Work

High-dose amoxicillin and pantoprazole regimen for Helicobacter pylori eradication: a multi-center, multinational randomized controlled trial

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Aim: The aim was to compare the efficacy of high-dose amoxicillin and pantoprazole dual therapy for Helicobacter pylori (HP) eradication in comparison with the clarithromycin-based quadruple regimen. Material and methods:The study was designed as a double blind, randomized controlled trial (RCT) on patients with confirmed HP infection referring to eight medical centers in three countries -Iran, Egypt, and Vietnam -during October 2021 to March 2022.After obtaining written consent, the participants were randomly divided into two groups to receive either high-dose amoxicillin and pantoprazole dual therapy (group A) or the clarithromycin-based quadruple regimen (group B) for 2 weeks and followed by 4 weeks of therapy with pantoprazole.Then the rate of HP eradication in each group was determined and compared.Results: Finally, 619 patients with confirmed HP infection were included and randomly divided into two groups.Eradication rates in groups A and B were 68.3% and 85.6%, respectively, based on intention-to-treat (ITT) analysis, and 72.2% and 89.8% according to per-protocol (PP) analysis (p < 0.0001).Group A had a lower rate of adverse events than group B (22.0% vs. 40.1%,p < 0.0001).There was no significant difference in the complete compliance rate between groups A and B (90.7% vs. 89.0%respectively, p = 0.718). Conclusions:The results of the current study show that for treating HP infection, high-dose amoxicillin-PPI dual therapy failed to achieve high eradication rates compared with a clarithromycin-based quadruple regimen.Clarithromycin-based quadruple therapy for H. pylori eradication has a higher eradication rate despite more side effects, and similar compliance compared to high-dose dual therapy.

Source: Gastroenterology Review

DOI: 10.5114/pg.2025.151887