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©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
Hybrid vs sequential therapy for eradication of Helicobacter pylori in Taiwan: A prospective randomized trial
Kuan-Yang Chen, Tsung-Jung Lin, Chin-Lin Lin, Hsi-Chang Lee, Chung-Kwe Wang, Deng-Chyang Wu
Kuan-Yang Chen, Institute of Clinical Medicine, National Yang-Ming University, Taipei City 10629, Taiwan
Kuan-Yang Chen, Institute of Neuroscience, National Chengchi University, Taipei City 11651, Taiwan
Kuan-Yang Chen, Tsung-Jung Lin, Chin-Lin Lin, Hsi-Chang Lee, Chung-Kwe Wang, Liver Center, Department of Gastroenterology, Ren-Ai Branch, Taipei City Hospital, Taipei City 10629, Taiwan
Deng-Chyang Wu, Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung City 80708, Taiwan
Deng-Chyang Wu, Division of Internal Medicine, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung Medical University, Kaohsiung City 80708, Taiwan
Deng-Chyang Wu, Center for Stem Cell Research, Kaohsiung Medical University Hospital, Kaohsiung City 80708, Taiwan
Deng-Chyang Wu, Department of Medicine, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung City 80708, Taiwan
Deng-Chyang Wu, Center for Infectious Disease and Cancer Research, Kaohsiung Medical University, Kaohsiung City 80708, Taiwan
Author contributions: Chen KY and Wu DC conceived and designed the study; Chen KY, Lin TJ, Lin CL, Lee HC and Wang CK performed the experiments; Chen KY and Lee HC analyzed the data; Chen KY and Lee HC wrote and revised the paper.
Institutional review board statement: All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008, and was reviewed and approved by the Institutional Review Board at Taipei City Hospital.
Informed consent statement: All participants were informed about the purpose and general procedures of this study and informed consent forms were signed prior to study enrollment.
Conflict-of-interest statement: The authors (Chen KY, Lin TJ, Lin CL, Lee HC, Wang CK and Wu DC) declare no conflict of interest relevant to this study.
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: Hsi-Chang Lee, MD, Liver Center, Department of Gastroenterology, Ren-Ai Branch, Taipei City Hospital, No. 10, Sec4 Ren-Ai Rd, Da-An Dist, Taipei City 10629, Taiwan.
dab73@tpech.gov.tw
Telephone: +886-2-27093600 Fax: +886-2-27047859
Received: January 20, 2015
Peer-review started: January 21, 2015
First decision: February 10, 2015
Revised: April 12, 2015
Accepted: July 8, 2015
Article in press: July 8, 2015
Published online: September 28, 2015
Processing time: 250 Days and 23 Hours
AIM: To evaluate the efficacy of sequential vs hybrid therapy in patients with Helicobacter pylori (H. pylori) infection.
METHODS: From March 2013 to May 2014, one hundred and seventy-five H. pylori infected patients who had not been treated for H. pylori before were randomized to receive either sequential therapy (rabeprazole 20 mg and amoxicillin 1 g twice daily for 5 d, followed by rabeprazole 20 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 5 d) or hybrid therapy (rabeprazole 20 mg and amoxicillin 1 g for 7 d, followed by rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 d). H. pylori status was confirmed by positive results of both rapid urease test and histology examination or a positive result of culture. Eradication efficacy was assessed by follow-up endoscopy with rapid urease test and histological examination 8 wk after the end of anti-H. pylori therapy, or 13C-urea breath test at least 4 wk after completion of treatment. The primary outcome was H. pylori eradication by intension-to-treat (ITT) and per-protocol (PP) analyses.
RESULTS: One hundred and sixty-seven patients (83 patients in the sequential group and 84 patients in the hybrid group) completed the study. The compliance rates were 97.6% and 97.7% for the two groups, respectively. The eradication rate was 78.2% for the sequential group and 92% for the hybrid group by ITT analysis (P = 0.01). The eradication rate was 81.9% for the sequential group and 96.4% for the hybrid group by PP analysis (P = 0.01). Univariate analysis for the clinical and bacterial factors did not identify any risk factors associated with treatment failure. Severe adverse events were observed in 2.3% of patients in the sequential group and 2.4% of those in the hybrid group.
CONCLUSION: Due to a grade A (> 95%) success rate for H. pylori eradication by PP analysis, similar compliance and adverse events, hybrid therapy seems to be an appropriate eradication regimen in Taiwan.
Core tip: The ideal therapy regimen for Helicobacter pylori (H. pylori) infection should achieve an eradication rate ≥ 90% on per-protocol analysis. Both the hybrid and sequential therapies have shown eradication rates superior to the standard triple therapy in several studies. To the best of our knowledge, this is the first study on the comparison between hybrid therapy and sequential therapy in Taiwan population. Hybrid regimen is a more effective therapy for H. pylori eradication than sequential regimen.
