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.