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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