Purified CBD reduced seizures in 38% of children with severe epilepsy
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.
Quick Facts
What This Study 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.
Key Numbers
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 They Did This
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.
Why This Research 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 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.
What This Study Doesn't 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.
Questions This Raises
- ?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?
Trust & Context
- Key Stat:
- 38% of patients achieved 50%+ seizure reduction
- Evidence Grade:
- Preliminary: open-label pilot study with no control group, though the 6-month duration adds value.
- Study Age:
- Published in 2019.
- Original Title:
- Purified Cannabidiol for Treatment of Refractory Epilepsies in Pediatric Patients with Developmental and Epileptic Encephalopathy.
- Published In:
- Paediatric drugs, 21(4), 283-290 (2019)
- Authors:
- Pietrafusa, Nicola(3), Ferretti, Alessandro(2), Trivisano, Marina, de Palma, Luca, Calabrese, Costanza, Carfì Pavia, Giusy, Tondo, Ilaria, Cappelletti, Simona, Vigevano, Federico, Specchio, Nicola
- Database ID:
- RTHC-02231
Evidence Hierarchy
A small preliminary study to test whether a larger study is feasible.
What do these levels mean? →Frequently Asked 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.
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Cite This Study
https://rethinkthc.com/research/RTHC-02231APA
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
MLA
Pietrafusa, Nicola, et al. "Purified Cannabidiol for Treatment of Refractory Epilepsies in Pediatric Patients with Developmental and Epileptic Encephalopathy.." Paediatric drugs, 2019. https://doi.org/10.1007/s40272-019-00341-x
RethinkTHC
RethinkTHC Research Database. "Purified Cannabidiol for Treatment of Refractory Epilepsies ..." RTHC-02231. Retrieved from https://rethinkthc.com/research/pietrafusa-2019-purified-cannabidiol-for-treatment
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.