Two Different 1-Week Quadruple Therapies Given Back-to-Back Consecutive Therapy for Difficult-to-Treat Helicobacter pylori Infection: A Pilot Study

Abstract

Introduction: We aim to evaluate the efficacy of 2 different 1-week quadruple therapies given back-to-back consecutive therapy in patients with difficult-to-treat Helicobacter pylori infection.

Methods: Patients with proven H. pylori infection were recruited after >3 failed standard quadruple eradication. They received consecutive therapy consisting of esomeprazole 40 mg or rabeprazole 20 mg twice daily, amoxicillin 1,000 mg twice daily, tetracycline 500 mg 4 times daily, and furazolidone 100 mg 3 times daily for the first 7 days, followed by colloidal bismuth pectin 200 mg twice daily in place of furazolidone 100 mg for another 7 days. Eradication rates, treatment-emergent adverse events (TEAEs), and compliance were assessed.

Results: Sixty-five patients were enrolled. The mean number of previous eradications was 3.6 (range: 3-7). The intention-to-treat and per-protocol eradication rates were 90.8% (59/65) and 95.1% (58/61). In total, 23.4% (15/64) of patients experienced drug-related TEAEs. No serious adverse events were observed. None of the patients required treatment for TEAEs, and 95.3% (61/64) showed good compliance. Overall, 51 patients (78.5%) were with the available antimicrobial susceptibility testing results. The resistance rates to clarithromycin, metronidazole, levofloxacin, and amoxicillin were 60.8% (31/51), 100% (51/51), 70.6% (36/51), and 2.0% (1/51), respectively. No resistance was detected to either furazolidone or tetracycline. However, in 54.9% of patients (28/51), H. pylori was resistant to 3 antibiotics (metronidazole, levofloxacin, and clarithromycin).

Discussion: Consecutive therapy, including amoxicillin, tetracycline, and furazolidone, achieved a good eradication rate (>90%), with desirable compliance and tolerability in difficult-to-treat H. pylori infection.

Trial registration: ClinicalTrials.gov NCT03658733.

Conflict of interest statement

Guarantor of the article: Xiu-Li Zuo, MD, PhD.

Specific author contributions: Jing Liu, MD, and Chao-Ran Ji, MD, contributed equally to this work. J.L., C-R.J., and Y-Y.L.: research design and drafting of the article. C.Q., J-N.H., M.W., B-S.L., M-J.L., J.W., and J.Z.: data collection. J.L. and C-R.J.: analysis and interpretation of data. X-L.Z. provided critical revision of the article. All authors read and approved the final article.

Financial support: This investigation was funded by the National Natural Science Foundation of China (81770538, 81570485) and Key Research and Development Program of Shandong Province (2017CXGC1215). This work was independent of the funding.

Potential competing interests: None to report.

Institutions participating in the study: The endoscopy unit, Qilu Hospital of Shandong University, Jinan, China; Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, China.

Trial identification number:ClinicalTrials.gov ID: NCT03658733, https://ichgcp.net/clinical-trials-registry/NCT03658733

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.

Figures

Figure 1.

Consolidated standards of reporting trials flowchart of this study. ITT, intention-to-treat; PP, per-protocol.