Safety and efficacy of new glyceryl trinitrate suppository formula: first double blind placebo-controlled clinical trial.
OBJECTIVE
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.
Emami
M H
MH
Isfahan University of Medical Sciences and Poursina Hakim Research Institute, Isfahan, Iran.
Sayedyahossein
S
S
Aslani
A
A
D045784:Abietanes / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics; D000293:Adolescent; D000328:Adult; D002908:Chronic Disease; D003113:Colonoscopy; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004339:Drug Compounding; D005260:Female; D005401:Fissure in Ano / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D005996:Nitroglycerin / Q000032:analysis; D014677:Pharmaceutical Vehicles; D011092:Polyethylene Glycols / Q000032:analysis; D013056:Spectrophotometry, Ultraviolet / Q000379:methods; D013488:Suppositories; D016896:Treatment Outcome; D014280:Triglycerides / Q000008:administration & dosage* / Q000032:analysis / Q000737:chemistry / Q000493:pharmacokinetics; D014945:Wound Healing / Q000187:drug effects
D045784:Abietanes; D014677:Pharmaceutical Vehicles; D013488:Suppositories; D014280:Triglycerides; C116056:poly(ethylene glycol)acetaldehyde hydrate; C009683:witepsol; C081556:glyceryl triabietate; D011092:Polyethylene Glycols; D005996:Nitroglycerin