←Epilepsy
Study register · detail Prospektive Open-Label-Studie · Epilepsy · 2017

Quality of Life in Childhood Epilepsy in pediatric patients enrolled in a prospective, open-label clinical study with cannabidiol.

Rosenberg et al. ·Epilepsia Impact 4.1
Clear benefit GRADE Low 110 citations
Samplen = 48 Pat.
Duration12 weeks
EndpointQOLCE
Blindingoffen
DesignProspektive Open-Label-Studie
Cannabinoidcbd
Routeoral
Key finding

CBD significantly improved quality of life in pediatric epilepsy patients, independent of changes in seizure frequency.

Summary

n=48 pediatric patients with treatment-resistant epilepsy; 12-week open-label CBD treatment resulted in +8,2 points QOLCE total improvement (p<0,001) — independent of seizure frequency changes. Subscales: energy/fatigue, memory, social interaction, behavior and global quality of life improved.

P
PopulationPediatric patients with treatment-resistant epilepsy, n=48 (substudy of a larger open-label study)
I
InterventionCannabidiol (CBD), oral, over 12 weeks (dose not specified)
O
OutcomeImprovement in QOLCE total score by 8,2 ± 9,9 points after 12 weeks (p < 0,001); improvements in energy/fatigue, memory, control/helplessness, cognitive function, social interactions, behavior and global QOL
Confidence in the evidence
Low

The second of four GRADE levels, the effect estimate is of limited reliability.

Downgraded for
Risk of biasImprecision
Quality profile
Sample size ★★★★★
Blinding Open-label
Effect size Clear benefit
Citations / year ★★★★★
Authors
Rosenberg EC, Louik J, Conway E, Devinsky O, Friedman D.
DOI 10.1111/epi.13815↗
Design: Prospektive Open-Label-Studie
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Abstract
Recent clinical trials indicate that cannabidiol (CBD) may reduce seizure frequency in pediatric patients with certain forms of treatment-resistant epilepsy. Many of these patients experience significant impairments in quality of life (QOL) in physical, mental, and social dimensions of health. In this study, we measured the caregiver-reported Quality of Life in Childhood Epilepsy (QOLCE) in a subset of patients enrolled in a prospective, open-label clinical study of CBD. Results from caregivers of 48 patients indicated an 8.2 ± 9.9-point improvement in overall patient QOLCE (p < 0.001) following 12 weeks of CBD. Subscores with improvement included energy/fatigue, memory, control/helplessness, other cognitive functions, social interactions, behavior, and global QOL. These differences were not correlated to changes in seizure frequency or adverse events. The results suggest that CBD may have beneficial effects on patient QOL, distinct from its seizure-reducing effects; however, further studies in placebo-controlled, double-blind trials are necessary to confirm this finding.
Indication
Further studies on Epilepsy
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The impediment to action advances action. — Marcus Aurelius