The rate of epileptic seizures decreased by an average of 86% among 10 children treated with a whole medicinal plant cannabis, reveals a case series published in the Open Access Journal. Pediatrics BMJ Open.
None of the children responded to other treatments, including the only CBD product licensed for their condition.
The findings prompted researchers to call for further exploration of the potential therapeutic benefits of the whole plant medical cannabis products.
The researchers say that substantial anecdotal evidence for the value of medicinal cannabis in treating childhood epilepsy has been accumulating since the 19th century. But there hasn’t been much recent scientific evidence for the effectiveness of whole cannabis plant extracts.
The whole hemp plant contains THC or THC for short, which is the main active ingredient of the plant responsible for the “high” property associated with recreational use, as well as cannabidiol, other neuroactive cannabinoids, and molecules such as terpenes.
Both recreational and medical cannabis It was made illegal in the UK under the Misuse of Drugs Act 1971, so cannabis research has largely been halted, the researchers note.
But motivated by parents whose children responded well to whole medicinal cannabis extracts, but not to traditional anti-epileptic drugs or purified cannabidiol (CBD oil), medicinal cannabis (whole plant) has been designated as a prescribed drug for severe childhood illness. epilepsy in 2018.
But doctors in the UK have been very reluctant to prescribe this drug to children with severe epilepsy, in large part due to the lack of confirmed clinical trial data.
The UK’s National Institute for Health and Clinical Excellence (NICE), which provides guidance on treatments and treatments to be adopted by the Health Service England, has agreed that real-world data, including case series, are valid sources of evidence, particularly when Difficult to do clinical trials – on children, for example.
In light of this, researchers evaluated the use of whole plant medicinal cannabis in 10 children whose severe epilepsy did not respond to conventional treatment, and two of them did not respond to the only pharmaceutical grade, purified CBD oil licensed for the condition. In children (Epidiolex).
The researchers wanted to assess the percentage change in monthly seizure frequency and the effect of medicinal cannabis on changes in the use of conventional epilepsy medications. They also wanted to report on strengths, doses used, and costs incurred.
All participants were recruited from two charities representing children who use medical cannabis to treat their acute epilepsy. The average age of the children was 6 years, but ranged from 1 to 13 years. They had a combination of epilepsy and three had other concurrent problems, including infantile spasms, learning disabilities, and global developmental delay.
Data was collected from their parents or caregivers over the phone or group video calls between January and May 2021.
The children tried an average of 7 conventional epilepsy drugs. After starting to take medicinal cannabis, this dropped to an average of 1 each, with 7 of the children stopping taking it completely.
The rate of monthly seizures for all 10 children decreased by an overall average of 86%.
A full chemical analysis of the plant medicinal cannabis products used is still being carried out, but the researchers were able to assess the content of THC and CBD. This showed that the children took in 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 got a free prescription from the NHS.
Parents and caregivers have reported significant improvements in the health and well-being of their children, including sleep, eating, behavior and cognition, after they began taking fully plant-based medicinal cannabis products. A few minor side effects, such as tiredness, have been reported.
This is an observational study involving a small number of participants. The researchers acknowledge that it was retrospective and based on parental recall, with no comparison group. And it’s possible that only parents whose medical cannabis worked well decided to get involved.
But the researchers highlight that their findings are in line with several observational and interventional studies showing a significant reduction in the frequency of seizures after treatment with medical cannabis.
Furthermore, new data indicates that medicinal hemp products that are all plant based are more effective than CBD products.
“Further research is needed to elucidate the mechanisms by which ingredients added to whole plant products lead to superior clinical outcomes,” the researchers wrote.
This should include comparing the unwanted effects of whole plant medicinal cannabis with the known harmful effects of conventional epilepsy drugs, they say.
But they concluded: “We believe that our data on whole plant medicinal cannabis in severe treatment-resistant epilepsy in childhood, provide evidence to support its introduction into the NHS within current NICE prescribing guidelines.
“Such a step would be very beneficial for families, who in addition to experiencing psychological distress due to the care of their chronic illnesses children. They also have to cover the heavy financial burden of their medication.”