Highlights
- •Parents in our study reported a 33% response to OCE.
- •Relocating to Colorado had a significant effect on response rates.
- •The response rate is similar to previously reported placebo response rates.
- •Reported response was not correlated with improved background EEG data.
- •Parents reported a variety of additional benefits of OCE and adverse reactions.
Abstract
Objective
Oral cannabis extracts (OCEs) have been used in the treatment of epilepsy; however,
no studies demonstrate clear efficacy. We report on a cohort of pediatric patients
with epilepsy who were given OCE and followed in a single tertiary epilepsy center.
Methods
A retrospective chart review of children and adolescents who were given OCE for treatment
of their epilepsy was performed.
Results
Seventy-five patients were identified of which 57% reported any improvement in seizure
control and 33% reported a >50% reduction in seizures (responders). If the family had moved to CO for OCE treatment,
the responder rate was 47% vs. 22% for children who already were in CO. The responder
rate varied based on epilepsy syndrome: Dravet 23%, Doose 0%, and Lennox–Gastaut syndrome
(LGS) 88.9%. The background EEG of the 8 responders where EEG data were available
was not improved. Additional benefits reported included: improved behavior/alertness
(33%), improved language (10%), and improved motor skills (10%). Adverse events (AEs)
occurred in 44% of patients including increased seizures (13%) and somnolence/fatigue
(12%). Rare adverse events included developmental regression, abnormal movements,
status epilepticus requiring intubation, and death.
Significance
Our retrospective study of OCE use in pediatric patients with epilepsy demonstrates
that some families reported patient improvement with treatment; however, we also found
a variety of challenges and possible confounding factors in studying OCE retrospectively
in an open-labeled fashion. We strongly support the need for controlled, blinded studies
to evaluate the efficacy and safety of OCE for treatment of pediatric epilepsies using
accurate seizure counts, formal neurocognitive assessments, as well as EEG as a biomarker.
This study provides Class III evidence that OCE is well tolerated by children and
adolescents with epilepsy.
Abbreviations:
OCEs (Oral cannabis extracts), LGS (Lennox–Gastaut syndrome), AEs (Adverse Events), CO (Colorado), Δ9-THC (Δ9-Tetrahydrocannabinol)Keywords
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Article info
Publication history
Accepted:
February 28,
2015
Received:
January 30,
2015
Identification
Copyright
© 2015 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
