Only 5 of 21 children with refractory epilepsy responded to oral cannabis extracts, a rate similar to placebo in randomized trials of pharmaceutical-grade CBD products.
Parents of children with epilepsy, pediatric neurologists, and medical cannabis researchers.
24% responder rate
What the researchers found
The 24% responder rate (50%+ seizure reduction) matched placebo rates from formal clinical trials. Three children (14%) stopped the extract early due to perceived worsening of seizures. CBD blood levels showed no significant association with response.
Why it matters
Many families turn to artisanal cannabis products for their children's epilepsy. This prospective study suggests these products may perform no better than placebo, possibly due to lower CBD doses than those used in pharmaceutical trials.
The numbers in context
32 enrolled, 21 analyzed; median age 10.3 years; median seizure frequency 2.7/day at baseline; 5/21 (24%) responded; median high CBD dose 0.9 mg/kg/day (vs. 10-20 mg/kg/day in pharmaceutical trials); 3/21 (14%) withdrew due to perceived seizure increase.
How the study worked
Prospective observational study enrolling 32 children; 21 completed the protocol with 4-week baseline and 12-week treatment periods. Seizure frequency, CBD, and THC-COOH blood levels assessed every 4 weeks.
What this study cannot tell us
Small sample (21), no control group, observational design. CBD doses used were much lower than in RCTs of pharmaceutical-grade products. Product variability among artisanal preparations likely.
How to read the evidence
Preliminary: small observational study without controls.
When this study was published
Published in 2019.
The bigger picture
The gap between artisanal and pharmaceutical CBD products is not just about purity. The doses families typically give their children may be far below the therapeutic threshold identified in clinical trials.
Questions still open
- Would higher doses of artisanal products improve response rates? Are families underdosing because of cost, availability, or fear of side effects?
Common questions
Why did artisanal cannabis extracts perform so poorly?
Did blood CBD levels predict who would respond?
Read the original research
Prospective evaluation of oral cannabis extracts in children with epilepsy.
Seizure, 72, 23-27
Citation
Knupp, Kelly G; Rice, John D; Helmkamp, Laura J; Galinkin, Jeffrey; Sempio, Cristina; Jost, Klawitter; Chapman, Kevin E. (2019). Prospective evaluation of oral cannabis extracts in children with epilepsy.. Seizure, 72, 23-27. https://doi.org/10.1016/j.seizure.2019.09.007
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