Efficacy and safety of tegoprazan-amoxicillin dual therapy versus bismuth-containing quadruple therapy for first-line Helicobacter pylori eradication: a systematic review and meta-analysis of randomized controlled trials.

Optimized bismuth quadruple therapy is a recommended first-line treatment for Helicobacter pylori infection but is limited by regimen complexity, whereas tegoprazan-amoxicillin dual therapy has emerged as a simplified alternative with limited comparative evidence. We conducted a systematic review and meta-analysis of randomized controlled trials comparing tegoprazan-amoxicillin dual therapy with bismuth-containing quadruple therapy (BQT) as first-line treatment for H. pylori infection. Electronic databases (PubMed, Embase, Web of Science Core Collection, and the Cochrane Library) were searched from inception through 24 December 2025. Intention-to-treat eradication rates were pooled using a random-effects model. Sensitivity analyses were performed by restricting comparators to proton pump inhibitor-based BQT. Safety outcomes were qualitatively synthesized. Five randomized controlled trials involving 1541 treatment-naïve participants were included. In intention-to-treat analyses, 14-day tegoprazan-amoxicillin dual therapy showed no statistically significant difference in eradication efficacy compared with BQT [risk ratio, 0.996; 95% confidence interval, 0.911-1.089; P = 0.93]. Sensitivity analysis restricted to proton pump inhibitor-based BQT yielded consistent results (risk ratio, 0.985; 95% confidence interval, 0.877-1.107; P = 0.80). Across individual studies, adverse events and treatment discontinuation were generally reported more frequently in BQT arms than in dual-therapy arms, although reporting of safety and adherence outcomes was not fully standardized. In randomized first-line trials, 14-day tegoprazan-amoxicillin dual therapy demonstrated eradication efficacy comparable to BQT. These findings suggest that 14-day tegoprazan-amoxicillin dual therapy may serve as an alternative first-line option, particularly when regimen simplicity and tolerability are prioritized.