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(Stroke. 2009;40:859.)
© 2009 American Heart Association, Inc.
Original Contributions |
From the Department of Pharmacology (C.C.), National University of Singapore, Singapore; the Department of Neurology (N.V., R.N.G.), National Neuroscience Institute, Singapore; Moleac (C.L., D.P.), Singapore; the Division of Neurology (B.P.L.C.), National University Hospital, Singapore; Evidence-Based Medicine (E.C.), Clinical Trials and Epidemiology Research Unit, Singapore; Hopital Lariboisiere (M.G.B.), Paris, France; and the University of Traditional Chinese Medicine (S.X.), Tianjin, Peoples Republic of China.
Correspondence to Christopher Chen, MD, Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Block MD11, Clinical Research Centre, #05-09, 10 Medical Drive, Singapore 117597. E-mail phccclh{at}nus.edu.sg
Background and Purpose— Stroke is a leading cause of death and disability worldwide. Despite improvements in acute stroke treatment, many patients only make a partial or poor recovery. Therefore, there is a need for treatments that would further improve outcome. Danqi Piantang Jiaonang (DJ; NeuroAid), a traditional Chinese medicine widely used in China to improve recovery after stroke, has been compared with another traditional Chinese medicine in 2 unpublished randomized clinical trials. The results of these studies were pooled and reanalyzed to assess efficacy and safety.
Methods— Six hundred five subjects were randomized in 2 randomized double-blinded, controlled trials to receive either DJ or Buchang Naoxintong Jiaonang. Subjects were treated for 1 month. Inclusion criteria were: (1) patients with recent (from 10 days to 6 months) ischemic stroke; (2) patients satisfying Western diagnostic standards for stroke and traditional Chinese medicine standards for diagnosis of apoplexy; and (3) Diagnostic Therapeutic Effects of Apoplexy score
10.
Results— The functional outcome, measured by the Comprehensive Function Score component of the Diagnostic Therapeutic Effects of Apoplexy scale, showed a statistically significant superiority of DJ over the control treatment group (relative risk, 2.4; 95% CI, 1.28 to 4.51; P=0.007). Tolerance was excellent in both groups.
Conclusions— The pooled analysis of 2 unpublished trials of DJ, a traditional Chinese medicine currently approved in China to improve neurological recovery after stroke, shows good tolerability and superiority of DJ over another traditional Chinese medicine also approved for stroke. A large double-blind randomized clinical trial is required to further assess the safety and efficacy of DJ.
Key Words: cerebral infarct randomized controlled trials stroke recovery traditional Chinese medicine
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