Australian Study Shows – A small but significant group had a notable reduction in their seizures
lmost all of the first 40 children given cannabidiol for severe epilepsy in Australia had an adverse event within three months — although most were mild and unrelated to the therapy, according to a study.
Although four children withdrew from the NSW study, more than half of the cohort showed at least some improvement in the eyes of their treating doctors and carers, say the authors of the paper published in the Medical Journal of Australia.
Paediatric neurologists tracked tolerability, adverse events and the subjective impressions of caregivers and treating neurologists among the first group of children with drug-resistant epilepsy and uncountable daily seizures enrolled in the ongoing NSW government-funded Compassionate Access Scheme.
The children, aged between 19 months and 16 years, received increasing doses of the non-psychotropic oral cannabis extract Epidiolex (GW Pharmaceuticals) to a target dose of 25mg/kg/day, on top of their normal epilepsy treatments, over 12 weeks from August 2016.
Parents and carers of the children had specifically requested the drug, which has been shown in recent human trials to reduce seizures in patients with certain forms of epilepsy.
Among the cohort, two children were forced to withdraw early because their rate of seizures increased with cannabidiol.
Two others were taken off the treatment because of poor liver function test results and significant somnolence resulting in respiratory depression.
Another 14 experienced increased seizures that were considered unrelated to the treatment.
All up, 39 out of 40 reported at least one adverse event, and 23 of these were serious enough to result in hospital admission or an increased stay — but only eight were believed linked to cannabidiol.
Lead author Dr John Lawson says the trial demonstrates that medical cannabis can be relatively safe in the short term.
“But you have to remember that this is a very sick patient group with a generally poor prognosis, so the balance between risk and benefits would favour taking a risk,” said Dr Lawson, a paediatric neurologist at Sydney Children’s Hospital, Randwick.
None of the children became completely free of seizures during the trial but doctors assessed seven as “much” or “very much” improved in overall health.
“A small but significant group had an 80% or 90% reduction in their seizures,” Dr Lawson said.
He stressed the results were not conclusive and more research would be required to properly demonstrate efficacy and long-term risk.
“Some children had more seizures, which is part of the message,” he said.
“There is huge demand for cannabis right now and some of it is driven by desperation among the families, and hope, but there is also big money behind this, too.
“There is no question that there are other motivations here that are much bigger than just the care of children — it is about a multibillion-dollar business.”