The purpose of this meta-analysis was to assess whether statins could reduce the morbidity of acute lung injury and acute respiratory distress syndrome (ALI/ARDS) in high-risk patients and improve the clinical outcomes of patients with ALI/ARDS. Studies were obtained from PubMed, Medline, Embase and Cochrane Central Register of Controlled Trials. Randomized controlled trials (RCTs) and cohort studies, which reported morbidity, mortality, ventilator-free days, length of stay in intensive care unit and hospital or oxygenation index, were included in our meta-analysis. Risk ratio (RR) and weighted mean difference (WMD) were calculated using fixed or random effect model. A total of 13 studies covering 12 145 patients were included. Both the only RCT (P= 0.10) and cohort studies (RR, 1.02; 95% CI, 0.67 to 1.55;P= 0.94) showed that statin therapy did not lower the morbidity of ALI/ARDS in high-risk patients. The mortality of ALI/ARDS patients was less likely to be improved by statins (RCT, RR, 1.00; 95% CI, 0.84 to 1.20;P= 0.97; cohort studies, RR, 1.04; 95% CI, 0.85 to 1.27;P= 0.72). Moreover, no significant difference was observed in ventilator-free days, length of stay in intensive care unit as well as hospital and oxygenation index. This meta-analysis suggests that statins neither provide benefit for lowering the morbidity of ALI/ARDS in high-risk patients nor improve the clinical outcomes of ALI/ARDS patients. Hence, it may not be appropriate to advocate statin use for the prevention and treatment of ALI/ARDS.