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:
Beom Jin KIM
1
;
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
;
Author Information
- Publication Type:Multicenter Study
- Keywords: Concomitant therapy; Disease eradication; Helicobacter pylori; Triple therapy; Sequential therapy
- MeSH: Amoxicillin; Arm; Clarithromycin; Disease Eradication; Helicobacter pylori; Helicobacter; Humans; Korea; Lansoprazole; Metronidazole; Prospective Studies
- From:Gut and Liver 2019;13(5):531-540
- CountryRepublic of Korea
- Language:English
- 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.
