One would be forgiven for assuming that there is nothing that CBD cannot fix. Cannabidiol (CBD), a compound found in the cannabis plant, is regularly extolled as a magical cure-all, touted to be able to ease chronic pain, to alleviate insomnia, and even to treat cancer. But according to preliminary research, there are clear differences in the capabilities of artisanal and pharmaceutical CBD — especially when it comes to treating epilepsy.
To date, the only CBD product to have received approval from the Food and Drug Administration (FDA) for medicinal use is for the treatment of epilepsy; specifically, to treat two rare and difficult-to-treat forms, Lennox-Gastaut syndrome and Dravet syndrome, usually seen in children. The name of the drug is Epidiolex. That means that any CBD product not approved by the FDA that’s marketed as a treatment for any disease or condition is currently illegal.
But just because it has been proven to help treat epilepsy, not all CBD products are cut from the same cloth — and the consumer CBD industry is subjected to little regulation.
Artisanal CBD — formulations that have not been approved by the FDA — are under no obligation to go through any kind of screening process. This means that quality and dose can vary widely.
In fact, some of the CBD products on the market may contain little, if any, of CBD at all. In a 2017 study published in JAMA, scientists report that 70 percent of the CBD products they tested did not contain the level of CBD that the packaging claimed it did. Some contained more, some way less, and some were even found to contain THC — the psychoactive component of cannabis that is responsible for the infamous “high”.
Another 2018 study, this one published in Forensic Science International, tested a variety of CBD vape liquids and found a dangerous synthetic cannabinoid called 5F-ADB (a Schedule-1 controlled substance). Some of the CBD products also contained dextromethorphan, a widely abused cough medicine.
In a preliminary study from researchers at the Children's National Hospital in Washington D.C., the efficacy of pharmaceutical-grade CBD — a formula of the compound that has received FDA-approval — was compared against that of artisanal CBD as a treatment method for epilepsy in children and teenagers. The researchers found that artisanal preparations of CBD were far less effective at preventing seizures than the regulated kind.
The findings will be presented at the American Academy of Neurology's 72nd Annual Meeting in Toronto, Canada, which takes place from April 25 to May 1, 2020.
Artisinal versus pharmaceutical
In the study, the medical charts of 31 children and teens, the average age being 10 years old, all diagnosed with a form of epilepsy, were followed for an average age of one year. Within the study group, 22 of the 31 subjects were being administered pharmaceutical-grade CBD, while nine were taking artisanal CBD.
When their medical history was reviewed, the researchers found that the children and teens who relied on only artisanal CBD displayed a massive 70 percent increase in seizures during the study. It is not known why this increase occurred.
Meanwhile, the patients who used CBD that was pharmaceutically produced had a 39 percent reduction in seizure frequency.
Another stark difference between the groups was their blood levels of CBD: Those taking pharmaceutical CBD had an average level of 124 nanograms per milliliter (ng/mL) of CBD in their blood. This compares to just 31 ng/mL for those taking artisanal CBD.
"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," study author Nathan T. Cohen, M.D., says. "They may want to reconsider because our research indicates that pharmaceutical CBD may indeed be more effective than artisanal CBD."
A number of the patients reported experiencing side effects due to the medication – and, surprisingly, of the 11 that did, all were taking pharmaceutical CBD. Side effects reported included sleepiness, low appetite, nausea, and diarrhea; some of the adverse reactions were so bad that six of the patients stopped taking the CBD. This may have been because the patients taking pharmaceutical-grade CBD were actually receiving the clinically recommended dose, and this is known to come with a variety of side effects similar to the ones seen in the study.
A major limitation of the study was that it was only observational. Future research should involve administering either pharmaceutical or artisanal CBD to patients with epilepsy and following their health over time.
This new, unpublished research serves as a cautionary tale to those using CBD to treat disease as serious as epilepsy — the current landscape of the commercial CBD industry is unregulated, and choosing pharmaceutical over artisanal CBD could make all the difference.
Objective: We hypothesize that cannabidiol (CBD) levels will be higher in patients taking pharmaceutical versus artisanal CBD and higher CBD levels will be associated with increased side effects and decreased seizure frequency.
Background: CBD is a neuroactive Cannabis-derivative with antiseizure properties. Pharmaceutical CBD was FDA-approved for the management of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome in June 2018 but artisanal CBD has utilized in various preparations since the late 1970s. These CBD preparations have varying manufacturing techniques and contain variable amounts of CBD/THC. It is our practice, when appropriate, to encourage transition from artisanal to pharmaceutical CBD.
Design/Methods: This is an IRB-approved retrospective chart review. We included patients with epilepsy treated with artisanal and/or pharmaceutical CBD who had serum CBD levels. Patients were identified by treating neurologists.
We recorded name, medical record number, date of birth, gender, epilepsy diagnosis, artisanal CBD dosage/concentration, pharmaceutical CBD dose, serum CBD level, seizure history, response to medication (percent reduction in motor seizures), and reported side effects.
Results: 31 patients met inclusion criteria, 48% female, mean age 10.1-years-old (range 3-20-years-old). Epilepsy syndromes were LGS 32%, Dravet 6%, and other epilepsy syndromes 62%. This includes 22 patients participating in a pharmaceutical CBD expanded access program from 9/2017-3/2019. Mean serum CBD level was 30.1 ng/mL in artisanal group and 124 ng/mL in the pharmaceutical group. At last follow-up (median follow-up 11.8 months (IQR 3.6-17.5 months), patients on artisanal CBD had 70% increase in overall seizures, while prescription CBD group had 39% reduction. 11 patients reported adverse effects (somnolence, emesis, diarrhea, diminished appetite), 6 of whom discontinued CBD due to side effects (all were in the prescription CBD group).
Conclusions: Pharmaceutical CBD achieves higher serum CBD levels and achieves better seizure control than artisanal CBD in refractory pediatric epilepsy patients. This group also reported increased adverse side effects.