Author: Tierney Baum, PhD, Strategic R&D Consultant
Editor: Gabrielle Rushing, PhD, Chief Scientific Officer
The last decade has seen a surge in the use of cannabis-derived products for the treatment of everything from aches and pains to anxiety and even heart issues. One such use is taking cannabidiol (CBD) to help improve seizure severity in individuals with epilepsy and other seizure disorders. A growing cultural and political acceptance in the United States has made these products easier to acquire and has increased their widespread use. However, there still lacks sufficient clear, quantitative data to help potential users understand how cannabis products might be used for different disorders.
In this Science Snapshot we will dive into what CBD is and current clinical evidence for its use in children with neurodevelopmental disorders.
Cannabis Terms Explained
Cannabis for Pediatric Epilepsy
Though there is currently little information on the effects of CBD for OCNDS patients, there are several published studies in patients with other neurodevelopmental disorders with seizure activity.
In a 2017 study of patients with Dravet syndrome, 43% of individuals had a 50% reduction in monthly seizures after daily CBD administration (Devinsky et al., 2017). In a similar 2018 study, researchers reported a 41.9% reduction in atonic seizures in patients with Lenox-Gastaut Syndrome (LGS) treated with daily CBD for the treatment period (Thiele et al., 2018). The results of these studies led to FDA approval of prescription CBD, called Epidiolex, in 2018 for patients with Dravet syndrome, LGS, and Tuberous Sclerosis Complex patients over one year of age. Epidiolex is a CBD-only medication with no THC
(Abu-Sawwa et. al, 2020).
A systematic review published in 2018 of 17 clinical trials of CBD treatment in children with epilepsy found that overall CBD treatment was more effective than placebo.
In these trials CBD treatment resulted in 48.7% of patients having a 50% reduction in seizures. There were also few adverse events reported in these trials (2.2% of patients) (Stockings et al., 2018). An adverse event is considered an unfavorable or unintended symptom from taking the study treatment; more details on possible side effects from CBD treatment in children are listed in the next section.
Placebo is often a sugar pill, water or saline injection, or something similar that is meant to have no medical effect in a patient. A placebo is used in a study because it is well documented that it is possible for a patient's symptoms to improve after only taking placebo; this is known as the
placebo effect. It is not fully understood what causes the placebo effect, but including a placebo in study design is important to understand the true effects of the medical treatment.
Though these reports are very promising, there are a couple of important considerations. Firstly, in the studies on Dravet and LGS, there were significant placebo effects on untreated patients. It is therefore difficult to conclude how effective CBD treatment alone was in these studies. Furthermore, patients in all studies mentioned received pharmaceutical grade CBD, which is highly pure and difficult to acquire outside of clinical research.
Risks and Other Considerations
Most of the CBD products available to consumers come in the form of extracts or artisanal products with the following concerns:
- High variability in CBD purity even from the same supplier
- Possible THC contaminants (most products are found to have some THC)
- Poor regulation
These issues create roadblocks for new research studying the effects of over-the-counter CBD products in children with neurodevelopmental disorders. However, studies conducted using these products on children still suggest an overall improvement in seizure activity (Tzadok et al.,2016; Huntsman et al., 2020).
Some studies have reported the following possible side effects/risks in using these products:
- Potential THC intoxication (with possible developmental risks)
- High rates of mild side effects
- Sleepiness, nausea, diarrhea, fatigue, decreased appetite
- Rare but serious side effects
- Increased liver enzymes, blood dyscrasias (disease that affects the blood, bone marrow, or lymph tissue, e.g., anemia), and worsened seizures
The Takeaway Message
While studies using both pharmaceutical-grade and over-the-counter CBD show overall promising results, parents are encouraged to consult with their doctor to ensure safe and informed use of these products. There are still many questions about dosage, effects on different seizure types, long term adverse effects, and other cannabinoid contaminants in each product.
Currently, CBD is shown to be likely effective in treating seizures in children but not necessarily more effective than conventional anti-seizure medications. Overall, the potential developmental risks to using CBD products should be weighed against the potential developmental harm of chronic seizures in these children (particularly in children who do not respond to anti-seizure medications).
More studies are needed to fully understand the effects of cannabinoids on children and no studies have been conducted to date on children with OCNDS and seizures. Anecdotally, the foundation has had 2 families report using this medication.
In 2022, President Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act into law. This law will continue to make it easier to conduct medical research on cannabis in the US. This law also makes it easier for doctors to discuss the benefits and risks with patients without violating the Controlled Substances Act.
* A Schedule 1 substance is a category of drugs that the U.S. government has classified as having a high potential for abuse, no currently accepted medical use in treatment, and a lack of accepted safety for use under medical supervision. This classification is part of the Controlled Substances Act, which regulates certain drugs and chemicals. Examples of Schedule 1 substances include heroin, LSD, and ecstasy. Because of this classification, these substances are illegal to manufacture, possess, or distribute in the United States, except for very limited research purposes with special permission from the government. The conflict between state and federal law arises because drug classification under federal law is slow to change, often due to political, regulatory, and societal factors. States, however, have been quicker to adapt to changing public attitudes toward cannabis, recognizing both its potential medical benefits and its economic advantages through taxation and regulation.
References
Abu-Sawwa R, Stehling C. Epidiolex (Cannabidiol) Primer: Frequently Asked Questions for Patients and Caregivers. J Pediatr Pharmacol Ther. 2020 Jan-Feb;25(1):75-77. doi: 10.5863/1551-6776-25.1.75. PMID: 31897080; PMCID: PMC6938286.
Devinsky O, Cross JH, Laux L, Marsh E, et al. Trial of cannabidiol for drug-resistant seizures in the Dravet syndrome. N Engl J Med 2017;376:2011–2020.
Huntsman, Richard J.*; Tang-Wai, Richard†; Shackelford, Alan E.‡. Cannabis for Pediatric Epilepsy. Journal of Clinical Neurophysiology 37(1):p 2-8, January 2020. | DOI: 10.1097/WNP.0000000000000641
Stockings E, Zagic D, Campbell G, et al. Evidence for cannabis and cannabinoids for epilepsy: a systematic review of controlled and observational evidence. J Neurol Neurosurg Psychiatry 2018;89:741–753.
Thiele EA, Marsh ED, French JA, Mazurkiewicz-Beldzinska M, et al. Cannabidiol in patients with seizures associated with Lennox-Gastaut Syndrome (GWPCARE4): a randomized, double blind, placebo controlled phase 3 trial. Lancet 2018;391:1085–1096.
Tzadok M, Uliel-Siboni S, Linder I, et al. CBD enriched medical cannabis for intractable pediatric epilepsy: the current Israeli experience. Seizure 2016;35:41–44.
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