10-day sequential therapy was more effective than 10-day triple-drug therapy for eradicating Helicobacter pylori infection.

M e t h o d s Design: Randomized controlled trial. Allocation: {Concealed}†.* Blinding: Blinded (patients, investigators, {data collectors, outcome assessors, data analysts, and safety and monitoring committee}†).* Follow-up period: 8 weeks. Setting: 2 hospitals in Bologna and Rome, Italy. Patients: 300 patients ≥ 18 years of age (mean age 49 y, 64% women) with dyspepsia or peptic ulcers who had never received treatment for H. pylori infection. Exclusion criteria included use of proton-pump inhibitors, H2-receptor antagonists, bismuth preparations, or antibiotics in the past 2 weeks; concomitant use of anticoagulants or ketoconazole and glucocorticoids; the Zollinger-Ellison syndrome; surgery of the esophagus or upper gastrointestinal tract; severe or unstable cardiovascular, pulmonary, or endocrine disease; renal or hepatic disease or dysfunction; hematologic disorders; cancer in the past 5 years; Barrett esophagus or highgrade dysplasia; and severe psychiatric or neurologic disorders. Intervention: Sequential (n = 150) or standard triple-drug therapy (n = 150). Sequential therapy consisted of pantoprazole, 40 mg, amoxicillin, 1 g, and placebo twice daily for 5 days; and pantoprazole, 40 mg, clarithromycin, 500 mg, and tinidazole, 500 mg, twice daily for the next 5 days. Standard therapy consisted of pantoprazole, 40 mg, clarithromycin, 500 mg, and amoxicillin, 1 g, twice daily for 10 days. Outcomes: Eradication of H. pylori infection (negative results on 13C-urea breath tests at 4 and 8 wk). Secondary outcomes were eradication of clarithromycinor metronidazoleresistant H. pylori infection, treatment adherence (> 90% of medication taken), and adverse events. Patient follow-up: 96% (100% included in the intention-to-treat analysis).