Pot Chemical and Kids' Hard-to-Treat Epilepsy
Pot Chemical and Kids' Hard-to-Treat Epilepsy
Preliminary studies link cannabidiol to seizure reduction, but drug interactions remain a concern
Now the two articles....
As a retired "Behavioral Therapist" I truly understand what Epilepsy is and how it can affect the people that have it. I also understand the effect Epilepsy has on family members of people with this illness.
Epilepsy is an illness that pulls at the heart of family members because there feels like you are almost totally out of control and you can't help those who have it. And if the afflicted person is a child it's even harder. Family members wish they could switch places or take on the illness of their child. They hunt for relief in all sorts of places. In fact, parents become desperate and seek alternative treatments which could lead them down a road that can and often time drain their pockets with little to no results.
I feel for them because they want and need help but they often run into people who only want their money and may not be able to provide any help what-so-ever. To this end, I want to provide for those who have interested two articles written by Mr. Thompson. One in 2015 and the other in 2017 dealing with the same topic. He has found some interesting information about CBD (Medical Aspect of Marijuana) and Epilepsy in children.
It is my hope that as time moves forward and the studies get better we'll have some solid answers to many questions regarding the CBD in Marijuana and it benefits.
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Epilepsy is a group of neurological disorders characterized by epileptic seizures.[10][11] Epileptic seizures are episodes that can vary from brief and nearly undetectable to long periods of vigorous shaking.[1] These episodes can result in physical injuries including occasionally broken bones.[1] In epilepsy, seizures tend to recur and as a rule, have no immediate underlying cause.[10]Isolated seizures that are provoked by a specific cause such as poisoning are not deemed to represent epilepsy.[12] People with epilepsy in some areas of the world experience stigma due to the condition.[1]
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By Dennis Thompson 2015
Evidence is mounting that a marijuana-derived oil might benefit some children with epilepsy whose seizures aren't controlled by approved medications, two new studies show.
Cannabidiol (CBD) significantly reduced seizures in as many as half of children with epilepsy, researchers planned to report Monday at the American Epilepsy Society's annual meeting, in Philadelphia.
But experts say these positive findings may have been influenced by a "placebo effect." All participants in these studies knew they were taking the oil, which could have affected reports of its effectiveness.
"We know that our placebo rates can be as high as 30 percent, and sometimes higher," said Dr. Amy Brooks-Kayal, American Epilepsy Society president, who wasn't involved in the studies.
"We don't know the real effect of the cannabidiol, and we won't until we complete the studies that are ongoing that are placebo-controlled and blinded," added Brooks-Kayal, who is also a professor of pediatrics, neurology and pharmaceutical sciences at the University of Colorado School of Medicine.
There also are concerns that cannabidiol may interact badly with some anti-seizure medications approved for epilepsy treatment, according to another study scheduled for presentation at the meeting.
Cannabidiol is a major chemical component of marijuana, said Dr. Orrin Devinsky, a neurologist at NYU Langone Medical Center's Comprehensive Epilepsy Center in New York City and co-author of one of the studies.
CBD doesn't produce intoxication like pot's other major chemical compound, THC. But, researchers believe it may interact with a brain receptor that plays a role in the development of seizures, Devinsky said.
"This receptor has several effects, but one of them may be to modulate the calcium inside and outside the neuron, which is very much related to the excitability of nerve cells," he explained.
Previous studies have shown some benefit in adults, and word has spread. Families with adults and children with epilepsy have flocked to states where medical marijuana is legal to seek treatment, Brooks-Kayal said.
"There is a fairly active and vocal group of families in Colorado who are using cannabidiol oils that are made artisanally," she said.
To see whether children with epilepsy would benefit from cannabidiol treatment, Devinsky led a study involving 261 people, mostly children, whose seizures had not been controlled using current anti-seizure medications. The average age of the participants was 11.
Everyone received a British-made cannabidiol oil called Epidiolex, which was administered as a drop on the tongue, Devinsky said. This was in addition to their current drug therapy.
After three months, seizure frequency declined by an average 45 percent in all participants. Almost half experienced a 50 percent or greater reduction in seizures, and about one of every 10 patients became seizure-free, the study found.
"This was a very, very treatment-resistant group, and the response was very promising," Devinsky said.
A second study from the University of California, San Francisco, explored the long-term effectiveness of cannabidiol for children with epilepsy, by adding the marijuana-derived oil to the regular drug regimen of about 25 kids for one year.
The study found that after a year, the treatment resulted in a 50 percent reduction in seizures for 10 participants -- about 40 percent of the group. One child remained seizure-free, but 12 of the initial participants dropped out of the study because the cannabidiol didn't seem to do them any good.
Although he said he would prescribe CBD to people with uncontrolled seizures, Devinsky said he is "very anxious" to see the results of ongoing randomized, controlled clinical trials. The results of one major trial are expected in the first quarter of 2016, he added.
