Efficacy and safety of triple therapy with vonoprazan for Helicobacter pylori eradication: A multicenter, prospective, randomized controlled trial
Abstract
Background: Helicobacter pylori (H. pylori) is a Gram-negative bacterium that relies on flagellar motility to colonize the stomach, damaging the gastric mucosa through various mechanisms and leading to various digestive disorders. Accurate assessment and precise treatment are essential in initial intensive therapy.
Aim: To investigate the efficacy and safety of a vonoprazan (VPZ)-based triple regimen for first-line eradication of H. pylori in China.
Methods: This multicenter noninferior randomized controlled trial (June 2022 to November 2023) involved 524 H. pylori-positive patients across 19 centers in Shandong, China. Participants were randomized to 14-day esomeprazole/bismuth/amoxicillin/clarithromycin (EBAC), 14-day VPZ/amoxicillin/clarithromycin (VACa), or 10-day VPZ/amoxicillin/clarithromycin (VACb) - all administered twice daily. Primary outcomes (eradication rates) were assessed via intention-to-treat (ITT) and per-protocol (PP) analyses. Secondary endpoints included adverse events and adherence. Noninferiority testing and χ 2 tests were used for statistical comparisons.
Results: A total of 524 patients participated in this study. In ITT analysis, the eradication rates of the EBAC, VACa, and VACb groups were 72.6% (127/175), 88.0% (154/175), and 83.3% (145/174), respectively (P = 0.001). The difference in the eradication rate between the EBAC and VPCa groups was 15.4% [95% confidence interval (CI): 7.3-23.6, P P = 0.018). In PP analysis, the eradication rates of the…
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: 524 participants or records.
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