Randomized Clinical Trial
Copyright ©2014 Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 28, 2014; 20(32): 11415-11421
Published online Aug 28, 2014. doi: 10.3748/wjg.v20.i32.11415
Furazolidone-based triple and quadruple eradication therapy for Helicobacter pylori infection
Yong Xie, Yin Zhu, Hong Zhou, Zhi-Fa Lu, Zhen Yang, Xu Shu, Xiao-Bai Guo, Hui-Zhen Fan, Jian-Hua Tang, Xue-Ping Zeng, Jian-Bo Wen, Xiao-Qing Li, Xing-Xing He, Jiu-Hong Ma, Dong-Sheng Liu, Cai-Bin Huang, Ning-Jian Xu, Nong-Rong Wang, Nong-Hua Lu
Yong Xie, Yin Zhu, Hong Zhou, Zhi-Fa Lu, Zhen Yang, Xu Shu, Xing-Xing He, Jiu-Hong Ma, Dong-Sheng Liu, Nong-Hua Lu, Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China
Xiao-Bai Guo, Department of Gastroenterology, Jiangxi Provincial People’s Hospital, Nanchang 330006, Jiangxi Province, China
Hui-Zhen Fan, Department of Gastroenterology, The People’s Hospital of Yichun City, Yichun 336000, Jiangxi Province, China
Jian-Hua Tang, Department of Gastroenterology, Ganzhou People’s Hospital, Ganzhou 341000, Jiangxi Province, China
Xue-Ping Zeng, Department of Gastroenterology, The Third Hospital of Nanchang, Nanchang 330009, Jiangxi Province, China
Jian-Bo Wen, Department of Gastroenterology, Pingxiang People’s Hospital, Pingxiang 337000, Jiangxi Province, China
Xiao-Qing Li, Department of Gastroenterology, Fengcheng People’s Hospital, Fengcheng 331100, Jiangxi Province, China
Cai-Bin Huang, Department of Gastroenterology, The First Affiliated Hospital of Gannan Medical College, Ganzhou 341000, Jiangxi Province, China
Ning-Jian Xu, Department of Gastroenterology, Yingtan City People’s Hospital, Yingtan 335000, Jiangxi Province, China
Nong-Rong Wang, Department of Gastroenterology, The Fourth Affiliated Hospital of Nanchang University, Nanchang 330003, Jiangxi Province, China
Author contributions: Xie Y and Zhu Y contributed equally to the study; Lu NH, Xie Y, Zhu Y and Shu Xu designed the study; Zhou H, Lu ZF, Guo XB, Fan HZ, Tang JH, Zeng XP, Wen JB, Li XQ, He XX, Ma JH, Liu DS, Huang CB, Xu NJ and Wang NR performed the study; Lu NH and Xie Y analyzed the data; Lu NH, Xie Y, Yang Z and Zhou H drafted the manuscript.
Supported by The National Science and Technology Major Projects for “Major New Drugs Innovation and Development” of China, No. 2011ZX09302-007-03; Jiangxi Province Talent 555 Project, and Jiangxi Society of Gastroenterology
Correspondence to: Nong-Hua Lu, MD, Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China. lunonghua@ncu.edu.cn
Telephone: +86-791-88692705 Fax: +86-791-88623153
Received: November 14, 2013
Revised: March 16, 2014
Accepted: May 29, 2014
Published online: August 28, 2014
Processing time: 287 Days and 20 Hours
Abstract

AIM: To evaluate the efficacy of furazolidone-based triple and quadruple therapy in eradicating Helicobacter pylori (H. pylori) in a multi-center randomized controlled trial.

METHODS: A total of 720 H. pylori positive patients with duodenal ulcer disease were enrolled at 10 different hospitals in Jiangxi province in China. The patients were randomly assigned to four treatment groups as follows: patients in Groups 1 and 3 received rabeprazole (10 mg), amoxicillin (1000 mg) and furazolidone (100 mg) twice daily for 7 and 10 d, respectively; patients in Groups 2 and 4 received rabeprazole (10 mg), bismuth (220 mg), amoxicillin (1000 mg) and furazolidone (100 mg) twice daily for 7 and 10 d, respectively. The primary outcome measure was H. pylori eradication rate 4 wk after treatment by intention-to-treat and per protocol analysis, while the secondary outcome measures were symptom and sign changes at the end of treatment and 4 wk after the end of treatment, as well as the proportion of patients who developed adverse events.

RESULTS: The demographic data of the four groups were not significantly different. Overall, 666 patients completed the scheme and were re-assessed with the 13C-urea breath test. The intention-to-treat analysis of the H. pylori eradication rates in Groups 1, 2, 3 and 4 were 74.44%, 82.78%, 78.89% and 86.11%, respectively. The H. pylori eradication rate in Group 4 was significantly higher than that in Group 1. According to the per protocol analysis, the H. pylori eradication rates in Groups 1, 2, 3 and 4 were 81.21%, 89.22%, 85.54% and 92.26%, respectively. The H. pylori eradication rate in Group 4 was significantly higher than that in Group 1. The number of adverse events was 15 (8.3%), 16 (8.9%), 15 (8.3%) and 17 (9.4%) in Groups 1, 2, 3 and 4, respectively, including dizziness, vomiting, diarrhea, nausea, skin rash, itchy skin, and malaise. The symptoms were relieved without special treatment in all of the patients.

CONCLUSION: Both 7- and 10-d quadruple furazolidone-based therapies achieve satisfactory H. pylori eradication rates.

Keywords: Helicobacter pylori infection; Furazolidone; Treatment; Eradication

Core tip: This is a large sample, multi-center reseach to evaluate the effects of furazolidone based regimens in Helicobacter pylori (H. pylori) eradication. In this study, the efficacy of furazolidone-based triple and quadruple therapies was investigated in patients with H. pylori positive duodenal ulcers. The present study found that both 7- and 10-d quadruple furazolidone-based therapies achieve satisfactory H. pylori eradication rates, which are recommended as an alternative treatment for H. pylori eradication.