Rioprostil and ranitidine in the treatment of prepyloric gastric ulcer. A double-blind comparative trial.

Rioprostil, a synthetic 16-methylprostaglandin E1, combines antisecretory with cytoprotective properties, the latter being active even at doses below those required for acid inhibition. To test whether rioprostil given in antisecretory doses would heal prepyloric ulcers rapidly, we assigned patients with endoscopically proved ulcers randomly to double-blind treatment with 100 micrograms rioprostil twice daily or 150 mg ranitidine twice daily for up to 8 weeks. Recruitment was terminated at the time point of planned interim analysis because the total healing rate was markedly lower than expected. Thirty patients were allocated to each treatment group. The cumulative healing rates at 4 and 8 weeks were 40% and 60%, respectively, in the rioprostil group versus 70% and 90%, respectively, in the ranitidine group (p less than 0.01). Pain relief occurred simultaneously in the two groups. No major adverse effects were noted. These findings question the clinical relevance of using 'cytoprotection' by prostaglandin analogues as treatment for prepyloric ulcer disease in the short term.