Vonoprazan versus rabeprazole in dual therapy with amoxicillin for Helicobacter pylori eradication: a prospective, multicenter, open-label, randomized controlled trial
Abstract
BACKGROUND: Both traditional proton pump inhibitors and the novel potassium-competitive acid blocker vonoprazan, when combined with high-dose amoxicillin in dual therapy, have shown promise for Helicobacter pylori (H. pylori) eradication. However, high-quality evidence directly comparing their efficacy and safety remains limited. This study aimed to compare the clinical efficacy and safety of rabeprazole-amoxicillin dual therapy versus vonoprazan-amoxicillin dual therapy for H. pylori eradication. METHODS: From April 1, 2024, to February 28, 2025, 318 H. pylori-positive patients were enrolled and randomly assigned in a 1:1 ratio to two treatment groups: the Rabeprazole Group (rabeprazole 20 mg twice daily; amoxicillin 1000 mg three times daily) and the Vonoprazan Group (vonoprazan 20 mg twice daily; amoxicillin 1000 mg three times daily). Both groups received a 14-day treatment course. A 13C-urea breath test was performed at least four weeks after treatment completion. H. pylori eradication rates, incidence of adverse events during treatment, and medication adherence were compared between the groups. RESULTS: In the intention-to-treat analysis, the eradication rates were 75.5% (95% CI: 68.8%-82.2%) in the Rabeprazole Group and 83.0% (95% CI: 77.2%-88.9%) in the Vonoprazan Group, with no statistically significant difference (P = 0.097). In the modified intention-to-treat analysis, the rates were 78.4% (95% CI: 71.9%-84.9%) and 88.6% (95% CI: 83.5%-93.7%), respectively,…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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