Epilepsie
Studienlage · Detail Systematische Review und Meta-Analyse · Epilepsie · 2021

Efficacy and safety of medical cannabinoids in children: a systematic review and meta-analysis

Gemischt GRADE Hoch 45 Zitate
Stichprobek = 8 Studien
DauerStudien bis 11. Mai 2020…
KontrollePlacebo
EndpunktAnfallsreduktion ≥50%
Verblindungdoppelblind
DesignSystematische Review und Meta-Analyse
Kernaussage

Cannabidiol zeigte klinische Verbesserung bei Dravet-Syndrom (50% Anfallsreduktion), war aber mit vermindertem Appetit assoziiert; mentale Nebenwirkungen wurden berichtet.

Zusammenfassung

Systematische Review und Meta-Analyse von k=8 RCTs zu medizinischen Cannabinoiden bei Kindern; CBD assoziiert mit ≥50%-Anfallsreduktion bei Dravet-Syndrom (RR=1,69, 95%-KI [1,20–2,36]) und Reduktion von Anfallsereignissen gesamt (RR=0,59, 95%-KI [0,36–0,97]); erhöhtes Risiko für verminderten Appetit bei höherer CBD-Dosis (RR=2,40, 95%-KI [1,39–4,15]).

P
PopulationKinder mit Dravet-Syndrom und anderen Indikationen, gepoolt aus 8 RCTs
I
InterventionMedizinische Cannabinoide (Cannabidiol, THC und andere Cannabis-Derivate)
C
KontrollePlacebo
O
OutcomeCBD assoziiert mit ≥50%-Reduktion der Anfallsrate (RR=1,69; 95%-KI [1,20–2,36]) und verbessertem Caregiver Global Impression of Change (Median Estimated Difference=-1; 95%-KI [-1,39–(-0,60)]) bei Dravet-Syndrom; kein Effekt für THC-haltige Produkte (RR=1,35; 95%-KI [0,46–4,03]); CBD assoziiert mit Appetitverlust (RR=2,40; 95%-KI [1,39–4,15])
Vertrauen in die Evidenz
Hoch

Höchste von vier GRADE-Stufen, die Effektschätzung ist sehr verlässlich.

Qualitätsprofil
Größe
Verblindung Doppelblind
Effektstärke Gemischt
Zitate / Jahr
Autoren
Treves N, Mor N, Allegaert K et al.
DOI 10.1038/s41598-021-02770-6
Design: Systematische Review und Meta-Analyse
Teilen
Abstract
Despite the increased use of medical cannabinoids, the efficacy and safety of the treatment among children remain uncertain. The objective was to study the efficacy and safety of medical cannabinoids in children. The search included studies through 11-May-2020. Selection criteria included studies evaluating efficacy and safety outcomes of medical cannabinoids (tetrahydrocannabinol, cannabidiol and other cannabis derivatives) versus control in children, independently assessed by two reviewers. Eight studies were included, all of which are randomized controlled trials. Cannabidiol is associated with 50% reduction in seizures rate (Relative Risk (RR) = 1.69, 95% CI [1.20-2.36]) and caregiver global impression of change (Median Estimated difference = (-1), 95%CI [-1.39-(-0.60)]) in Dravet syndrome, compared to placebo. While cannabidiol was associated with a reduction in reported seizure events (RR = 0.59, 95% CI [0.36-0.97]), no association was found in products contained also tetrahydrocannabinol (RR = 1.35, 95% CI [0.46-4.03]). Higher dose of cannabidiol was associated with decreased appetite (RR = 2.40, 95% CI [1.39-4.15]). A qualitative assessment suggests that medical cannabinoids might be associated with adverse mental events. In conclusion, cannabidiol is associated with clinical improvement in Dravet syndrome. However, cannabidiol is also associated with decreased appetite. Adverse mental events were reported as well, however, more research should be performed to assess well this outcome.

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