Clinical Trial Review: CBD use in pediatric patients with Dravet Syndrome
Dravet Syndrome (DS) is a rare and debilitating form of childhood epilepsy that is usually resistant to standard medical treatment. This study evaluated the effectiveness and safety of CBD for this condition by reviewing only clinical trials research published in the last 10 years. It was published in March 2024 in the European Journal of Medical Research.
DS is known to have significant effects on children (starts at 4-12 months):
- recurrent febrile and afebrile seizures
- ataxia (loss of muscle control)
- cognitive impairment
- developmental delays
The authors included 10 clinical trials covering a total of 1,724 participants.
The CBD dosages ranged from 2.5 to 30 mg/kg/day. For reference, for a 50 pound (23 kg) child, the dose would range from about 58 mg per day to 690 mg per day. The minimum length of the trials was 4 weeks and the maximum was 72 weeks.
Most of the preparations were highly purified CBD in liquid form for oral administration. The average dose was 22 mg/kg/day, or about 506 mg CBD per day for a 50 pound child.
They measured effectiveness by the percentage reduction in convulsive and total seizures. They also used the Subject/Clinician Global Impression of Change (SCGIC) scale, and the Childhood Epilepsy Questionaire to evaluate changes in Quality of Life.
Summary of key results:
The reduction in seizure frequency for convulsive seizures ranged from 38 to 74%, and for total seizures, it varied from 40 to 84%
SCGIC scale reported improvements in the range of 81–84%
Adverse events or side effects that were observed:
- somnolence (22.6%)
- diarrhea (11.9%)
- transaminase (a liver enzyme) elevation
- loss of appetite
Authors' conclusions:
This review consolidates evidence from multiple clinical trials, affirming the potential of CBD as a promising treatment option for pediatric patients with DS.
CBD's efficacy and acceptable safety profile make it a valuable addition to the therapeutic tools for DS.
CBD demonstrated substantial reductions in seizure frequency, with some patients achieving seizure freedom.
The findings emphasised the consistency of CBD's efficacy across different patient subgroups.
The safety profile of CBD was generally acceptable, with adverse events often being manageable.
The full text article is here at PubMed Central.
Source:
Aderinto N, Olatunji G, Kokori E, Ajayi YI, Akinmoju O, Ayedun AS, Ayoola OI, Aderinto NO. The efficacy and safety of cannabidiol (CBD) in pediatric patients with Dravet Syndrome: a narrative review of clinical trials. Eur J Med Res. 2024 Mar 18;29(1):182. doi: 10.1186/s40001-024-01788-6. PMID: 38500226; PMCID: PMC10949818.