Furazolidone‐containing triple and quadruple eradication therapy for initial treatment for Helicobacter pylori infection: A multicenter randomized controlled trial in China |
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| Authors: | Yong Xie Zhenyu Zhang Junbo Hong Wenzhong Liu Hong Lu Yiqi Du Weihong Wang Jianming Xu Xuehong Wang Lijuan Huo Guiying Zhang Chunhui Lan Xiaoyan Li Yanqing Li Hong Wang Guoxin Zhang Yin Zhu Xu Shu Ye Chen Jiangbin Wang Nonghua Lu the Chinese Society of Gastroenterology Chinese Study Group on Helicobacter pylori |
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| Affiliation: | 1. Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Jiangxi, China;2. Department of Gastroenterology, Nanjing First Hospital, Jiangsu, China;3. Department of Gastroenterology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China;4. Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China;5. Department of Gastroenterology, Peking University First Hospital, Beijing, China;6. Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University, Anhui, China;7. Department of Gastroenterology, Qinghai University Affiliated Hospital, Qinghai, China;8. Department of Gastroenterology, First Hospital of Shanxi Medical University, Shanxi, China;9. Department of Gastroenterology, Xiangya Hospital of Central South University, Hunan, China;10. Department of Gastroenterology, Daping Hospital and the Research Institute of Surgery of Third Military Medical University, Chongqing, China;11. Department of Gastroenterology, First Affiliated Hospital of Kunming Medical College, Yunnan, China;12. Department of Gastroenterology, Qilu Hospital of Shandong University, Shandong, China;13. Department of Gastroenterology, Guangzhou First People's Hospital, Guangdong, China;14. Department of Gastroenterology, Jiangsu Province Hospital, Jiangsu, China;15. Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China;16. Department of Gastroenterology, China‐Japan Union Hospital of Jilin University, Changchun, Jilin, China |
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| Abstract: | Background The efficacy of Helicobacter pylori (H. pylori) eradication has steadily declined, primarily because of antibiotic resistance. This study aimed to evaluate the efficacy and safety of furazolidone eradication therapies as initial treatments for H. pylori infection. Methods A national, multicenter, open‐label, randomized controlled trial was performed at 16 sites across 13 provinces in China to evaluate the efficacy and safety of furazolidone‐containing therapies for H. pylori infection. Treatment naïve patients were randomly assigned to: esomeprazole 20 mg, bismuth 220 mg, amoxicillin 1000 mg, and furazolidone 100 mg twice daily for 10 and 7 days (FAB 10 and FAB 7; the same therapy without bismuth (FA 10 and FA 7). The primary and secondary outcomes were the eradication rate and regimen safety, respectively. Treatment success was assessed by the 13C urea breath test at least 4 weeks after treatment completion. Results Overall, according to intention‐to‐treat (ITT) analysis, the eradication rates for FAB 10 and FAB 7 were 86.6% (95% confidence interval [CI], 79.9%‐93.2%) and 83.6% (95% CI, 76.3%‐90.9%) and for FA 10 and FA 7 were 82.4% (95% CI, 74.9%‐89.8%) and 77.6% (95% CI, 69.4%‐85.8%), respectively. According to per‐protocol analysis, the overall eradication rates for FAB 10 and FAB 7 were 94.7% (95% CI, 90.3%‐99.1%) and 90.8% (95% CI, 85.1%‐96.5%) and for FA 10 and FA 7 were 90.6% (95% CI, 84.9%‐96.3%) and 85.1% (95% CI, 78.2%‐92.1%), respectively. The overall prevalence of side effects was 8.1%. Conclusions Furazolidone‐containing therapies, particularly the tested 10‐day quadruple therapy, exhibited satisfactory efficacy and safety. This 10‐day quadruple therapy represents a promising initial treatment strategy for Chinese patients. |
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| Keywords: | furazolidone
Helicobacter pylori
quadruple therapy triple therapy |
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