At the same time, children in the placebo group only had a slight reduction in seizures, from about 15 to 14 seizures a month.
According to the Epilepsy Foundation, there aren't any medications that can fully control seizures in children with Dravet syndrome now. The study is based on the first large-scale clinical trial testing the effects of CBD on seizures. "This isn't saying people with epilepsy should smoke cannabis", Sadleir said.
CBD is one of more than 80 active cannabinoid chemicals in the plant and is classified alongside heroin and LSD as a Schedule 1 controlled substance by the DEA.
Cannabidiol, or CBD, is derived from cannabis plants, but does not cause users to get high The company procudes high cannabidiol (CBD) content cannabis with THC (psychoactive component) content below the Swiss legal limit. He is an epilepsy researcher at the University of Melbourne in Australia, where medical marijuana was legalized previous year, and has worked with Devinsky in the past.
For years, desperate patients and parents have argued for more research and wider access to marijuana, with only anecdotal stories and small, flawed studies on their side.
The short span of the study meant it was unclear what the long term effects of this medication on a child's developing brain might be.
The trial took place over 14 weeks with 120 children with Dravets Syndrome, a severe potentially lethal form of epilepsy, participating, 60 of whom were given a placebo and the other 60 given cannabidiol. The kids and their caretakers didn't know if they were taking CBD or a placebo.
During the study, the patients stayed on their normal treatment regimen, and half of them also received cannabidiol while the remainder were given a placebo.
Because both media coverage of cannabis use in epilepsy and inconsistent classification of medical marijuana usage in different U.S. states have short-circuited the rigorous scientific protocols of the U.S. Food and Drug Administration (FDA), quality validation may be lacking. Three patients stopped having seizures entirely while getting treated with CBD oil. The 52 children in the study took the medication over a 14-week period and results showed the drug cutting the median number of seizures from 12.4 to 5.9. But they also experienced more adverse side effects like diarrhea, vomiting, fatigue and drowziness.
"I am delighted that we finally have high-level evidence that cannabidiol is effective for uncontrolled seizures in Dravet syndrome", says Professor Scheffer. "I have to say we don't know", said Cross. "It's not like the hemp oils that you can buy from the internet, which are so variable in their content". While the frequency of total seizures of all types was significantly reduced with cannabidiol, there was no significant reduction in nonconvulsive seizures.
"It's a big landmark in the scientific study of cannabis, and it's a major landmark in epilepsy care", Devinsky said. He added that it should be a priority. Unlike other forms of epilepsy, seizures can not be managed with drugs.
"This trial represents the beginning of solid evidence for the use of cannabinoids in epilepsy", Samuel F. Berkovic, of the Epilepsy Research Centre at the University of Melbourne, wrote in an accompanying editorial.