Comparative efficacy of misoprostol and cimetidine in the treatment of acute duodenal ulcer. Results of major studies.

Misoprostol, a synthetic methyl ester of prostaglandin E1, has been shown to possess potent antisecretory activity in addition to a mucosal protective effect. Several multicenter double-blind, placebo-controlled trials confirmed the efficacy of misoprostol in the treatment of duodenal ulcer when administered at 800 micrograms in two or four divided doses daily. This report summarizes three cimetidine-controlled trials conducted in three separate geographic areas (Europe, Argentina, and Japan). The trials were double blind, randomized, and endoscopically controlled. In all studies, healing was defined as the absence of ulcer on endoscopy. The efficacy of misoprostol in the treatment of duodenal ulcer was shown to be equivalent to that of the histamine H2-receptor antagonist. In the Argentine study, the rate of disappearance of mucosal erosions was significantly greater for misoprostol than for cimetidine. Misoprostol was well tolerated. Mild and transient diarrhea not necessitating treatment or withdrawal occurred in 4 to 9 percent of the misoprostol-treated patients. These results indicate that misoprostol has a unique anti-ulcer action and represents a significant addition to the physician's armamentarium in the total medical management of duodenal ulcer.