The New England Journal of Medicine has just published a peer-reviewed study showing the efficacy of Cannabidiol (CBD) oil in the treatment of Dravet syndrome–a drug-resistant seizure with a high mortality rate.
This trial showed that cannabidiol reduced the frequency of convulsive seizures among children and young adults with the Dravet syndrome over a 14-week period but was associated with adverse events including somnolence and elevation of liver-enzyme levels. Additional data are needed to determine the long-term efficacy and safety of cannabidiol for the Dravet syndrome.
Marijuana is currently a ‘Schedule 1’ drug, which means, among other things, that it is classified having no currently accepted medical use in treatment in the United States. The classification of cannabis has been a hot-button issue recently, and as more peer-reviewed studies from respected medical institutions are published, the argument that cannabis (in part or whole) has no medical value will be more difficult to uphold.
How the study was conducted
A randomized, double-blind study of children 2-18 years old. Participants in the study needed to have been diagnosed with Dravet syndrome, and have had at least four seizure in the past month while being on anti-seizure medication.
Results of the cannabidiol study
Researches saw a decrease in the number of seizure over the course of the study by the group taking CBDs compared to the month-long “baseline” period for each group. The number of convulsive seizures decreased by 22.8%
From the study’s summary:
The difference in favor of cannabidiol was seen in the first month of the maintenance period, during which the median number of convulsive seizures per month declined from 12.4 to 5.0 in the cannabidiol group and from 14.9 to 13.0 in the placebo group
Adverse side effects
As with most medications, there were some adverse side effects, which included loss of appetite, vomiting, and diarrhea (though the side effects mostly went away with a decreased dose). The doses of cannabidiol given were either 5, 10, or 20 mg/kg/day, and the doses were slowly increased over a seven-day period until the assigned dose was achieved, and then maintained.
Sleepiness (somnolence) was the most commonly reported side effect.
What’s next for CBD clinical trials?
This study, and the overall positive results represent a great step forward in the serious pursuit of establishing (scientifically) the medicinal value of cannabidiol specifically, and cannabis as a whole.
In looking at what this means for the future of legitimate, peer-reviewed cannabis research, Samuel F. Berkovic, M.D summed it up best in his editorial Cannabinoids for Epilepsy — Real Data, at Last:
This trial represents the beginning of solid evidence for the use of cannabinoids in epilepsy. It requires replication. Future trials may answer further questions about the applicability of cannabinoids to the many other syndromes of childhood epilepsy and to treatment in adults. After an era dominated by anecdote and obfuscated by medicolegal issues and emotionally infused debate, more scientific studies are under way. Much more research is needed to understand the basic science, benefits, and risks of cannabinoids in epilepsy.