Epileptic seizure frequency fell by 86% in kids treated with whole plant medicinal cannabis
None of the children had responded to other treatments, including the only cannabidiol (CBD) product licensed for their condition.
The findings prompt the researchers to call for further exploration of the potential therapeutic benefits of whole plant medicinal cannabis products.
Substantial anecdotal evidence on the value of medicinal cannabis for treating childhood epilepsies has been accumulating since the 1800s, say the researchers. But there’s not been much recent scientific evidence on the effectiveness of whole plant cannabis extracts.
Whole plant cannabis includes tetrahydocannabinol or THC for short, the main active ingredient of the plant that is responsible for the characteristic ‘high’ associated with recreational use, plus cannabidiol, other neuroactive cannabinoids, and molecules such as terpenes.
Both recreational and medical cannabis were made illegal in the UK under the Misuse of Drugs Act 1971 so cannabis research largely ceased, point out the researchers.
But prompted 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 (whole plant) cannabis was designated a prescription medicine 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, largely because of the lack of confirmatory clinical trial data.
The UK’s National Institute for Health and Clinical Excellence (NICE), which provides guidance on which treatments and therapies the health service in England should adopt, has accepted that real world data, including case series, are valid sources of evidence, particularly where it’s difficult to carry out 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 hadn’t responded to conventional treatment, and two of whom hadn’t responded to the only pharmaceutical grade, purified CBD oil licensed for the condition in children (Epidyolex).
The researchers wanted to assess the percentage change in monthly seizure frequency and the impact of medicinal cannabis on changes in conventional epilepsy drug use. They also wanted to report the strengths and doses used and the costs incurred.
All the participants were recruited from two charities representing children using medicinal cannabis to treat their severe epilepsy. The children’s average age was 6, but ranged from 1 to 13 years. They had a range of epilepsies and three had other concurrent issues, including infantile spasms, learning disabilities, and global developmental delay.
Data were collected from their parents or carers via phone or video conference calls between January and May 2021.
The children had tried an average of 7 conventional epilepsy drugs. After starting to take medicinal cannabis, this fell to an average of 1 each, with 7 of the children stopping them completely.
Monthly seizure frequency reduced for all 10 children by an overall average of 86%.
Full chemical analysis of the whole plant medicinal cannabis products used is ongoing, but the researchers were able to assess the THC and CBD content. This showed that the children took an average of 5.15 mg THC and 171.8 mg CBD every day.
The average monthly cost of the medicinal cannabis products was £874. One child had obtained their prescription for free on the NHS.
Parents and carers reported significant improvements in the health and wellbeing of their children, including in sleep, eating, behaviour and cognition after they started to take whole plant medicinal cannabis products. Only a few minor side effects, such as tiredness, were reported.
This is an observational study involving a small number of participants. And the researchers acknowledge that it was retrospective and relied on parental recall, with no comparator group. And it’s possible that only those parents in whom medicinal cannabis worked well decided to take part.
But the researchers highlight that their findings are in line with several observational and controlled interventional studies showing significant reductions in seizure frequency after treatment with medicinal cannabis.
What’s more, the new data suggest that whole plant medicinal cannabis products are more effective than CBD products.
“Further research is required to elucidate the mechanisms by which the respective additive constituents of whole-plant products lead to superior clinical results,” write the researchers.
And this must include comparing the unwanted effects of whole plant medicinal cannabis with the known harmful effects of conventional epilepsy medicines, they say.
But they conclude: “We believe that our data on whole-plant medical cannabis in childhood-onset severe treatment-resistant epilepsy, provides evidence to support its introduction into the NHS within current NICE prescribing guidelines.
“Such a move would be hugely beneficial to the families, who in addition to having the psychological distress of looking after their chronically ill children, have also to cover the crippling financial burden of their medication.”
Notes for editors
Research: Medical cannabis for severe treatment resistant epilepsy in children: a case series of 10 patients doi:10.1136/bmjpo-2021-001234
Journal: BMJ Paediatrics Open
Funding: None declared
Link to AMS press release labelling system: https://press.psprings.co.uk/ AMSlabels.pdf
Externally peer reviewed? Yes
Evidence type: Observational
Cannabis oil: ‘I’ve spent £34,000 to keep my epileptic daughter alive’
Laws around the use of medical cannabis were changed in England in 2018 to recognise its benefit for some patients. BBC News spoke to the families of three children with severe epilepsy about the battle they have faced to get the treatment.
‘We felt we had to break the law’
Indie-Rose’s family have run out of the drug Bedrolite which dramatically improved her quality of life
Tannine Montgomery says she has spent £34,000 and broken the law to keep her daughter alive.
