Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial

Summary Background Helicobacter pylori is associated with benign and malignant diseases of the upper gastrointestinal tract, and increasing antibiotic resistance has made alternative treatments necessary. Our aim was to assess the efficacy and safety of a new, single-capsule treatment versus the gol...

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Published in:	The Lancet (British edition) 2011-03, Vol.377 (9769), p.905-913
Main Authors:	Malfertheiner, Peter, Prof, Bazzoli, Franco, Prof, Delchier, Jean-Charles, Prof, Celiñski, Krysztof, Prof, Giguère, Monique, PhD, Rivière, Marc, MD, Mégraud, Francis, Prof
Format:	Article
Language:	eng
Subjects:	Adolescent Adult adults amoxicillin Amoxicillin - administration & dosage Anti-Bacterial Agents - administration & dosage Anti-Ulcer Agents - administration & dosage Anti-Ulcer Agents - adverse effects antibiotic resistance Bacterial diseases Bacterial diseases of the digestive system and abdomen Biological and medical sciences bismuth Breath Tests clarithromycin Clarithromycin - administration & dosage Clarithromycin - adverse effects Clinical medicine Drug Combinations Drug resistance Drug Resistance, Bacterial Drug therapy Drug Therapy, Combination Female gastrointestinal system General aspects Helicobacter Infections - diagnosis Helicobacter Infections - drug therapy Helicobacter pylori Histology Human bacterial diseases Humans Infectious diseases Internal Medicine Male Medical sciences metronidazole Metronidazole - administration & dosage Metronidazole - adverse effects Middle Aged Miscellaneous Omeprazole - administration & dosage Omeprazole - adverse effects Organometallic Compounds - administration & dosage Organometallic Compounds - adverse effects patients potassium Public health. Hygiene Public health. Hygiene-occupational medicine Studies Tablets tetracycline Tetracycline - administration & dosage Tetracycline - adverse effects therapeutics urea Young Adult
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Summary:	Summary Background Helicobacter pylori is associated with benign and malignant diseases of the upper gastrointestinal tract, and increasing antibiotic resistance has made alternative treatments necessary. Our aim was to assess the efficacy and safety of a new, single-capsule treatment versus the gold standard for H pylori eradication. Methods We did a randomised, open-label, non-inferiority, phase 3 trial in 39 sites in Europe, comparing the efficacy and safety of 10 days of quadruple therapy with omeprazole plus a single three-in-one capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline (quadruple therapy) versus 7 days of omeprazole, amoxicillin, and clarithromycin (standard therapy) in adults with recorded H pylori infection. Patients were randomly assigned treatment according to a predetermined list independently generated by Quintiles Canada (Ville St-Laurent, QC, Canada). Our study was designed as a non-inferiority trial but was powered to detect superiority. Our primary outcome was H pylori eradication, established by two negative13 C urea breath tests at a minimum of 28 and 56 days after the end of treatment. Our assessment for non-inferiority was in the per-protocol population, with subsequent assessment for superiority in the intention-to-treat population (ie, all participants randomly assigned treatment). This study is registered with ClinicalTrials.gov , number NCT00669955. Findings 12 participants were lost to follow-up and 101 were excluded from the per-protocol analysis. In the per-protocol population (n=339), the lower bound of the CI for treatment with quadruple therapy was greater than the pre-established non-inferiority margin of −10% (95% CI 15·1–32·3; p
ISSN:	0140-6736 1474-547X