Treatment of Benign Gastric Ulcer: A Comparative Clinical Trial of Rioprostil and Ranitidine

Abstract

This study is a multicentre, double-blind, double-dummy, two-way, parallel group comparison of the efficacy and safety of rioprostil and ranitidine in the treatment of active gastric ulcer. Ninety-one patients with gastric ulcer are randomly allocated to treatment with either rioprostil 300 micrograms b.d., or ranitidine, 150 mg b.d. The duration of treatment is 4 weeks, or 8 weeks for the patients who are improved but not healed at 4 weeks. Clinical, endoscopic and laboratory assessments are made before treatment, and after each treatment period. Therapeutic success is defined as complete endoscopic healing of the ulcer. At the end of the treatment period, either 4 or 8 weeks, healing rates are 69% in the rioprostil group, and 66% in the ranitidine group; this difference is not significant (p = 0.86). After the first 4 weeks of treatment the healing rates are 44% and 55% in the rioprostil and ranitidine groups, respectively. The incidence of adverse effects is 22% in the rioprostil group, and 7% in the ranitidine group (p = 0.036). Diarrhoea is the most common side effect (12%), but is usually intermittent and mild. We conclude that rioprostil, 300 micrograms b.d., for up to 8 weeks is as effective as ranitidine, 150 mg b.d., in the treatment of benign gastric ulcer.