Evaluation of the efficacy and safety of cannabidiol-rich cannabis extract in children with autism spectrum disorder: randomized, double-blind, and placebo-controlled clinical trial.

Autor:	Silva EAD Junior; Programa de Pós-Graduação em Neurociência Cognitiva e Comportamento, Departamento de Psicologia, Universidade Federal da Paraíba (UFPB), João Pessoa, PB, Brazil., Medeiros WMB; Programa de Pós-Graduação em Neurociência Cognitiva e Comportamento, Departamento de Psicologia, Universidade Federal da Paraíba (UFPB), João Pessoa, PB, Brazil., Santos JPMD; UFPB, João Pessoa, PB, Brazil., Sousa JMM; UFPB, João Pessoa, PB, Brazil., Costa FBD; UFPB, João Pessoa, PB, Brazil., Pontes KM; UFPB, João Pessoa, PB, Brazil., Borges TC; UFPB, João Pessoa, PB, Brazil., Espínola C Neto Segundo; UFPB, João Pessoa, PB, Brazil., Andrade E Silva AH; Departamento de Estatística, UFPB, João Pessoa, PB, Brazil., Nunes ELG; Sociedade Brasileira de Estudos da Cannabis Sativa (SBEC), São Paulo, SP, Brazil., Alves NT; Departamento de Psicologia, UFPB, João Pessoa, PB, Brazil., Rosa MDD; Departamento de Fonoaudiologia, UFPB, João Pessoa, PB, Brazil., Albuquerque KLGD; Sociedade Brasileira de Estudos da Cannabis Sativa (SBEC), São Paulo, SP, Brazil. Departamento de Fisiologia e Patologia, UFPB, João Pessoa, PB, Brazil.
Jazyk:	angličtina
Zdroj:	Trends in psychiatry and psychotherapy [Trends Psychiatry Psychother] 2024; Vol. 46, pp. e20210396. Date of Electronic Publication: 2022 May 26.
DOI:	10.47626/2237-6089-2021-0396
Abstrakt:	Objective: Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and social interaction and by restricted and repetitive patterns of behavior. Some studies have shown that substances derived from Cannabis sativa improve the quality of life of children with ASD without causing serious adverse effects, thus providing an alternative therapeutic option. The objective of this study was to evaluate the efficacy and safety of a cannabis extract rich in cannabidiol (CBD) in children with ASD. Methods: In this randomized, double-blind, placebo-controlled clinical trial, 60 children, aged from 5 to 11 years, were selected and divided into two groups: the treatment group, which received the CBD-rich cannabis extract, and the control group, which received the placebo. They both used their respective products for a period of 12 weeks. Statistical analysis was done by two-factor mixed analysis of variance (two-way ANOVA). Results: Significant results were found for social interaction (F1,116 = 14.13, p = 0.0002), anxiety (F1,116 = 5.99, p = 0.016), psychomotor agitation (F1,116 = 9.22, p = 0.003), number of meals a day (F1,116 = 4.11, p = 0.04), and concentration (F1,48 = 6.75, p = 0.01), the last of which was only significant in mild ASD cases. Regarding safety, it was found that only three children in the treatment group (9.7%) had adverse effects, namely dizziness, insomnia, colic, and weight gain. Conclusion: CBD-rich cannabis extract was found to improve one of the diagnostic criteria for ASD (social interaction), as well as features that often co-exist with ASD, and to have few serious adverse effects. Competing Interests: No conflicts of interest declared concerning the publication of this article.
Databáze:	MEDLINE
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