Evidence map›Paper›PMID 35617670›Full record

Trial reportTrends in psychiatry and psychotherapy2024

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.

Estácio Amaro da Silva, Wandersonia Moreira Brito Medeiros, João Paulo Mendes Dos Santos, João Marçal Medeiros de Sousa, Filipe Barbosa da Costa, Katiúscia Moreira Pontes, Thaís Cavalcanti Borges, Carlos Espínola, Ana Hermínia Andrade E Silva, Eliane Lima Guerra Nunes and 3 more

Open access · diamondAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trends in psychiatry and psychotherapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
8.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 51 citations in OpenAlex.

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  9. The Current State of Unapproved Cannabidiol Product Use in Children.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025
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  11. Cannabis, cannabinoids and health: a review of evidence on risks and medical benefits.European archives of psychiatry and clinical neuroscience · 2025
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Estácio Amaro da SilvaPrograma de Pós-Graduação em Neurociência Cognitiva e Comportamento, Departamento de Psicologia, Universidade Federal da Paraíba (UFPB), João Pessoa, PB, Brazil.
Wandersonia Moreira Brito MedeirosPrograma de Pós-Graduação em Neurociência Cognitiva e Comportamento, Departamento de Psicologia, Universidade Federal da Paraíba (UFPB), João Pessoa, PB, Brazil.
João Paulo Mendes Dos SantosUFPB, João Pessoa, PB, Brazil.
João Marçal Medeiros de SousaUFPB, João Pessoa, PB, Brazil.
Filipe Barbosa da CostaUFPB, João Pessoa, PB, Brazil.
Katiúscia Moreira PontesUFPB, João Pessoa, PB, Brazil.
Thaís Cavalcanti BorgesUFPB, João Pessoa, PB, Brazil.
Carlos EspínolaUFPB, João Pessoa, PB, Brazil.
Ana Hermínia Andrade E SilvaDepartamento de Estatística, UFPB, João Pessoa, PB, Brazil.
Eliane Lima Guerra NunesSociedade Brasileira de Estudos da Cannabis Sativa (SBEC), São Paulo, SP, Brazil.
Nelson Torro AlvesDepartamento de Psicologia, UFPB, João Pessoa, PB, Brazil.
Marine Diniz da RosaDepartamento de Fonoaudiologia, UFPB, João Pessoa, PB, Brazil.
Katy Lísias Gondim Dias de AlbuquerqueSociedade Brasileira de Estudos da Cannabis Sativa (SBEC), São Paulo, SP, Brazil. Departamento de Fisiologia e Patologia, UFPB, João Pessoa, PB, Brazil.
Universidade Federal da Paraíba · BRCentro Universitário da Cidade · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAutism 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.

methodsIn 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).

resultsSignificant 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.

conclusionCBD-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.

Indexed as

Autism Spectrum DisorderCannabidiolCannabisChildChild, PreschoolDouble-Blind MethodHumansPlant ExtractsQuality of LifeCannabidiolPlant ExtractsAutistic spectrum disordercannabidiolcannabischild behaviorclinical trial

Identifiers

PMID35617670
PMCPMC11332686
OpenAlexW4282944263

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.