Avaliação da eficácia e segurança do extrato de Cannabis rico em canabidiol em crianças com o transtorno do espectro autista: “ensaio clínico randomizado, duplo-cego e placebo controlado”

Abstract

Objectives: Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by persistent deficits in social communication, social interaction and restricted and repetitive patterns of behavior. Some studies have shown that substances derived from Cannabis sativa are improving the quality of life of children with ASD, without causing serious adverse effects, making it a valid therapeutic alternative. Therefore, this randomized, double-blind, controlled placebo clinical trial aimed to evaluate the efficacy, safety and tolerability of a cannabis-based product, in autistic children. Method: 60 children aged between 5 and 12 years old were divided into two groups: treated group, which received the cannabis-based product containing cannabi-diol (CBD), and the control group, which received the placebo, both used the product for a period of 12 weeks. To evaluate the efficacy, ATEC and a semi-structured interview with care-givers were used before and after using the product, as well as adverse effects and tolerability were assessed, through weekly medical monitoring, throughout the entire research. Results: The following parameters were evaluated: cognitive and behavioral aspects, language, sleep and eating habits before starting treatment with placebo/cannabis and at the end of the clinical trial, through the analysis of mixed variance of two factors (two way ANOVA). Significant results were found for social interaction [F(1,116)=14.13, p=0.0002)], anxiety [F(1,116)=5.99, p=0.016], psychomotor agitation [F(1,116)=9.22, n=0.003)], number of meals per day [F(1,116)=4.11, n=0.04)] and concentration [F (1,48)= 6.75, p=0.01], this being significant only in mild autistic individuals. Regarding safety, it was found that only three children in the treated group (9.7%) had adverse effects, being dizziness and insomnia in one child, colic in another and weight gain in another participant of the 31 who were in the cannabis group. Conclusion: It was found that CBD-rich cannabis extract improved one of the diagnostic criteria for ASD (social interaction), as well as often coexisting characteristics, in addition to few and not serious adverse effects.