Berberine as an add therapy for Helicobacter pylori infection:a randomized controlled trial
Objective:The present study aimed to assess the efficacy and safety of berberine combination in the bismuth containing quadruple therapy(BCQT)regimen as the first-line therapy for Helicobacter pylori(H.pylo-ri)eradication.Methods:This randomized,open-label,controlledtrial enrolled 80 patients with untreated H.py-lori infection.Participants in the berberine group received eradication therapy with a rabeprazole-amoxicillin-clar-ithromycin-bismuth-berberine regimen for 14 days,whereas those in the control group received a rabeprazole-amoxicillin-clarithromycin-bismuth regimen for the same duration.The primary outcomes were eradication rate and side effects rate.Results:Five participants in the berberine group dropped out due to intolerant side effects,while two participants in the control group opted out due to rash and loss to follow-up.In the intention-to-treat(ITT)and per-protocol(PP)analyses,the eradication rates in the berberine group were lower than those in the control group,without significant differences(PP:85.71％vs 89.47％,P=0.447;ITT:75.00％vs 85.00％,P=0.201).The total side-effect rate in the berberine group was higher than that in the control group(74.29％vs 50.00％,P=0.029).Conclusion:We concluded that the combination of berberine and BCQT results in elevated and severe side effects.The hypothesis that berberine as an add-on therapy would improve eradication rate of BC-QT was not confirmed.
万方数据
维普
