Efficiency of nitroglycerine and diltiazem coadministration comparison with topical bethanechol and diltiazem in the treatment of chronic anal fissures: A randomized clinical trial

Abstract

Background and Aim: Anal fissure is one of the common anorectal disorders that there are various therapies for it. The aim of this study is to evaluate the effect of Nitroglycerin plus Diltiazem vs either of topical Diltiazem and Bethanechol alone in the treatment of chronic anal fissure. Materials and Methods: The present randomized double-blind clinical trial was performed on 90 patients with chronic anal fissure referred to gastroenterology clinic of Tohid Hospital, Sanandaj, Iran, from March 2016 to February 2017, That randomly were divided into three equal groups (n = 30): A: combination therapy (1% Nitroglycerin plus 5% Diltiazem gel), B: Diltiazem (5% Diltiazem gel) and C: Bethanechol (0.1% Bethanechol gel). The drugs were administered topically three times daily for 8 weeks. After 4 and 8 weeks’ administration wound condition, pain and bleeding was assessed. Data were analyzed by SPSS v.19 software with Chi-square test. Results: At the beginning of the study, there was no significant difference in mean of age, sex, fissure location, hemorrhoids, bleeding and pain between the three groups (P> 0.05). Four weeks after treatment, there was no significant difference between the three groups in terms of the Wound healing (P = 0.41), pain (P = 0.10) and bleeding (P = 0.07). After 8 weeks, there was a significant difference for pain in the treatment groups (P = 0.04), so that in the diltiazem group, pain was significantly decreased in comparison to Betanchenol and There was no significant difference between the three groups in the case of Wound healing (P = 0.10) and bleeding (P = 0.69). Conclusion: Topical use of diltiazem is a more appropriate option for treatment of chronic fissure than other two drugs.