Imagine parents obtaining illegal drugs to save their children. This idea sounds preposterous, but this scenario was a reality for many families with kids suffering from severe epilepsy in Australia (Suraev et al. 2018). These testimonies led to researchers branching out to discover if this treatment was a viable option. Millions of children suffer from treatment-resilient, intractable epilepsy. The health care system is stumped, and families are scrambling to find ways to find a solution. Surprisingly enough, those in Australia turned to marijuana. The theory of medical marijuana as a legitimate treatment for epilepsy has long been argued for, and researchers are struggling to draw a conclusion. A new study suggests medical marijuana may now become widely accepted as a last-resort treatment. Researchers across the nation came together to attempt to find the answer to a complex question.
This study was spearheaded by Dr. Orrin Devinsky, a professor at New York University; Dr. Eric Marsh, a pediatric neurologist at the University of Pennsylvania; Dr. Daniel Friedman, a researcher at the Epilepsy center of New York university; and their respective research teams. They received their funding from GW Pharmaceuticals and the Epilepsy Therapy Project of the Epilepsy Foundation. Their mission was simple: discover if medical marijuana can really be considered a safe and effective way to fight childhood epilepsy when all else fails. Over the course of twelve months, starting in January of 2014, these researchers collected a group of potential subjects. At the beginning of 2015, the trial finally began (Devinsky et al. 2015).
Patients—ages varying from one to thirty years old—were given a starting dose of two milligrams per kilogram of body weight of an oral cannabinoid (the main chemical within the cannabis plant). Over the course of the four-week trial period, this dose was steadily increased daily until the subject could not tolerate the dose or it reached the maximum dosage of either twenty-five or fifty (dose depended on testing site) mg/kg. Researchers had two goals in mind when observing the subjects. First, to find if cannabis is a safe and tolerable treatment. Second, to specifically discover the efficacy of medical marijuana at lowering the median percentage of mean monthly frequency of motor seizures.
The researchers needed to overcome a bias caused by one detail: marijuana is still an illicit substance. In the early 2000s, educational campaigns were launched to “warn” the public of the harmful consequences of marijuana (West and O’Neal 2004). In reality, these campaigns scared many people into believing a stigma that marijuana carried irreversible effects. To counteract this stigma, researchers had to ensure the safety of marijuana as treatment was a top priority within the trial. Subjects were asked to report any adverse conditions. Out of the 162 patients that were asked to report information for safety and tolerance analysis, 128 reported adverse effects (79%); however, only 5 patients, or 3%, had to withdraw from the study due to adverse effects. The most common side effects were drowsiness, decreased appetite, diarrhea, and fatigue (Devinksy et al. 2015). Status epilepticus, a seizure lasting longer than 5 minutes which can cause permanent brain damage, was reported in 9 patients, but there is no concrete evidence that shows marijuana as the cause. Overall, the researchers decided the side effects are potentially minor enough to believe medical marijuana is safe enough to treat children, but the researchers admitted future trials may necessary (Devinsky et al. 2016).
Ultimately, 137 patients were a part of the efficacy analysis. Researchers observed the mean frequency of monthly motor seizures. Motor seizures are classified as any seizure that causes a change in muscle activity. The results found the median percentage of mean frequency had decreased by 36.5% (Devinsky et al. 2015). These findings were published in The Lancet, a Neurology journal. This data infers medical marijuana has the potential to be used as a treatment for children suffering from unmanage and treatment-resilient epilepsy. Although it is not a cure, medical marijuana may be the glimmer of hope these children, and their families, are desperate for. These findings are instrumental for the future of epilepsy treatment. Children with epilepsy this severe are struggling to maintain a quality of life high enough to enjoy any aspects of life, so any treatment that even has the potential to ease this suffering is incredible. This trial can pave the way for a variety of future research.
Even if the findings are incredible, this trial does not lack flaws. It is an open-label trial, which means both the researchers and the subjects are aware of all aspects of the trial. Even in this study, this flaw creates bias. It is self-reported results, so subjects may report information as a result of the placebo-effect. The only way to procure true results is through a double-blind, placebo-controlled study. Without a control group, we cannot compare the results with a high enough level of confidence. This was the main issue the authors recognized in a response to a letter of criticism (Devinksy et al. 2016). Additionally, the subjects had varying ongoing treatments at the start of the trial and were not properly categorized. The underlying treatments could all react differently with medical marijuana, so it would have been beneficial to properly categorize by this variable and observe the groups. This trial has the potential to be repeated, and could draw more conclusive results if the suggestions above are used.
When the stigma around marijuana is avoided, there is the potential to find significant benefits of its medical use. The researcher team involved in this study successfully showcased the benefits. Future researchers can utilize these findings, and learn from the trial’s mistakes. The Scientific world has the potential to move towards proving the efficacy of medical marijuana, and even better understand marijuana as a whole.
References:
Devinsky O, March E, Friedman D, Thiele E, Laux L, Sullivan J, Miller I, Flamini R, Wifong A, Filloux F. et al. 2015 Dec. 23. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial. Lancet. [Accessed 2020 Aug 19];15(3):270-278. https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(15)00379-8/fulltext#%20. doi:10.1016/S1474-4422(15)00379-8
Suraev A, Lintzeris N, Stuart J. et al. 2018 July 5. Composition and use of cannabis extracts for childhood epilepsy in the Australian community. Sci Rep 8. [Accessed 2020 Aug 19];10154 (2018). https://www.nature.com/articles/s41598-018-28127-0. doi:10.1038/s41598-018-28127-0
West S, O’Neal K. 2004 June. Project D.A.R.E. outcome effectiveness revisited. Am J Public Health. 94(6):1027–1029.
Devinsky O, Marsh E, Friedman D. 2016. Cannabidiol in patients with treatment-resistant epilepsy – Authors’ reply. Lancet. 15(6):545–546. doi:10.1016/S1474-4422(16)00120-4.
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