Gut Liver.
2019 Sep;13(5):531-540. 10.5009/gnl19136.
Ten-Day Concomitant, 10-Day Sequential, and 7-Day Triple Therapy as First-Line Treatment for Helicobacter pylori Infection: A Nationwide Randomized Trial in Korea
- Kim BJ
- Lee H
- Lee YC
- Jeon SW
- Kim GH
- Kim HS
- Sung JK
- Lee DH
- Kim HU
- Park MI
- Choi IJ
- Yoon SM
- Kim SW
- Baik GH
- Lee JY
- Kim JI
- Kim SG
- Kim J
- Lee J
- Kim JG
- Kim JJ
- Korean College of Helicobacter and Upper Gastrointestinal Research
- Affiliations
-
- 1Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea. jgkimd@cau.ac.kr
- 2Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. jjkim@skku.ac.kr
- 3Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
- 4Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.
- 5Department of Internal Medicine, Pusan National University School of Medicine, Busan, Korea.
- 6Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
- 7Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.
- 8Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seoul, Korea.
- 9Department of Internal Medicine, Jeju National University School of Medicine, Jeju, Korea.
- 10Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University College of Medicine, Busan, Korea.
- 11Center for Gastric Cancer, National Cancer Center, Goyang, Korea.
- 12Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.
- 13Department of Internal Medicine, Chonbuk National University Hospital, Chonbuk National University Medical School, Jeonju, Korea.
- 14Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
- 15Department of Internal Medicine, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Korea.
- 16Department of Internal Medicine, Yeouido St. Mary Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
- 17Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
- 18Medical Research Collaborating Center, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
- 19Department of Prevention and Management, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.
- KMID: 2458510
- DOI: http://doi.org/10.5009/gnl19136
Abstract
- BACKGROUND/AIMS
This nationwide, multicenter prospective randomized controlled trial aimed to compare the efficacy and safety of 10-day concomitant therapy (CT) and 10-day sequential therapy (ST) with 7-day clarithromycin-containing triple therapy (TT) as first-line treatment for Helicobacter pylori infection in the Korean population.
METHODS
Patients with H. pylori infection were assigned randomly to 7d-TT (lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for 7 days), 10d-ST (lansoprazole 30 mg and amoxicillin 1 g twice daily for the first 5 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 500 mg twice daily for the remaining 5 days), or 10d-CT (lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily for 10 days). The primary endpoint was eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses.
RESULTS
A total of 1,141 patients were included. The 10d-CT protocol achieved a markedly higher eradication rate than the 7d-TT protocol in both the ITT (81.2% vs 63.9%) and PP analyses (90.6% vs 71.4%). The eradication rate of the 10d-ST protocol was superior to that of the 7d-TT protocol (76.3% vs 63.9%, ITT analysis; 85.0% vs 71.4%, PP analysis). No significant differences in adherence or serious side effects were found among the three treatment arms.
CONCLUSIONS
The 10d-CT and 10d-ST regimens were superior to the 7d-TT regimen as standard first-line treatment in Korea.
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