A comparison of omeprazole and ranitidine for duodenal ulcer in South African patients. A multiracial study.

The study was a multicenter double-blind parallel-group comparison of omeprazole, a proton-pump inhibitor, with the H2-receptor antagonist, ranitidine, in 206 patients with duodenal ulcer. There were 145 men and 62 women of mixed racial origin with an average age of 40 years (range 19-76); 63 of them were white, 7 black, 135 coloured and 1 Asian. Each drug was given for four weeks and ulcer healing rate, symptom relief, and adverse events were recorded and compared between treatment groups. Patients received either 20 mg omeprazole once daily in the morning (N = 104) or ranitidine 300 mg once daily at night (N = 106). Healing rates were significantly higher in the omeprazole group than in the ranitidine group at both two weeks (80% vs 52%, P less than 0.001) and four weeks (95% vs 85%, P less than 0.05), using the "per protocol" approach, and these results were confirmed using the "intention to treat" approach. Omeprazole-treated patients reported significantly less daytime epigastric pain (P = 0.02) and heartburn (P = 0.04) after two weeks than ranitidine-treated patients. By four weeks, there were no significant differences in symptom reporting between groups. Both treatments were well tolerated, and there were no serious adverse events.

RCT Entities:   Population Interventions Outcomes