TORONTO – Pediatric refractory epilepsy patients who used pharmaceutical-grade cannabidiol (CBD) had higher CBD serum levels and better seizure control than patients using artisanal CBD, a small study showed.
Mean serum CBD level was 30.1 ng/mL in patients with epilepsy who used artisanal CBD and 124 ng/mL in those taking prescription CBD, reported Nathan Cohen, MD, of Children’s National Hospital in Washington D.C., and co-authors, in an early-release abstract from the American Academy of Neurology annual meeting, which will be held here in April.
At a median follow-up of 11.8 months, patients on artisanal CBD experienced a 70% increase in overall seizures, while the prescription CBD group had a 39% reduction.
„We see many patients with refractory seizures and families who are searching for treatment options to help their children,” Cohen said. „There has been greater interest in natural treatment options, which has been driven by the increasingly shifting legalization status of marijuana-based products.”
„It’s our practice, when appropriate, to encourage transition from artisanal to pharmaceutical CBD,” he added. „We hope that physicians — and patients and their families — can use these data to help make better-informed decisions about cannabidiol-based products to treat pharmaco-resistant epilepsy,” he told MedPage Today.
Pharmaceutical-grade cannabidiol (Epidiolex) was approved by the FDA in 2018 to treat seizures in patients age 2 and older with Lennox-Gastaut syndrome or Dravet syndrome, two rare forms of severe epilepsy. Pharmaceutical cannabidiol is a component of the Cannabis sativa plant that doesn’t cause the intoxication or euphoria that comes from tetrahydrocannabinol (THC). Artisanal CBD has been used since the late 1970s and may contain variable amounts of CBD and THC.
Lower serum CBD levels in patients using artisanal CBD isn’t surprising, noted Robert Carson, MD, PhD, of Vanderbilt University Medical Center in Nashville, who wasn’t involved with the research.
„The doses we use for pharmaceutical CBD start at 5 mg/kg/day and increase to 20 mg/kg/day,” Carson told MedPage Today. „In my experience, very few families could afford to dose artisanal CBD at doses approaching the 20 mg/kg/day range.”
In their study, Cohen and colleagues conducted a retrospective chart review of 31 children and teens with an average age of 10, following them for about a year. All had some form of epilepsy; 32% had Lennox-Gastaut syndrome and 6% had Dravet syndrome. About half of the group was female. The study was not initiated or supported by Epidiolex’s maker.
A total of 22 patients were taking pharmaceutical-grade CBD and nine patients were being treated with artisanal CBD. Prescription CBD patients were participants in a pharmaceutical CBD expanded access program from September 2017 to March 2019. Artisanal CBD patients were identified by treating neurologists.
All 11 patients in the study who reported side effects in the study — somnolence, emesis, diarrhea, and diminished appetite — were taking pharmaceutical CBD. Six of those participants stopped treatment due to adverse events.
„It would be interesting to compare the side effect profiles of the two products at equivalent serum levels,” Carson noted. „Especially at the higher doses, the differences in THC content between the products — which I would expect to be higher in the artisanal group — may contribute to additional side effects in the artisanal group that may not be seen with the pharmaceutical product.”
This study is limited by its small sample size, retrospective nature, and possible selection bias. Unmeasured factors, including variations in artisanal CBD manufacturing processes, may have influenced results. The findings need to be confirmed in a larger study, Cohen said.
„Families continue to use artisanal products and report benefits at doses far lower than the doses we typically use with the pharmaceutical-grade CBD,” Carson observed. „This study may suggest that those doses are not adequate for long-term seizure control, reinforcing why we dose the pharmaceutical grade product the way we do.”
Disclosures
This study received no funding.
Cohen declared no conflicts of interest.