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Study breakdown

Purified CBD reduced seizures in 38% of children with severe epilepsy

Pilot StudyPreliminary evidence
The takeaway

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?
No. Epidiolex is a pharmaceutical-grade CBD product approved by the FDA. This study used an artisanal 98-99% pure CBD oil formulation available in Italy.
Why didn't CBD help all the children?
Epilepsy is highly heterogeneous, and different seizure types respond to different treatments. The 62% non-response rate is consistent with other epilepsy treatments and highlights the need to identify which patients are most likely to benefit.

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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