Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: A randomized study

A randomized, open-labeled, prospective controlled trial comparing sequential vs. standard triple-drug therapy was carried out at Lokmanya Tilak Municipal General Hospital, Mumbai. Two hundred and thirty-one patients with dyspepsia were randomized to a 10-day sequential regimen (40 mg of pantoprazole, 1 g of amoxicillin, each administered twice daily for the first 5 days, followed by 40 mg of pantoprazole, 500 mg of clarithromycin, and 500 mg of tinidazole, each administered twice daily for the remaining 5 days) or to standard 14-day therapy (40 mg of pantoprazole, 500 mg of clarithromycin, and 1 g of amoxicillin, each administered twice daily).

The eradication rate achieved with the sequential regimen was significantly greater than that obtained with the triple therapy. Per-protocol eradication rate of sequential therapy was 92.4 % (95 % CI 85.8–96.1 %) vs. 81.8 % (95 % CI 73.9–87.8 %) (p = 0.027) for standard drug therapy. Intention-to-treat eradication rates were 88.2 % (95 % CI 80.9–93.0 %) vs. 79.1 % (95 % CI 71.1–85.4 %), p = 0.029, respectively. The incidence of major and minor side effects between therapy groups was not significantly different (14.6 % in the triple therapy group vs. 23.5 % in sequential group, p = 0.12). Follow up was incomplete in 3.3 % and 4.7 % patients in standard and sequential therapy groups, respectively. Sequential therapy includes one additional antibiotic (tinidazole) that is not contained in standard therapy.