Diltiazem vs. glyceryl tri-nitrate for symptomatic relief in anal fissure: a randomised clnical study.

OBJECTIVE: To further resolve the clinical equipoise on the choice of chemical sphincterotomy agent for early symptomatic relief of anal fissure by comparing the effectiveness of 2% Diltiazem gel with 0.2% Glyceryl TriNitrate. METHODS: The randomized clinical trial was conducted at Aga Khan University Hospital, Karachi, from February 1, to July 30, 2008, and comprised 60 adult patients with anal fissure who were equally randomised to either Diltiazem or Glyceryl TriNitrate after taking informed consent. The creams were applied locally; the former twice daily, and the latter three times a day for a period of two weeks. The rest of the treatment was standard. Patients were followed up in clinic by the principal investigator at two weeks for primary outcome i.e. self-reported symptomatic relief on Visual Analogue Scale, and secondary outcomes i.e. side effects and the overall cost of treatment. RESULTS: Of the total, 31 (52%) patients were males and the overall mean age was 37 +/- 11 years. Patients, who used Diltiazem reported more symptomatic relief than Glyceryl TriNitrate (p < 0.01). Side effects were found more in Glyceryl TriNitrate than Diltiazem (p < 0.01), and most common side effect in the former group was headache in 12 (40%) patients. Cost of the treatment was not significantly different between both treatment arms (p < 0.28). CONCLUSION: Chemical sphincterotomy with topical 2% Diltiazem gel is an effective first-line treatment for early symptomatic relief of anal fissures, owing to negligible side effects.