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Study register · detail Prospektive Beobachtungsstudie · Epilepsy · 2021

Cannabidiol-enriched oil in children and adults with treatment-resistant epilepsy-does tolerance exist?

Uliel-Sibony et al. ·Brain and Development Impact 1.2
Mixed GRADE Very low 29 citations
Samplen = 92 Pat.
Durationmean follow-up period 19,8 ±…
EndpointSeizure frequency
Blindingn.a.
DesignProspektive Beobachtungsstudie
Cannabinoidkombination
THC:CBD20:1
Routeoral
Key finding

CBD oil reduced seizure frequency in more than half of patients, however a quarter developed tolerance with diminishing efficacy.

Summary

Prospective study with n=92 patients (1-37 years, mean 11,8 years) with treatment-refractory epilepsy; CBD-enriched oil (CBD:THC=20:1), mean dose 11,3 mg/kg/d. Responder rate (>50% seizure reduction) 54%, 9% seizure-free. Follow-up 19,8±12,5 months (range 3-45). Tolerance development in 25% (21/84) after an average of 7,3±5,4 months; negative correlation between duration of epilepsy and tolerance development (p=0,038). 31% discontinuation due to lack of efficacy or side effects.

P
PopulationChildren and adults with treatment-refractory epilepsy, n=92, age 1–37 years
I
InterventionCBD-enriched cannabis oil (CBD/THC ratio 20:1), mean CBD dose 11,3 mg/kg/day orally
O
OutcomeResponder rate (>50% seizure reduction) 54%; 9% seizure-free; tolerance development in 25% of patients after a mean of 7,3 months; negative correlation between duration of epilepsy and tolerance development (p=0,038)
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
Uliel-Sibony S, Hausman-Kedem M, Fattal-Valevski A, Kramer U
DOI 10.1016/j.braindev.2020.06.018↗
Design: Prospektive Beobachtungsstudie
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Indication
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The impediment to action advances action. — Marcus Aurelius