Epilepsy Patients Who Use Commercial CBD Products Have Higher Quality of Life, Study Finds
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People with epilepsy who use non-prescription CBD products have a higher quality of life and benefit from improved sleep and less anxiety compared to their peers who do not use CBD, according to new research.
The study, published in the peer-reviewed journal Epilepsy & Behavior, did not see any significant changes in seizure frequency between these two groups. However, the researchers from Johns Hopkins University and the Realm of Caring Foundation believe that future studies with more narrow inclusion criteria may see a different outcome.
Even so, they argue that the observed improvements to patient quality of life alone are enough to highlight the need for controlled trials looking at non-pharmaceutical CBD products, to evaluate if and how they can be used most effectively by people with epilepsy.
The study was partly funded by Canopy Growth, a major Canadian cannabis company, and Lundbeck, a Danish international pharmaceutical company.
Artisanal CBD users take fewer prescriptions and use healthcare services less often
All of the participants in the new observational study came from a patient registry operated by Realm of Caring, a cannabis education and research non-profit, or were recruited from social media posts. In total, the study covered 71 adults with epilepsy and 209 adult caregivers to children or dependent adults with epilepsy who reported using commercially available artisanal CBD products for medicinal reasons. A control group of 29 adults and 109 caregivers who did not use CBD were also included.
Participants were given a web-based survey designed to measure several areas related to health, including overall quality of life, sleep quality, pain, anxiety and depression, and healthcare utilization. Patients were also asked to detail the frequency and extent of their CBD product use and report any relevant adverse effects they may have experienced. Follow-up surveys were offered to participants every three months, with participants completing an average of 2.6 follow-ups over the course of the study period.
“We looked at a lot of important variables that are both epilepsy and seizure-related, and then also those that don’t receive as much attention in clinical trials or in the literature. The really interesting results were related to everyday variables that I think a lot of us now take for granted,” study author Dr Nicolas Schlienz, director of research at Realm of Caring, told Analytical Cannabis.
“We saw improvements in quality of life among epilepsy users. We also saw improvements to anxiety and depression and sleep. While those variables may not be the focus of clinical trials very often, you still want to see those improvements among these among any patients. Because if you don’t have those, then you would have epilepsy or seizures affecting a lower quality of life, making that even more difficult for the patient.”
These benefits – the elevated quality of life, lower psychiatric symptom scores, and improved sleep quality – were seen in both the cross-sectional comparisons as well as the longitudinal comparisons made across the follow-up studies.
The observational study also found that those with epilepsy who use artisanal CBD products tolerated their epilepsy medications with fewer adverse side effects, used fewer prescription medications overall, and had lower odds of utilizing healthcare services (such as emergency room visits or sick leave days) compared to their non-CBD-using counterparts.
Study limitations may explain the negligible difference in seizure control
While the artisanal CBD users did report slightly fewer seizures than the non-users, this difference was not statistically significant. This was an interesting finding, as pharmaceutical CBD medicines such as Epidiolex have demonstrated their ability to suppress seizure frequency in multiple clinical trials. These medicines are so effective and have so few adverse events associated with them that Epidiolex has already been approved for the treatment of rare refractory epilepsies in the United States and European Union.
“We had epilepsy patients and controls, and we didn’t find any differences related to seizure variables, such as severity or frequency. And we were struck by that,” recalled Schlienz.
“So, we probed a little bit deeper, and a lot of the people that are in our registry [Realm of Caring’s Observational Research Registry], their seizures were well controlled before even enrolling in the study. So there wasn’t really much room to get that signal.”
In their paper, the researchers offer a second additional hypothesis to explain this finding. The median CBD dose reported by the participants was just 1.4 milligrams per kilogram per day (mg/kg/day), significantly lower than the 10-20 mg/kg/day maintenance dose normally recommended for Epidiolex. It is possible that at this low dosage the anti-seizure effect may not be as effective, especially given the fact that most patients in the cohort were already taking traditional anticonvulsant medication to control their seizures.
With this in mind, the researchers suggest that future studies could consider imposing more stringent experimental controls on CBD dosing frequency, dose amounts, and product chemotype/composition, in order to better assess the seizure control outcomes.
Why are researchers so interested in artisanal CBD products?
With Epidiolex already approved for use in epilepsy, it may seem like an odd choice to investigate commercially-available artisanal CBD products for epilepsy in this much detail. But as the researchers explain, there is still a large group of CBD users who are using these artisanal products for medicinal purposes.
“The healthcare system can be pretty complex, so a lot of people may not have access to Epidiolex due to access issues, health insurance plans, you name it,” said Schlienz. “But there’s no shortage of artisanal CBD products in the US – you see them everywhere. Accessibility is a big factor, and that led us to want to know more about artisanal CBD.”
So long as accessibility remains an issue, it follows that there will be people who feel they have no choice but to use these commercially-available products. As the market continues to grow and develop at breakneck speed, the goal for researchers will be to ensure that scientific understanding can answer the questions of these users and ensure that there is evidence-based advice available to all who need it.
“I have no idea how many different companies produce CBD in the US – it will be hundreds and hundreds, and that’s aside from the CBD that’s imported in from China and other countries. I guess the natural question becomes, how do we know that this is the real thing? Is it strong enough? Is it safe?” Schlienz said.
“Whenever I tell someone that I’m a cannabis researcher they might ask me, how much should I use? And I love hearing that question,” he adds. “But there’s a lot to be done, because we don’t know the answers. I’m sure there are thousands of nurses and physicians and other healthcare experts that get these questions. Having high-quality data to inform that, that is what will move our understanding of this plant forward.”