Cannabinoid-based interventions for behavioral outcomes in children and adolescents with autism spectrum disorder: A systematic review of safety and effectiveness.
Vasconcelos et al.·Progress in neuro-psychopharmacology & biological psychiatryImpact 3.4
GemischtGRADEHoch0 Zitate
Stichprobek = 12 Studien
Dauerunklar
KontrollePlacebo
EndpunktGlobaler klinischer Eindruck
Verblindungunklar
DesignSystematic Review
Cannabinoidvollspektrum
THC:CBD20:1
”Kernaussage
Responder-Raten für globale Besserung zeigten Vorteil (49% vs 21%), aber standardisierte Outcomes waren überwiegend nicht signifikant; Evidenz bleibt begrenzt.
Zusammenfassung
Systematische Review zu Cannabinoiden bei Kindern/Adoleszenten mit Autismus; k=12 Studien (4 RCTs, 8 nicht-RCTs), 6 laufende Trials identifiziert. Überwiegend Vollspektrum-Extrakte mit CBD:THC-Ratio 20:1, Titration bis ~10 mg/kg/Tag. Responder-Rate für globale Verbesserung vs. Placebo 49% vs. 21%; Verbesserung sozialer Kommunikation. Keine Zwischen-Gruppen-Differenzen für Schlaf oder Gesamtsymptomatik; repetitive Verhaltensweisen nicht-signifikanter Trend. Nebenwirkungen meist mild (Somnolenz, Appetitänderungen, Schlafprobleme, Irritabilität); keine schwerwiegenden behandlungsbezogenen Events. GRADE-Sicherheit sehr niedrig.
P
PopulationKinder und Jugendliche mit Autismus-Spektrum-Störung (ASD)
I
InterventionCannabinoid-basierte Interventionen, v.a. CBD und CBD:THC-Kombinationen (häufig 20:1-Extrakte, Titration bis ca. 10 mg/kg/Tag)
C
KontrollePlacebo (in RCTs); keine Kontrolle (in Beobachtungsstudien)
O
OutcomeGlobale Verbesserungsrate 49% vs. 21% (Verum vs. Placebo) und verbesserter sozialer Kommunikation in einem RCT; kein signifikanter Unterschied bei Schlaf, Gesamtsymptomatik oder repetitiven Verhaltensweisen; unerwünschte Ereignisse meist mild (Somnolenz, Appetitveränderungen, Schlafprobleme, Irritabilität)
Vertrauen in die Evidenz
Sehr niedrigNiedrigModeratHoch
Hoch
Höchste von vier GRADE-Stufen, die Effektschätzung ist sehr verlässlich.
Qualitätsprofil
Größe★★★★★
Verblindung—
EffektstärkeGemischt
Zitate / Jahr★★★★★
Autoren
Vasconcelos QDJS, de Freitas RF, Freitas MC, de Andrade IP, Brandao CB, Nascimento CE, Neves KR, Magalhaes PS, Filho VB, Oliveira GL
Background: Autism spectrum disorder (ASD) lacks effective options for core symptoms. Cannabinoids, especially cannabidiol (CBD) and combined CBD:Delta9-tetrahydrocannabinol (THC) formulations, are of interest, but clinical evidence is heterogeneous.
Purpose: To evaluate the effectiveness and safety of cannabinoid-based interventions for behavioral outcomes in children and adolescents with
Asd. Methods: Six databases (Scopus, Web of Science, Embase, Cochrane Library, PubMed, PsycINFO) were searched from February 2024 to June 2025. Risk of bias was assessed using RoB 2 (randomized controlled trials [RCTs]) and the Newcastle-Ottawa Scale (non-RCTs); certainty was evaluated with
Grade. Results: Twelve studies (4 RCTs, 8 non-RCTs) were included; six ongoing trials were identified. Most interventions used full-spectrum extracts with high CBD:THC ratios (often 20:1), with titration up to approximately 10 mg/kg/day; doses varied across studies. Responder rates for global improvement vs placebo (49% vs 21%) and greater improvement in social communication. No between-group differences were observed for sleep or overall symptom severity, and repetitive behaviors showed a non-significant trend toward improvement. Non-RCTs studies suggested benefits but had high risk of bias and very low certainty. Adverse events were mostly mild and non-serious (e.g., somnolence, appetite changes, sleep problems, irritability); no treatment-related serious adverse events were reported.
Conclusions: Evidence remains limited. A whole-plant 20:1 extract improved global clinical impression and social communication in one RCT, whereas other standardized outcomes were null. Current data support only cautious, adjunctive use under medical supervision. Larger, well-designed RCTs using validated outcomes are needed to clarify efficacy, optimal formulations, and long-term safety. PROSPERO registration: CRD42024508518.