Dan Shen agents for acute ischaemic stroke
Abstract
Background
Based mainly on experimental data which indicates improvement to the cerebral microcirculation, Dan Shen, a form of herbal medicine, is widely used in the treatment of acute ischaemic stroke in China. We aimed to assess the evidence from randomised controlled trials of their effects.
Objectives
To review the randomised or quasi‐randomised controlled trials of Dan Shen agents for acute ischaemic stroke. The primary objective was to determine whether Dan Shen agents improve 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.
Search methods
We searched the Cochrane Stroke Group Trials Register (last searched September 2003), the register of the Cochrane Complementary Field (last searched September 2003) and the Chinese Stroke Trials Register (last searched September 2003). In addition we searched the following bibliographic databases: The Cochrane Central Register of Controlled Trials (The Cochrane Library,Issue 4, 2002), MEDLINE (1996 to December 2002), EMBASE (1980 to December 2002), CINAHL (1982 to December 2002), AMED (1985 to December 2002) and China Biological Medicine Database (CBM‐disc 1979 to December 2002). We handsearched 10 Chinese journals, searched clinical trials and research databases, scanned reference lists and contacted the pharmaceutical company manufacturing Dan Shen.
Selection criteria
Randomised controlled trials or quasi‐randomised controlled clinical trials comparing Dan Shen agents with placebo or open control (no placebo) in patients with acute ischaemic stroke.
Data collection and analysis
Two reviewers independently selected trials for inclusion, assessed trial quality and extracted the data.
Main results
Eight potentially eligible trials were identified, of which three trials (304 patients) were included. Two trials were excluded and 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 three included trials. Only one trial reported adverse events. Three trials measured the outcome "significant improvement in neurological deficit at the end of treatment". Compound Dan Shen agents were associated with a significant increase in the number of patients with the outcome (Peto Odds Ratio (OR) 2.72, 95% Confidence Interval (CI) 1.10 to 6.72). No deaths were reported within the first two weeks of treatment or during the whole follow‐up period (21 to 28 days). The trials did not include any assessment of quality of life.
Authors' conclusions
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.
PICOs
Plain language summary
Dan Shen agents, a form of herbal medicine, are widely used in China but are of unproven benefit in patients with acute ischaemic stroke.
Animal experiments in clinical practice suggest that Dan Shen agents might improve cerebral microcirculation. This review identified all randomised or quasi‐randomised trials of Dan Shen agents in 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 and large scale randomised controlled trials are needed to guide clinical practice.
