Toshihiro Nishizawa1, Takama Maekawa, Noriko Watanabe, Naohiko Harada, Yasuo Hosoda, Masahiro Yoshinaga, Toshiyuki Yoshio, Hajime Ohta, Syuuji Inoue, Tatsuya Toyokawa, Haruhiro Yamashita, Hiroki Saito, Toshio Kuwai, Shunsuke Katayama, Eiji Masuda, Hideharu Miyabayashi, Toshio Kimura, Yuko Nishizawa, Masahiko Takahashi, Hidekazu Suzuki. 1. *Division of Gastroenterology, National Hospital Organization, Tokyo Medical Center †Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine ∥∥∥Department of Pharmacy, National Center for Global Health and Medicine, Tokyo ‡Division of Gastroenterology, National Hospital Organization, Kyoto Medical Center, Kyoto §Division of Gastroenterology, National Hospital Organization, Mie Central Medical Center, Mie ∥Division of Gastroenterology, National Kyushu Medical Center, Fukuoka ¶Division of Gastroenterology, National Hospital Organization, Saitama National Hospital, Wako #Division of Gastroenterology, National Hospital Organization, Beppu Medical Center, Beppu **Division of Gastroenterology, National Hospital Organization, Osaka Medical Center †††Division of Gastroenterology, National Hospital Organization, Osaka Minami Medical Center, Kawachinagano, Osaka ††Division of Gastroenterology, National Hospital Organization, Kanazawa Medical Center, Kanazawa, Ishikawa §§Division of Gastroenterology, National Hospital Organization, Fukuyama Medical Center ##Division of Gastroenterology, National Hospital Organization, Kure Medical Center, Hiroshima ∥∥Division of Gastroenterology, National Hospital Organization, Okayama Medical Center, Okayama ¶¶Division of Gastroenterology, National Hospital Organization, Asahikawa Medical Center, Asahikawa §§§Division of Gastroenterology, National Hospital Organization, Hokkaido Medical Center, Sapporo, Hokkaido ***Division of Gastroenterology, National Hospital Organization, Yonago Medical Center, Yonago, Tottori, Japan ‡‡Division of Gastroenterology, Kochi National Hospital, Kochi ‡‡‡Division of Gastroenterology, National Hospital Organization, Matsumoto Medical Center, Mesa, Matsumoto, Nagano.
Abstract
BACKGROUND:Helicobacter pylori eradication rates achieved with a first-line regimen of clarithromycin (CLR) combined with amoxicillin (AMX) and a proton pump inhibitor have recently fallen to ≤80% because of the increasing incidence of CLR resistance in Japan. This randomized multicenter trial aimed to compare the eradication success of 2 first-line triple therapy regimens: rabeprazole, amoxicillin, and clarithromycin (RAC) versus rabeprazole, amoxicillin, and metronidazole (RAM). METHODS: A total of 124 consecutive patients infected with H. pylori were randomized into one of two 7-day therapeutic regimens: RAC (n=60) or RAM (n=64). Eradication was confirmed by the C-urea breath test. Adverse effects were also assessed. RESULTS:Intention-to-treat and per protocol H. pylori eradication rates were 73.3%/77.2% in the RAC group and 90.6%/93.5% in the RAM group. The eradication rate of RAM therapy was significantly higher than that of RAC therapy. CLR, metronidazole, and AMX resistance was found in 36.2%, 2.1%, and 0% of patients, respectively. In addition, no relevant differences in adverse effects were observed. CONCLUSIONS:Metronidazole-based therapy (RAM) was superior to standard CLR-based therapy (RAC) for first-line H. pylori eradication. This reflects the progressive increase in CLR resistance observed in Japan.
RCT Entities:
BACKGROUND:Helicobacter pylori eradication rates achieved with a first-line regimen of clarithromycin (CLR) combined with amoxicillin (AMX) and a proton pump inhibitor have recently fallen to ≤80% because of the increasing incidence of CLR resistance in Japan. This randomized multicenter trial aimed to compare the eradication success of 2 first-line triple therapy regimens: rabeprazole, amoxicillin, and clarithromycin (RAC) versus rabeprazole, amoxicillin, and metronidazole (RAM). METHODS: A total of 124 consecutive patients infected with H. pylori were randomized into one of two 7-day therapeutic regimens: RAC (n=60) or RAM (n=64). Eradication was confirmed by the C-urea breath test. Adverse effects were also assessed. RESULTS: Intention-to-treat and per protocol H. pylori eradication rates were 73.3%/77.2% in the RAC group and 90.6%/93.5% in the RAM group. The eradication rate of RAM therapy was significantly higher than that of RAC therapy. CLR, metronidazole, and AMX resistance was found in 36.2%, 2.1%, and 0% of patients, respectively. In addition, no relevant differences in adverse effects were observed. CONCLUSIONS:Metronidazole-based therapy (RAM) was superior to standard CLR-based therapy (RAC) for first-line H. pylori eradication. This reflects the progressive increase in CLR resistance observed in Japan.
Authors: Camelia Quek; Son T Pham; Kieu T Tran; Binh T Pham; Loc V Huynh; Ngan B L Luu; Thao K T Le; Kelly Quek; Van H Pham Journal: F1000Res Date: 2016-04-13