Misoprostol, a
synthetic prostaglandin E1 (
PGE1) methyl ester analog has potent antisecretory and cytoprotective effects on the gastric and duodenal mucosa which should make it an effective
drug in the treatment of gastric and
duodenal ulcer. In two multicenter, randomised, double-blind, controlled studies involving over 900 patients with endoscopically proven benign
gastric ulcer and in six similar studies involving over 2000 patients with active
duodenal ulcers, differing doses of
misoprostol have been compared with either placebo
therapy or with conventional doses of
cimetidine. In these studies
misoprostol 800 mcg daily given as two or four divided doses has been shown to produce rates of complete
ulcer healing and
pain relief which were significantly superior to placebo
therapy and comparable to those achieved with
cimetidine.
Drug related adverse effects were infrequent. A dose related
diarrhea occurred in a small proportion of patients which seldom necessitated
suspension of
therapy. Because of the known uterotropic effect of
prostaglandins the
drug should not be used in pregnant women or women of child bearing age unless they are using adequate
contraceptive measures. No clinically significant adverse, hematological or biochemical effects have been reported. Two studies suggested that
misoprostol reduced the adverse effect of smoking on the healing of
duodenal ulcer. In addition,
misoprostol has been shown to protect the gastro-duodenal mucosa from the damaging effects of alcohol and non-steroidal anti-inflammatory drugs. This action may prove of value in the treatment of
ulcer patients who are inveterate smokers, alcohol users or who are compelled to consume non-steroidal anti-inflammatory drugs for
pain relief from rheumatic and allied diseases.