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Study register · detail Elterlichen-Survey (Querschnitt, online) · Epilepsy · 2017

Report from a Survey of Parents Regarding the Use of Cannabidiol (Medicinal cannabis) in Mexican Children with Refractory Epilepsy.

Aguirre-Velázquez et al. ·Neurology Research International
Clear benefit GRADE Very low 37 citations
Samplen = 53 Pat.
DurationSeptember 2016
EndpointSeizure reduction
Blindingn.a.
DesignElterlichen-Survey (Querschnitt, online)
Cannabinoidcbd
Routeoral
Key finding

Parents reported a seizure reduction in 81,3% of children under cannabidiol, in 16% complete seizure freedom.

Summary

n=53 children (9 months – 18 years) with refractory epilepsy in Mexico (47% Lennox-Gastaut, 30% unspecified, 19% West syndrome); 47,1% had previously received ≥9 anticonvulsants. Parent reports: 81,3% reported seizure reduction under CBD; moderate to marked reduction in 51%, 16% seizure-free. No serious adverse effects; mild AEs (increased appetite, changes in sleep) in 42%. Uncontrolled observational data with strong selection and reporting bias.

P
PopulationChildren with refractory epilepsy (9 months to 18 years), n=53 (thereof 43 from Mexico); parents as reporters
I
InterventionCannabidiol (medical cannabis), oral use, dose not specified
O
OutcomeSeizure reduction in 81,3% of cases; moderate to significant reduction in 51%; seizure freedom in 16%; reduction in number of antiepileptic drugs in 20,9% of cases; mild adverse effects in 42%
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 Clear benefit
Citations / year ★★★★★
Authors
Aguirre-Velázquez CG.
DOI 10.1155/2017/2985729↗
Design: Elterlichen-Survey (Querschnitt, online)
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Abstract
Structured online surveys were used to explore the experiences of the parents of children with refractory epilepsy using medicinal cannabis in Mexico during September 2016. The surveys, which were completed in full, were reviewed, and 53 cases of children aged between 9 months and 18 years were identified. Of these, 43 cases (82%) were from Mexico and 10 (18%) were from Latin American countries. Of the 43 Mexican cases, the diagnoses were as follows: 20 cases (47%) had Lennox-Gastaut syndrome (LGS); 13 cases (30%) had unspecified refractory epilepsy (URE); 8 cases (19%) had West syndrome (WS); 1 case (2%) had Doose syndrome (DS); and 1 case (2%) had Ohtahara syndrome (OS). In total, 47.1% of cases had previously been treated with 9 or more anticonvulsant therapies. The parents reported a decrease in convulsions when cannabidiol was used in 81.3% of the cases; a moderate to significant decrease occurred in 51% of cases, and 16% of cases were free from seizure. The number of antiepileptic drugs being used was reduced in 9/43 (20.9%) cases. No serious adverse effects were reported, with only some mild adverse effects, such as increased appetite or changes in sleep patterns, reported in 42% of cases.
Indication
Further studies on Epilepsy
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973 citations
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n=120 Dravet-Syndrom (therapierefraktär), CBD 20mg/kg/d vs. Placebo über 14 Wochen; median konvulsive Anfallsreduktion 38,9% (CBD) vs. 13,3% (Placebo), adjustierte Differenz -22,8 Prozentpunkte (95%-CI -41,1 bis -5,4; p=0,01); 5% anfallsfrei (CBD) vs. 0% (Placebo).

10.1056/nejmoa1611618 View study →
S Thiele et al. · 2018 · The Lancet
881 citations
Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 trial
Clear benefit RCT

Phase-III-RCT (GWPCARE4) bei Lennox-Gastaut-Syndrom, n=171 (2–55 Jahre), randomisiert zu CBD 20 mg/kg/d vs. Placebo über 14 Wochen. Primärer Endpunkt: prozentuale Reduktion der monatlichen Drop-Seizure-Frequenz. Multizentrisch (24 Zentren USA, Niederlande, Polen). 14 Patienten in CBD-Gruppe, 1 in Placebo-Gruppe brachen ab. [Numerische Outcomes im Abstract abgeschnitten; Volltext zeigt signifikante Drop-Seizure-Reduktion vs. Placebo].

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The impediment to action advances action. — Marcus Aurelius