Jae Jin Hwang1, Dong Ho Lee1, Hyuk Yoon1, Cheol Min Shin1, Young Soo Park1, Nayoung Kim1. 1. 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.
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 (13)C-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.
RCT Entities:
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. pyloriinfection 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. pyloriinfection was defined as a negative (13)C-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. pyloriinfection.
Authors: H G Park; M K Jung; J T Jung; J G Kwon; E Y Kim; H E Seo; J H Lee; C H Yang; E S Kim; K B Cho; K S Park; S H Lee; K O Kim; S W Jeon Journal: Aliment Pharmacol Ther Date: 2011-11-08 Impact factor: 8.171
Authors: Jung H Kwon; Dong H Lee; Byeong J Song; Jung W Lee; Jin J Kim; Young S Park; Nayoung Kim; Sook-Hyang Jeong; Jin-Wook Kim; Sang H Lee; Jin H Hwang; Hyun C Jung; In S Song Journal: Helicobacter Date: 2010-04 Impact factor: 5.753
Authors: Jun-Won Chung; Young Kul Jung; Yoon Jae Kim; Kwang Ahn Kwon; Jung Ho Kim; Jong Joon Lee; Sung Min Lee; Ki Baik Hahm; Sun Mi Lee; Jin Yong Jeong; Sung-Cheol Yun Journal: J Gastroenterol Hepatol Date: 2012-11 Impact factor: 4.029