If CBD proves effective in controlled trials, it could be two to five years before the drug is approved by the U.S. Food and Drug Administration, Devinsky noted.
Federal regulators also will have to weigh potential interactions of cannabidiol with other anti-seizure drugs. Another study scheduled for presentation at the meeting found that CBD appeared to enhance the effects of the epilepsy medication levetiracetam (Keppra), when given to lab mice.
However, the oil appeared to interact negatively with two other drugs, clobazam (Onfi) and carbamazepine (Tegretol), the University of Utah researchers found.
Data and conclusions presented at meetings should be considered preliminary until published in a peer-reviewed medical journal.
By Dennis Thompson 2017 Up Date:
A landmark clinical trial has shown that a compound in marijuana can ease life-threatening seizures in children with a rare and devastating form of epilepsy.
Cannabidiol -- a non-intoxicating chemical -- reduced seizure frequency by 39 percent in patients with Dravet Syndrome, researchers report.
This is the first randomized, controlled trial to show that cannabidiol (CBD) can help control seizures in some people with epilepsy, said study author Dr. Orrin Devinsky. He is director of the Comprehensive Epilepsy Center at NYU Langone Medical Center in New York City.
"It's a big landmark in the scientific study of cannabis, and it's a major landmark in epilepsy care," Devinsky said. "After four millennia of using cannabis to treat epilepsy, we now have for the first time scientifically rigorously obtained data that this specific compound works in this specific form of epilepsy."
Brandy Fureman, vice president of research and new therapies for the Epilepsy Foundation, agreed that the new trial provides "gold standard" evidence of cannabidiol's effectiveness.
"We now have strong evidence that CBD [cannabidiol] can be helpful for some people with Dravet Syndrome," Fureman said. "This trial provides important information for doctors and families who are trying to decide if CBD should be tried in their child's particular case, how it can be administered safely, and what side effects to watch out for."
The clinical trial relied on a liquid formulation of cannabidiol called Epidiolex, which was developed by British company GW Pharmaceuticals.
Epidiolex has not been approved by the U.S. Food and Drug Administration. GW Pharmaceuticals -- which paid for the clinical trial -- expects to file for FDA approval of the drug this year.
In the trial, Devinsky and his colleagues recruited 120 children and teenagers with Dravet Syndrome, which generally starts causing severe seizures within the first year of life. The seizures often are prolonged and repetitive; 1 in 5 children with Dravet Syndrome do not live to see age 20, Devinsky said.
The patients, ranging in age from 2 to 18, were randomly assigned to receive every day either 20 milligrams of liquid Epidiolex or a placebo, on top of their usual medication. The study took place across 23 sites in the United States and Europe, and lasted 14 weeks.
Children receiving Epidiolex experienced fewer seizures, going from an average of 12 convulsive seizures a month before the study to about six seizures a month. Three patients' seizures stopped entirely.
At the same time, children in the placebo group only had a slight reduction in seizures, from about 15 to 14 seizures a month.
More than 9 out of 10 children did experience side effects from treatment with Epidiolex, the researchers found. The most common side effects were vomiting, fatigue and fever.
Although these symptoms generally were mild to moderate, eight children in the Epidiolex group withdrew from the trial due to side effects, compared to one patient in the placebo group.
The study appears in the May 25 issue of the New England Journal of Medicine.
Despite the side effects, Epidiolex seems as safe as other epilepsy medications, said Dr. Samuel Berkovic, director of the University of Melbourne's Epilepsy Research Center in Australia.
"Side effects are always an issue, but the drug was tolerated about as well as conventional anti-epileptic drugs," said Berkovic, who wrote an editorial accompanying the clinical trial report.
"Like other epilepsy medications, CBD appears to work for some people and not for others," Fureman said. "Like other epilepsy treatments, there are side effects of CBD that should be considered."
Cannabidiol-based treatments are available in the 29 states that have approved medical marijuana, Devinsky said.
The problem is that these products aren't manufactured under strict FDA oversight, and might contain varying levels of cannabidiol. The products also might contain THC, the biochemical in marijuana that produces a high, Devinsky said.
"Hopefully, in the next year to two years Epidiolex would get FDA approval, and then this drug could be available in pharmacies and people could have it covered by their health insurance," Devinsky said.
"In the interim, people are getting something like this from medical dispensaries in states with legalized medical marijuana," he continued. "The question is, how different are batches to batches."
SOURCES: Orrin Devinsky, M.D., director, Comprehensive Epilepsy Center, NYU Langone Medical Center, New York City; Brandy Fureman, Ph.D., vice president, research and new therapies, Epilepsy Foundation; Samuel Berkovic, M.D., director, University of Melbourne's Epilepsy Research Center, Australia; May 25, 2017, New England Journal of Medicine
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