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

Abstract 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.

Cannabis and cannabinoid use in autism spectrum disorder: a systematic review

Abstract Introduction Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by persistent deficits in social communication and social interaction, associated with the presence of restricted and repetitive patterns of behavior, interests, or activities. Cannabis has been used to alleviate symptoms associated with ASD. Method We carried out a systematic review of studies that investigated the clinical effects of cannabis and cannabinoid use on ASD, according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA checklist). The search was carried out in four databases: MEDLINE/PubMed, Scientific Electronic Library Online (SciELO), Scopus, and Web of Science. No limits were established for language during the selection process. Nine studies were selected and analyzed. Results Some studies showed that cannabis products reduced the number and/or intensity of different symptoms, including hyperactivity, attacks of self-mutilation and anger, sleep problems, anxiety, restlessness, psychomotor agitation, irritability, aggressiveness perseverance, and depression. Moreover, they found an improvement in cognition, sensory sensitivity, attention, social interaction, and language. The most common adverse effects were sleep disorders, restlessness, nervousness and change in appetite. Conclusion Cannabis and cannabinoids may have promising effects in the treatment of symptoms related to ASD, and can be used as a therapeutic alternative in the relief of those symptoms. However, randomized, blind, placebo-controlled clinical trials are necessary to clarify findings on the effects of cannabis and its cannabinoids in individuals with ASD. Systematic review registration International Prospective Register of Systematic Reviews (PROSPERO), code 164161.

Dificuldades Iniciais no Aprendizado do Exame Físico na Percepção do Estudante / Initial Difficulties in Learning the Physical Exam According to the Student's Perception

Resumo: Introdução: Ao longo da formação no curso de Medicina, o estudante enfrenta diversas situações que podem ser geradoras de insegurança e ansiedade, entre as quais se destacam as primeiras aulas práticas com pacientes que tradicionalmente ocorrem na disciplina de Semiologia Médica. A realização do primeiro exame físico com um paciente real é uma potencial circunstância geradora de estresse para os que dão seus primeiros passos na construção de habilidades indispensáveis à carreira médica. A forma de lidar com o estresse advindo desses encontros é bastante individual e relaciona-se com diversos fatores inerentes ao estudante e ao modelo de ensino adotado. O presente estudo propõe-se a identificar as principais adversidades relatadas pelos alunos na sua iniciação ao exame físico. Método: Para tanto, realizou-se um estudo exploratório, com abordagem qualitativa, executado durante as atividades do Módulo Horizontal Básico 4 (MHB4), o qual está inserido na grade curricular do quarto semestre do curso de Medicina da Universidade Federal da Paraíba. Uma amostra de 35 estudantes foi dividida em seis grupos focais. A coleta de dados foi realizada na oitava semana do semestre letivo e ocorreu simultaneamente em todos os grupos. A discussão iniciou-se por meio da pergunta norteadora "Quais são as dificuldades encontradas durante o exame físico do paciente?". Procedeu-se, então, à gravação das falas dos alunos, com posterior transcrição, na íntegra, de todo o material textual, o qual foi submetido à análise de conteúdo por meio do método preconizado por Bardin. Resultados: As falas dos alunos foram elencadas em cinco categorias nomeadas como: insegurança e inexperiência; submissão do paciente; sensação de estar incomodando o paciente; direcionamento de gênero; escolha do paciente por conveniência. A partir dessa análise foi possível observar que a realização do primeiro exame físico é um evento gerador de grande estresse emocional para os estudantes. Questões como a insegurança, a inexperiência e a sensação de estar utilizando o paciente como um objeto são citadas como fatores que geram desconforto nos estudantes e dificultam seu aprendizado. Conclusões: As percepções dos estudantes são de insegurança, inexperiência e invasão da privacidade de um paciente que se encontra numa situação de passividade diante da situação. Nesse contexto, o enfrentamento das dificuldades toma proporções maiores e irrealísticas no aprendizado do exame físico.

