groups), dosing and frequency and cross-overs. Dichotomous outcome measures included Non-healing of the fissure (a combination of persistence and recurrence), and Adverse events (including incontinence, headache, infection, anaphylaxis). Continuous outcome measures included measures of pain relief and anorectal manometry.

Main results

48 different comparisons of the ability of medical therapies to heal anal fissure have been reported in 53 RCTs. Eleven agents were used (nitroglycerin ointment (GTN), isosorbide dinitrate, Botulinum toxin (Botox), diltiazem, nifedipine (Calcium channel blockers or CCBs), hydrocortisone, lignocaine, bran, minoxidil, indoramin, and placebo) as well as anal dilators and surgical sphincterotomy.
GTN was found to be marginally but significantly better than palcebo in healing anal fissure (48.6% vs. 37%, p < 0.004), but late recurence of fissure was common, in the rangeof 50% of those intially cured. Botox and CCBs were equivalent to GTN in efficacy with fewer adverse events. No medical therapy cameclose to the efficacy of surgical sphincterotomy, though none in these RCTs was associated with the risk of incontinence.

Authors' conclusions

Medical therapy for chronic anal fissure, acute fissure and fissure in children may be applied with a chance of cure that is marginally better than placebo, and, for chronic fissure in adults, far less effective than surgery.

 

Plain language summary

Non surgical therapy for anal fissure.

Anal fissure is a painful ulcer usually occurring in the posterior midline of the skin just outside the entry to the rectum. Its persistence is due to spasm of the internal sphincter muscle. Relief with healing of chronic fissures until very recently has been achieved by surgical procedures aimed at ablation of the sphincter spasm. Because of the the risk of incontinence, medical alternatives for surgery have been sought. Among the older medications, bran is effective in preventing recurrence of acute fissure. Local application of muscle relaxing therapy is effective in healing chronic anal fissure, though not as well as surgery, and with considerable risk of adverse events during therapy.

 

摘要

背景

肛裂(anal fissure)之非手術治療

由於以手術治療肛裂會造成失能及有失禁的風險，有必要尋找其他治療方法如藥物療法。近期研發的放鬆肛門平滑肌的藥物可達到肛裂癒合的手術效果

目標

評估各種治療肛裂藥物的效率及副作用

搜尋策略

搜尋詞彙包括“肛裂隨機“。時間是1966至2006年5月。以下為搜尋的詳細資料

選擇標準

在受試者被隨機分配到非手術治療組的研究中，比較組可能包括藥物治療或是安慰組。慢性肛裂，急性肛裂及兒童肛裂也被納入此研究中，但與炎性腸病(inflammatory bowel disease)，癌症或肛門感染有關的非典型肛裂則不被採用

資料收集與分析

數據來自於已發表的報告及會議摘要,評估randomization的方式, blinding,“intentiontotreat' 及中途退出,治療及支持性療法(應用到雨組上),劑量,頻率及交互作用。Dichotomous outcome measures 包括無法癒合之肛裂(包括一直無法癒合和復發)及副作用(包括失禁，頭痛，感染，過敏)。Continuous outcome measures 包括疼痛改善程度及肛門直腸的壓力

主要結論

在53個RCTs中,有48個在比較藥物治療對肛裂癒合的能力。當中使用的11種藥物(nitroglycerin ointment (GTN), isosorbide dinitrate, Botulinum toxin (Botox), diltiazem, nifedipine (Calcium channel blockers or CCBs), hydrocortisone, lignocaine, bran, minoxidil, indoramin, and placebo),肛門擴張器和括約肌切開術.相對於安慰組, GTN對肛裂的癒合有顯注效果(48.6% vs. 37%, p < 0.004),但在初期癒合後的病人當中有後期復發的機率高達50%。Botox and CCBs 的效果與GTN相同但副作用較少。所有藥物的治療效果都不及括約肌切開術，雖然這些RCTs當中沒有與失禁風險相關

作者結論

以藥物治療慢性,急性及兒童肛裂的效果只比安慰組稍有效，但對成人慢性肛裂而言效果遠差於手術治療

翻譯人

本摘要由國泰綜合醫院張世昌翻譯

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌

總結

肛裂之非手術治療。肛裂是多發生在最靠近直腸入口皮膚的後中線部位的疼痛潰瘍。其持續性是因為內括約肌痙孿。以手術治癒慢性肛裂的方法是切開內括約肌，但因為這有造成失禁的風險，有必要尋找其他如藥物療法。在比較舊的藥物中，bran有效於預防急性肛裂的復發。局部肌肉鬆弛法雖然對治療慢性肛裂有效，但效果仍不及手術，而且治療期間也有相當的風險及副作用