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ABSTRACT: Background
This randomized, open-label trial aimed to compare the efficacy of 10-day bismuth-containing quadruple therapy (BQT) with 7-day proton-pump inhibitor-clarithromycin containing standard triple therapy (STT) as an empirical first-line Helicobacter pylori therapy.Methods
Participants with H. pylori infection were randomly assigned to either 10-day BQT (daily doses of bismuth 300 mg, four times; lansoprazole 30 mg, twice; metronidazole 500 mg, three times; and tetracycline 500 mg, four times) or 7-day STT (lansoprazole 30 mg; amoxicillin 1,000 mg; and clarithromycin 500 mg; each given twice daily). Participants who failed initial therapy were crossed over to the alternative treatment regimen. Primary outcome was the eradication rates of first-line treatment by intention-to-treat analysis.Results
Study participants (n?=?352) were randomized to receive either 10-day BQT (n?=?175) or 7-day STT (n?=?177). The BQT-group achieved a significantly higher eradication rate than the STT-group in the intention-to-treat analysis (74.3% vs 57.1%, respectively; P?=?0.001), modified intention-to-analysis (87.2% [130/149] vs 68.7% [101/147], respectively; P?Trial registrationClinicalTrials.gov, NCT02557932. Registered 23 September 2015, https://clinicaltrials.gov/ct2/show/NCT02557932?term=NCT02557932&draw=2&rank=1 .
SUBMITTER: Kim YI
PROVIDER: S-EPMC7923489 | biostudies-literature | 2021 Mar
REPOSITORIES: biostudies-literature
Kim Young-Il YI Lee Jong Yeul JY Kim Chan Gyoo CG Park Boram B Park Jin Young JY Choi Il Ju IJ
BMC gastroenterology 20210302 1
<h4>Background</h4>This randomized, open-label trial aimed to compare the efficacy of 10-day bismuth-containing quadruple therapy (BQT) with 7-day proton-pump inhibitor-clarithromycin containing standard triple therapy (STT) as an empirical first-line Helicobacter pylori therapy.<h4>Methods</h4>Participants with H. pylori infection were randomly assigned to either 10-day BQT (daily doses of bismuth 300 mg, four times; lansoprazole 30 mg, twice; metronidazole 500 mg, three times; and tetracycline ...[more]