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Safety and Efficacy of New Glyceryl Trinitrate Suppository Formula: First Double Blind Placebo-Controlled Clinical Trial

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Diseases of the Colon & Rectum

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.

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Acknowledgments

The authors thank friends at Poursina Hakim Research Institute, Isfahan Medical Student Research Committee, and Miss Aliyari for their kind support.

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Authors and Affiliations

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

    M. H. Emami M.D., S. Sayedyahossein M.D. & A. Aslani Ph.D.

  2. Poursina Hakim Research Institute, Isfahan, P.O. Box 81465-1798, Isfahan, Iran

    S. Sayedyahossein M.D.

Authors
  1. M. H. Emami M.D.
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  2. S. Sayedyahossein M.D.
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  3. A. Aslani Ph.D.
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Corresponding author

Correspondence to S. Sayedyahossein M.D..

Additional information

Supported by Isfahan University of Medical Sciences and Poursina Hakim Research Institute.

Read at the Iranian Congress of Gastroenterology and Hepatology (ICGH 2006), Tehran, Iran.

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Emami, M.H., Sayedyahossein, S. & Aslani, A. Safety and Efficacy of New Glyceryl Trinitrate Suppository Formula: First Double Blind Placebo-Controlled Clinical Trial. Dis Colon Rectum 51, 1079–1083 (2008). https://doi.org/10.1007/s10350-008-9226-3

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  • DOI: https://doi.org/10.1007/s10350-008-9226-3

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