Randomised clinical trial: simvastatin as adjuvant therapy improves significantly the Helicobacter pylori eradication rate--a placebo-controlled study.
BACKGROUND
The eradication rate of Helicobacter pylori with standard treatments are decreasing worldwide.


OBJECTIVE
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.


CONCLUSIONS
In this randomised clinical trial simvastatin as adjuvant to standard therapy improves significantly the H. pylori eradication rate.
Department of Internal Medicine, Holy Family Hospital, Faculty of Medicine in the Galilee, Bar-Ilan University, Nazareth, Israel. w.nseir@yahoo.com
W
W
Nseir
H
H
Diab
M
M
Mahamid
O
O
Abu-Elheja
M
M
Samara
A
A
Abid
J
J
Mograbi
D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects; D054328:Proton Pump Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D019821:Simvastatin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D054328:Proton Pump Inhibitors; D000658:Amoxicillin; D019821:Simvastatin; D017291:Clarithromycin; D009853:Omeprazole