Randomized Clinical Trial
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Sep 21, 2015; 21(35): 10234-10241
Published online Sep 21, 2015. doi: 10.3748/wjg.v21.i35.10234
Efficacy of moxifloxacin-based sequential and hybrid therapy for first-line Helicobacter pylori eradication
Jae Jin Hwang, Dong Ho Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim
Jae Jin Hwang, Dong Ho Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do 463-707, South Korea
Author contributions: Hwang JJ and Lee DH were responsible for the study conception and design, data analysis and interpretation, and manuscript drafting; Yoon H, Shin CM, Park YS, and Kim N critically revised the article for important intellectual content; all the authors reviewed and approved the final version to be published.
Institutional review board statement: The study was reviewed and approved by the Seoul National University Bundang Hospital Institutional Review Board.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declare no conflict of interests.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dong Ho Lee, MD, Department of Internal Medicine, Seoul National University Bundang Hospital, 300 Gumi-dong, Bundang-gu, Seongnam, Gyeonggi-do 463-707, South Korea. dhljohn@yahoo.co.kr
Telephone: +82-31-7877006 Fax: +82-31-7874051
Received: April 10, 2015
Peer-review started: April 10, 2015
First decision: May 18, 2015
Revised: June 2, 2015
Accepted: July 8, 2015
Article in press: July 8, 2015
Published online: September 21, 2015
Abstract

AIM: To evaluate the efficacy of moxifloxacin-based sequential therapy (MBST) versus hybrid therapy as a first-line treatment for Helicobacter pylori (H. pylori) infection.

METHODS: From August 2014 to January 2015, 284 patients with confirmed H. pylori infection were randomized to receive a 14-d course of MBST (MBST group, n = 140) or hybrid (Hybrid group, n = 144) therapy. The MBST group received 20 mg rabeprazole and 1 g amoxicillin twice daily for 7 d, followed by 20 mg rabeprazole and 500 mg metronidazole twice daily, and 400 mg moxifloxacin once daily for 7 d. The Hybrid group received 20 mg rabeprazole and 1 g amoxicillin twice daily for 14 d. In addition, the Hybrid group received 500 mg metronidazole and 500 mg clarithromycin twice daily for the final 7 d. Successful eradication of H. pylori infection was defined as a negative 13C-urea breath test 4 wk after the end of treatment. Patient compliance was defined as “good” if drug intake was at least 85%. H. pylori eradication rates, patient compliance with treatment, and adverse event rates were evaluated.

RESULTS: The eradication rates in the intention-to-treat (ITT) analysis were 91.4% (128/140; 95%CI: 90.2%-92.9%) in the MBST group and 79.2% (114/144; 95%CI: 77.3%-80.7%) in the Hybrid group (P = 0.013). The eradication rates in the per-protocol (PP) analysis were 94.1% (128/136; 95%CI: 92.9%-95.6%) in the MBST group and 82.6% (114/138; 95%CI: 80.6%-84.1%) in the Hybrid group (P = 0.003). The H. pylori eradication rate in the MBST group was significantly higher than that of the Hybrid group for both the ITT (P = 0.013) and the PP analyses (P = 0.003). Both groups exhibited full compliance with treatment (MBST/Hybrid group: 100%/100%). The rate of adverse events was 11.8% (16/136) and 19.6% (27/138) in the MBST and Hybrid group, respectively (P = 0.019). The majority of adverse events were mild-to-moderate in intensity; none were severe enough to cause discontinuation of treatment in either group.

CONCLUSION: MBST was more effective and led to fewer adverse events than hybrid therapy as a first-line treatment for H. pylori infection.

Keywords: Helicobacter pylori, First-line treatment, Eradication, Moxifloxacin, Sequential therapy, Hybrid therapy

Core tip: To our knowledge, this is the first study to evaluate the efficacy of 14-d treatment with moxifloxacin-based sequential therapy compared with hybrid therapy as a first-line treatment for Helicobacter pylori (H. pylori) infection. Our study shows that moxifloxacin-based sequential therapy is more effective with fewer adverse events compared with hybrid therapy. The high rates of H. pylori eradication and patient compliance with treatment, and low rate of adverse events seen here suggest that moxifloxacin-based sequential therapy is a suitable alternative to standard triple therapy.