Safflower yellow for acute ischemic stroke: A systematic review of randomized controlled trials.

OBJECTIVES Stroke is one of the most common causes of mortality worldwide. Safflower yellow is widely used for the treatment of acute ischemic stroke in China. Several trials comparing safflower yellow and placebo or no intervention were unavailable for prior meta-analysis. Here, we present an updated and expanded systematic review, including four new trials, to evaluate the efficacy and safety of safflower yellow for the treatment of acute ischemic stroke. METHODS A comprehensive search was performed in Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, the Allied and Complementary Medicine Database (AMED), China National Knowledge Infrastructure (CNKI), China Biological Medicine Database (CBM), CQVIP Information and Wanfang Database until January 2013. Only randomized controlled trials (RCTs) evaluating the efficacy and safety of safflower yellow for acute ischemic stroke were included. Two researchers (Fan, S.Y. and Lin, N.) independently extracted data, assessed the study quality, and selected trials for inclusion. RESULTS 7 RCTs with 762 participants were included. None of the included studies were of high methodological quality. The meta-analysis showed that safflower yellow was more effective assessed by neurological improvement rate [odds ratio (OR), 3.11; 95% confidence interval (CI) 2.06-4.68, P<0.05] compared with control group. No death was reported in any of the included studies during the follow up period. Only four trials reported adverse events, and skin rash was observed in the treatment group of one trial. CONCLUSIONS Safflower yellow seems to be effective and safe in the treatment of acute ischemic stroke. However, RCTs of high methodological quality are warranted before drawing any conclusion on the efficacy or safety of safflower yellow for acute ischemic stroke.