Ten-Day Quadruple Therapy Comprising Low-Dose Rabeprazole, Bismuth, Amoxicillin, and Tetracycline Is an Effective and Safe First-Line Treatment for Helicobacter pylori Infection in a Population with High Antibiotic Resistance: a Prospective, Multicenter, Randomized, Parallel-Controlled Clinical Trial in China.

Abstract

The objective of this study was to investigate the efficacy and safety of 10-day bismuth quadruple therapy with amoxicillin, tetracycline, or clarithromycin and different doses of rabeprazole for first-line treatment of Helicobacter pylori infection. This multicenter, randomized, parallel-controlled clinical trial was conducted between March 2013 and August 2014. A total of 431 H. pylori-infected patients with duodenal ulcers were enrolled and randomized into four treatment groups (1:1:1:1) for 10 days, as follows: (i) a group receiving a low dose of rabeprazole of 10 mg twice a day (b.i.d.) (LR dose) plus bismuth, amoxicillin, and clarithromycin (LR-BAC); (ii) a group receiving LR plus bismuth, amoxicillin, and tetracycline (LR-BAT); (iii) a group receiving a high dose of rabeprazole of 20 mg b.i.d. (HR dose) plus bismuth, amoxicillin, and clarithromycin (HR-BAC); and (iv) a group receiving HR-BAT. Antimicrobial susceptibility was assessed by the Etest method. The primary outcome was H. pylori eradication at 4 weeks after the treatment. The per-protocol (PP) eradication rates in the LR-BAC, LR-BAT, HR-BAC, and HR-BAT groups were 94.1%, 91.9%, 94.8%, and 91.9%, respectively, while the intention-to-treat (ITT) eradication rates in those groups were 87.2%, 87.2%, 87.7%, and 86%, respectively. There was no significant difference between the four groups in PP analysis (P = 0.799) and ITT analysis (P = 0.985). The efficacies of four-treatment therapy were not affected by antibiotic resistance. The adverse events in the four treatment groups were similar; central nervous system (CNS) and gastrointestinal symptoms were the most common reported. Bismuth-containing quadruple therapy with low-dose rabeprazole, amoxicillin, and tetracycline is a good option for first-line treatment of H. pylori infection in a population with high antibiotic resistance. (This study is registered at Chinese Clinical Trials Registry [www.chictr.org.cn] under number ChiCTR1800014832.).

• Authors: Yong Xie, Zhenhua Zhu, Jiangbin Wang, Lingxia Zhang, Zhenyu Zhang, Hong Lu, Zhirong Zeng, Shiyao Chen, Dongsheng Liu, Nonghua Lv, the Chinese Study Group on Helicobacter pylori, Chinese Society of Gastroenterology
• Journal: Antimicrobial agents and chemotherapy (Antimicrob Agents Chemother) Vol. 62 Issue 9 (09 2018) ISSN: 1098-6596 [Electronic] United States
• PMID: 29914954 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018 Xie et al.

Chemical References

• Anti-Bacterial Agents
• Protein Synthesis Inhibitors
• Proton Pump Inhibitors
• Rabeprazole
• Amoxicillin
• Tetracycline
• Clarithromycin
• Bismuth

Topics

• Adolescent
• Adult
• Aged
• Amoxicillin (therapeutic use)
• Anti-Bacterial Agents (therapeutic use)
• Bismuth (therapeutic use)
• China
• Clarithromycin (therapeutic use)
• Drug Resistance, Microbial (drug effects)
• Drug Therapy, Combination (methods)
• Female
• Helicobacter Infections (drug therapy)
• Helicobacter pylori (drug effects)
• Humans
• Male
• Middle Aged
• Prospective Studies
• Protein Synthesis Inhibitors (therapeutic use)
• Proton Pump Inhibitors (therapeutic use)
• Rabeprazole (therapeutic use)
• Tetracycline (therapeutic use)
• Young Adult