Chronic anal fissure; a randomised, double blind, placebo controlled trial of 0.5% glyceryl trinitrate ointment

ABSTRACT

Topical application of glyceryl trinitrate [GTN] ointment heals anal fissures, providing an alternative to the traditional first line treatment of surgical sphincterotomy. Tathlith General Hospital Saudi Arabia. January 2001 -April 2003. To determine the effectiveness and safety of topical 0.5% glyceryl trinitrate [GTN] in the management of chronic anal fissure. Individual Patients were randomized to receive 0.5%GTN paste or placebo three times per day for six weeks in addition to oral senna and/or lactulose. Patients took laxatives alone for further 6 weeks. Patients were followed every week for six weeks and then fortnightly for another six weeks to assess pain scores and were given advice. Fifty patients were recruited in this study and 44 patients completed the trial [23 in the GTN group and 21 in the placebo group], patients who could not complete the study were excluded. At 6 weeks, 74% of patients had no pain in the GTN group as compared to the 29% in the placebo group. In 26% of cases treatment was unsuccessful. At three month follow up there was no early recurrence. The prevalence of headaches was 65% in GTN group [reported by 15 patients] and 24% in placebo group [reported by 5 patients]. Mean pain scores were lower in the GTN group as compared to the placebo group. The use of 0.5% GTN induces healing of chronic anal fissures and may be used as a first line of treatment in patients with chronic anal fissure. Successful treatment may come at the expense of a high incidence of headaches