Animal experiments in clinical practice suggest that Dan Shen agents might improve cerebral microcirculation. This review identified six randomised or quasi-randomised trials of Dan Shen agents involving 494 patients with acute ischaemic stroke. There was no evidence that Dan Shen agents did more good than harm. There is not enough evidence to support the routine use of Dan Shen agents to promote recovery after stroke. Further high-quality, large-scale randomised controlled trials are needed to guide clinical practice.
The methodological quality of all included studies was poor, and reliable conclusions could not be drawn from the present data. Further high-quality randomised controlled trials should be performed.
Based mainly on experimental data that indicates improvement to the cerebral microcirculation, Dan Shen, a herbal medicine, is widely used in the treatment of acute ischaemic stroke in China.
To assess the effects of Dan Shen agents in patients with acute ischaemic stroke.
We searched the Cochrane Stroke Group Trials Register (last searched July 2006), the register of the Cochrane Complementary Field (last searched July 2006) and the Chinese Stroke Trials Register (last searched August 2006). In addition, we searched the following bibliographic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 2, 2006), MEDLINE (1996 to August 2006), EMBASE (1980 to August 2006), CINAHL (1982 to August 2006), AMED (1985 to August 2006), and the China Biological Medicine Database (CBM-disc) (1979 to August 2006). We handsearched 10 Chinese journals, searched clinical trials and research databases, scanned reference lists and contacted the pharmaceutical company manufacturing Dan Shen. We also attempted to contact trial authors to obtain further data.
Randomised or quasi-randomised controlled trials comparing Dan Shen agents with placebo or open control in patients with acute ischaemic stroke.
Two review authors independently selected trials for inclusion, assessed trial quality, and extracted the data.
Six trials involving 494 patients were included. Three trials are awaiting assessment. Numbers of deaths and dependent patients at the end of follow up of at least three months were not reported in the six included trials. Only two trials reported adverse events. All trials measured the outcome 'significant improvement in neurological deficit at the end of treatment'. Dan Shen agents were associated with a significant increase in the number of patients with the outcome (Peto odds ratio 3.02, 95% confidence interval 1.73 to 5.26). No deaths were reported within the first two weeks of treatment or during the whole follow-up period. The trials did not include any assessment of quality of life.