• W Nseir, H Diab, M Mahamid, O Abu-Elheja, M Samara, A Abid, and J Mograbi.
• Department of Internal Medicine, Holy Family Hospital, Faculty of Medicine in the Galilee, Bar-Ilan University, Nazareth, Israel. w.nseir@yahoo.com
• Aliment. Pharmacol. Ther. 2012 Aug 1; 36 (3): 231-8.

BackgroundThe eradication rate of Helicobacter pylori with standard treatments are decreasing worldwide.AimTo determine whether adding simvastatin as adjuvant to triple regimen in patients with H. pylori infection will improve the eradication rate.MethodsWe conducted a double-blind, placebo-controlled, randomised clinical trial comparing a 7-day, triple eradication regimen consisting of two antibiotics (clarithromycin 500 mg and amoxicillin 1 g, all twice per day) plus a proton pump inhibitor (omeprazole 20 mg twice daily) supplemented with simvastatin 20 mg (CAO + S) or a comparable placebo (CAO + P). Both the simvastatin and the placebo were taken orally twice daily for 1 week in 113 patients with H. pylori infection. The presence of H. pylori was determined by positive rapid urease test and histology. Eradication was confirmed by ¹³C-urea breath test at least 1 month after treatment. Adverse effects were assessed by questionnaire.ResultsA total of 113 patients underwent randomisation. Intention-to-treat analysis (ITT; n = 113) eradication rates were: CAO + S (86%; 95% CI: 78-92%), CAO + P (69%; 95% CI: 64-74%). Per protocol analysis (PP; n = 108) eradication rates were: CAO + S (91%; 95% CI: 84-94%), CAO + P (72%; 95% CI: 65-78%). Eradication rates were higher with CAO + S than CAO + P in PP and ITT (P = 0.03, P = 0.04 respectively). No differences were demonstrated between the two groups concerning compliance or adverse effects.ConclusionIn this randomised clinical trial simvastatin as adjuvant to standard therapy improves significantly the H. pylori eradication rate.© 2012 Blackwell Publishing Ltd.

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