Abstract
BACKGROUND AND OBJECTIVE: In recent years, the use of high-dose dual therapy based on PPI and amoxicillin (PPI-HDDT) has shown satisfactory efficacy in eradicating Helicobacter pylori (H. pylori) as a first-line treatment. Vonoprazan (VPZ), a new potassium-competitive acid blocker, exhibits rapid, potent, and enduring acid inhibitory effects in comparison to PPI. However, to date, evidence comparing VPZ-based HDDT (VPZ-HDDT) with PPI-HDDT for eradication of H. pylori remains limited. This meta-analysis aimed to systematically evaluate the effect of the two regimens for first-line H. pylori eradication. METHODS: This meta-analysis searched PubMed, Embase, Cochrane Library, and Web of Science (from inception to October 1, 2025) for randomized controlled trials (RCTs) comparing VPZ-HDDT vs. PPI-HDDT in treatment-naive H. pylori patients. Utilize a random-effects model for meta-analysis to ascertain the pooled relative risk (RR) with a 95% confidence interval (CI). RESULTS: Four RCTs (involving 1,807 patients) were included. Based on the intention-to-treat (ITT) and per-protocol (PP) analysis data, the results of the meta-analysis consistently demonstrated that the H. pylori eradication rate in the VPZ-HDDT group is higher than that in the PPI-HDDT group (ITT analysis: 88.0 vs. 82.7%, RR = 1.05, 95% CI:1.00-1.10, P = 0.04; I (2) = 28%; PP analysis: 92.3 vs. 87.3%, RR = 1.04, 95% CI:1.01-1.08, P = 0.02; I (2) = 15%). There were no statistically significant differences in the incidence of total adverse events (8.6 vs. 10.6%, RR = 0.78, 95% CI:0.59-1.04, P = 0.09) and compliance (97.1 vs. 95.6%, RR = 1.02, 95% CI:0.99-1.05, P = 0.22) between the VPZ-HDDT group and the PPI-HDDT group. CONCLUSIONS: VPZ-HDDT exhibits superior H. pylori eradication rate over the PPI-HDDT regimen, with comparable safety and compliance. SYSTEMATICREVIEWREGISTRATION: https://osf.io/fxju2.