CBD Oil For Children’s Seizures

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Further therapeutic benefits of whole plant products now worth exploring, say researchers Epileptic seizure frequency fell by an average of 86% among 10 children treated with whole plant medicinal cannabis, reveals a case series, published in the open access journal BMJ Paediatrics Open. None of the children had responded to other treatments, including the only cannabidiol […] Preliminary data on 7 children treated with a medicinal cannabis oil in a Phase 1 study underway in Canada show a safe reduction in seizure frequency.

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.

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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.

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“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
Subjects: People

Cannabidiol Oil Safely Lessens Seizures in Treatment-resistant Children, Early Trial Data Show

Severe epilepsy in children with Dravet and Lennox-Gastaut syndrome can be safely treated with a medicinal cannabis oil that includes, at low dose, the intoxicating compound in marijuana known as THC, preliminary results of a Phase 1 clinical study suggest.

“What makes these results really exciting is it opens up as a treatment option for kids who have failed to respond to traditional medications,” said Richard Huntsman, MD, pediatric neurologist and lead author of the study, said in a news release.

Increasing evidence suggests that non-psychotropic cannabis-derived compounds, such as pharmaceutical grade cannabidiol (CBD), can help to manage seizures in children with treatment-resistant epilepsy. But little guidance exists for doctors on the proper concentration and dosing of CBD and other cannabinoids, as well as on their pharmacological characteristics.

“The resultant inability to provide evidence-based dosing and therapeutic monitoring of cannabis-based products in children … leads to a reluctance by many physicians to authorize CBD-enriched cannabis herbal extract to these patients,” the researchers wrote.

A team led by researchers at University of Saskatchewan, Canada, are conducting an open-label Phase 1 clinical study (NCT03024827) called CARE-E. Scientists are exploring the safety and impact of increasing doses of CBD-enriched cannabis herbal extract (CHE) used as add-on therapy in up 28 children (ages 1 to 10) with epileptic encephalopathy resistant to standard anticonvulsant therapy. The mixture, called CanniMed 1:20, contains 1 mg/ml of THC and 20 mg/ml of CBD.

The trial is still recruiting at clinical sites in British Columbia, Manitoba, Quebec and Saskatchewan. More information is available here.

Data on the first seven children, four with Dravet syndrome and three with Lennox-Gastaut, enrolled at the University of Saskatchewan’s clinical site made up this report.

All started CHE treatment with an initial CBD dose of 2–3 mg/kg per day. Over the following three months, the dose was increased every four weeks up to a maximum of 10–12 mg/kg per day. Children were then weaned off CHE over their final month of trial participation.

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Caregivers were asked to monitor and record daily seizure frequencies throughout the study.

All seven children had fewer seizures while taking CHE at a CBD equivalent dose of 5–6 mg/kg per day, data showed. Six experienced a 25% drop in seizure frequency and four a decrease of more than 50%.

At the maximum tested dose (10–12 mg/kg per day), CHE led to an average seizure reduction across all children of 74%, with three being seizure free.

After the weaning period, these children continued to experience fewer seizures compared to pre-treatment, without any changes in their anti-convulsant treatment regimen.

In general, CHE with CBD equivalent dose of 10–12 mg/kg per day was found to lower electrical activity in the brain, as determined by electroencephalography (EEG).

“The preliminary data suggest an initial CBD target dose of 5–6 mg/kg/day when a 1:20 THC:CBD CHE is used,” the study concluded. “The reduction in seizure frequency seen suggests improved seizure control when a whole plant CHE is used. Plasma THC levels suggest a low risk of THC intoxication when a 1:20 THC:CBD CHE is used in doses up to 12 mg/kg CBD/kg/day.”

Better quality of life was also reported, with greatest improvements being on the cognitive, social and emotional functioning subscales of the Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55).

“Some of the improvements in quality of life were really dramatic with some of the children having huge improvements in their ability to communicate with their families. Some of these children started to talk or crawl for the first time. They became more interactive with their families and loved ones,” Huntsman said.

Data also showed the treatment was generally safe and well-tolerated.

Most common adverse reactions reported were occasional episodes of nausea and vomiting, diarrhea, increased appetite, difficulty sleeping, and spasticity (uncontrolled muscle movement and/or contraction). No clinically significant events were directly attributed to treatment with CHE.

Although the benefits of CHE seemed to be associated with the relative CBD dose, analysis of its metabolism in the body suggested a potential saturation effect with increased oral bioavailability in some patients. This finding suggests the “need to limit dose sizes and not to simply continue increasing doses until an appropriate effect is observed,” the researchers wrote.

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