Six-year-old Indie-Rose, from Clare in Suffolk, has severe epilepsy and can have up to 50 seizures a month without medical cannabis oil.
Since it was legalised two years ago, only a handful of NHS prescriptions have been issued.
The Department of Health and Social Care says more research is needed before it can be routinely prescribed.
Ms Montgomery says her daughter’s life has been transformed since she started taking medical cannabis three years ago.
“We went from constant seizures and being in hospital all the time to her being happy and attending school,” she says.
It remains illegal to import cannabis oils without a special licence.
Ms Montgomery says the family flew to the Netherlands to obtain it from a Dutch doctor, using a private UK prescription, because the NHS refused to pay for it.
It was costing them £1,500 a month – a cost which would triple if they acquired the licence. Their medication was seized last year at Stansted Airport.
Since Covid-19 restrictions were placed on travel, the family has been unable to fly. They have now run out of the oil, called Bedrolite, and Indie-Rose has started having severe seizures again.
They are also concerned that Brexit will have implications for obtaining it.
What is medical cannabis?
- Medical cannabis is a broad term used by doctors to describe treatments – such as oral tablets, oils and sprays – that have some similar ingredients to recreational cannabis, but will not get you “high”
- These products are made by pharmaceutical companies under the same strict controls as other medications. That means you have to get them on prescription
- Some cannabis-based medicines – such as Epidyolex for epilepsy – have been approved for use by the NHS
- Other products that might claim to be medical cannabis, such as “CBD oil” or hemp oil, are available to buy legally as food supplements from health stores
- There is no guarantee these are of good quality or provide any health benefits and doctors should be consulted before any new medication is taken
Ms Montgomery says: “We have never wanted to break the law. We felt we had to, to keep Indie-Rose alive, but that option is not even open to us at the moment.
“I’m not sleeping and my anxiety is through the roof.”
‘His quality of life has really improved’
Charlie’s mother Ali (pictured) and father Matt have mounted a legal review against the NHS guidelines
When medical cannabis was legalised, the National Institute for Health and Care Excellence (NICE) produced guidance for the NHS saying there was not enough evidence to recommend cannabis-based medicines for severe epilepsy.
Epidoylex is recommended by NICE, but many families say it has not worked for their children.
Charlie Hughes went from having up to 120 seizures a day to fewer than 20 after obtaining cannabis oil
The parents of three-year-old Charlie Hughes, from Norwich, are mounting the first legal challenge to the guidelines.
Charlie went from having up to 120 seizures a day to fewer than 20, became more vocal, took an interest in his toys and began to feed himself after taking Bedrolite, his family says.
But doctors say they cannot prescribe it due to the guidelines.
Charlie’s family could no longer afford Bedrolite, which was costing them up to £3,000 a month, so they switched to a cheaper version from Israel called Celixir20, which costs them £600 a month.
They were offered Epidoylex on the NHS, but did not want to risk giving it to Charlie after speaking to other families.
His father Matt Hughes said: “Last week he painted his first picture, he is doing so well, his quality of life has really improved. It is so unfair that the burden is on us to fund it.”
‘Alfie goes months without seizures’
Alfie Dingley, pictured with his mother, became the first person in the UK to be granted a licence for the drug Bedrolite
Alfie Dingley, who has a severe and rare form of epilepsy, helped bring about the legalisation of medical cannabis.
In June 2018, the nine-year-old, from Kenilworth, in Warwickshire, became the first person in the UK to be granted a licence for Bedrolite. It is thought only two other people have had it granted since.
It followed a campaign led by his mother Hannah Deacon, who says the NHS prescription changed their lives.
She says: “Alfie goes for months at a time without seizures. It is not a cure, but we are not dealing with life-threatening emergencies every week.
“He was violent and aggressive before and we had no quality of life.
“It needs to be available to everyone. It will save the NHS millions of pounds a year by reducing the time children with severe epilepsy spend in hospital.”
Miss Deacon says there has been a “campaign of fear” against medical cannabis which has left doctors scared to prescribe it.
“We are so lucky, but we feel so bad for the other families in this terrible situation,” she says.
“It is barbaric what they have had to go through to keep their families safe.”
She has set up a charitable organisation called MedCan Support with Matt Hughes to help other families in this situation.
What did the Department for Health say?
A spokesman said Epidoylex could be prescribed on the NHS because there was clear evidence of its “safety, clinical and cost-effectiveness”.
He said they sympathised with “patients dealing with challenging conditions” but “more evidence” was needed “to routinely prescribe and fund other treatments on the NHS and we continue to back further research and look at how to minimise the costs of these medicines”.
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