A multicenter, double-blind, randomized controlled study of omeprazole versus ranitidine in the treatment of duodenal ulcer in Israel.
A multicenter, double-blind, randomized, controlled study of 203 Israeli patients with endoscopically proven duodenal ulcer is described. The study compares the efficacy (i.e., ulcer healing and relief of symptoms) and safety of 20 mg omeprazole once daily in the morning, with those of 300 mg ranitidine once daily at night. The omeprazole group had significantly higher cumulative healing rates than the ranitidine group both at day 15 (71% vs. 55%, P < 0.03) and day 29 (94% vs. 86%, P < 0.05). The efficacy was unaffected by known risk factors such as smoking. The omeprazole group had significantly fewer days with pain than the ranitidine group (median 1 vs. 3.5 days) (P < 0.03). There were no differences in ulcer size, symptoms or healing rates between Ashkenazi and Sephardic patients who were born in Israel, or who had immigrated to Israel. In summary, the present study confirms the efficacy and safety of omeprazole in the treatment of duodenal ulcer. Omeprazole provides more rapid relief of the symptoms and heals a greater proportion of duodenal ulcers, within 2-4 weeks, than ranitidine.