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

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.

Keywords: Concomitant therapy; Disease eradication; Helicobacter pylori; Sequential therapy; Triple therapy.

Fig. 1

Flow diagram of the study. A total of 1,141 patients participated in the study, of which 1,137 were included in the analyses. ITT, intention-to-treat; TT, triple therapy; ST, sequential therapy; CT, concomitant therapy; PP, per-protocol; UBT, urea breath test.

Fig. 2

Eradication rates in the three treatment groups in the intent-to-treat (ITT) analysis. In the ITT analysis, the eradication rate in the 10 days (10d)-ST group was significantly higher than that in the 7d-TT group (76.3% vs 63.9%, p<0.001). The eradication rate in the 10d-CT group was significantly higher than that in the 7d-TT group (81.2% vs 63.9%, p<0.001). TT, triple therapy; ST, sequential therapy; CT, concomitant therapy.

Fig. 3

Eradication rates in the three treatment groups in the per-protocol (PP) analysis. In the PP analysis, the eradication rate in the 10 days (10d)-ST group was significantly higher than that in the 7d-TT group (85.0% vs 71.4%, p<0.001). The eradication rate in the 10d-CT group was significantly higher than that in the 7d-TT group (90.6% vs 71.4%, p<0.001). TT, triple therapy; ST, sequential therapy; CT, concomitant therapy.