A randomized trial of oral vs. topical diltiazem for chronic anal fissures

INTRODUCTION: Chemical sphincterotomy has proved effective in treating chro nic anal fissure. Glyceryl trinitrate is the most widely used agent, and to pical 0.2 percent glyceryl trinitrate ointment heals up to two thirds of ch ronic anal fissures. Unfortunately, however, many patients experience troub lesome headaches as a side effect of this treatment. This study assessed th e effectiveness of oral and topical diltiazem in healing chronic fissures. METHODS: Fifty consecutive patients with chronic anal fissures were randoml y assigned to receive oral (60 mg) or topical (2 percent gel) diltiazem twi ce daily for up to eight weeks. Anal manometry was performed before and aft er the first dose, and blood pressure was recorded at 15-minute intervals. Patients were reviewed fortnightly, pain was expressed with a visual linear analog scale, blood pressure was recorded, fissure healing was assessed, a nd side effects were noted. RESULTS: Twenty-four patients received oral dil tiazem, and 26 received topical diltiazem. Mean (+/- standard error of the mean) maximum resting anal pressures fell by 15 and 23 percent from 95 +/- 4 to 81 +/- 4 and from 102 +/- 5 to 79 +/- 5 cm H2O in the two groups, resp ectively. There was no significant reduction in blood pressure during the s tudy or at follow-up in either group. Fissure healing was complete in 9 pat ients (38 percent) receiving oral diltiazem and 15 (65 percent) on topical treatment by eight weeks. Oral diltiazem caused side effects in eight patie nts (rash, two; headaches, two; nausea or vomiting, three; reduced smell an d taste, one), whereas no side effects were seen in those receiving topical therapy (P = 0.001). CONCLUSION: Oral and topical diltiazem heal chronic a nal fissures. Topical diltiazem is more effective, achieving healing rates comparable to those reported with topical nitrates, with significantly fewe r side effects.