Ten-day concomitant, 10-day sequential, and 7-day triple therapy in first-line treatment of Helicobacter pylori infection: a randomized nationwide trial in Korea.

Abstract

Background/Aims\nThis nationwide multicenter, prospective, randomized, controlled trial aimed to compare the efficacy and safety of the 10-day concomitant therapy (CT) and 10-day sequential therapy (ST) with those of the 7-day clarithromycin-containing triple therapy (TT) as first-line treatment for Helicobacter pylori infection in the Korean population.\n\n\nMethods\nPatients 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 rates of treatments by intention-to-treat (ITT) and per-protocol (PP) analysis.\n\n\nResults\nA total of 1141 patients were included. The 10d-CT achieved a markedly higher eradication rate than the 7d-TT, using both the ITT (81.2% versus 63.9%) and PP analysis (90.6% versus 71.4%). The eradication rate of the 10d-ST was superior to that of 7d-TT (76.3% versus 63.9%, ITT analysis; 85.0% versus 71.4%, PP analysis). No significant difference in adherence and serious side effects was found among the three treatment arms.\n\n\nConclusion\n10d-CT and 10d-ST regimens were superior to 7d-TT as standard first-line treatment in Korea.