The frequency of epileptic seizures decreased by an average of 86% among 10 children treated with whole-plant medicinal cannabis, according to a series of cases, published in the open access journal BMJ Pediatrics Open.
None of the children had responded to other treatments, including the only cannabidiol product (CBD) licensed for their condition.
The findings lead researchers to call for further exploration of the potential therapeutic benefits of whole-plant cannabis medicinal products.
According to researchers, substantial anecdotal evidence has accumulated on the value of medicinal cannabis for the treatment of childhood epilepsy since the 1800s. But there has been little recent scientific evidence on the effectiveness of cannabis extracts in whole plants.
Whole plant cannabis includes tetrahydrocannabinol or the abbreviated THC, the main active ingredient in the plant that is responsible for the “high” characteristic associated with recreational use, in addition to cannabidiol, other neuroactive cannabinoids, and molecules such as terpenes.
Both recreational and medical cannabis were outlawed in the United Kingdom under the Drug Abuse Act of 1971, so that cannabis research was largely discontinued, the researchers note.
But motivated by parents whose children had responded well to whole-plant medicinal cannabis extracts, but not to conventional antiepileptic drugs or purified cannabidiol (CBD oil), medicinal cannabis (whole plant) was designated as a drug with prescription for the treatment of severe childhood epilepsy in 2018..
But doctors in the UK have been extremely reluctant to prescribe this to children with severe epilepsy, in large part due to a lack of confirmatory clinical trial data.
The UK’s National Institute for Health and Clinical Excellence (NICE), which provides guidance on what treatments and therapies the UK health service should adopt, has agreed that real-world data, including case series, they are valid sources of evidence, especially when it is difficult. to conduct clinical trials, in children, for example.
In light of this, the researchers evaluated the use of whole-plant medicinal cannabis in 10 children whose severe epilepsy had not responded to conventional treatment, and two of whom had not responded to the CBD oil alone. purified pharmaceutical grade licensed for the disease. in children (Epidyolex).
The researchers wanted to assess the percentage change in monthly seizure frequency and the impact of medical cannabis on changes in drug use for conventional epilepsy. They also wanted to report the concentrations and doses used and the costs incurred.
All participants were recruited from two charities representing children who used medicinal cannabis to treat their severe epilepsy. The average age of the children was 6 years, but ranged from 1 to 13 years. They had a series of epilepsies and three had other concurrent problems, such as childhood spasms, learning difficulties, and overall developmental delay.
Data was collected from their parents or caregivers by phone calls or video conferencing between January and May 2021.
The children had tried an average of 7 conventional drugs for epilepsy. After starting to take medical cannabis, it dropped to an average of 1 each, and 7 of the children left it completely.
The monthly seizure rate was reduced for all 10 children by an overall average of 86%.
The full chemical analysis of all the medicinal plant cannabis products used is ongoing, but the researchers were able to assess the THC and CBD content. This showed that children took an average of 5.15 mg of THC and 171.8 mg of CBD each day.
The average monthly cost of cannabis medicinal products was £ 874. One child had obtained his free prescription from the NHS.
Parents and caregivers reported significant improvements in their children’s health and well-being, including sleep, eating, behavior, and cognition after starting to take whole-plant medicinal cannabis products. Only a few minor side effects were reported, such as fatigue.
This is an observational study that includes a small number of participants. And the researchers acknowledge that it was retrospective and was based on parental memory, without any comparative group. And it is possible that only those parents in whom medical cannabis worked well will decide to participate.
But the researchers point out that their findings are in line with several observational and controlled intervention studies that show significant reductions in the frequency of seizures after treatment with medical cannabis.
In addition, new data suggest that whole-plant medicinal cannabis products are more effective than CBD products.
“Further research is needed to elucidate the mechanisms by which the respective additive components of whole plant products lead to superior clinical outcomes,” the researchers write.
And that should include comparing the unwanted effects of whole-plant medicinal cannabis with the known harmful effects of conventional epilepsy medications, they say.
But they conclude: “We believe that our data on whole-plant medicinal cannabis in severe epilepsy resistant to early childhood treatment provide evidence to support its introduction into the NHS within the current NICE prescribing guidelines.
“This measure would be very beneficial for families, who in addition to suffering the psychological distress of caring for their chronically ill children, also have to cover the heavy financial burden of their medication.”
Source:
Magazine reference:
Zafar, R., et al. (2021) Medical cannabis for severe treatment-resistant epilepsy in children: a series of cases in 10 patients. Open BMJ Pediatrics. doi.org/10.1136/bmjpo-2021-001234.
