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Abstract
<jats:p>Objective: To compare the efficacy and safety of tegoprazan-based high-dose amoxicillin dual therapy versus standard bismuth-containing quadruple therapy for Helicobacter pylori (H. pylori) eradication, and to evaluate the non-inferiority of the dual regimen. Methods: This single-center, prospective, open-label cohort study enrolled 200 treatment-naïve patients with H. pylori infection confirmed by ¹³C/¹⁴C-urea breath test between August 2024 and March 2026. Patients voluntarily selected either the dual therapy group (tegoprazan 50 mg twice daily plus amoxicillin 1.0 g three times daily for 14 days; n=100) or the quadruple therapy group (lansoprazole 20 mg twice daily, amoxicillin 1.0 g twice daily, furazolidone 0.1 g twice daily, and colloidal bismuth pectin 0.15 g three times daily for 14 days; n=100). The primary endpoint was the eradication rate assessed at least 4 weeks post-treatment. Analyses were conducted using the full analysis set (FAS), modified full analysis set (mFAS), and per-protocol set (PPS). Non-inferiority was predefined with a margin of -10%. Multivariable logistic regression was employed to adjust for potential confounders (age, gender). Results: In the FAS, the eradication rate was 95.0% (95% CI: 88.7%–98.4%) in the dual therapy group versus 91.0% (95% CI: 83.6%–95.8%) in the quadruple therapy group. The risk difference was 4.0% (95% CI: -3.4% to 4.0%), with the lower limit of the CI above the prespecified non-inferiority margin (-10%), meeting the non-inferiority criterion (P&lt;0.001). Superiority testing showed no statistically significant difference (P=0.2676). In the PPS, eradication rates were 96.9% versus 91.9%, confirming non-inferiority. After multivariable adjustment, the aOR for successful eradication with dual therapy was 1.961 (95% CI: 0.643–6.675). Subgroup analysis revealed a significant interaction between sex and treatment effect (Pinteraction=0.0047), with a trend toward superior efficacy in males (RD=12.1%, 95% CI: 0%–12.1%). Safety profiles were comparable, with adverse event rates of 4.0% versus 2.0% (P=0.6827), and no serious adverse events reported. Conclusion: In treatment-naïve patients, 14-day tegoprazan-amoxicillin dual therapy achieves the prespecified non-inferiority margin compared to standard bismuth-containing quadruple therapy, with a favorable safety profile. This simplified regimen serves as an effective alternative for first-line eradication, potentially offering enhanced benefits in male patients. Given the observational design, these findings are exploratory and warrant validation in prospective randomized controlled trials.</jats:p>