Different Doses of Ilaprazole for Dual Therapy Versus Bismuth-Quadruple Therapy for Helicobacter pylori Infection: A Three-Arm, Randomized Clinical Trial.

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 per-protocol analysis. The adverse event rates were 28.0%, 10.2%, 10.8% in Groups A, B, and C, respectively (p < 0.001), while patient compliance rates were 91.1%, 98.1%, 98.7%, respectively (p = 0.001). Sex, smoking history, alcohol intake, and sharing tableware or cups did not affect the efficacy of the three treatment regimens. CONCLUSIONS: The standard- or high-dose dual therapy with ilaprazole demonstrated superior efficacy, safety, and patient compliance compared to quadruple therapy. No significant differences were observed between these dual therapies, which are expected to become promising alternatives for the primary treatment of H. pylori infection. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2400086862.