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Randomised clinical trial: simvastatin as adjuvant therapy improves significantly the Helicobacter pylori eradication
1Department of Internal Medicine, Holy Family Hospital, Faculty of Medicine in the Galilee, Bar-Ilan University, Nazareth, Israel. w.nseir@yahoo.com
Background:
The eradication rate of Helicobacter pylori with standard treatments are decreasing worldwide.
Aim:
To determine whether adding simvastatin as adjuvant to triple regimen in patients with H. pylori infection will improve the eradication rate.
Methods:
We 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.
Results:
A 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.
Conclusion:
In this randomised clinical trial simvastatin as adjuvant to standard therapy improves significantly the H. pylori eradication rate.
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