People who suffer from epilepsy may not all desire to turn to medical cannabis or cannabidiol (CBD) to ease their symptoms. Yet, due to the recent findings of clinical trials, the signing of the 2018 Farm Bill, approval of Epidiolex, and the recent Medical Marijuana and Cannabidiol Research Expansion Act of December 2022, there may be more reason to try CBD than ever before [1, 2, 3]. There is hope on the horizon that CBD may be used as a treatment or complementary therapy for drug-resistant epilepsy.
Let’s take a look at the results of recent clinical trials, so you can make an educated choice about trying CBD.
Why Is Drug-Resistant Epilepsy?
When Epidiolex was approved, it opened the doors to further research on the effectiveness of CBD when treating drug-resistant epilepsy in children. There are many instances where seizures cannot be controlled with epilepsy medication, and so it is described as “intractable” or “drug resistant.” It is believed that about 25% of epilepsy cases in children and one-third of epileptic adults suffer from drug-resistant epilepsy. Some rare forms of epilepsy, like Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS), also fall under this category.
Clinical Trials On The Use Of Cannabidiol In The Treatment Of Epilepsy
In April 2019, a review of 14 clinical trials in phases 1, 2, and 3 of studies on CBD and epilepsy was published [4]. The researchers noted that, in many of the trials, the administration was short-term (about 10 days to 3 months on average) and the participants saw little to no side effects. In one study, only 5% of the patients who received a medium dose of CBD and 9.5% who had a high dose experienced adverse effects. Another reviewed trial noted that 14.3% of the participants “showed complete resolution of spams and hypsarrhythmia on day 14” of the study.
The review went on to say that several trials confirmed a 5 mg to 20 mg per day dose of CBD for children with Dravet syndrome. Half of the assessed trials used the 20 mg/day dosage and observed few non-serious adverse effects.
When summarizing the review, the researchers stated that “abnormal liver function was noted” in some participants who were taking concomitant valproate. However, because the adverse effects were not considered serious, CBD was declared a low-risk compound.
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A Focused Review Of Evidence And Gaps In Cannabidiol Research
October 2020 saw another review of clinical trials released, in which the researchers looked at the effectiveness of CBD for LGS and DS, as well as the associated adverse effects [5]. The researchers compared several studies, including those using medical cannabis, to see if THC was safer than CBD. “We do not recommend cannabis or other THC-rich compounds,” the researchers stated in the review, as the compounds may “present a risk of dependence, depression, psychosis, and suicide attempt.”
In the review, the researchers stated the safety profile of CBD is preferable. Adverse effects are mild, ranging from reduced appetite, vomiting, fever, fatigue, and drowsiness. Most trials also found that these side effects of CBD rarely last longer than the first month of usage.
In terms of safety and dosage, the reviewed studies leaned towards 10 mg and 20 mg a day, as these doses saw the greatest
One current failing of research—that CBD use among adult populations must be more thoroughly investigated—was also noted by the team conducting the review. It was also mentioned that the long-term safety of CBD must be the focus of future trials, as most are done with short-term side effects in mind.
Study On Long-Term Efficacy And Safety Of Cannabidiol
In 2014, a cannabidiol expanded access program (EAP) was opened up to provide patients with treatment-resistant epilepsy (TRE) [6]. The wide-reaching study offered CBD at 35 epilepsy centers in the US. Immediate results were published in 2016, but further results were provided in December 2022 on the long-term efficacy and safety of routine CBD use. The patients received 2-10 mg/kg/day of Epidiolex, with the dosage increasing up to 50 mg/kg by the end of the 192 weeks in which the study was conducted.
At the beginning of the study, there were 892 participants, but 322 individuals withdrew due to either adverse effects (7%) or a lack of efficacy (19%). The patients were also taking anti-seizure medications (ASMs) alongside Epidiolex. Upon reviewing the data, the researchers found that the median percentage reduction of convulsive seizures was 50-67% and total seizures were 46-66% when Epidiolex was used alongside the patient’s prescribed ASM.
However, one thing to take away from the study was that 88% of the participants experienced some kind of adverse effect. The most common were diarrhea, somnolence, and seizures. Yet, the additional Epidiolex did sustain seizure reduction in most patients for 192 weeks, providing evidence that the medication does indeed treat drug-resistant epilepsy.
Looking For High-Quality CBD?
Research using CBD has opened many windows into relief from treatment-resistant epilepsy. Evidence points to CBD benefiting those with epilepsy. That said, more research is needed. Most of the research has focused on children and took place over a short period of time. Although CBD has potential, there are also adverse effects to keep in mind, should you wish to give it a try.
Be sure to speak with a medical professional before purchasing CBD for yourself or someone you know.
Selecting high-quality CBD is also important. When you want the best, turn to Sugar Bottom Hemp. You are bound to find something to love in our wide selection of CBD products. Plus, you get peace of mind knowing that our CBD is sourced from organic hemp and analyzed by independent third-party labs. Check out our online store today or send us your questions!
Resources
1. Hemp Production and the 2018 Farm Bill. (2019, July 25). U.S. Food And Drug Administration. https://www.fda.gov/news-events/congressional-testimony/hemp-production-and-2018-farm-bill-07252019
2. Office of the Commissioner. (2020, July 31). FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease. U.S. Food And Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-new-indication-drug-containing-active-ingredient-derived-cannabis-treat-seizures-rare
3. Advocacy: Medical Cannabis CBD. (n.d.). Epilepsy Foundation. https://www.epilepsy.com/advocacy/priorities/medical-cannabis-cbd
4. Silvestro, S., Mammana, S., Cavalli, E., Bramanti, P., & Mazzon, E. (2019). Use of Cannabidiol in the Treatment of Epilepsy: Efficacy and Security in Clinical Trials. Molecules, 24(8), 1459. https://doi.org/10.3390/molecules24081459
5. Silva, G. D., Del Guerra, F. B., de Oliveira Lelis, M., & Pinto, L. F. (2020). Cannabidiol in the Treatment of Epilepsy: A Focused Review of Evidence and Gaps. Frontiers in Neurology, 11. https://doi.org/10.3389/fneur.2020.531939
6. Szaflarski, J. P., Devinsky, O., Lopez, M., Park, Y. D., Zentil, P. P., Patel, A. D., Thiele, E. A., Wechsler, R. T., Checketts, D., & Sahebkar, F. (2022). Long‐term efficacy and safety of cannabidiol in patients with treatment‐resistant epilepsies: 4‐year results from the expanded access program. Epilepsia. https://doi.org/10.1111/epi.17496
