Medical Cannabis, CBD Oil, & Epidiolex®
The cannabis sativa plant, commonly known as marijuana, is a traditional herbal medicine that has been used to treat a variety of conditions for thousands of years. Its significant anticonvulsant effects were described by physicians in ancient China, India and the Middle East - dating as far back as 1000 BCE. Cannabis was used in Western medicine to treat epilepsy as early as the 1800’s. Medicinal tinctures made from the cannabis plant were widely available in the United States up through the early part of the 20th century.
Despite its medicinal qualities, cannabis use was criminalized during the 20th century due to its psychotropic effects, its potential for abuse, and complicated as well for controversial political reasons. Until recently, this has prevented much clinical pharmaceutical research. However, because of the advocacy of parent organizations and patient groups, 29 US states decriminalized the use of cannabis for medical purposes. (Though legislation exists in the US Senate to change the way it is regulated, medical cannabis treatment remains prohibited at the federal level.)
Today, research into the medicinal uses of the cannabis plant and its over 750 chemical components is seeing a renaissance. Research centers in San Diego and Philadelphia have been established to study its medical use. At least one pharmaceutical company is producing and testing potential medicines derived from the cannabis plant to treat refractory (drug-resistant) epilepsy, traumatic brain injury and autism.
The two primary components of cannabis that have been isolated and studied are THC (tetrahydrocannabinol) and CBD (cannabidiol). THC is psychoactive and produces the “high” that is associated with marijuana use. THC has been shown to have both anti-seizure and pro-seizure effects. (A recent Israel-based study showed a 7% increase in seizure activity from medical marijuana containing THC.) CBD, on the other hand, is non-psychoactive and has been shown to have anti-seizure effects.
Both CBD and THC are present in “medical marijuana” that is sold through dispensaries. CBD oil is derived from whole plant sources, therefore contains both CBD and THC - but in varying amounts. Because CBD oils are manufactured and sold as a dietary supplements, each manufacturer has its own preparation and components, with CBD and THC amounts that may vary from batch to batch.
CBD (Cannabidiol) Oil
CBD oil is an herbal tincture from especially hybridized cannabis plants. Specific formulations low in THC and high in CBD are available for sale in states where medical marijuana is legal and over the internet. CBD oil is marketed as a dietary supplement and its medicinal properties are not regulated by law. Indeed CBD oil sales may be illegal by federal standards.
Recent research on CBD oil and medical cannabis has shown that there is evidence that it is helpful in controlling seizures, especially in Dravet and Lennox-Gastaut syndromes. However, CBD has a number of reported side effects. In open-labeled studies, side effects included sleepiness, diarrhea, fatigue, and decreased appetite. CBD also has interactions with some epilepsy medications. Moreover, CBD oil and medical cannabis are not standardized or regulated by the FDA. To help navigate the use of CBD oils, including advice for dosage and drug interactions, the Society of Cannabis Clinicians established a referral directory to help parents find knowledgeable physicians willing to advise patients on its use. (http://cannabisclinicians.org/)
Despite legal concerns, parents and patient advocates have banded together to test the most medically promising CBD oils. Realm of Caring Foundation, founded by the makers of Charlotte’s Web a low-THC, high CBD oil, is a non-profit dedicated to research and education about CBD oils. To participate in research, parents can contact them at their website.
Cannabis-derived synthetic pharmaceuticals: Epidiolex®
Some synthetically produced cannabinoids have approved, legal therapeutic applications. For instance, Marinol®, a synthetically produced form of THC, has approval for its anti-nausea and appetite stimulating properties. Sativex®, a synthetic combination of THC and CBD, has approval for spasticity.
Epidiolex®, a synthetic CBD-based compound, is currently being tested as a treatment for refractory epilepsy (including Dravet and Lennox-Gastaut syndromes), Tuberous Sclerosis Complex, traumatic brain injury, and autism.
Produced by GW Pharmaceuticals, researchers recently conducted successful open-label (meaning that no placebo was given) and randomized control trials in the United Kingdom. In these studies, children with drug-resistant epilepsy (specifically with Dravet and Lennox-Gastaut syndromes) were given Epidiolex. In the open-label study, 45% of patients had a 50%+ reduction in seizure activity. In the randomized control study, both study and control groups had a significant reduction in seizures, showing a substantial placebo effect. However, the group receiving Epidiolex had a 27% greater reduction in seizures versus the control group.
In 2018, the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. FDA recommended that the agency approve Epidiolex for children with Lennox-Gastaut syndrome and Dravet syndrome. It awaits final FDA approval.
GW Pharmaceuticals is also testing a homologous CBD compound called cannabidivarin for seizures in children with Rett syndrome, epilepsy, autism spectrum disorders.