Comparison of 10-Day Course of Triple Therapy Versus 14-Day Course for Eradication of Helicobacter pylori Infection in an Indonesian Population: Double-Blinded Randomized Clinical Trial

Abstract

Objective: The aim of this study was to compare the effectiveness of 10-day course of triple therapy versus a 14-day course in the treatment of H.pylori infection in an Indonesian population. Methods: A double-blinded randomized clinical trial was included patients, Indonesian population, with H.pylori infection conducted in Cipto Mangunkusumo Hospital, Jakarta; Cilincing District General Hospital, Jakarta; and West Nusa Tenggara General Hospital, Mataram, during October 2016 - April 2017. Patients were randomized to be given triple therapy as Rabeprazole 20 mg, Amoxicillin 1,000 mg, and Clarithromycin 500 mg twice daily, for 14 days or 10 days plus 4 days placebo. Eradication was evaluated with UBT at least 4 weeks after completion the therapy. Results: A total of 75 patients (38 in the 14-day group and 37 in the 10-day group) were included to the study. In the intention-to-threat analysis, eradication rate was 67.6% (95% CI. 52.5%-82.6%) for the 10-day group versus 86.8% (95% CI. 76.0%-97.5%) for the 14-day group (p = 0.046), whereas per protocol analysis obtained 73.5% (95% CI. 58.6%-88.3%) for the 10-day versus 91.9% (95% CI. 84.1%-99.6%) in the 14-day group (p = 0.039). Adverse events were not significantly different between the two groups. Conclusion: A 14-day course was more effective than 10-day course of triple therapy as first-line for eradication of H.pylori infection in an Indonesian population.