By Kerry Grens
NEW YORK (Reuters Health) - A Chinese herbal remedy marketed to improve stroke recovery failed to exceed the benefits of a placebo in a large, three-month clinical trial.
"There's no evidence of efficacy," said Dr. James Brorson, medical director of the University of Chicago Stroke Center, who was not involved in the study.
Still, the researchers are not completely discouraged by the results.
"Yes, we had hoped for a larger effect, but the results of the trial suggest that this may be the case for certain groups of patients," said Dr. Christopher Chen, the report's lead author and a professor at the National University of Singapore.
Chen's research was supported in part by Moleac, the company that markets the herbal medicine, called NeuroAiD.
NeuroAiD is a blend of extracts from plants, leeches, beetles, scorpions and antelope horn.
Some earlier studies had hinted that the compound could help people recover from an ischemic stroke, the most common kind, caused by a blood vessel blockage in the brain.
According to David Picard, the CEO of Moleac, NeuroAiD is sold in at least 25 countries, and 20,000 people have taken it.
It is currently not available through U.S.-based vendors, although consumers can buy it online. A three month regimen costs about $1,500.
Brorson said there is a huge need for treatments to help in stroke recovery because there is no treatment guaranteed to help repair the brain damage caused by strokes.
Chen and his colleagues decided to compare the effect of NeuroAiD to a placebo among people who had recently suffered an ischemic stroke.
More than 800 people agreed to be in the study and half were randomly assigned to get NeuroAiD and the other half to a dummy medication. Neither the patients nor the doctors knew which pills each participant was taking.
For three months, all the patients took 12 capsules a day.
At the beginning and end of the study, the patients' disability level was assessed based on a six-point scale called the modified Rankin scale.
A score of zero to one indicates no or insignificant disability, while five is the worst and six is death.
After three months, the distribution of patients in each disability category on the scale was the same for the placebo group and the NeuroAiD group, Chen's team reports in the journal Stroke.
The results mean the herbal medicine did not help people recover their function.
David Picard, the CEO of Moleac, said he was not discouraged by the results.
Although the findings were not statistically significant, Picard said it's possible that NeuroAiD does work for a subset of patients.
Chen's team found that if they analyzed the outcomes of only the patients who had started taking NeuroAiD 48 hours or more after their stroke, there was some suggestion of a benefit.
However, the slight improvement remained statistically insignificant, meaning it could have been due to chance.
"What we learned from this is we should design studies in the future for patients with an established deficit and possibly a longer treatment period," Picard told Reuters Health.
Chen said in an email to Reuters Health that studies have shown NeuroAiD to be safe. And given that there are no proven stroke-recovery medicines, "NeuroAiD remains a good therapeutic option to explore," he wrote.
Brorson said the possibility that NeuroAiD might work on patients if it's given only at later time points "is a stretch."
"That idea is counterintuitive to those of us who are trying to treat stroke earlier," he told Reuters Health.
"So what we'd really need is evidence to support that idea. And I think absent that, we have to take this at face value as evidence against any significant benefit of this compound," he added.
SOURCE: http://bit.ly/16c3lfd Stroke, online June 18, 2013.
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