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- Title
The HOMER Study: The Effect of Increasing the Dose of Metronidazole When Given with Omeprazole and Amoxicillin to Cure Helicobacter pylori Infection.
- Authors
Bardhan, Karna Dev; Bayerdörffer, Ekkehard; Van Zanten, Sander J. O. Veldhuyzen; Lind, Tore; Mégraud, Francis; Delchier, Jean Charles; Hellblom, Magnus; Stubberöd, Arild; Burman, Carl Fredrik; Gromark, Per-Olof; Zeijlon, Lars
- Abstract
Background. Helicobacter pylori eradication with omeprazole, amoxycillin, and metronidazole is both effective and inexpensive. However, eradication rates with different dosages and dosing vary, and data on the impact of resistance are sparse. In this study, three different dosages of omeprazole, amoxycillin, and metronidazole were compared, and the influence of metronidazole resistance on eradication was assessed. Methods. Patients (n = 394) with a positive H. pylori screening test result and endoscopy-proven duodenal ulcer in the past were enrolled into a multicenter study performed in four European countries and Canada. After baseline endoscopy, patients were randomly assigned to treatment for 1 week with either omeprazole, 20 mg twice daily, plus amoxycillin, 1,000 mg twice daily, plus metronidazole, 400 mg twice daily (low M); or omeprazole, 40 mg once daily, plus amoxycillin, 500 mg three times daily, plus metronidazole, 400 mg three times daily (medium M); or omeprazole, 20 mg twice daily, plus amoxycillin, 1,000 mg twice daily, plus metronidazole, 800 mg twice daily (high M). H. pylori status at entry was assessed by a 13C urea breath test and a culture. Eradication was defined as two negative 13C-urea breath test results 4 and 8 weeks after therapy. Susceptibility testing using the agar dilution method was performed at entry and in patients with persistent infection after therapy. Results. The eradication rates, in terms of intention to treat (ITT) (population n = 379) (and 95% confidence interval [CI]) were as follows: low M 76% (68%, 84%), medium M 76% (68%, 84%), and high M 83% (75%, 89%). By per-protocol analysis (population n = 348), the corresponding eradication rates were: low M 81%, medium M 80%, and high M 85%. No H. pylori strains were found to be resistant to amoxycillin. Prestudy resistance of H. pylori strains to metronidazole was found in 72 of 348 (21%) of the cultures at entry (range, 10%–39% in the five...
- Subjects
DOSE-effect relationship in pharmacology; HELICOBACTER pylori infections; METRONIDAZOLE; DRUG synergism; DRUG efficacy; DRUG therapy
- Publication
Helicobacter, 2000, Vol 5, Issue 4, p196
- ISSN
1083-4389
- Publication type
Article
- DOI
10.1046/j.1523-5378.2000.00030.x