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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
Gut and Liver ; : 531-540, 2019.
Article in English | WPRIM | ID: wpr-763873
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.
Subject(s)

Full text: Available Index: WPRIM (Western Pacific) Main subject: Arm / Prospective Studies / Helicobacter pylori / Helicobacter / Clarithromycin / Disease Eradication / Lansoprazole / Amoxicillin / Korea / Metronidazole Type of study: Controlled clinical trial / Practice guideline / Observational study Limits: Humans Country/Region as subject: Asia Language: English Journal: Gut and Liver Year: 2019 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Main subject: Arm / Prospective Studies / Helicobacter pylori / Helicobacter / Clarithromycin / Disease Eradication / Lansoprazole / Amoxicillin / Korea / Metronidazole Type of study: Controlled clinical trial / Practice guideline / Observational study Limits: Humans Country/Region as subject: Asia Language: English Journal: Gut and Liver Year: 2019 Type: Article