The effect of atorvastatin on inflammatory markers in sulfur mustard gas induced bronchitis; a randomized double-blinded, placebo-control clinical trial

Abstract

Background: This study was performed to evaluate the anti-inflammatory effect of atorvastatin in patients with chronic bronchitis, exposed to sulfur mustard gas. Methods: In this randomized double-blinded clinical trial we recruited patients with chronic bronchitis after exposure to sulfur mustard gas. Ninety men 45-75 years old diagnosed with chronic bronchitis after exposure to mustard gas during the Iran-Iraq war, were randomly assigned to receive either atorvastatin (40 mg) or placebo once a day for 3 months. The interleukin 6 (IL-6), tumor necrosis factor α (TNF-α), procalcitonin, highly sensitive CRP and COPD assessment test (CAT) score was compared at baseline and after 12 weeks. Results: After consuming atorvastatin for 12 weeks, IL-6 level (mean difference [95%CI]; 0.2[-0.05, 0.5]), TNF-α(mean difference [95%CI]; -0.07[-0.2, 0.07]), high sensitive CRP(mean difference [95%CI] -0.1[-1.2, 0.9]), and procalcitonin (mean difference [95%CI]; 0.003[-0.02, 0.03]) did not change significantly. However, in the placebo group, only IL-6 (mean difference [95%CI]; 0.6[0.2, 1.05]) decreased significantly after 12 weeks, but levels of high sensitive CRP (mean difference [95%CI]; -0.3[-1.4, 0.8]) TNF-α (mean difference [95%CI]; -0.2[-0.34, -0.06]) and procalcitonin (mean difference [95%CI]; 0.02[-0.001, 0.04]) did not change significantly. After 12 weeks, the mean differences in TNF- α, IL-6 level, high sensitive CRP, procalcitonin, and CAT score did not significantly differ between the two groups. Conclusions: The administration of 40 mg atorvastatin for 3 months did not significantly change the inflammatory markers or the quality of life of patients exposed to mustard gas with chronic bronchitis.Trial registration: IRCT, IRCT138904144312N1. Registered 16 August 2014, https://en.irct.ir/trial/4577