Fourteen-and Ten-Day Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for Helicobacter pylori Eradication-A Noninferiority, Multicenter, Randomized Controlled Trial
Abstract
BACKGROUND AND AIM: Tegoprazan has shown great potential in the eradication of Helicobacter pylori infection. This study aims to evaluate the efficacy and safety of Tegoprazan-based dual therapy for H. pylori eradication.
METHODS: This was a noninferiority, multicenter, randomized controlled trial in China. Subjects were randomly assigned to three groups: the 14-THA group, the 10-THA group (Tegoprazan 50 mg twice/day, Amoxicillin 1 g 3 times/day, for 14 and 10 days), and the B-quadruple group (esomeprazole 20 mg, bismuth 220 mg, Amoxicillin 1 g, twice/day, tetracycline 0.5 g 3 times/day, for 14 days). The three groups' eradication rates, adverse events, and compliance were compared.
RESULTS: A total of 228 individuals were included in the randomization. According to the per-protocol analysis (PP), modified intention-to-treat (MITT) analysis, and intention-to-treat (ITT) analysis, there was no statistically significant difference between the 14-THA group and B-quadruple group (PP: 90.3% vs. 91.8%, MITT: 84.8% vs. 90.5%, ITT: 73.7% vs. 75.0%, p > 0.05). However, the 10-THA group has a lower eradication rate than the B-quadruple group (PP: 67.2% vs. 91.8%, MITT: 64.1% vs. 90.5%, ITT: 53.9% vs. 75.0%, p 0.05).
CONCLUSION: The eradication rate of the 14-THA group is > 90%, which is not inferior to the current bismuth-containing quadruple regimen, with a favorable safety profile. However, the efficacy of the 10-THA dual therapy is unacceptable.
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: 228 participants or records.
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