Epilepsy
Study register · detail Retrospektive Fallserie · Epilepsy · 2020

Cannabidiol for Treating Lennox-Gastaut Syndrome and Dravet Syndrome in Korea.

Mixed GRADE Very low 33 citations
Samplen = 44 Pat.
Duration3 and 6 months
EndpointSeizure frequency reduction
Blindingn.a.
DesignRetrospektive Fallserie
Cannabinoidcbd
Routeoral
Key finding

Oral CBD achieved a clinically relevant seizure reduction in a subset of pediatric LGS and DS patients with a tolerable side effect profile.

Summary

Retrospective case series, n=44 children (LGS n=34, Dravet n=10); CBD (start 5 mg/kg/day, maintenance 10 mg/kg/day); LGS: seizure reduction 52,9% after 3 months, 29,4% after 6 months; >50% reduction in 32,3% (3 mon.) / 20,6% (6 mon.); DS: >50% reduction in 30% (3 mon.) / 20% (6 mon.); no life-threatening adverse events.

P
PopulationPediatric patients (2–18 years) with Lennox-Gastaut syndrome (LGS, n=34) or Dravet syndrome (DS, n=10) in Korea
I
InterventionOral cannabidiol (CBD), starting dose 5 mg/kg/day, maintenance dose 10 mg/kg/day
O
OutcomeSeizure frequency reduction >50% after 3 months: LGS 32,3%, DS 30%; after 6 months: LGS 20,6%, DS 20%; adverse events in 36,3% (mainly gastrointestinal), no life-threatening events
Confidence in the evidence
Very low

The lowest GRADE level, the effect estimate remains uncertain.

Downgraded for
Imprecision
Quality profile
Sample size
Blinding
Effect size Mixed
Citations / year
Authors
Koo CM, Kim SH, Lee JS, Park BJ, Lee HK, Kim HD, Kang HC.
DOI 10.3346/jkms.2020.35.e427
Design: Retrospektive Fallserie
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Abstract
<h4>Background</h4>For the first time in Korea, we aimed to study the efficacy and safety of cannabidiol (CBD), which is emerging as a new alternative in treating epileptic encephalopathies.<h4>Methods</h4>This study was conducted retrospectively with patients between the ages of 2-18 years diagnosed with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) were enrolled from March to October 2019, who visited outpatient unit at 3 and 6 months to evaluate medication efficacy and safety based on caregiver reporting. Additional evaluations, such as electroencephalogram and blood tests, were conducted at each period also. CBD was administered orally at a starting dose of 5 mg/kg/day, and was maintained at 10 mg/kg/day.<h4>Results</h4>We analyzed 34 patients in the LGS group and 10 patients in the DS group between the ages of 1.2-15.8 years. In the 3-month evaluation, the overall reduction of seizure frequency in the LGS group was 52.9% (>50% reduction in 32.3% of the cases), and 29.4% in the 6-month evaluation (more than 50% reduction in 20.6%). In DS group, the reduction of seizure frequency by more than 50% was 30% and 20% in the 3-month and 6-month evaluation, respectively. Good outcomes were defined as the reduction of seizure frequency by more than 50% and similar results were observed in both LGS and DS groups. Adverse events were reported in 36.3% of total patients of which most common adverse events were gastrointestinal problems. However, no life-threatening adverse event was reported in both LGS and DS during the observation period.<h4>Conclusion</h4>In this first Korean study, CBD was safe and tolerable for use and could be expected to potentially reduce the seizure frequency in pediatric patients with LGS or DS.

The impediment to action advances action. — Marcus Aurelius