In a prospective study of 49 children with drug-resistant epileptic encephalopathies, 80% responded to adjunctive CBD treatment, with a median 66% reduction in monthly seizure frequency.
Parents of children with epilepsy, neurologists, medical cannabis researchers
80% of children responded; median seizure reduction was 66%
What the researchers found
Of 49 children followed for 3-12 months, 80% responded to CBD add-on therapy. Seizure reduction of at least 25% occurred in 77.6%, at least 50% in 73.5%, and at least 75% in 49%. Mean monthly seizure frequency dropped from 959 to 381 (median decrease 66%, p < 0.001). The most common adverse effect was drowsiness (32%), often resolved by adjusting clobazam dose.
Why it matters
Children with drug-resistant epileptic encephalopathies have few treatment options. Real-world effectiveness data from diverse clinical settings supplements evidence from controlled trials.
The numbers in context
49 children analyzed; mean age 10.5 years; median age at first seizure 7 months. 80% responders. 73.5% achieved 50%+ seizure reduction. 49% achieved 75%+ reduction. Median seizure frequency decrease: 66%. Drowsiness in 32%.
How the study worked
Prospective cohort study at a single pediatric hospital in Buenos Aires, Argentina. 50 patients with drug-resistant epileptic encephalopathies enrolled between October 2018 and October 2019. CBD oil added to standard antiseizure medications. Mean follow-up: 8.5 months.
What this study cannot tell us
Open-label, single-center, no control group; relatively small sample; interim analysis with variable follow-up periods; the drowsiness-clobazam interaction suggests some benefit may come from altered clobazam metabolism.
How to read the evidence
Prospective single-center cohort without a control group; results are consistent with but less rigorous than randomized controlled trials.
When this study was published
Published in 2020.
The bigger picture
This study from Argentina adds to growing real-world evidence supporting CBD as an adjunctive therapy for severe childhood epilepsy, consistent with the randomized trial data that led to FDA approval of Epidiolex.
Questions still open
- How much of the seizure reduction is from CBD directly vs. its interaction with clobazam? Will the benefits persist long-term beyond 12 months?
Common questions
What types of epilepsy were treated?
Were there serious side effects?
Read the original research
Effectiveness of cannabidiol in a prospective cohort of children with drug-resistant epileptic encephalopathy in Argentina.
Seizure, 80, 75-80
Citation
Caraballo, Roberto; Demirdjian, Graciela; Reyes, Gabriela; Huaman, Marina; Gutierrez, Robinson. (2020). Effectiveness of cannabidiol in a prospective cohort of children with drug-resistant epileptic encephalopathy in Argentina.. Seizure, 80, 75-80. https://doi.org/10.1016/j.seizure.2020.06.005
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