A study conducted by Rayyan Zafar and his colleagues from the Imperial College London was recently published in BMJ Paediatrics Open. This investigation evaluated the efficacy of whole-plant cannabis as a treatment for children with epilepsy. They found that seizure frequency was reduced in patients with intractable epilepsies who were treated with whole-plant cannabis.
What is Whole-Plant Cannabis?
Whole-Plant Cannabis includes cannabidiol, terpenes and other molecules, neuroactive cannabinoids, as well as tetrahydrocannabinol (THC), the psychoactive compound which causes the “high.”
In the UK, recreational cannabis and medical cannabis were both deemed illegal in 1971. This was despite ongoing anecdotal evidence for their potential to treat epilepsy.
In 2018, following activism from families with epilepsy, whole plant cannabis was deemed eligible to be offered as prescription for childhood epilepsy. There are now two NHS cannabis based products for children. The surge of activism came from parents who were seeing that their kids weren’t responding well to CBD oil (purified cannabidiol) or other anti epileptic drugs (AEDs). What they did respond to was whole plant extracts.
Despite this approval, many doctors are still wary about prescribing it. This is because there aren’t any randomized controlled clinical trials in this patient population. This type of trial is deemed the gold standard for demonstrating a drug’s safety and efficacy, and without one, doctors are hesitant to prescribe.
However, something that could lead to an increase in prescriptions is a recommendation from NICE, UK’s agency for medical guidance. NICE has just recently stated that real world medical data such as case studies are valid medical evidence. Particularly, this type of evidence should be analyzed and deemed valid for indications where clinical trials are difficult. For instance, conditions in children.
With this new guidance, Dr. Zafar and his team began an examination of whole-plant cannabis in children with epilepsy.
The Study
This study included 10 patients who had severe epilepsy and were between the ages of 1 and 13. Three of the participants also had another medical issue (global developmental delay, learning disability, and infantile spasms). All the patients had not responded to traditional treatments (they had tried, on average, 7). Two of the children also hadn’t responded to the CBD oil called Epidiolex, which is the only kind approved for children. The team assessed monthly seizure frequency with whole plant cannabis compared to typical AEDs. They found that seizure frequency fell on average 86% for all of the children when the whole plant was used.
All of the data in this trial was observational, collected from the patient’s parents via phone or video call over the course of 5 months.
7 of the children completely stopped using conventional treatments during this trial. On average, the children were taking 5.15mg of THC as well as 171.8mg of CBD daily. Improvements were documented in overall behavior, eating, sleeping, cognition, and more. Whole-plant cannabis was found to be superior to CBD products in this patient sample. Side effects were mild and rare (such as tiredness).
Patients paid on average £874 for the treatment, but one patient obtained a free prescription by the NHS.
There were a few study limitations which the researchers made clear. This was a small, observational study which relied on data from parents. Additionally, there wasn’t a control group. This means that there may be a selection bias for who decided to participate. For these reasons and more, further research is needed.
Some of the additional research which is needed are studies which evaluate what kind of mechanism whole-plant cannabis works by which CBD does not. Further, we need to compare the unwanted side effects of whole plant cannabis with traditional epilepsy drugs.
Ultimately, the researchers are hopeful that whole-plant cannabis could become a life-changing treatment for patients diagnosed with childhood-onset severe treatment-resistant epilepsy.
You can read more about this study and treatment here.
