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Randomised clinical trial: simvastatin as adjuvant therapy improves significantly the H elicobacter pylori eradication rate ‐ a placebo‐controlled study
Author(s) -
Nseir W.,
Diab H.,
Mahamid M.,
AbuElheja O.,
Samara M.,
Abid A.,
Mograbi J.
Publication year - 2012
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2012.05161.x
Subject(s) - medicine , placebo , clarithromycin , regimen , gastroenterology , simvastatin , helicobacter pylori , adverse effect , omeprazole , amoxicillin , intention to treat analysis , antibiotics , alternative medicine , pathology , microbiology and biotechnology , biology
Summary Background The eradication rate of H elicobacter 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 13 C ‐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.