Abstract: Introduction: During Medical School, the student faces several situations that can generate insecurity and anxiety, and among them, the one that stands out is the first practical class with patients, which traditionally occur during the Medical Semiology course. Performing the first physical examination in a real patient is a potential stress-inducing situation for those who take their first steps towards building the necessary skills for a medical career. The way one deals with the stress generated by these situations is quite individual and is related to several factors inherent to the student and to the teaching model adopted. The present study aims to identify the main adversities reported by students in their initiation to physical examination. Method: An exploratory study with a qualitative approach was carried out during the activities of the Basic Horizontal Module 4 (MHB4), which is part of the curriculum of the fourth semester of the Medical School at Federal University of Paraíba. A sample of 35 students was divided into 6 focal groups. Data collection was performed in the eighth week of the semester and occurred simultaneously in all groups. The discussion began with the guiding question "What are the difficulties faced during the physical examination of the patient?". The student's speeches were recorded and then transcripted in full and the material was submitted to content analysis using the method recommended by Bardin¹. Results: The students' statements were listed into 5 categories: insecurity and inexperience; patient's submission; feeling of bothering the patient; gender targeting; selection of the patient for convenience. Based on this analysis it was possible to observe that the performance of the first physical examination is an event that causes much emotional stress to students. Issues such as insecurity, inexperience and the feeling of using the patient as an object are mentioned as factors that causes discomfort to students and hinder their learning process. Conclusions: The students' perceptions are those of insecurity, inexperience and invasion of the patient's privacy, who is in a passive situation. In this context, the process of facing the difficulties takes on bigger and unrealistic proportions in the learning process of physical examination.

Psychiatric comorbidities among adolescents with and without anxiety disorders: a community study / Comorbidades psiquiátricas entre adolescentes com e sem transtornos de ansiedade: um estudo da comunidade

ABSTRACT Objective To evaluate, in a community sample of adolescents, the presence of comorbidities in different anxiety disorders. Methods This is a cross-sectional study, initially composed of 2,457 adolescents, aged between 10-17 years old, from public schools of the area covered by the Basic Health Unit of a university hospital. We applied the Screen for Child Anxiety Related Emotional Disorders (SCARED) to assess for anxiety disorders. Then, 138 positive cases in the screening were assessed for mental disorders through the Schedule for Affective Disorder and Schizophrenia for School-Age Children – Present and Lifetime Version (K-SADS-PL). Results Patients with anxiety disorders had more association with other anxiety disorders, as well as depression, and enuresis. The most common comorbidity described in our study was between generalized anxiety disorder and separation anxiety disorder (OR = 4.21, 95% CI 1.88, 9.58). Significant association was observed between other disorders such as enuresis and separation anxiety disorder (OR = 3.81, 95% CI 1.16, 12.49), as well as depression and generalized anxiety disorder (OR = 3.40; 95% CI 1.52, 7.61). Conclusion Our study showed a relevant presence of comorbidities adolescents with anxiety disorders, selected from a community sample, especially regarding other anxiety disorders. Nevertheless, further studies are needed to confirm our findings.

RESUMO Objetivo Avaliar, em uma amostra comunitária de adolescentes, a presença de comorbidades nos distintos transtornos de ansiedade. Métodos Estudo transversal, composto por 2.457 adolescentes de 10 a 17 anos, provenientes das escolas públicas da área de abrangência da Unidade Básica de Saúde de um hospital universitário, que foram avaliados para transtornos de ansiedade, por meio da Screen for Child Anxiety Related Emotional Disorders (SCARED). Desses, 138 casos foram positivos pela SCARED e avaliados para transtornos mentais, por meio do Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL). Resultados Pacientes com transtornos de ansiedade apresentavam mais comorbidades com outros transtornos de ansiedade, bem como com depressão e enurese. As comorbidades mais frequentes descritas em nosso estudo foram transtorno de ansiedade generalizada e transtorno de ansiedade de separação (OR = 4,21; IC 95% 1,88; 9,58). Foi observada associação significativa com outros transtornos, tais como enurese com transtorno de ansiedade de separação (OR = 3,81; IC 95% 1,16; 12,49) e depressão com transtorno de ansiedade generalizada (OR = 3,40; IC 95% 1,52; 7,61). Conclusão A presença de comorbidades em adolescentes com transtornos de ansiedade selecionados de uma amostra comunitária foi frequente. Estudos complementares para confirmar nossos resultados são necessários.