More than 100 traditional Chinese medicines (TCM) are being used in patients with stroke to enhance post-stroke recovery in China and other parts of the world for many years. These medicines have been claimed to have anti-oxidant, anti-inflammatory and anti-glutamate affects, in addition to their ability to dilate blood vessels, suppress platelet aggregation, protect against reperfusion injury and to increase the tolerance of the ischemic tissue to hypoxia.
Though, their safety profile has been projected to be adequately reasonable, no convincing data has come up yet to prove its efficacy in post-stroke recovery. Danqi Piantang Jiaonang is one of these medicines which is marketed internationally with the name of Neuroaid. It has been tested in two randomized trials against another Chinese traditional medicine, Buchang Naoxintong Jiaonang (BNJ).
What were the methods?
Both of these trials were conducted at 6 medical centers in China. Patients with recent ischaemic stroke diagnosed according to the Western medical standards were enrolled. Patients were enrolled both as in-patient and out-patient after a signed informed consent. There were 200 patients in the first trial and 405 patients in the second trial. Patients were enrolled if they had a recent ischaemic stroke (between 15 days to 6 months; restoration stage according to TCM criteria) , an age range between 18-70 years.
The pooled analysis of these trials was analyzed to assess the safety and efficacy of the two study drugs.
What were the results?
No difference was seen in gender, age, time from stroke onset, or stroke severity score between the two groups. Mean age was 58 years and majority of patients were male. Over 30% patients in both the groups were enrolled after 60 days of stroke. The analysis suggested that as compared to BNJ, the patients in the Neuroaid group were more likely to gain improvement in the functional outcome score at 1 month. However no significant benefit was observed in either group in terms of neurological deficit score and individual scores. The only side effects reported were nausea and vomiting.
What are the limitations of study?
The efficacy of Neuroaid was tested against another similar medication without many comparisons with a placebo agent. The patient population was very heterogenous in terms of time from stroke onset with a significant proportion of patients recruiting after 120 days. Lack of data about the etiologic classification of stroke; the co morbid conditions like hypertension etc; the use of antiplatelet or other therapeutic agents; concomitant rehabilitation therapy; as well as lack of long-term follow up require that more data from randomized controlled trials report the projected positive effect of Neuroaid on the functional outcome of these patients. It is also noteworthy that brain has a natural ability of neuronal plasticity and recovery especially in the first few months of stroke. Therefore, the efficacy of Neuroaid in post-stroke recovery still remains to be proven as an adjunct for post-stroke recovery in patients with ischaemic stroke. A larger trial is planned and results eagerly awaited due to its favourable side effect profile.
1.C Chen, N Venketasubramanian, RN Gan, C Lambert, D Picard, BPL Chan, et al. Danqi Piantang Jiaonang (DJ), a Traditional Chinese Medicine, in Poststroke Recovery. Stroke 2009; 40: 859-63.