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.

OBJECTIVE

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

METHODS

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

METHODS

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.

METHODS

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.

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 placebo in healing anal fissure (48.6% vs. 37%, p < 0.004), but late recurrence of fissure was common, in the range of 50% of those initially cured. Botox and CCBs were equivalent to GTN in efficacy with fewer adverse events. No medical therapy came close to the efficacy of surgical sphincterotomy, though none in these RCTs was associated with the risk of incontinence.

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.