A Randomized, Multicenter and Noninferiority study of Amoxicillin plus Berberine vs Tetracycline plus Furazolidone in Quadruple Therapy for Helicobacter pylori Rescue Treatment.

AIM: The infection of Helicobacter pylori (H. pylori) has a close association with gastric ulcers and gastric adenocarcinoma. This study was designed to assess the efficacy and safety of quadruple regimen with amoxicillin plus berberine vs tetracycline plus furazolidone in H. pylori rescue treatment. METHODS: We conducted a randomized, open-label, multicenter, noninferiority trial. Subjects with previous treatment failures recruited from 5 centers were randomized (1:1) to accept regimen with esomeprazole and bismuth plus either berberine and amoxicillin (BA group) or tetracycline and furazolidone (TF group) for 14 days. The H. pylori infection status was confirmed at 4-8 weeks after treatment. The eradication rate was the study's primary outcome and trial's secondary outcomes included the rates of symptom improvement, compliance and adverse events. This study was registered at ClinicalTrials.gov (NCT03609892). RESULTS: 658 subjects were consecutively enrolled in total. ITT analysis demonstrated that the two therapies achieved a similar eradication rate (76.3% vs 77.5%; P = 0.781). PP analysis reached a similar result (81.5% vs 85%; P = 0.278). Difference in the eradication rate achieved by BA quadruple regimen was greater than the preestablished margin of noninferiority, at -10% (the lower bounds of the 95% CI were - 7.66% and - 9.43%, respectively). The rate of adverse events was lower for BA than TF therapy (18.5% vs 26.1%, P = 0.024). The rates of compliance and symptom improvement were similar for the two therapies. CONCLUSION: The efficacies of the two regimens in rescue treatment were both not satisfactory, and two groups showed no significant difference. This article is protected by copyright. All rights reserved.