An Australian trial used the cannabis extract cannabidiol (CBD) to treat 40 children suffering from severe, hard-to-treat epilepsy. The study found that CBD has some positive effects with manageable side effects.
Parents and doctors believe that many of the children had shown improved overall health, but the researchers clarified in their report that the trial was not designed to draw conclusions on medical marijuana’s efficacy.
Safety, not efficacy
Lead author John Lawson, who is a pediatric neurologist at Sydney’s Children’s Hospital, said that the study’s main aim was about safety. According to him, they found a few safety concerns, but those safety issues were, overall, very manageable and that the drug was very safe for the majority.
How the study was conducted
The study was a statewide trial done in New South Wales and it involves children in the state who were very sick with drug-resistant epilepsy. More specifically, these were children enrolled in the New South Wales Compassionate Access Scheme who were having seizures multiple times a day, who have been hospitalized recently for their epilepsy, and who have previously failed on about nine anti-epilepsy drugs.
During the 12-week trial, these children received CBD as an adjunct anti-epileptic drug, which was titrated to 25mg/kg/day maximum for up to 12 weeks.
Results of the study
According to the findings, the drug only gave extensive symptom relief for a select number of patients.
Following CBD treatment, about one in five children were described as very much improved from their baseline, while about half of them reported very slight improvement or no improvement at all.
Moreover, 39 patients reported at least one adverse event. But many of these were considered to be unrelated to the CBD treatment.
The parents or caregivers of 12 children felt that the overall health of the patients had significantly improved. In fact, clinicians assessed that seven children as being very much improved.
Meanwhile, 17 children were admitted to the hospital during the trial, but it was not out of the ordinary over the last year for them.
The researchers wrote that there wasn’t any significant change in the number of episodes of status epilepticus or rescue medication episodes. Additionally, no participants reported total absence of seizures.
Study not a measure of efficacy
The researchers pointed out that their study had no objective measure of efficacy. They explained that the strict eligibility criteria for participants meant that seizure frequency changes could not be quantified.
What’s more, the treating clinician was given the freedom to change the CBD doses throughout the trial, so the results cannot really be attributed exclusively to CBD.
The researchers concluded that there is a need for further research on CBD products.
The study was published in the Medical Journal of Australia.