Efficacy and Safety of Cannabidiol Plus Standard Care vs Standard Care Alone for the Treatment of Emotional Exhaustion and Burnout Among Frontline Health Care Workers During the COVID-19 Pandemic A Randomized Clinical Trial

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Crippa, Jose Alexandre S. ^{[1, 2]} ; Zuardi, Antonio W. ^{[1, 2]} ; Guimaraes, Francisco S. ^{[3, 2]} ; Campos, Alline Cristina ^[3] ; Osorio, Flavia de Lima ^{[1, 2]} ; Loureiro, Sonia Regina ^[1] ; dos Santos, Rafael G. ^{[1, 2]} ; Souza, Jose Diogo S. ^[1] ; Ushirohira, Juliana Mayumi ^[1] ; Pacheco, Julia Cozar ^[1] ; Ferreira, Rafael Rinaldi ^[3] ; Mancini Costa, Karla Cristinne ^[3] ; Scomparin, Davi Silveira ^[3] ; Scarante, Franciele Franco ^[3] ; Pires-Dos-Santos, Isabela ^[3] ; Mechoulam, Raphael ^[4] ; Kapczinski, Flavio ^{[5, 2, 6]} ; Fonseca, Benedito A. L. ^[7] ; Esposito, Danillo L. A. ^[7] ; Pereira-Lima, Karina ^{[8, 9]} ; Sen, Srijan ^[9] ; Andraus, Maristela Haddad ^[10] ; Hallak, Jaime E. C. ^{[1, 2]} ; Cannab, Burnout Distress Prevention

Afiliação do(s) autor(es)

^[1] Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Neurosci & Behav, Av Bandeirantes 3900, BR-14049900 Ribeirao Preto, SP - Brazil

^[2] Natl Inst Sci & Technol Translat Med, Sao Paulo - Brazil

^[3] Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Pharmacol, Ribeirao Preto, SP - Brazil

^[4] Hebrew Univ Jerusalem, Sch Pharm, Inst Drug Res, Jerusalem - Israel

^[5] McMaster Univ, Dept Psychiat & Behav Neurosci, Hamilton, ON - Canada

^[6] Univ Fed Rio Grande do Sul, Fac Med, Dept Psychiat, Grad Program Psychiat & Behav Sci, Porto Alegre, RS - Brazil

^[7] Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Internal Med, Ribeirao Preto, SP - Brazil

^[8] Univ Fed Sao Paulo, Dept Psychiat, Sao Paulo - Brazil

^[9] Univ Michigan, Sch Med, Dept Psychiat, Ann Arbor, MI - USA

^[10] Chromatox Lab, Sao Paulo - Brazil

• Tipo de documento: Artigo Científico
• Fonte: JAMA NETWORK OPEN; v. 4, n. 8 AUG 13 2021.
• Citações Web of Science: 0

Resumo

IMPORTANCE Frontline health care professionals who work with patients with COVID-19 have an increased incidence of burnout symptoms. Cannabidiol (CBD) has anxiolytic and antidepressant properties and may be capable of reducing emotional exhaustion and burnout symptoms. OBJECTIVE To investigate the safety and efficacy of CBD therapy for the reduction of emotional exhaustion and burnout symptoms among frontline health care professionals working with patients with COVID-19. DESIGN, SETTING, AND PARTICIPANTS This prospective open-label single-site randomized clinical trial used a 1:1 block randomization design to examine emotional exhaustion and burnout symptoms among frontline health care professionals (physicians, nurses, and physical therapists) working with patients with COVID-19 at the Ribeirao Preto Medical School University Hospital in Sao Paulo, Brazil. Participants were enrolled between June 12 and November 12, 2020. A total of 214 health care professionals were recruited and assessed for eligibility, and 120 participants were randomized in a 1:1 ratio by a researcher who was not directly involved with data collection. INTERVENTIONS Cannabidiol, 300 mg (150 mg twice per day), plus standard care or standard care alone for 28 days. Main Outcomes and Measures The primary outcome was emotional exhaustion and burnout symptoms, which were assessed for 28 days using the emotional exhaustion subscale of the Brazilian version of the Maslach Burnout Inventory-Human Services Survey for Medical Personnel. RESULTS A total of 120 participants were randomized to receive either CBD, 300 mg, plus standard care (treatment arm; n = 61) or standard care alone (control arm; n = 59) for 28 days. Of those, 118 participants (59 participants in each arm; 79 women {[}66.9%]; mean age, 33.6 years {[}95% CI, 32.3-34.9 years]) received the intervention and were included in the efficacy analysis. In the treatment arm, scores on the emotional exhaustion subscale of the Maslach Burnout Inventory significantly decreased at day 14 (mean difference, 4.14 points; 95% CI, 1.47-6.80 points; partial eta squared {[}eta(2)(p)] = 0.08), day 21 (mean difference, 4.34 points; 95% CI, 0.94-7.73 points; eta(2)(p) = 0.05), and day 28 (mean difference, 4.01 points; 95% CI, 0.43-7.59 points; eta(2)(p) = 0.04). However, 5 participants, all of whom were in the treatment group, experienced serious adverse events: 4 cases of elevated liver enzymes (1 critical and 3 mild, with the mild elevations reported at the final 28-day assessment) and 1 case of severe pharmacodermia. In 2 of those cases (1 with critical elevation of liver enzymes and 1 with severe pharmacodermia), CBD therapy was discontinued, and the participants had a full recovery. CONCLUSIONS AND RELEVANCE In this study, CBD therapy reduced symptoms of burnout and emotional exhaustion among health care professionals working with patients during the COVID-19 pandemic. However, it is necessary to balance the benefits of CBD therapy with potential undesired or adverse effects. Future double-blind placebo-controlled clinical trials are needed to confirm the present findings. (AU)

• Processo FAPESP: 08/09009-2 - Uso crônico de crack: densidade de transportador de dopamina, fatores genéticos e funcionamento executivo
• Beneficiário: Acioly Luiz Tavares de Lacerda
• Modalidade de apoio: Auxílio à Pesquisa - Regular
• Processo FAPESP: 20/12110-9 - Canabidiol (CBD) em pacientes com sintomas leves a moderados do Coronavirus 2019: um ensaio clínico randomizado, duplo-cego, controlado por placebo
• Beneficiário: José Alexandre de Souza Crippa
• Modalidade de apoio: Auxílio à Pesquisa - Pesquisa em Políticas Públicas