Different Doses of Ilaprazole for Dual Therapy Versus Bismuth-Quadruple Therapy for Helicobacter pylori Infection: A Three-Arm, Randomized Clinical Trial
Abstract
Background: Current Helicobacter pylori (H. pylori) eradication regimens-standard triple, bismuth-containing quadruple, and non-bismuth quadruple therapies-still face issues such as adverse effects and poor compliance. High-dose dual therapy, with its simplicity, lower pill burden, and comparable efficacy, has recently gained attention. However, existing studies are largely single-center with small sample sizes and lack sufficient evidence-based support. This study aims to further evaluate the efficacy and safety of ilaprazole-based dual and quadruple therapies for H. pylori eradication.
Methods: This was a prospective, multicenter, randomized controlled, non-inferiority clinical trial conducted at five hospitals from January to November 2023. A total of 480 patients were randomly assigned to one of three treatment groups for 14 days: Group A (ilaprazole 5 mg, amoxicillin 1 g, clarithromycin 500 mg, and bismuth potassium citrate 220 mg, all administered twice daily), Group B (ilaprazole 5 mg twice daily and amoxicillin 1 g three times daily), and Group C (ilaprazole 10 mg twice daily and amoxicillin 1 g three times daily). The eradication rates, adverse events, and patient compliance were recorded.
Results: The eradication rates of H. pylori in Groups A, B, and C were 76.9%, 88.1%, and 88.7% (p = 0.004) by intention-to-treat analysis, respectively, and 78.3%, 90.4%, and 91.0% (p = 0.001) using modified intention-to-treat analysis, and 81.8%, 92.1%, 92.2% (p = 0.005) by…
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: 480 participants or records.
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