Comparative evaluation of 0.2% glyceryl trinitrate vs. 2% diltiazem ointment in treatment of chronic anal fissure treatment - a randomized trial

Abstract

Introduction

The initial management of chronic anal fissures nowadays is increasingly becoming medical since surgical procedures may be complicated by prolonged healing of wounds, higher incidence of incontinence of flatus/ mucous, anaesthesia requirement and higher cost. Medical treatment can be carried out on an outpatient basis and is cost-effective.

Aim and study design

We conducted a prospective randomised trial to comparatively evaluate the topical efficacy and complications of 0.2% GTN vs. 2% Diltiazem ointment in patients with chronic anal fissure.

Methods

A total of fifty patients were randomly assigned to two groups of 25 patients each, all of whom were treated with topical medication twice daily for a period of six weeks: group A was treated with 0.2% glyceryl trinitrate and group B with 2% diltiazem. None of the patients in either group received analgesics in any form during the course of treatment and follow-up. Cases of acute anal fissure, pregnancy, Crohn’s disease, HIV, tuberculosis, fistula in ano or anal cancer, known allergy to drugs, heart disease, hypertension and patients who refused consent were excluded.

Observation

The mean age of patients in both groups (34.6±12.8 vs. 30.6±9.5 years) was comparable. Group A (GTN) comprised 19 males and 6 females and Group B (Diltiazem) 17 males and 8 females (p>.05). The mean duration of symptoms for both groups was 16.64±12.3 vs. 16.08±11.9 weeks, and the mean pain score of patients before treatment was 8.64±0.95 vs. 8.44±1.19 weeks, which was comparable. Perceptible pain relief as compared to pretreatment levels was recorded for both groups after six weeks of therapy (p=.905). Complete healing was observed in 72% patients in group A vs. 80% in group B at the end of six weeks (p value 0.508). Headache was reported in 36% patients in group A and 8% in group B; this difference was statistically significant (p value 0.041). The incidence of recurrence in both groups was comparable at 3-month follow-up (p value 0.756).

Conclusion

Both 0.2% GTN and 2% Diltiazem ointment are equally effective in chronic anal fissure treatment in terms of symptomatic pain relief, healing and recurrence, but headache is a troublesome side effect in patients treated with glyceryl trinitrate ointment. When considering medical management of chronic anal fissure, 2% Diltiazem ointment may be preferable as first-line treatment.

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Correspondence to Rajesh Godara.

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Bansal, A.R., Kumar Yadav, P., Godara, R. et al. Comparative evaluation of 0.2% glyceryl trinitrate vs. 2% diltiazem ointment in treatment of chronic anal fissure treatment - a randomized trial. Hellenic J Surg 88, 25–30 (2016). https://doi.org/10.1007/s13126-016-0278-x

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Keywords

  • Chronic anal fissure
  • glyceryl trinitrate
  • diltiazem ointment