Background: Dan Shen, a form of herbal medicine, are widely used in the treatment of acute ischaemic stroke in China. We aimed to assess the evidence from randomized/quasi-randomised controlled trials of their effects. Objective: The primary objective was to determine whether Dan Shen agents improve a functional outcome without causing undue harm in patients with acute ischaemic stroke. Secondary objectives were to assess the effect of Dan Shen agents on impairment and on quality of life.

Methods: This review has drawn on the search strategy developed for the Stroke Group as a whole. Searches were performed in Cochrane Controlled Trials Register, Medline, Embase, China Biological Medicine Database. We handsearched 10 kinds of important Chinese journals. The primary outcomes were: 1) Death or dependency at the end of long term follow-up. 2) Adverse events. Secondary outcome measures were: 1) Measures of neurological deficit at the end of treatment. 2) Death within the first two weeks of treatment and during the whole follow-up period. 3) Quality of life.

Results: 8 potentially eligible trials were identified, of which 3 trials (304 patients) were included. 2 trials were excluded and 3 trials are waiting for assessment. Numbers of death and dependency at the end of long term follow-up at least three months were not reported in the 3 included trials. Only one trial reported the adverse events. 3 trials measured neurological deficit at the end of treatment. Dan Shen agents were associated with a significant improvement in neurological deficit iPeto OR 2.72 95%CI 1.10-6.72 j. There was no death within the first two weeks of treatment and during the whole follow-up period and there was no assessment on quality of life.

Conclusion: There were too few patients and outcome events to draw reliable conclusions from the present data. The methodological qualities of all included studies were poor. Further high-quality randomised controlled trials should be performed.