Abstract

metronidazole (500 mg/12h)] or treatment (same four drugs taken concomitantly for ten days). Eradication was confirmed with 13C-urea breath test or histology 8 weeks after treatment. Adverse events (AEs) and treatment compliance were evaluated with questionnaires and residual medication count. Results: 342 consecutive patients were randomized. Mean age was 47 years, 60% were females, 23% were smokers, and 20% had peptic ulcer. Intention-to-treat eradication was 89.6% (95%CI=86-93%) for the concomitant, and 85.2% (81-89%) for the regimen (p=0.153). Respective perprotocol rates were 91.2% (88-95%) and 86.2% (82-90%) (p=0.131). Compliance was 89% for and 86% for sequential. AEs were reported in 65% of patients (no significant differences were found between treatments). AEs were mostly mild (60%) or moderate (35%) and had an average length of 6.5 days. Only 7 patients discontinuated treatment due to AEs. Multivariate analysis for sex, age, smoking habit, presence of ulcer and type of treatment found no association with effectiveness, although concomitant treatment showed an odds ratio of 1.5 towards better eradication rate in a borderline significance confidence interval (95%CI=0.8-2.9). Conclusion: Our results suggest that eradication rate differences between sequential and treatments are lower than 10%. However, a non-statistically significant trend towards an advantage (5%) of regimen was observed. The rate of adverse events was high but their intensity was mild and duration was short.

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