Assessing the non-inferiority of a 10-day compared with a 14-day vonoprazan–amoxicillin dual therapy regimen for H. pylori eradication: a systematic review and meta-analysis

Abstract

Helicobacter pylori infection affects approximately 50% of the global population and remains a major cause of peptic ulcer disease and gastric cancer. Vonoprazan, a novel potassium-competitive acid blocker, has emerged as a promising alternative to proton pump inhibitors in H. pylori eradication regimens. Vonoprazan-amoxicillin dual therapy offers a simplified treatment approach with potentially high eradication rates. However, the optimal treatment duration remains uncertain, with important implications for patient adherence, adverse events, and antimicrobial resistance. This systematic review and meta-analysis aimed to evaluate whether 10-day vonoprazan-amoxicillin dual therapy is non-inferior to the standard 14-day regimen for H. pylori eradication in adults. We conducted a systematic search of major medical databases for randomized controlled trials published up to September 27, 2025. The primary outcome was H. pylori eradication rate, with secondary outcomes including adverse events and treatment compliance. Risk differences with 95% confidence intervals were calculated for primary outcomes, and risk ratios with 95% confidence intervals were calculated for secondary outcomes, using a random-effects model. Quality assessment was performed using the Cochrane Risk of Bias 2.0 tool. Seven randomized controlled trials were identified, of which six trials were included in the quantitative analysis. In the intention-to-treat population (n = 2,587), the pooled risk difference for eradication rate was − 0.03 (95% CI: -0.06 to -0.01, P = 0.008), with the lower confidence interval limit above the prespecified non-inferiority margin of -0.1, demonstrating non-inferiority of the 10-day regimen. Per-protocol analysis (n = 2,358) confirmed these findings with a risk difference of -0.04 (95% CI: -0.06 to -0.01, P = 0.009), also with the lower confidence interval limit above the non-inferiority margin. No significant differences were observed for adverse events (P = 0.67) or treatment compliance (P = 0.88). 10-day vonoprazan-amoxicillin dual therapy is non-inferior to a 14-day regimen for H. pylori eradication in adults, with comparable safety profiles and compliance rates. While promising, the evidence is confined to Chinese populations, which limits generalizability to other settings. Further research in diverse ethnic groups and geographic regions is warranted to confirm these findings worldwide. Not applicable.