Artisanal CBD not as effective as pharmaceutical CBD for reducing seizures
February 27, 2020
Science Daily/American Academy of Neurology
Children and teens with epilepsy who were treated with pharmaceutical cannabidiol (CBD) had much better seizure control than those who were treated with artisanal CBD, according to a preliminary study to be presented at the American Academy of Neurology's 72nd Annual Meeting in Toronto, Canada, April 25 to May 1, 2020.
CBD is a cannabis component that relieves stress and anxiety and has anti-seizure properties. It does not produce a "high" like another cannabis component called tetrahydrocannabinol (THC). Pharmaceutical CBD for epilepsy does not have THC. It is FDA approved for use in two severe forms of childhood epilepsy, Dravet syndrome and Lennox-Gastaut syndrome, which do not respond well to other medications. Artisanal CBD is manufactured using varying techniques and contains variable amounts of CBD and THC.
"The use of medical cannabis to treat various medical conditions has grown in recent years. While not always legal, artisanal CBD has been available longer, so some people have been using it to treat epilepsy for years," said study author Nathan T. Cohen, M.D., of Children's National Hospital in Washington D.C., and a member of the American Academy of Neurology. "They may want to reconsider because our research indicates that pharmaceutical CBD may indeed be more effective than artisanal CBD."
For the study, researchers reviewed the medical charts of 31 children and teens with an average age of 10 who were followed for an average age of one year. All had some form of epilepsy including 32% with Lennox-Gastaut syndrome and 6% with Dravet syndrome. Of the group, 22 were taking pharmaceutical CBD and nine were taking artisanal CBD. Researchers recorded medication doses, levels of CBD in the blood, seizure history and reduction in seizures with medication and side effects.
Those taking artisanal CBD had an average level of CBD in the blood of 31 nanograms per milliliter (ng/mL) compared to 124 ng/mL for those taking pharmaceutical CBD.
Researchers found children and teens taking artisanal CBD had a 70% increase in seizures during the study. Those taking prescription CBD had a 39% reduction in seizures.
However, 11 participants reported side effects. All were taking pharmaceutical CBD. Side effects included sleepiness, low appetite, nausea and diarrhea. Six of those participants stopped taking pharmaceutical CBD due to side effects.
"The difference in seizure control is dramatic and is definitely of concern since many people continue to use artisanal CBD," said Cohen. "However, a limitation of our study is that it was small. More research is needed to see if similar results are found in larger groups of people."
Another limitation of the study was that it was a look back at medical records. It did not involve participants who were given either pharmaceutical or artisanal CBD and then followed over time.
https://www.sciencedaily.com/releases/2020/02/200227160545.htm
Medical marijuana liquid extract may bring hope for children with severe epilepsy
April 13, 2015
Science Daily/American Academy of Neurology (AAN)
A medicinal liquid form of marijuana may show promise as a treatment for children with severe epilepsy that is not responding to other treatments, according to a study released today that will be presented at the American Academy of Neurology's 67th Annual Meeting in Washington, DC, April 18 to 25, 2015.
The study involved 213 people, ranging from toddlers to adults, with a median age of 11 who had severe epilepsy that did not respond to other treatments. Participants had Dravet syndrome and Lennox-Gastaut syndrome, epilepsy types that can lead to intellectual disability and lifelong seizures, as well as 10 other types of severe epilepsy.
The participants were given the drug cannabidiol, a component of marijuana that does not include the psychoactive part of the plant that creates a "high." The drug is a liquid taken daily by mouth. Participants all knew they were receiving the drug in the open-label study, which was designed to determine whether the drug was safe and tolerated well.
Researchers also measured the number of seizures participants had while taking the drug. For the 137 people who completed the 12-week study, the number of seizures decreased by an average of 54 percent from the beginning of the study to the end. Among the 23 people with Dravet syndrome who finished the study, the number of convulsive seizures had gone down by 53 percent by the end of the study. For the 11 people with Lennox-Gastaut syndrome who finished the study, there was a 55 percent reduction in the number of atonic seizures, which cause a sudden loss of muscle tone.
