Ten-day sequential versus triple therapy for Helicobacter pylori eradication: a prospective, open-label, randomized trial

Abstract

Background and aim: Increased resistance of Helicobacter pylori to antibiotics has increased the need to develop new first-line treatments for H. pylori. We have prospectively evaluated 10-day sequential versus conventional triple therapy in peptic ulcer patients.

Methods: One hundred and fifty-nine patients with peptic ulcer diseases were prospectively randomized to receive 10 days of lansoprazole, amoxicillin, and clarithromycin (conventional triple therapy) or 5 days of lansoprazole and amoxicillin followed by 5 days of lansoprazole, clarithromycin, and metronidazole (sequential therapy). Post-treatment H. pylori status was determined by the (13) C-urea breath test. Eradication rates, antibiotic resistance rates by agar dilution method, drug compliance, and side-effects were compared.

Results: The intention-to-treat eradication rates were 75.9% (95% CI 66.5-85.3%, 60/79) in the sequential therapy group and 58.7% (95% CI 47.9-69.5%, 47/80) in the conventional triple therapy group (P = 0.01), while the per-protocol eradication rates were 86.8% (95% CI 78.7-94.8%, 59/68) and 67.6% (95% CI 56.5-78.7%, 46/68) (P = 0.01), respectively. Compliance and side-effects were similar in the two groups. Culture of H. pylori showed that 18.2% were resistant to clarithromycin, 41.9% to metronidazole. Dual resistance to both antibiotics was 9.6%.

Conclusions: Although 10-day sequential therapy yielded a higher H. pylori eradication rate than 10-day conventional triple therapy, the sequential therapy protocol did not result in a sufficiently satisfactory eradication rate. This might be related to the higher antibiotics resistance rate especially to dual resistance. More effective regimens are needed to overcome antibiotic resistance in Korea.