Randomised clinical trial: simvastatin as adjuvant therapy improves significantly
the Helicobacter pylori eradication rate--a placebo-controlled study.
Author(s): Nseir W, Diab H, Mahamid M, Abu-Elheja O, Samara M, Abid A, Mograbi J.
Affiliation(s): Department of Internal Medicine, Holy Family Hospital, Faculty of Medicine in the
Galilee, Bar-Ilan University, Nazareth, Israel. w.nseir@yahoo.com
Publication date & source: 2012, Aliment Pharmacol Ther. , 36(3):231-8
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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