SCIENTIFIC AMERICAN: A rigorous study validates a cannabis-derived treatment for a rare, drug-resistant childhood epilepsy
Medical researchers have confirmed what some desperate parents have been claiming for yearsthat a nonpsychoactive component of marijuana known as cannabidiol (CBD) can reduce epileptic seizures in some children.
Published in The New England Journal of Medicine, the findings stem from a double-blind, placebo-controlled studythe most scientifically rigorous type of investigation possible. This study clearly establishes cannabidiol as an effective anti-seizure drug for this disorder and this age group," says principal investigator Orrin Devinsky, director of the Comprehensive Epilepsy Center at New York University Langone Medical Center. It certainly deserves to be studied in other types of epilepsy.
A total of 120 children and teenagers with Dravet syndromea rare disorder marked by drug-resistant seizures that can be nearly continuous in some caseswere part of the study. They were divided into an experimental group, which received the test drug, and a placebo group, which was given a medically inactive compound. Over the course of 14 weeks the youngsters receiving CBD experienced a median number of 5.9 convulsive seizures per month (down from 12.4) compared with 14.1 convulsions per month (down from 14.9) for the placebo group. The new findings are consistent with previous, less-stringent studies of the same drug, a compound called Epidiolex, made by U.K.based GW Pharmaceuticals. (GW funded the new study.)
As the current paper points out, interest in cannabidiol for the treatment of epilepsy was generated by media reports of efficacy in children with Dravet syndrome. The star of many of those reports was Charlotte Figi, now 10, of Colorado, who was having hundreds of seizures a month by age three when her parents decided to treat her with cannabidiol. Unlike the better-known marijuana component tetrahydrocannabinol (THC), cannabidiol does not make users high. Twenty-nine states and the District of Columbia have legalized marijuana for medical use, and the conditions approved for treatment can vary from state to state. Sixteen states have laws that specifically allow the use of CBD to treat seizures.
The Figis treated their daughter with a specially prepared CBD-containing oil, now known as Charlottes Web, which is derived from hemp, a type of cannabis containing less than 0.3 percent THC by weight. They reported dramatic improvement. As word spread, more families tried CBD and the positive anecdotes piled up. Thats certainly one of the motivations for this research, Devinsky says. He notes there is also plenty of animal model data as well as anecdotes from the late 1800s about Indian hemp, another type of cannabis, that was used to treat epilepsy. And there are even mentions of the approach in Sumerian tablets going back 3,800 years. The parents added fuel to the fire, he says, but that anecdotal evidence was there for millennia.
All of the patients in the new trial fit the criteria for severe, drug-resistant epilepsy and were taking other seizure medications. Whereas there was a statistically and clinically significant median reduction in convulsive seizures of 39 percent in the treated group, only three of the 52 patients receiving cannabidiol became completely seizure-free. And 93 percent of those patients reported troublesome side effectsincluding sleepiness (the most common symptom), vomiting, fatigue, decreased appetite, diarrhea and elevated levels of liver enzymes. Eight of the cannabidiol patients stopped participating in the study as a result of the more severe side effects. The study authors indicate some of those issues could have been caused by interactions with other epilepsy drugs. Also, there was no significant reduction in nonconvulsive seizures, which are essentially brief staring spells in which a person is unaware of his or her surroundings for several seconds. The study notes this could be because cannabidiol only affects convulsive seizures or because nonconvulsive seizures cannot be reliably counted by parents in developmentally delayed children.
Nevertheless, 62 percent of caregivers in the cannabidiol group said their childs overall condition improved during the trial, compared with 34 percent in the placebo group. After the trial caregivers of participants in both the placebo and experimental groups were given the option of continuing treatment with cannabidiol in what is called an open-label extension of the study. More than 100 families from both groups took researchers up on the offer...snip
...Going forward, GW Pharmaceuticals plans to seek U.S. Food and Drug Administration approval of Epidiolex in the next few months as a treatment for Dravet syndrome and LennoxGastaut syndrome, another seizure disorder...SNIP
MORE: https://www.scientificamerican.com/article/marijuana-treatment-reduces-severe-epileptic-seizures/
Ohhhh Please Mr. FDA can't we PLEASE have your "approval"?? What a load of rubbish.
Reminder: The US DHHS HOLDS A PATENT ON THE USE OF CANNABINOIDS
US PATENT #6630507
Poster Comment:
ENOUGH OF THE NONSENSE THAT CANNABIS IS NOT MEDICINE!
It is, and Scientific American - AND THE US DHHS, agrees. End of debate.