[Misoprostol and cimetidine in the treatment of duodenal ulcer. A multicenter Swiss double-blind study]

The efficacy and tolerance of misoprostol a synthetic prostaglandin E1 analogue-and of cimetidine were evaluated in the treatment of duodenal ulcer following a double blind multicenter design. A group of Swiss gastroenterologists recruited 119 patients with endoscopically proven acute duodenal ulcer. They were enrolled and treated according to a uniform protocol either with misoprostol 4 X 50 micrograms daily, with misoprostol 4 X 200 micrograms daily or with cimetidine 4 X 300 mg daily. Patients who were healed after 4 or 8 weeks were followed during 6 months. Cumulative healing rates at 4 weeks in groups receiving misoprostol 200 micrograms, misoprostol 800 micrograms or cimetidine 1200 mg daily were 42%, 58% and 71% respectively. Patients treated with cimetidine showed a more rapid improvement of symptoms than patients treated with misoprostol. Symptomatic recurrences after ulcer healing occurred in almost 40% of the patients within 6 months, irrespective of the type of acute ulcer treatment. Risk factors for slowed healing and increased rate of recurrence were evaluated in the present study, and the results were compared with the results of two previous trials performed according to a similar protocol. Smoking appeared to slow healing and to favor relapses. Moderate consumption of alcohol appeared to decrease the relapse rate. In the present trial, ulcer size was associated with ulcer pain but not with ulcer healing.