Multi-center clinical study of rabeprazole in the treatment of peptic ulcer Clinical study group of rabeprazole, Correspondence

2001 
Objective To evaluate the effect and safety of Rabeprazole at the dose of 10 mg per day on peptic ulcer, comparing with omeprazole at the dose of 20 mg per day. Methods In this randomized, open label, controlled clinical trial, 137 patients with duodenal or gastric ulcers were randomized into two groups: i.e. rabeprazole 10 mg qd, or omeprazole 20 mg qd. There were 70 patients in rabeprazole group and 67 patients in omeprazole group. The treatment lasted 4 weeks in the duodenal ulcer group, and 6 weeks in the gastric ulcer group. Results For patients with duodenal ulcer and gastric ulcer, there were no statistical differneces between these two groups in improving pain symptoms and time of pain resolution after treatment( P 0.05). Among patients with duodenal ulcer, the cure rate and healing rate in the rabeprazole group were not significantly different from those in the omeprazole group(38.5% and 98.1% respectively, versus 26.0% and 94.0% respectively, P 0.05). Among patients with gastric ulcers, the cure and healing rate in the rabeprazole group were also not significanltly different from those of omeprazole (50.0% and 100.0% respectively, versus 35.3% and 94.1% respectively, P 0.05). The incidence of adverse events in the rabeprazole group was 4.3%, which was not significanlty different from that of omeprazole group(4.5%). Conclusion Rabeprazole at the dose of 10 mg per day was able to cure peptic ulcer safely and effectively. It was equivalent to omeprazole at the dose of 20 mg per day in terms of pain resolution and ulcer healing.
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