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HELICOBACTER PYLORI |
1 Department of Internal Medicine and Gastroenterology, University of Bologna, Bologna, Italy
2 Gastroenterology Unit, L Sacco Hospital, Milan, Italy
3 Division of Anatomic Pathology, University of Genoa, Genoa, Italy
4 Department of Internal Medicine, Policlinico Gemelli, Rome, Italy
Correspondence to:
Correspondence to:
Professor Franco Bazzoli
Dipartimento di Medicina Interna e Gastroenterologia, Università di Bologna, Policlinico S Orsola, Via Massarenti 9, 40138 Bologna, Italy;franco.bazzoli{at}Unibo.it
Background: Triple therapy is recommended for Helicobacter pylori eradication, yet consensus on the duration of treatment is lacking.
Aim: To compare the efficacy and safety of 1- and 2-week regimens of omeprazole, amoxicillin and clarithromycin in a large, multicentre, double-blind and randomised study.
Methods: A total of 909 H pylori-positive patients with duodenal ulcer, enrolled in 81 endoscopy units in Italy, were randomised to receive omeprazole, amoxicillin and clarithromycin for either 1 week (OAC1W) or 2 weeks (OAC2W) or omeprazole and amoxicillin for 2 weeks. H pylori eradication was assessed by histological examination and carbon-13 urea breath test 4 weeks after treatment.
Results: Both the intention-to-treat (ITT; n = 907) and per protocol (PP; n = 661) analyses showed no significant differences between the eradication rates of OAC1W (ITT 79.7%; PP 83.6%) and OAC2W (ITT 81.7%; PP 84.9%; ITT p = 0.53; PP p = 0.71). Both triple omeprazole, amoxicillin and clarithromycin regimens gave significantly higher eradication rates compared with omeprazole and amoxicillin treatment (ITT 44.6%; PP 42.8%; p<0.001). Poor compliance was reported in 18.6%, 17.3% and 15.1% (p = 0.51) of patients for OAC2W, OAC1W and omeprazole and amoxicillin, respectively. Adverse events occurred in 9.9% and 9.6% (p = 0.88) of patients for OAC2W and OAC1W, respectively, and in 5.9% for omeprazole and amoxicillin (p = 0.11).
Conclusions: 1-week and 2-week triple treatments for H pylori eradication are similar in terms of efficacy, safety and patient compliance.
Abbreviations: 13C-UBT, carbon-13 urea breath test; ITT, intention-to-treat; OAC1W, omeprazole 20 mg twice daily and amoxicillin 1 g twice daily and clarithromycin 500 mg twice daily for 1 week, followed by omeprazole 20 mg twice daily and placebo for 1 week; OAC2W, omeprazole 20 mg twice daily and amoxicillin 1 g twice daily and clarithromycin 500 g twice daily for 2 weeks; PPI, proton pump inhibitor
Relevant Article
Gut 2007 56: 1021-1023.
This article has been cited by other articles:
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  L Fuccio, L Laterza, R M Zagari, V Cennamo, D Grilli, and F. Bazzoli Treatment of Helicobacter pylori infection BMJ, September 15, 2008; 337(sep15_1): a1454 - a1454. [Full Text]
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 X. Calvet, A. Villoria, and M. Vergara Could Increasing the Duration of Triple Therapy Be a Clinically Useful Strategy? Ann Intern Med, April 15, 2008; 148(8): 624 - 624. [Full Text] [PDF]
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L. Fuccio, M. E. Minardi, R. M. Zagari, D. Grilli, N. Magrini, and F. Bazzoli Meta-analysis: Duration of First-Line Proton-Pump Inhibitor-Based Triple Therapy for Helicobacter pylori Eradication Ann Intern Med, October 16, 2007; 147(8): 553 - 562. [Abstract] [Full Text] [PDF]
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 A. Zullo, V. De Francesco, C. Hassan, S. Morini, and D. Vaira The sequential therapy regimen for Helicobacter pylori eradication: a pooled-data analysis Gut, October 1, 2007; 56(10): 1353 - 1357. [Abstract] [Full Text] [PDF]
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One week of triple therapy usually eradicates H pylori BMJ, May 26, 2007; 334(7603): 1082 - 1082. [Full Text] [PDF]
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