Topical Diltiazem vs. topical Glyceril trinitrate in the treatment of chronic anal fissure: A prospective, randomized, double-blind trial

摘要

Background and study aims: Chemical sphincterotomy is a new way for the treatment of chronic anal fissure which avoids the risk of faecal incontinence associated with traditional surgical methods. The aim of this study was to compare topical Diltiazem with topical Glyceril trinitrate in the treatment of chronic anal fissure. Patients and methods: 61 patients (10 Male, 51 Female) between 16-81 years of age with chronic anal fissure were included in this prospective, randomized, double-blind trial. The patients were randomly allocated to either Diltiazem gel (2%) or Glyceril trinitrate ointment (0.2%) and were asked to use the treatment twice daily for 8 weeks. Each patient was reviewed every two weeks; pain scores, healing and side effects were assessed. Results: Healing occurred in 33 of 36 (91.66%) patients treated with Diltiazem after 6 weeks and 15 of 25 (60%) patients treated with Glyceril trinitrate after 8 weeks which shows a significant difference in favour of Diltiazem (P < 0.001). The rest of the patients were either non-compliant or did not heal and underwent surgery. Headache occurred in all of the patients treated with Glyceril trinitrate but none of the patients treated with Diltiazem developed headache. The frequency of other side-effects was also less in patients treated with Diltiazem (P < 0.001). Conclusions: Diltiazem gel was found to be superior to Glyceril trinitrate ointment due to significantly higher healing rate and fewer side-effects.