Ten-day sequential versus triple therapy for Helicobacterpylori eradication: A prospective, open-label, randomized trial

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 10days of lansoprazole, amoxicillin, and clarithromycin (conventional triple therapy) or 5days of lansoprazole and amoxicillin followed by 5days of lansoprazole, clarithromycin, and metronidazole (sequential therapy). Post-treatment H.pylori status was determined by the ¹³C-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.