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Study register · detail Kohortenstudie · Epilepsy · 2018

Efficacy of CBD-enriched medical cannabis for treatment of refractory epilepsy in children and adolescents - An observational, longitudinal study.

Hausman-Kedem et al. ·Brain & development Impact 1.2
Mixed GRADE Very low 102 citations
Samplen = 46 Pat.
Durationat least 3 months
EndpointSeizure frequency
Blindingn.a.
DesignKohortenstudie
Cannabinoidkombination
THC:CBD20:1
Routeoral
Key finding

56% of patients showed ≤50% reduction in monthly seizure frequency, but 46% reported adverse effects, which were the main reason for treatment discontinuation.

Summary

Longitudinal observational study in refractory epilepsy in childhood/adolescence (n=46, age 1-20 years), CBD/THC 20:1 oil (median 18 months follow-up, average CBD dose 11,4 mg/kg/d). 56% of patients (n=26) achieved ≥50% reduction in mean monthly seizure frequency (parent-reported). Younger age at treatment start (<10 years) and higher CBD dose (>11 mg/kg/d) associated with better response. Adverse effects in 46% of patients (mainly somnolence, decreased appetite, diarrhoea).

P
PopulationChildren and adolescents (1–20 years) with treatment-refractory epilepsy of various aetiologies, n=46 (efficacy analysis) or n=57 (total)
I
InterventionCBD-rich cannabis oil extract (CBD/THC ratio 20:1), mean CBD dose 11,4 mg/kg/d, oral
O
Outcome56% of patients (26/46) achieved a ≥50% reduction in mean monthly seizure frequency; younger age (<10 years) and higher CBD dose (>11 mg/kg/d) associated with better response
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
Hausman-Kedem M, Menascu S, Kramer U
DOI 10.1016/j.braindev.2018.03.013↗
Design: Kohortenstudie
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Abstract
The objective of this observational study was to evaluate the efficacy of medical cannabis for the treatment of refractory epilepsy. Fifty-seven patients (age 1-20 years) with epilepsy of various etiologies were treated with Cannabis oil extract (CBD/THC ratio of 20:1) for at least 3 months (Median follow up time-18 months). Forty-Six Patients were included in the efficacy analysis. Average CBD dose was11.4 mg/kg/d. Twenty-six patients (56%) had </=50% reduction in mean monthly seizure frequency. There was no statistically significant difference in response rate among various epilepsy etiologies, and cannabis strain used. Younger age at treatment onset (<10 years) and higher CBD dose (>11 mg/kg/d) were associated with better response to treatment. Adverse reactions were reported in 46% of patients and were the main reason for treatment cessation. Our results suggest that adding CBD-enriched cannabis extract to the treatment regimen of patients with refractory epilepsy may result in a significant reduction in seizure frequency according to parental reports. Randomized controlled trials are necessary to assess its true efficacy.
Indication
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The impediment to action advances action. — Marcus Aurelius