A randomized noninferiority trial comparing tegoprazan triple therapy and bismuth quadruple therapy for Helicobacter pylori eradication
Abstract
Rising antibiotic resistance has compromised the efficacy of standard
Helicobacter pylori
(
H. pylori
) eradication regimens. This multicenter trial aimed to evaluate whether a simplified tegoprazan-based triple therapy (TAD) is non-inferior to tegoprazan-based bismuth quadruple therapy (TADB) in a high-resistance setting. In this randomized, open-label, non-inferiority trial conducted across nine centers in China, 274 treatment-naïve patients were randomized (1:1) to receive either Group TAD (tegoprazan 50 mg, amoxicillin 1000 mg, doxycycline 100 mg) or Group TADB (TAD plus bismuth potassium citrate 600 mg) twice daily for 14 days. In the per-protocol (PP) analysis, eradication rates were 91.7% (111/121) for Group TAD and 96.0% (120/125) for Group TADB. Using the Newcombe score method against a pre-specified non-inferiority margin of -10%, the difference in per-protocol eradication rates was − 4.3% (95% CI: -9.8% to 2.0%), successfully establishing statistical non-inferiority. Intention-to-treat (ITT) analysis yielded consistent results (83.5% vs. 85.1%,
P
= 0.835). Group TAD demonstrated a significantly superior safety profile (22.6% vs. 46.1% AEs,
P
< 0.001). A simplified tegoprazan-based triple therapy is non-inferior to its bismuth-containing counterpart, offering high efficacy with a significantly improved safety profile and reduced pill burden. Chinese Clinical Trial Registry, ChiCTR2500102215. Registered 2025-05-12 (Retrospectively registered).
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.
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