Eradication of Helicobacter pylori With Vonoprazan-Amoxicillin Dual Therapy as an Alternative for Bismuth-Based Quadruple Therapy: A Systematic Review and Noninferiority Meta-Analysis.

INTRODUCTION

Whether the efficacy of vonoprazan-amoxicillin dual therapy (VADT) for Helicobacter pylori eradication is clinically acceptable compared with guideline-recommended bismuth-based quadruple therapy (BQT) remains uncertain. Prior analyses have largely relied on superiority frameworks.

METHODS

PubMed, EMBASE, and CENTRAL were searched through December 23, 2025, for randomized controlled trials (RCTs) comparing VADT with BQT for H. pylori eradication. Intention-to-treat and per-protocol eradication were summarized through Bayesian meta-analysis as absolute risk differences. Noninferiority margins were prespecified at -10%, -5%, and 0% (superiority). Adverse events (AEs) were evaluated as secondary outcomes. Evidence certainty was assessed using GRADE.

RESULTS

Eighteen Asian RCTs (5866 participants) were included. In intention-to-treat analyses, VADT achieved an absolute eradication increase of +2.27% compared with BQT (95% credible interval [CrI] -1.34% to +5.71%). The posterior probability of noninferiority exceeded 99% for the -10% and -5% margins but declined to 90.41% at 0%. In per-protocol analyses, eradication showed an absolute decrease of 0.28% (95% CrI -3.30% to +4.17%), with noninferiority probabilities exceeding 99% for the -10% and -5% margins, but declining to 56.43% at 0%. VADT was associated with significantly lower rates of dysgeusia, dizziness/headache, nausea/vomiting, and overall mild AEs. Evidence certainty was moderate for intention-to-treat noninferiority in Eastern populations and low or very low for all other Eastern and Western analyses.

DISCUSSION: VADT may be a reasonable alternative in East Asian settings where tolerability or regimen simplicity is a priority, but evidence is insufficient to support generalization to Western or non-Asian populations.