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

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.