Tegoprazan-based dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori eradication: a prospective, multicenter, open-label, non-inferiority, randomized controlled trial
Abstract
Background Current standard therapies for Helicobacter pylori (H. pylori) are limited by side effects and antibiotic resistance. Evidence suggests that high-dose amoxicillin dual therapy with a proton pump inhibitor offers comparable efficacy with an improved safety profile. Methods This trial substituted the novel acid blocker tegoprazan for a proton pump inhibitor in the dual therapy regimen. We enrolled 400 patients with confirmed H. pylori infection from the gastroenterology departments of multiple general hospitals in Jiangsu Province between March 2024 and September 2025. Participants were randomly assigned in a 1:1 ratio to a 14-day course of either TA dual therapy (tegoprazan 50 mg twice daily and amoxicillin 1000 mg three times daily) or TBQ quadruple therapy (tegoprazan 50 mg, amoxicillin 1000 mg, furazolidone 100 mg, and colloidal bismuth pectin 300 mg, all twice daily). A 13C- or 14C-urea breath test was performed at least 4 weeks after treatment completion to assess the primary outcome of eradication rate. Secondary outcomes included the incidence of adverse events and medication adherence. Results In the intention-to-treat analysis, eradication rates were 87.5% (95% CI: 82.9 to 92.1%) for the TA group and 89.5% (95% CI: 85.3 to 93.8%) for the TBQ group. Non-inferiority of the TA regimen was established (P = 0.006). Similar results were observed in the modified intention-to-treat (90.7% vs. 94.7%; P = 0.012 for non-inferiority) and per-protocol analyses (90.6%…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 400 participants or records.
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