Objectives To assess the efficacy and safety of dl-3-butylphthalide for patients with acute ischemic stroke. Methods We collected randomized controlled trials, which compared dl-3-butylphthalide agents with placebo or open control in patients with acute ischaemic stroke, by searching the electronic bibliographic databases, scanning references listed in articles and handsearching journals. Meta-analysis was conducted based on the methods recommended by the Cochrane Collaboration. Results Twenty-one trials involving 2 123 patients were included, of which 2 were placebo-controlled and 19 were open-label controlled. Meta-analysis of 10 trials (n=958), in which neurological deficits were assessed by CSS, suggested that there were significant differences favoring butylphthalide in the mean change of neurological deficits’ score during the treatment period [MD=2.30, 95%CI (1.57, 3.03)]. Meta-analysis of 6 trials (n=590), in which neurological deficits were assessed by NIHSS, also favored butylphthalide [MD=2.06, 95%CI (0.65, 3.46)]. Adverse events (AEs) were reported in 13 trials. Gastrointestinal discomfort (1.7%~8%) and abnormal liver function including abnormal ALT (1.4%~17.5%) and abnormal AST (1.9%~8.82%) were the two most common AEs. However, no severe adverse events (SAEs) were reported. Numbers of dead and dependent patients at the end of followup (at least three months) were not reported in the 21 included trials. Quality of life was not assessed in any of the trials. Conclusion Dl-3-butylphthalide can improve the neurological function after acute ischemic stroke and appears to be safe. However, further study is needed to confirm its effects for lowering rates of death and dependency.
