A randomized, multicenter and noninferiority study of amoxicillin plus berberine vs tetracycline plus furazolidone in quadruple therapy for Helicobacter pylori rescue treatment

Jian Zhang, Chuan Han, Wen Quan Lu, Na Wang, Si Ran Wu, Yong Xi Wang, Jin Ping Ma, Jie Hong Wang, Cheng Hao, Dong Hong Yuan, Na Liu, Yong Quan Shi, Jian Zhang, Chuan Han, Wen Quan Lu, Na Wang, Si Ran Wu, Yong Xi Wang, Jin Ping Ma, Jie Hong Wang, Cheng Hao, Dong Hong Yuan, Na Liu, Yong Quan Shi

Abstract

Objective: Helicobacter pylori (H. pylori) infection is closely associated with gastric ulcers and gastric adenocarcinomas. We aimed to assess the efficacy and safety of a quadruple regimen with amoxicillin plus berberine vs tetracycline plus furazolidone in rescue therapy for H. pylori eradication.

Methods: We conducted a randomized, open-label, multicenter, noninferiority trial. Patients with previous treatment failures recruited from five centers were randomized (1:1) to receive a regimen with esomeprazole and bismuth plus either berberine and amoxicillin (the BA group) or tetracycline and furazolidone (the TF group) for 14 days. Their H. pylori infection status was confirmed 4-8 weeks after treatment. The primary outcome was the eradication rate. The secondary outcomes included the rates of symptom improvement, compliance, and adverse events. This study was registered at ClinicalTrials.gov (NCT03609892).

Results: Altogether 658 participants were consecutively enrolled. An intention-to-treat analysis demonstrated that the two regimens achieved a similar eradication rate (76.3% vs 77.5%; P = 0.781). The per-protocol analysis reached a similar result (81.5% vs 85.0%; P = 0.278). The eradication rate reached in the BA group was greater than the pre-established 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 the BA group than the TF group (18.5% vs 26.1%, P = 0.024). Rates of compliance and symptom improvement were similar for the two therapies.

Conclusion: The efficacy of both regimens in rescue treatment for H. pylori eradication was satisfactory, 14-day BA-based quadruple therapy is noninferior to the TF-based therapy.

Keywords: Helicobacter pylori; amoxicillin; berberine; rescue therapy.

Conflict of interest statement

None.

© 2020 The Authors. Journal of Digestive Diseases published by Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

Figures

FIGURE 1
FIGURE 1
Flow diagram of the study. Abbreviations: BA, berberine and amoxicillin; ITT, intention‐to‐treat; PP, per‐protocol; TF, tetracycline and furazolidone

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