Recent medical research reports show that severe epilepsy in children with Dravet and Lennox-Gastaut syndrome can be safely treated with a medicinal marijuana oil containing THC, the intoxicating compound in marijuana at low dose. Richard Huntsman, MD, pediatric neurologist and lead author of the study, reported in the research “Dosage Related Efficacy and Tolerability of Cannabidiol in Children With Treatment-Resistant Epileptic Encephalopathy: Preliminary Results of the CARE-E Study,” published in the journal Frontiers in Neurology, that what made the results of the study really exciting was the fact that it opened up as a treatment option for kids who had failed to respond to traditional medications.
Further research on this also resulted in increasing evidence suggesting that non-psychotropic marijuana-derived compounds, such as pharmaceutical grade cannabidiol (CBD), are ideal for the management of seizures in children with treatment-resistant epilepsy. According to the researchers little guidance exists for doctors on the ideal concentration and dosing of CBD and other cannabis compound, not leaving out their pharmacological characteristics and this inability of providing concentration and dosing evidence of marijuana-based products in children has lead to reluctance by many doctors to authorize CBD-enriched marijuana herbal extract to these patients.
A team led by researchers at University of Saskatchewan, Canada conducted an open-label Phase 1 clinical study (NCT03024827) known as CARE-E aimed at exploring the safety and impact of increasing doses of CBD-enriched marijuana herbal extract (CHE) used as add-on therapy in up 28 children with ages ranging 1 to 10) suffering with epileptic encephalopathy which is very resistant to standard anticonvulsant drugs. They came up with a mixture, called CanniMed 1:20, composed of 1 mg/ml of THC and 20 mg/ml of CBD.
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The first seven children, four suffering with Dravet syndrome and three Lennox-Gastaut patients, who enrolled at the University of Saskatchewan’s clinical site were all administered CHE treatment with an initial CBD dose of 2–3 mg/kg per day. The doses were increased every four weeks up to a maximum of 10–12 mg/kg per day over the following three months, and the administration of CHE was stopped during their final month of trial participation and various caregivers instructed to monitor and record daily seizure frequencies throughout the study.
RESULTS OF THE STUDY
The result of the study revealed that all seven children had fewer seizures while taking CHE at a CBD equivalent dose of 5–6 mg/kg per day. Six of the children experienced a 25% drop in seizure frequency and four children experienced a decrease in frequency of seizures of more than 50%.
The results also revealed that CHE led to an average seizure reduction across all children of 74%, with three being seizure free when it was administers at a maximum dose of 10–12 mg/kg per day.
After the administration of CHE was stopped, it was noticed that these children continued to experience fewer seizures compared to pre-treatment, and there were no changes in their anti-convulsant treatment regimen.
The research finding in general was thus that CHE with CBD equivalent dose of 10–12 mg/kg per day was revealed to lower electrical activity in the brain and the preliminary results concluded that an initial CBD target dose of 5–6 mg/kg/day is ideal when a 1:20 THC:CBD CHE is used.
This research also reported better quality of life, with greatest improvements functioning for subscales of the quality of life in childhood epilepsy questionnaire such as on the cognitive, social and emotional functioning (QOLCE-55). This was justified by the fact that some of the improvements in quality of life were really dramatic with some of the children showing tremendous improvements in their ability to communicate with their families while others started to talk or crawl for the first time. The study reported that these children became more interactive with their families and loved ones.
The research report also showed that the treatment was generally safe and well-tolerated as most common adverse effects reported consisted of occasional episodes of nausea and vomiting, diarrhea, increased appetite, difficulty sleeping, and spasticity, with no clinically significant effects directly attributed to treatment with CHE.
Conclusion
The researchers concluded that despite the fact that the benefits of CHE seemed to be associated with the relative CBD dose, an analysis of the metabolism of this treatment in the human body suggested a potential saturation effect with increased oral bioavailability in some patients, thus it is advisable to limit the dose sizes and not to simply continue increasing doses until an appropriate effect is observed.