Tegoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication: A Prospective, Randomized, Multicenter Study in Fujian, China
Abstract
INTRODUCTION: Few studies have investigated the efficacy and safety of tegoprazan-amoxicillin (TA) dual therapy for Helicobacter pylori eradication. We aim to evaluate the effectiveness and safety of different dosages of TA dual therapy for H. pylori eradication.
METHODS: This prospective, randomized, open-label, multicenter study was conducted at four centers in Fujian, China. H. pylori-infective patients were randomized 1:1:1 to receive one of the following treatments: bismuth quadruple therapy (BQT, esomeprazole 20 mg twice daily + potassium bismuth citrate 240 mg twice daily + amoxicillin 1 g twice daily + clarithromycin 500 mg twice daily), tegoprazan-amoxicillin dual therapies (TA-qd, tegoprazan 50 mg once daily + amoxicillin 1 g thrice daily; TA-bid, tegoprazan 50 mg twice daily + amoxicillin 1 g thrice daily) for 14 days. The primary outcome was noninferiority in eradication rates of the different TA groups compared to the BQT group. Secondary outcomes encompassed an assessment of adverse reactions and clinical symptom relief. Additionally, exploratory outcomes were focused on the shifts in gut microbiota and a cost-effectiveness analysis.
RESULTS: A total of 321 patients were enrolled. The eradication rates in the BQT group, TA-qd group, and TA-bid group were 85.05% (91/107), 85.98% (92/107), and 85.98% (92/107) in the intention-to-treat analysis (ITT) (BQT vs. TA-qd, 95% CI -8.50% to 10.36%, noninferiority p = 0.012; BQT vs. TA-bid, 95% CI -8.50% to 10.36%,…
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: 321 participants or records.
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