on January 22, 2009
Published online before print January 22, 2009, doi: 10.1161/STROKEAHA.108.531616
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Submitted on July 25, 2008
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, People's Republic of China. * To whom correspondence should be addressed. 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widely used in China to improve recovery after stroke, has been compared with another traditional Chinese medicine in 2 unpublished randomized clinical trials.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 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 Conclusions—The pooled analysis of 2 unpublished trials of DJ, a traditional Chinese medicine currently approved in China to improve neurological recovery after stroke, shows good tolerability and superiority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.
Accepted on August 12, 2008
Danqi Piantang Jiaonang (DJ), a Traditional Chinese Medicine, in Poststroke Recovery
Christopher Chen MD*;
10.
Key words: cerebral infarct • randomized controlled trials • stroke recovery • traditional Chinese medicine