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KMID : 1188320190130050531
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Gut and Liver
2019 Volume.13 No. 5 p.531 ~ p.540
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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
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Kim Beom-Jin
Lee Hyuk
Lee Yong-Chan
Jeon Seong-Woo
Kim Gwang-Ha
Kim Hyun-Soo
Sung Jae-Kyu
Lee Dong-Ho
Kim Heung-Up
Park Moo-In
Choi Il-Ju
Yoon Soon-Man
Kim Sang-Wook
Baik Gwang-Ho
Lee Ju-Yup
Kim Jin-Il
Kim Sang-Gyun
Kim Ja-Youn
Lee Joong-Yup
Kim Jae-Gyu
Kim Jae-J.
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Abstract
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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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KEYWORD
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Concomitant therapy, Disease eradication, Helicobacter pylori, Triple therapy, Sequential therapy
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