In 29 pediatric patients with severe developmental and epileptic encephalopathy, artisanal CBD oil reduced seizure frequency by 50% or more in 38% of patients, with one becoming seizure-free.
Parents of children with epilepsy, pediatric neurologists, and researchers studying CBD for seizure disorders.
38% of patients achieved 50%+ seizure reduction
What the researchers found
Eleven of 29 patients (37.9%) achieved 50% or greater seizure reduction. One patient became seizure-free. No patients experienced worsening seizure frequency. Adverse effects were reported in 7 patients (24%), mostly somnolence, decreased appetite, and diarrhea, all mild and transient.
Why it matters
Pharmaceutical-grade CBD (Epidiolex) was approved in the US for Dravet and Lennox-Gastaut syndromes but was not available internationally. This study tested artisanal purified CBD in a broader range of severe epilepsies, showing potential benefit beyond the approved indications.
The numbers in context
29 patients enrolled. 41.4% male. Mean age: 9.3 years (range 1.9-16.3). Mean CBD exposure: 11.2 months. 37.9% had 50%+ seizure reduction. 1 patient seizure-free. 62.1% had no benefit. 24.1% had mild adverse effects.
How the study worked
Single-center, prospective, open-label study at Bambino Gesu Children's Hospital in Rome. Patients aged 1-18 with treatment-refractory developmental and epileptic encephalopathy received purified CBD oil (98-99% pure) at 2-25 mg/kg/day added to existing antiepileptic drugs for at least 6 months.
What this study cannot tell us
Open-label study with no placebo group or blinding. Small sample size. Artisanal formulation, not pharmaceutical-grade. All patients were on concurrent antiepileptic drugs.
How to read the evidence
Preliminary: open-label pilot study with no control group, though the 6-month duration adds value.
When this study was published
Published in 2019.
The bigger picture
This adds to the growing evidence that CBD has anti-seizure properties across multiple epilepsy types, not just the two FDA-approved indications. The high rate of non-responders (62%) also underscores that CBD is not a universal epilepsy treatment.
Questions still open
- Which epilepsy subtypes respond best to CBD? Could higher doses or different formulations improve the response rate? Are the non-responders fundamentally different from responders?
Common questions
Is this the same as Epidiolex?
Why didn't CBD help all the children?
Read the original research
Purified Cannabidiol for Treatment of Refractory Epilepsies in Pediatric Patients with Developmental and Epileptic Encephalopathy.
Paediatric drugs, 21(4), 283-290
Citation
Pietrafusa, Nicola; Ferretti, Alessandro; Trivisano, Marina; de Palma, Luca; Calabrese, Costanza; Carfì Pavia, Giusy; Tondo, Ilaria; Cappelletti, Simona; Vigevano, Federico; Specchio, Nicola. (2019). Purified Cannabidiol for Treatment of Refractory Epilepsies in Pediatric Patients with Developmental and Epileptic Encephalopathy.. Paediatric drugs, 21(4), 283-290. https://doi.org/10.1007/s40272-019-00341-x
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