Treatment of duodenal ulcer with ranitidine, a new histamine H2-receptor antagonist.

Fifty patients with endoscopically verified duodenal ulcer were treated with either 100 mg of ranitidine hydrochloride (corresponding to 89.4 mg of ranitidine base) or identical placebo tablets twice daily under double-blind conditions. One patient did not attend for the second endoscopy and was excluded. Endoscopic examination after 4 weeks of treatment showed that the ulcer had healed in 23 out of 25 patients (92%) treated with ranitidine and in 11 out of 24 patients (46%) treated with placebo (P < 0.01). The ranitidine-treated patients had significantly less ulcer symptoms during treatment. Antacid consumption was also less in the ranitidine than in the placebo-treated group, but the difference was not significant. After 4 weeks in the double-blind study 14 of the 15 patients with unhealed ulcer received open treatment with ranitidine for 4-6 weeks. The ulcer healed in all but one patient. No serious side effects of ranitidine were observed.

Maintenance treatment of duodenal ulcer patients with a single bedtime dose of cimetidine.

Fifty-eight patients with endoscopically verified duodenal ulcers were treated with cimetidine, 1 g/day, for 6--10 weeks. The ulcers healed in 52 out of the 54 patients completing the treatment (96.3%). Forty-seven of the patients with healed ulcer were randomly allocated to 1 year of maintenance treatment, 23 patients with cimetidine, 400 mg at night, and 24 patients with placebo tablets. In the cimetidine-treated group 2 out of the 20 patients (10%) completing the trial had recurrence of ulceration, whereas 16 out of the 23 patients (70%) completing the placebo treatment had ulcer recurrence (p less than 0.001). The drug was well tolerated and, except for a marked increase in serum transaminases in three patients, no serious side effects were seen.