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

Young-Il Kim, Jong Yeul Lee, Chan Gyoo Kim, Boram Park, Jin Young Park, Il Ju Choi, Young-Il Kim, Jong Yeul Lee, Chan Gyoo Kim, Boram Park, Jin Young Park, Il Ju Choi

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 < 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) CONCLUSIONS: 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://ichgcp.net/clinical-trials-registry/NCT02557932?term=NCT02557932&draw=2&rank=1 .

Keywords: Helicobacter pylori; Quadruple therapy; Triple therapy.

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Fig. 1
Fig. 1
Study flows. STT, proton-pump inhibitor-clarithromycin containing standard triple therapy; BQT, bismuth-containing quadruple therapy; ITT, intention-to-treat; UBT, urea breath test; PP, per-protocol
Fig. 2
Fig. 2
Eradication rates of first-line therapy according to study drug compliance (*P value < 0.001 between 7-day PPI-clarithromycin containing triple therapy and 10-day bismuth-containing quadruple therapy). PPI, proton-pump inhibitor

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