Stroke. 2007;38:3095-3096
Published online before print October 4, 2007,
doi: 10.1161/STROKEAHA.107.491662
(Stroke. 2007;38:3095.)
© 2007 American Heart Association, Inc.
Dan Shen Agents for Acute Ischemic Stroke
Bo Wu, MD, PhD;
Ming Liu, MD
Shihong Zhang, MD
From the Stroke Clinical Research Unit, Department of Neurology (B.W, M.L, S.Z), and the Key Laboratory of Human Disease Biotherapy of the State and Ministry of Education (M.L), West China Hospital, Sichuan University.
Correspondence to Prof Ming Liu, Stroke Clinical Research Unit, Department of Neurology, West China Hospital, Sichuan University, No. 37, Guo Xue Xiang, Chengdu, 610041, Sichuan Province, P.R. China. E-mail wyplmh{at}hotmail.com
Graeme J. Hankey MD, FRCP Section Editor:
Key Words: Dan Shen • ischemic stroke • meta-analysis • systematic review
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Introduction
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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.
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Objectives
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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.
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Search Strategy
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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.
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Selection Criteria
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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.
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Data Collection and Analysis
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Two reviewers independently selected trials for inclusion, assessed
trial quality and extracted the data.
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Main Results
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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.
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Figure. Effect of Dan Shen agents compared with control on improvement with neurological deficit at the end of treatment.
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Implications for Practice
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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.
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Implications for Research
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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.
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Acknowledgments
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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.
Disclosures
None.
Received April 18, 2007;
accepted April 25, 2007.
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Reference
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1. Sze FK-h, Yeung FF, Wong E, Lau J. Does Danshen improve disability after acute ischaemic stroke?
Acta Neurol Scand. 2005; 111: 118–125.
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Introduction
Objectives