Misoprostol, a synthetic PGE1 analog, in the treatment of duodenal ulcers

Abstract

Misoprostol, a synthetic analog of prostaglandin E₁, inhibits gastric acid production and is cytoprotective at doses well tolerated by patients in preliminary trials. This multicenter double-blind study was performed in out-patients with endoscopically demonstrated duodenal ulcers, to compare the efficacy in ulcer healing and the safety of two dosages of misoprostol and placebo. Up to six antacid tablets daily were permitted for pain. 308 patients enrolled and were randomized to three treatment groups: placebo, misoprostol 50 μg and misoprostol 200 μg. After two weeks of treatment, the three groups had similar percentages of patients with complete ulcer healing. However, after four weeks, 76.6% of patients taking misoprostol 200 μg q.i.d. had complete healing, compared with 42.6% on misoprostol 50 μg q.i.d. and 51% on placebo (P<0.001, 200 μg versus placebo). Patients taking misoprostol 200 μg used less antacid than the others. Diarrhea, mild and self-limiting, was present in 13% of the 200 μg group versus 5% on placebo. We conclude that misoprostol 200 μg q.i.d. is effective, safe and well tolerated in the treatment of duodenal ulcers.