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
- Author(s)
- Beom Jin Kim; Hyuk Lee; Yong Chan Lee; Seong Woo Jeon; Gwang Ha Kim; Hyun-Soo Kim; Jae Kyu Sung; Dong Ho Lee; Heung Up Kim; Moo In Park; Il Ju Choi; Soon Man Yoon; Sang Wook Kim; Gwang Ho Baik; Ju Yup Lee; Jin Il Kim; Sang Gyun Kim; Jayoun Kim; Joongyup Lee; Jae Gyu Kim; Jae J. Kim
- Keimyung Author(s)
- Lee, Ju Yup
- Department
- Dept. of Internal Medicine (내과학)
- Journal Title
- Gut and Liver
- Issued Date
- 2019
- Volume
- 13
- Issue
- 5
- Keyword
- Concomitant therapy; Disease eradication; Helicobacter pylori; Triple therapy; Sequential therapy
- 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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