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 Israel i patients with endoscopically proven duodenal ulcer is described. The study compares the efficacy (i.e., ulcer healing and relief of sympto ms) and safety of 20 mg omeprazole once daily in the morning, with tho se of 300 mg ranitidine once daily at night. The omeprazole group had significantly higher cumulative healing rates than the ranitidine grou p 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 smoki ng. The omeprazole group had significantly fewer days with pain than t he 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 sa fety of omeprazole in;he treatment of duodenal ulcer. Omeprazole provi des more rapid relief of the symptoms and heals a greater proportion o f duodenal ulcers, within 2-4 weeks, than ranitidine.