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

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

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.

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abietanes / administration & dosage*
  • Abietanes / chemistry
  • Abietanes / pharmacokinetics
  • Adolescent
  • Adult
  • Chronic Disease
  • Colonoscopy
  • Cross-Over Studies
  • Double-Blind Method
  • Drug Compounding
  • Female
  • Fissure in Ano / diagnosis
  • Fissure in Ano / drug therapy*
  • Fissure in Ano / metabolism
  • Humans
  • Male
  • Middle Aged
  • Nitroglycerin / analysis
  • Pharmaceutical Vehicles
  • Polyethylene Glycols / analysis
  • Spectrophotometry, Ultraviolet / methods
  • Suppositories
  • Treatment Outcome
  • Triglycerides / administration & dosage*
  • Triglycerides / analysis
  • Triglycerides / chemistry
  • Triglycerides / pharmacokinetics
  • Wound Healing / drug effects

Substances

  • Abietanes
  • Pharmaceutical Vehicles
  • Suppositories
  • Triglycerides
  • poly(ethylene glycol)acetaldehyde hydrate
  • witepsol
  • glyceryl triabietate
  • Polyethylene Glycols
  • Nitroglycerin