Ten-day bismuth-containing quadruple therapy versus 7-day proton pump inhibitor-clarithromycin containing triple therapy as first-line empirical therapy for the Helicobacter pylori infection in Korea: a randomized open-label trial

摘要

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. 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. 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??0.001) and per-protocol analysis (92.9% [105/113] vs 70.1% [94/134], respectively; P??0.001). Although there was no serious adverse event, the compliance was lower with BQT than STT as a higher proportion of participants in the BQT-group discontinued therapy because of adverse events than those in the STT-group (23.1% vs 9.1%, respectively; P?=?0.001) Ten-day BQT had higher eradication rates compared to that of the 7-day STT as an empirical first-line treatment for H. pylori eradication in Korea. Trial registration: ClinicalTrials.gov, NCT02557932. Registered 23 September 2015, https://clinicaltrials.gov/ct2/show/NCT02557932?term=NCT02557932&draw=2&rank=1 .