Dan Shen Agents for Acute Ischemic Stroke
Graeme J. Hankey MD, FRCP Section Editor:
Based mainly on experimental data which indicates improvement to the cerebral microcirculation, Dan Shen, a herbal medicine, is widely used in the treatment of acute ischemic stroke in China. Whether the existing clinical evidence is good enough to support its routine use in stroke is not clear.1
Our objective was to assess the effects of Dan Shen agents in patients with acute ischemic stroke. The primary objective was to determine whether Dan Shen agents improve functional outcome without causing undue harm in patients with acute ischemic stroke. The secondary objectives were to assess the effect of Dan Shen agents on impairment and on quality of life.
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 (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 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 authors to obtain further data.
Selection criteria comprised randomized controlled trials or quasi-randomized controlled clinical trials comparing Dan Shen agents with placebo or open control (no placebo) in patients with acute ischemic stroke.
Data Collection and Analysis
Two reviewers independently selected trials for inclusion, assessed trial quality and extracted the data.
Six trials involving 494 patients were included. Three trials are awaiting assessment. The methodological quality of included trials was poor. Three trials did not report the method of randomization. Two trials were quasi-randomized controlled clinical trials. Only 1 trial allocated participants by random number but did not describe whether allocation concealment was used. Numbers of deaths and dependent patients at the end of follow-up of at least 3 months were not reported in the 6 included trials. Only 2 trials reported mild adverse events that need not any further treatment. 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% CI, 1.73 to 5.26; see the Figure). The trials did not include any assessment of quality of life.
Implications for Practice
This review does not provide any evidence to support the routine use of Dan Shen agents for the treatment of patients with acute ischemic stroke.
Implications for Research
This review suggests that Dan Shen agents may improve neurological impairment after acute ischemic stroke. High-quality, large-scale randomized trials are needed to confirm or refute these results because the quality of included trials in this review was generally poor. Future trials should overcome the limitations of the trials presented in this review; in particular, they should assure adequate concealment of allocation, blinding of outcome assessors, and use a functional outcome as the primary outcome measured at long-term follow up.
Note: The full text of this review should be cited as: Wu B, Liu M, Zhang S. Dan Shen agents for acute ischaemic stroke. Cochrane Database of Systematic Reviews. 2007, Issue 2. Art. No.:CD004295. DOI: 10.1002/14651858.CD004295.pub3. This article is based on a Cochrane Review published in The Cochrane Library 2007, Issue 2 (see www.thecochranelibrary. com for information). Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and The Cochrane Library should be consulted for the most recent version of the review.
We would like to thank Prof Peter Sandercock for his advice on this review, Hazel Fraser and Brenda Thomas for their help with this review.
Sources of Funding
This work was funded by Sichuan Provincial Administration Bureau for Traditional Chinese Medicine (Grant No. 200203), China Medical Board of New York USA (No. 98-680), Chinese Cochrane Centre, Chinese Centre of Evidence-based Medicine, West China Hospital, Sichuan University CHINA.
- Received April 18, 2007.
- Accepted April 25, 2007.