Efficacy and Safety of Tegoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication: A Systematic Review and Meta-Analysis With Trial Sequential Analysis of Randomized Controlled Trials.

BACKGROUND

Antibiotic resistance undermines conventional Helicobacter pylori (H. pylori) eradication therapies. Tegoprazan-amoxicillin (TA) dual therapy is a promising alternative, but its efficacy and safety compared with other treatment regimens remain unclear. The aim of this meta-analysis was to comprehensively evaluate the efficacy and safety of TA dual therapy in eradicating H. pylori.

METHODS

PubMed, Embase, CENTRAL, and Web of Science were searched from inception to December 2025. Eligible randomized controlled trials (RCTs) compared TA dual therapy with bismuth-containing quadruple therapy (BQT) or proton pump inhibitor (PPI)-based high-dose dual therapy (PPI-HDDT) in adults with H. pylori infection. The outcomes were H. pylori eradication rate, adverse events, and medication adherence. Evidence quality was assessed via GRADE.

RESULTS

Six RCTs (n = 1909) were included. TA dual therapy showed no significant difference in eradication rate compared with BQT (n = 5 RCTs, ITT analysis: 78.0% vs. 81.4%, RR = 0.97, 95% CI: 0.88-1.05, p = 0.44; PP analysis: 84.6% vs. 86.2%, RR = 0.96, 95% CI: 0.87-1.06, p = 0.39; low-quality evidence), confirmed by trial sequential analysis. TA dual therapy had a lower overall adverse event rate (11.3% vs. 22.5%, RR = 0.50, 95% CI: 0.37-0.67, p < 0.00001; moderate-quality evidence) but similar adherence (95.7% vs. 94.5%, RR = 1.01, 95% CI: 0.99-1.03, p = 0.31; moderate-quality evidence) compared with BQT. Efficacy and safety were comparable between TA dual therapy and PPI-HDDT (n = 1 RCT).

CONCLUSIONS

The TA dual therapy exhibits similar efficacy compared with BQT and PPI-HDDT for H. pylori eradication, with a better safety profile compared with BQT. However, its overall eradication efficacy is suboptimal, necessitating further regimen optimization in the future.