High-dose dual therapy with a clavulanic acid component for Helicobacter pylori infection treatment: A Randomized Controlled Trial

Background: Several drug regimens such as Dual and quadruple therapy are used to eradicate Helicobacter pylori. This study was performed to compare the Dual therapy (DT) regimen (Rabeprazole, Amoxicillin, and Co-Amoxiclav) and the quadruple therapy (QT) regimen group (Rabeprazole, Amoxicillin, Metronidazole, and Bismuth) to eradicate Helicobacter pylori (H. pylori).Methods: ۲۲۰ eligible patients were included in the study (۱۰۸ in the DT and ۱۱۲ in the QT group). Randomization will be performed in a simple randomization method by using a table of random numbers and patients were divided into two groups. The DT regimen consisted of amoxicillin ۵۰۰ mg three times daily (TDS) with Co-amoxiclav ۶۲۵ mg TDS and Rabeprazole ۲۰ mg TDS for two weeks. The standard QT regimen included amoxicillin ۱۰۰۰ mg twice daily (BID), bismuth ۵۰۰ mg BID, metronidazole ۵۰۰ mg BID, and rabeprazole BID for two weeks. Two weeks after the end of the treatment period, patients were evaluated for eradication of H. pylori with H. pylori stool antigen test.Results: ۱۰۴ patients in the DT group and ۱۰۶ people in the QT group were able to complete the treatment course. The eradication rate was ۸۶.۵۴% (n = ۹۰) and ۸۸.۴۶% (n = ۹۲) in the quadruple and dual drug treatment groups, respectively. No significant difference was observed between the two groups in H. pylori eradication rate (P=۰.۵۴۴).Conclusion: According to this study, it can be concluded that adding the clavulanic acid component to the eradication regimen has no effect and is not recommended.

Keywords:

Helicobacter pylori , Rabeprazole , Co-amoxiclav , High dose dual drug therapy