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.