High-dose amoxicillin and pantoprazole regimen for Helicobacter pylori eradication: a multi-center, multinational randomized controlled 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 8 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.