Topical diltiazem hydrochloride and glyceryl trinitrate in the treatment of chronic anal fissure

Abstract

Objective: To compare the symptomatic relief, healing and side-effects of topical diltiazem (DTZ) and glyceryl trinitrate in the treatment of chronic anal fissure.

Study design: Randomized controlled trial.

Place and duration of study: The Surgical Outpatient Department of Civil Hospital, Karachi, from March 2006 to February 2007.

Methodology: Patients with chronic anal fissure were included in the study and randomized to two groups. One group was administered topical 2% diltiazem hydrochloride and other was given 0.2% glyceryl trinitrate (GTN), perianally twice daily for 8 weeks. Patients with anal fissure due to other diseases like inflammatory bowel disease, malignancy, sexually transmitted diseases, previous treatment with local ointment or surgery; patients who required anal surgery for any concurrent disease like hemorrhoids, pregnant women and patients with significant cardiovascular conditions were excluded. There were four follow-up sessions during the course of treatment. Healing and side-effects were recorded. Analysis was done by SPSS version 10 on intention-to-treat basis. Chi-square was used where appropriate.

Results: Eighty patients with symptomatic chronic anal fissure were included in the study and equally divided into two groups. After 8 weeks of treatment healing occurred in 31 of 40 patients treated with diltiazem and 33 of 40 patients treated with GTN (p = 0.576). There were less side-effects with DTZ (n=13) than with GTN (n=29, p < 0.001]. In particular, headache occurred more commonly with GTN (n=27) than with DTZ (n=9, p < 0.0001).

Conclusion: Diltiazem hydrochloride and glyceryl trinitrate were equally effective in healing chronic anal fissure. Diltiazem caused fewer side-effects particularly headache than glyceryl trinitrate ointment. Diltiazem may be the first-line treatment for chemical sphincterotomy for the chronic anal fissure.