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Abstract
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.
- 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
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- 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
Footnotes
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Published Online First 6 October 2006
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Funding: This study was sponsored by AstraZeneca, Bracco SpA. and Malesci SpA.
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Competing interests: RMZ has received reimbursement from Janssen-Cilag and Abbot for attending symposia, and fees for speaking from AstraZeneca, Takeda and Abbott. GB-P has received funds for research from Takeda (for a member of his staff) and from AstraZeneca (for publishing a book). RF has received fees for speaking from and has performed consultancy work for AstraZeneca. GG has received reimbursement for attending symposia. ER has received funds for organising education from Malesci and funds for consulting from AstraZeneca. FB has received fees for speaking from AstraZeneca and Takeda, reimbursement for organising education from Altana and has carried out consultancy work for AstraZeneca.
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