Double-blind study comparing cimetidine and two doses of a slow release formulation of trimoprostil in duodenal ulcer patients with a 6-month follow-up.
120 adult outpatients with endoscopically proven duodenal ulcer were randomly allocated to three groups of 40, treated in a double-blind manner with cimetidine 400 mg twice daily, trimoprostil 3 mg twice daily and trimoprostil 3 mg at bedtime. Trimoprostil was administered as a slow release formulation. Healing rates after 4 weeks were 78, 74 and 58%, respectively, the difference being not significant (p = 0.12). Similarly there was no significant difference regarding subjective symptoms, side effects and biochemical analysis. Healed patients were followed at bimonthly intervals for 6 months. The relapse rates were 71, 59 and 61% for patients initially treated with cimetidine, trimoprostil 6 or 3 mg, respectively, a difference not statistically significant.