Medical cannabis preparation showed acceptable safety in 10 young patients with drug-resistant epilepsy
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.
Quick Facts
What This Study 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.
Key Numbers
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 They Did This
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.
Why This Research 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 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.
What This Study Doesn't 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.
Questions This Raises
- ?How does a THC-containing preparation compare to purified CBD alone for epilepsy?
- ?Would therapeutic drug monitoring improve outcomes and reduce adverse events?
Trust & Context
- Key Stat:
- THC-CBD blood levels correlated with administered doses
- Evidence Grade:
- Preliminary: very small open-label pilot study without controls.
- Study Age:
- Published in 2020 in Complementary Therapies in Medicine.
- Original Title:
- Safety and pharmacokinetics of medical cannabis preparation in a monocentric series of young patients with drug resistant epilepsy.
- Published In:
- Complementary therapies in medicine, 51, 102402 (2020)
- Authors:
- 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
- Database ID:
- RTHC-02571
Evidence Hierarchy
A small preliminary study to test whether a larger study is feasible.
What do these levels mean? →Frequently Asked Questions
Was the treatment safe for children?
Most patients tolerated it, but 6 of 10 experienced side effects (digestive, sleep, or behavioral issues) and 2 stopped treatment. The researchers described the overall safety profile as acceptable for a pilot study.
How is this different from Epidiolex?
Unlike Epidiolex (purified CBD), this preparation contained both THC and CBD from whole cannabis. The THC:CBD ratio was 3:5. Whether the presence of THC adds benefit or risk compared to CBD alone is not yet known.
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Cite This Study
https://rethinkthc.com/research/RTHC-02571APA
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
MLA
Gherzi, Marcella, et al. "Safety and pharmacokinetics of medical cannabis preparation in a monocentric series of young patients with drug resistant epilepsy.." Complementary therapies in medicine, 2020. https://doi.org/10.1016/j.ctim.2020.102402
RethinkTHC
RethinkTHC Research Database. "Safety and pharmacokinetics of medical cannabis preparation ..." RTHC-02571. Retrieved from https://rethinkthc.com/research/gherzi-2020-safety-and-pharmacokinetics-of
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.