In a pilot study of 10 young patients (ages 2.5-23.2) with drug-resistant epilepsy, a cannabis decoction containing THC and CBD showed a good safety profile, though 2 patients stopped treatment due to adverse events.
Pediatric neurologists, pharmacologists, and families considering cannabis-based epilepsy treatment.
THC-CBD blood levels correlated with administered doses
What the researchers found
The cannabis preparation was generally well tolerated, with adverse events in 6 of 10 patients (mostly GI, sleep, or behavioral issues). Two patients discontinued. THC and CBD blood levels correlated with administered doses, supporting the feasibility of therapeutic drug monitoring.
Why it matters
This is one of the few studies examining a whole-plant cannabis preparation (rather than purified CBD) in pediatric epilepsy, providing pharmacokinetic data that could guide dosing in future studies.
The numbers in context
10 patients enrolled. Cannabis FM2: 5.2-7.2% THC, 8.2-11.1% CBD (ratio 3:5). CBD doses: 1-4 mg/kg/day. 6/10 had adverse events. 2/10 discontinued. 64% retention at 6 months would apply if extrapolated.
How the study worked
Prospective open trial enrolling 10 patients (ages 2.5-23.2) with drug-resistant epilepsy. Patients received a galenic decoction of Italian cannabis FM2 (THC:CBD ratio 3:5). CBD doses were titrated from 1 to 4 mg/kg/day. Safety and pharmacokinetics were monitored.
What this study cannot tell us
Very small sample (10 patients), no control group, and open-label design. The galenic decoction preparation may vary between batches. Short follow-up.
How to read the evidence
Preliminary: very small open-label pilot study without controls.
When this study was published
Published in 2020 in Complementary Therapies in Medicine.
The bigger picture
The correlation between administered dose and blood levels is clinically important because it suggests cannabis-based epilepsy treatments could be monitored with blood tests, similar to conventional anticonvulsants.
Questions still open
- How does a THC-containing preparation compare to purified CBD alone for epilepsy? Would therapeutic drug monitoring improve outcomes and reduce adverse events?
Common questions
Was the treatment safe for children?
How is this different from Epidiolex?
Read the original research
Safety and pharmacokinetics of medical cannabis preparation in a monocentric series of young patients with drug resistant epilepsy.
Complementary therapies in medicine, 51, 102402
Citation
Gherzi, Marcella; Milano, Giulia; Fucile, Carmen; Calevo, Maria Grazia; Mancardi, Maria Margherita; Nobili, Lino; Astuni, Pietro; Marini, Valeria; Barco, Sebastiano; Cangemi, Giuliana; Manfredini, Luca; Mattioli, Francesca; De Grandis, Elisa. (2020). Safety and pharmacokinetics of medical cannabis preparation in a monocentric series of young patients with drug resistant epilepsy.. Complementary therapies in medicine, 51, 102402. https://doi.org/10.1016/j.ctim.2020.102402
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