A total of 12 people, or 6 percent, stopped taking the drug due to side effects. Side effects that occurred in more than 10 percent of participants included drowsiness (21 percent), diarrhea (17 percent), tiredness (17 percent) and decreased appetite (16 percent).
Study author Orrin Devinsky, MD, of New York University Langone Comprehensive Epilepsy Center and a Fellow of the American Academy of Neurology, said that these are early findings and larger, placebo-controlled, double-blind trials are needed to measure the effectiveness of the drug.
"So far there have been few formal studies on this marijuana extract," Devinsky said. "These results are of great interest, especially for the children and their parents who have been searching for an answer for these debilitating seizures."
https://www.sciencedaily.com/releases/2015/04/150413183743.htm
Cannabis-based medicine may reduce seizures for children with difficult-to-treat epilepsy
April 30, 2019
Science Daily/American Academy of Neurology
Taking a pharmaceutical formulation of cannabidiol, a cannabis-based medicine, cut seizures nearly in half for children with a rare and severe type of epilepsy called Dravet syndrome, according to a phase 3 study released today that will be presented at the American Academy of Neurology's 71st Annual Meeting in Philadelphia, May 4 to 10, 2019. Dravet syndrome, which starts in infancy, can lead to intellectual disability and frequent, prolonged seizures. Cannabidiol is derived from marijuana that does not include the psychoactive part of the plant that creates a "high."
"It's exciting to be able to offer another alternative for children with this debilitating form of epilepsy and their families," said study author Ian Miller, MD, of Nicklaus Children's Hospital, formerly Miami Children's Hospital, in Florida. "The children in this study had already tried an average of four epilepsy drugs with no success and at the time were taking an average of three additional drugs, so to have this measure of success with cannabidiol is a major victory."
The study involved 199 children with an average age of 9 who were divided into three groups. One group received 20 milligrams per kilogram (mg/kg) per day of cannabidiol, the second group received 10 mg/kg per day and the third group received a placebo.
Seizures were recorded for four weeks before the treatments were started to establish a baseline. Then the participants received the treatment for 14 weeks. By the end of the study, seizures with convulsions had decreased for those taking the high dose of the drug by 46 percent and by 49 percent for those taking the lower dose of the drug, compared to 27 percent for those taking the placebo.
Total seizures reduced by 47 percent for those in the high dose group, by 56 percent for those in the lower dose group and by 30 percent for those in the placebo group. In the high dose group, 49 percent of the participants had their seizures cut in half or more, compared to 44 percent in the low dose group and 26 percent in the placebo group.
All of the groups reported side effects, with 90 percent of the high dose group, 88 percent of the low dose group and 89 percent of the placebo group. The most common side effects were decreased appetite, diarrhea, sleepiness, fever and fatigue. About 25 percent of those in the high dose group had serious side effects, compared to 20 percent of those in the low dose group and 15 percent of those in the placebo group. Only participants in the high dose group stopped taking the drug due to side effects; that number was 7 percent.
"Based on these results, dose increases above 10 mg/kg per day should be carefully considered based on the effectiveness and safety for each individual," Miller said.
https://www.sciencedaily.com/releases/2019/04/190430164219.htm
Content of illicit cannabis extracts used to treat children with epilepsy revealed
Families who turned to black market did not get CBD-rich products; majority reduced seizures
July 5, 2018
Science Daily/University of Sydney
A pioneering study has found Australian parents who turned to medicinal cannabis to treat children with epilepsy overwhelmingly (75 percent) considered the extracts as "effective." Contrary to parental expectations, extracts generally contained low doses of cannabidiol (CBD) -- commonly considered to be a key therapeutic element and that has been successfully used in recent clinical trials to treat epilepsy.
The research, which commenced two years ago by the University of Sydney's Lambert Initiative for Cannabinoid Therapeutics, not only sheds light on the composition of cannabis used in the community but also reveals the legal, bureaucratic, and cost issues faced by families who relied on the products, as well as demonstrating the barriers to accessing medicinal cannabis.
