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Dis Colon Rectum. 2008 Jul;51(7):1079-83. doi: 10.1007/s10350-008-9226-3. Epub 2008 May 10.

Safety and efficacy of new glyceryl trinitrate suppository formula: first double blind placebo-controlled clinical trial.

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1
Isfahan University of Medical Sciences and Poursina Hakim Research Institute, Isfahan, Iran.

Abstract

PURPOSE:

This study was designed to assess the safety and efficacy of 0.2 percent glyceryl trinitrate suppository form in the healing of chronic anal fissure.

METHODS:

Thirty-four patients with symptomatic chronic anal fissures were assigned to 0.2 percent glyceryl trinitrate suppository (n = 21) or placebo (n = 13) in a double blind design. Patient's symptom scores were registered at first visit. A validated daily chart was given to assess their symptoms on a daily basis. Both groups received psyllium from the beginning of the study. They were assessed at two-week intervals for six weeks. Then, they started a washout period of one month and after that were crossed over for another six weeks. Chi-squared, t-tests, and analysis of variance were used for statistical analysis.

RESULTS:

Complete healing at six weeks was achieved in 12 of 21 patients (57 percent) in the glyceryl trinitrate group and 5 of 13 patients (38 percent) in the placebo (P < 0.05). The overall healing rates at the end of study were 15 of 21 (71 percent) vs. 11 of 13 (84 percent) in the glyceryl trinitrate and placebo groups, respectively (P > 0.05).

CONCLUSIONS:

Application of 0.2 percent glyceryl trinitrate suppository form represents a new, promising, and effective treatment for chronic anal fissure.

PMID:
18470565
DOI:
10.1007/s10350-008-9226-3
[Indexed for MEDLINE]

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