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Gastroenterology Review
eISSN: 1897-4317
ISSN: 1895-5770
Gastroenterology Review/Przegląd Gastroenterologiczny
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abstract:
Original paper

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

Pezhman Alavinejad
1
,
Samira Mohamadi
1
,
Mohammad Javad Rezaei
,
Abazar Parsi
1
,
Ahmad Hormati
2
,
Eskandar Hajiani
1
,
Omid Eslami
3
,
Morteza Nayebi
4
,
Siamak Baghaei
1
,
Mohammed Hussien Ahmed
5
,
Quang Trung Tran
6
,
Azam Satari
1

  1. Alimentary Tract Research Center, Clinical Sciences Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
  2. Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Shariati Hospital, Department of Internal Medicine, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran
  3. Department of Internal Medicine, Tehran University of Medical Sciences, Tehran, Iran
  4. Kerman University of Medical Sciences, Kerman, Iran
  5. Iran University of Medical Sciences, Tehran, Iran
  6. Department of Internal Medicine, University of Medicine and Pharmacy, Hue University, Vietnam
Gastroenterology Rev
DOI: https://doi.org/10.5114/pg.2025.151887
Online publish date: 2025/06/09
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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.

keywords:

amoxicillin, clarithromycin, Helicobacter pylori, eradication rate, dual therapy
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