A double-blind endoscopically controlled trial of ranitidine in a high incidence area.

Fifty patients with endoscopically diagnosed uncomplicated duodenal ulcers were given ranitidine 150 mg twice daily, or placebo for 4 weeks in a randomised double-blind study. After 4 weeks, 76% of patients on ranitidine showed healing. Fifteen (60%) were completely healed, 5 (20%) were partly healed, and 5 had active unchanged ulcers. On placebo, 6 (27%) were completely healed, 6 (27%) were partly healed, 10 had active unchanged ulcers and 3 had absconded. Grouping partly healed with active ulcers, a Z value of 2.23 was obtained in the Mantel-Haenszel Test; p = 0.013 in favour in ranitidine over placebo. Of ten patients who were partly healed or active after ranitidine in Stage 1, 7 healed on one further course in an open study, and 3 were active after 2 further courses. Of 16 patients who were partly healed or active after placebo, 3 healed on one course of ranitidine, 6 healed on 2 courses of ranitidine, 6 remained active after 2 courses, and 1 absconded. No side-effects were noted. Ranitidine is a safe and effective therapy for active duodenal ulceration.

RCT Entities:   Population Interventions Outcomes