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
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
Medical marijuana for children with developmental and behavioral disorders?
February 5, 2015
Science Daily/Wolters Kluwer Health: Lippincott Williams and Wilkins
As medical marijuana becomes increasingly accepted, there is growing interest in its use for children and adolescents with developmental and behavioral problems such as autism spectrum disorders (ASD) and attention-deficit/hyperactivity disorder (ADHD), according to a review in the February Journal of Developmental & Behavioral Pediatrics, the official journal of the Society for Developmental and Behavioral Pediatrics.
That's despite a lack of studies showing any clinical benefit of cannabis for young patients with these disorders -- whereas evidence strongly suggests harmful effects of regular marijuana use in the developing brain. Scott Hadland, MD, MPH, John R. Knight, MD, and Sion Kim Harris, PhD of Boston Children's Hospital write, "Given the current scarcity of data, cannabis cannot be safely recommended for the treatment of developmental or behavioral disorders at this time."
"Children with severe ASD cannot communicate verbally and may relate to the world through loud, repetitive shrieking and hand-flapping that is very disruptive to their families and all those around them," comments Dr Knight, the study's senior author. "So my heart goes out to families who are searching for something, anything to help their child," he continues. "But in using medicinal marijuana they may be trading away their child's future for short-term symptom control."
Known Harmful Effects of Marijuana in Children and Teens...
The review was prompted by rapid changes in US marijuana policy, with marijuana being permitted for medical use in many jurisdictions and legalized in others. "Amidst this political change, patients and families are increasingly asking whether cannabis and its derivatives may have therapeutic utility for a number of conditions, including developmental and behavioral disorders in children and adolescents," according to Dr Knight and colleagues.
They review the important pharmacological properties of cannabis and related compounds, along with data on marijuana use in the population. Adolescents with developmental and behavioral disorders -- especially ADHD -- may be predisposed to early and heavier substance use. Meanwhile, a growing body of evidence links cannabis to "long-term and potentially irreversible physical, neurocognitive, psychiatric, and psychosocial adverse outcomes."
Over time, regular cannabis use by adolescents has been linked to persistent declines in intelligence quotient and increased risk of addiction, major depression, anxiety disorders, and psychotic thinking. The adolescent brain may be uniquely susceptible to the harmful effects of marijuana, reflecting the role of the cannabinoid receptors in normal neurodevelopment. Brain abnormalities in adults who are heavy marijuana users may have their origin in neurodevelopmental changes starting in adolescence.
...With Little Data on Benefits in Developmental or Behavioral Disorders
While cannabis has been proposed to have a broad range of clinical benefits in adults, "At this time, good evidence is almost entirely lacking for its application in pediatric developmental and behavioral conditions," Dr Knight and coauthors write.
"The scant research that we have on adolescent use is alarming enough," says Leonard Rappaport MD, MS, Chief of the Division of Developmental Medicine at Boston Children's Hospital and past president of the Society for Developmental and Behavioral Pediatrics. "But we are really moving into entirely new territory when we consider giving cannabis to children as that has not even been done in neurotypical children, let alone those with developmental or behavioral problems."
And yet, a number of online groups are advocating the use of "medical marijuana" for children with autism, ADHD, and other developmental and behavioral conditions. These groups often cite evidence from animal research, or from a small number of clinical reports, to claim beneficial effects of cannabis in children. Those beneficial effects are likely from cannabidiols, which also benefit children with uncommon forms of epilepsy and have limited euphoric effects; rather than tetrahydrocannabinol (THC), with its strong euphoric and neurotoxic effects.
This movement, coupled with the increased willingness of physicians to prescribe cannabis, "may result in issuing of medical marijuana permits for developmental or behavioral diagnoses for which no data on efficacy, safety, or tolerability exist," the researchers write. They note that if and when studies of cannabis for developmental and behavioral conditions are performed, they will likely use extracts formulations of known dosage -- rather than plant forms of medical marijuana, which vary widely in strength and effects. Dr Knight adds, "We need more research on cannabidiols, and development of products that are high in cannabidiols and low in THC."
Dr Knight and coauthors hope their article will draw attention to the potential harmful effects of marijuana in young people -- as well as lack of evidence on its effects in those with developmental or behavioral disorders. They conclude, "As marijuana policy evolves and as the drug becomes more readily available, it is important that practicing clinicians recognize the long-term health and neuropsychiatric consequences of regular use."
https://www.sciencedaily.com/releases/2015/02/150205122733.htm