Alimentary Pharmacology & Therapeutics · 2003 · 69 citations · 18 references
MedicinePharmacologyPharmacotherapyAntimicrobial PharmacotherapyClinical PharmacologyGastrointestinal PharmacotherapyAnti-inflammatory PharmacologyGastrointestinal PharmacologyHelicobacter Pylori Eradication TherapyPeptic Ulcer DiseasePeptic Ulcer PharmacotherapyHelicobacter Pylori EradicationHelicobacter Pylori InfectionInfected UlcersNonsteroidal Anti-inflammatory Drug UseNonsteroidal Anti-inflammatory Drug-induced UlcersNsaid-induced Ulcer PreventionPeptic Ulcer Disease EradicationRecurrence
AIM: To study whether prophylaxis with lansoprazole could prevent relapse of ulcers after eradication of Helicobacter pylori in patients with NSAID-related peptic ulcers. METHODS: Patients who presented with peptic ulcers and were found to be infected with H. pylori while receiving NSAIDs were recruited into the study. They received, twice daily, lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 1 week, followed by lansoprazole 30 mg daily for 4 weeks. Patients with healed ulcers and H. pylori eradicated were given naproxen 750 mg daily, and randomly assigned to receive lansoprazole 30 mg daily or no treatment for 8 weeks. The primary endpoint was the cumulative recurrence of symptomatic and complicated ulcers. RESULTS: At the end of the 8-week treatment period, significantly fewer patients (1/22, 4.5%, 95% confidence interval [CI] 0-23) in the lansoprazole group compared with the group that received H. pylori eradication alone (9/21, 42.9%, 95% CI 22-66) developed recurrence of symptomatic and complicated ulcers (log rank test P=0.0025). CONCLUSIONS: Lansoprazole significantly reduced the cumulative relapse of symptomatic and complicated ulcers in patients requiring NSAIDs after eradication of H. pylori.
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A Multiple Testing Procedure for Clinical Trials
Peter C. O’Brien, Thomas R. Fleming · Biometrics · 1979 · 3.3K citations
Francis K.L. Chan, S.C. Sydney Chung, Bing Yee Suen et al. · New England Journal of Medicine · 2001 · 631 citations