A DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP STUDY OF OMEPRAZOLE AND RANITIDINE IN KOREAN PATIENTS WITH GASTRIC-ULCER

The efficacy of the proton pump inhibitor omeprazole, 20 mg every morning, was compared with that of the H-2-receptor antagonist ranitidine, 150 mg every morning and at bedtime, in a double-blind randomized parallel group study in 250 patients with gastric or prepyloric ulcers. At both 4 and 8 weeks, significantly more patients had healed ulcers in the omeprazole group than the ranitidine group, whether the results were analysed on a per-protocol or an intention-to-treat basis. At 4 weeks, 74% of patients in the omeprazole group were healed compared with 51% in the ranitidine group (P = 0.001), and at 8 weeks the corresponding values were 99 and 82% (P = 0.001, per-protocol cohort). Omeprazole treatment and small ulcer size significantly increased the probability of healing, but smoking had no significant effect. Patients in the omeprazole group had significantly fewer occurrences of daytime epigastric pain during the first 4 weeks than the ranitidine group (P = 0.0037), as shown by their diary cards. Both treatments were well tolerated.