The study found that the main psychoactive ingredient in cannabis, tetrahydrocannabidiol (THC), and the closely related compound THCA, were present in most extracts, although the quantity was generally not enough to produce intoxicating effects. Just over half the extracts were associated with a seizure reduction of 75-100 percent, which reinforces observations from animal studies and case reports of anticonvulsant effects of THC and THCA. As well, 65 percent were associated with other beneficial effects like improved cognition (35 percent) and language skills (24 percent).
The findings are published today by Springer Nature in its leading journal, Scientific Reports.
Lead author and PhD candidate with the Lambert Initiative at the Brain and Mind Centre, Ms Anastasia Suraev, said just under half the families who used medicinal cannabis reduced their antiepileptic medication.
"Our findings highlight the huge unmet clinical need in the management of treatment-resistant epilepsy in childhood," said Miss Suraev, from the School of Psychology.
Corresponding author and academic director of the Lambert Initiative, Professor Iain McGregor, said: "Although the illicit extracts we analysed contained low doses of CBD, three in four were reported as 'effective', indicating the importance of researching the cannabis plant in its entirety for the treatment of epilepsy.
"And despite the overwhelming presence of generally low levels of THC, concentrations did not differ between samples perceived as 'effective' and 'ineffective'.
"Our research indicates there is a potential role for other cannabinoids, alone or in combination with conventional drugs, in treatment-resistant epilepsy -- and this warrants further investigation so we can hopefully develop safer and more effective medicines."
https://www.sciencedaily.com/releases/2018/07/180705115620.htm
Cannabis use in people with epilepsy revealed: Australian survey
People with epilepsy resort to cannabis products when anti-epileptic drug side-effects are intolerable, epilepsy uncontrolled
March 9, 2017
Science Daily/University of Sydney
The first Australian nationwide survey on the experiences and opinions of medicinal cannabis use in people with epilepsy has revealed that 14 per cent of people with epilepsy have used cannabis products as a way to manage seizures.
The study showed that of those with a history of cannabis product use, 90 per cent of adults and 71 per cent of parents of children with epilepsy reported success in managing seizures after commencing using cannabis products.
Published in Epilepsy & Behaviour, the Epilepsy Action Australia study, in partnership with The Lambert Initiative at the University of Sydney, surveyed 976 respondents to examine cannabis use in people with epilepsy, reasons for use, and any perceived benefits self-reported by consumers (or their carers).
The survey revealed:
* 15 per cent of adults with epilepsy and 13 per cent of parents/guardians of children with epilepsy were currently using, or had previously used, cannabis products to treat epilepsy.
* Across all respondents, the main reasons for trying cannabis products were to manage treatment-resistant epilepsy and to obtain a more favourable side-effect profile compared to standard antiepileptic drugs.
* The number of past antiepileptic drugs was a significant predictor of medicinal cannabis use in both adults and children with epilepsy.
"This survey provides insight into the use of cannabis products for epilepsy, in particular some of the likely factors influencing use, as well as novel insights into the experiences of and attitudes towards medicinal cannabis in people with epilepsy in the Australian community," said lead author Anastasia Suraev from The Lambert Initiative.
"Despite the limitations of a retrospective online survey, we cannot ignore that a significant proportion of adults and children with epilepsy are using cannabis-based products in Australia, and many are self-reporting considerable benefits to their condition.
"More systematic clinical studies are urgently needed to help us better understand the role of cannabinoids in epilepsy," she said.
Co-author of the paper Carol Ireland, CEO of Epilepsy Action Australia, who was recently appointed to the Australian Government's new Australian Advisory Council on the Medicinal Use of Cannabis, said: "Cannabis products are often what people turn to when they have been unable to control their epilepsy with conventional medication."
"This highlights a growing need to educate consumers and health professionals on the use of cannabis by people with epilepsy, and to provide safe and timely access to cannabinoid medicine in order to lessen people's reliance on illicit black-market products" she said.
https://www.sciencedaily.com/releases/2017/03/170309120525.htm