Epilepsy And The Effectiveness Of Cannabidiol Therapy
There’s a growing interest in the potential medical uses of cannabidiol (CBD), a non-psychoactive compound found in cannabis. CBD has been studied for its various effects, and it has shown promise in reducing seizures, particularly in children with drug-resistant epilepsy.
CBD’s Phase III studies showed positive effects on seizures in specific epilepsy syndromes, leading to Epidyolex approval in Europe for LGS and DS, often used with clobazam. In the USA, Epidyolex is approved independently for these epilepsy subtypes, highlighting CBD’s efficacy.
With CBD’s overall safety and the need for new treatment options, especially for drug-resistant epilepsy, researchers saw promise in CBD as an antiseizure medication. Their study aimed to collect real-world data on CBD usage, dosing, side effects, and effectiveness in over 300 individuals with various forms of epilepsy, both children and adults.
Overview of the Study
The study investigated the potential uses of cannabidiol (CBD) beyond its approved treatments for Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), and tuberous sclerosis complex (TSC). While CBD is already approved for these specific epilepsy syndromes, the researchers in this study are interested in exploring its antiseizure effects in a broader context.
They aim to determine whether CBD may have benefits in treating other forms of epilepsy beyond the three syndromes mentioned. This suggests a broader investigation into the potential efficacy of CBD as an antiseizure treatment.
Methods
The study was conducted across 16 different epilepsy centers. The procedures focused on analyzing the effectiveness and how well patients tolerated Cannabidiol (CBD) for the treatment of epilepsy.
Epidyolex® was utilized by 70.7% of patients, while 29.3% received CBD in the form of NRF 22.10, a CBD solution in medium-chain triglycerides available without a prescription in German pharmacies. Both were included in the study due to their nearly identical CBD content and similar composition.
The study involved patients with epilepsy who received CBD as an antiseizure medication. Six patients treated with non-oral CBD formulations were excluded. Local ethics committee approval was obtained for the retrospective analysis, and informed consent was not required.
Data on seizures and treatment were collected from medical records, and seizure outcomes were assessed by specialists based on patient history, seizure diaries, and parental input for minors. The assessment included seizure freedom, seizure reduction over 50%, seizure reduction under 50%, or no effect/worsening. Missing data were minimal, and no patient needed to be excluded.
Data were managed in REDCap, and statistical analysis was conducted using IBM SPSS Statistics Version 25, with specific tests indicated in the results section. Results with a P-value under 0.05 were considered statistically significant, and figures were generated using GraphPad Prism version 9.3.1.
Results
The median age of the patients was 11.3 years, ranging from newborns to individuals as old as 72 years. Among these patients, 235 were children and adolescents, while 76 were adults.
It’s important to note that CBD treatment in this study was considered off-label in 91.3% of cases. This was primarily due to reasons such as the patient’s age, the specific type of epilepsy they had, the absence of adjunct therapy with clobazam, or the application of higher doses than what is typically recommended.
The study revealed that the CBD titration regimens, which refer to the process of adjusting the CBD dosage, were slower than the recommended guidelines. Surprisingly, despite the use of higher doses, especially in children, CBD treatment was generally well-tolerated.
Approximately 36.9% of all patients experienced a notable reduction in seizure frequency of more than 50%, and this improvement was observed across different epilepsy subtypes, irrespective of whether they were taking clobazam alongside CBD. This suggests that CBD had a positive impact on seizure control for a significant portion of the patient population.
The study’s median observation period lasted for about 15.8 months, during which researchers closely monitored the patients.
However, it’s worth noting that around one-third of the patients had to discontinue CBD therapy within the observation period. This was often due to adverse effects or a perceived lack of effectiveness in managing their epilepsy.
Adverse effects were reported frequently among the patient population, with nearly half of them experiencing these unwanted side effects during the course of CBD treatment.
Final Thoughts
The study reveals that CBD, which is derived from cannabis, has an antiseizure effect that’s on par with other medications designed to prevent seizures. The good news is that CBD appears to be safe for people with epilepsy, regardless of the specific type of epilepsy they have.
Interestingly, using CBD alongside another medication called clobazam didn’t seem to make the outcomes any better. In other words, the combination of CBD and clobazam didn’t show a significant advantage over using CBD alone.
When it comes to dosage, it turns out that higher doses of CBD can be used to reduce seizure frequency, especially in children. Even at these elevated doses, CBD still appears to be safe.
The results of this study are indeed promising and provide a compelling reason to delve deeper into the potential advantages of CBD in managing various forms of epilepsy. Currently, CBD is predominantly approved for specific epilepsy syndromes, but these findings indicate that it might be beneficial for a broader spectrum of epilepsy types. This opens up exciting possibilities for expanding the use of CBD as a treatment for epilepsy beyond the limited scope it currently has.
What’s particularly noteworthy is that this research hints at the prospect of utilizing CBD as an effective treatment for very young children, including those who are under the age of 2. Epilepsy in very young children can be especially challenging to manage, and the availability of a safe and potentially effective option like CBD could be a game-changer for both patients and healthcare providers.
This revelation underscores the importance of further research and clinical trials to explore the full potential of CBD as a versatile and safe antiseizure medication for various age groups and epilepsy subtypes. It’s an exciting step toward improving the quality of life for those affected by epilepsy, regardless of their specific circumstances.
In a nutshell, this study opens the door for more research and clinical trials to potentially expand the approved use of CBD in managing epilepsy across various subtypes and age groups, offering hope for improved treatment options.
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