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
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 1,909 participants or records.
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