Department of Neuroscience and Behavior, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.
National Institute for Science and Technology-Translational Medicine, São Paulo, Brazil.
JAMA Netw Open. 2021 Aug 2;4(8):e2120603. doi: 10.1001/jamanetworkopen.2021.20603.
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.
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 Ribeirão Preto Medical School University Hospital in São 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.
Cannabidiol, 300 mg (150 mg twice per day), plus standard care or standard care alone for 28 days.
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.
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 [ηp2] = 0.08), day 21 (mean difference, 4.34 points; 95% CI, 0.94-7.73 points; ηp2 = 0.05), and day 28 (mean difference, 4.01 points; 95% CI, 0.43-7.59 points; ηp2 = 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.
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.
ClinicalTrials.gov Identifier: NCT04504877.
重要性：与 COVID-19 患者一起工作的一线医护人员出现倦怠症状的发生率增加。大麻二酚（CBD）具有抗焦虑和抗抑郁作用，可能能够减轻情绪疲惫和倦怠症状。
目的：研究 CBD 治疗对与 COVID-19 患者一起工作的一线医护人员情绪疲惫和倦怠症状的减轻效果。
设计、地点和参与者：这是一项前瞻性开放标签单中心随机临床试验，采用 1:1 块随机设计，在巴西圣保罗里贝朗普雷托医学院附属医院检查与 COVID-19 患者一起工作的一线医护人员（医生、护士和物理治疗师）的情绪疲惫和倦怠症状。参与者于 2020 年 6 月 12 日至 11 月 12 日期间入组。共招募了 214 名医护人员进行资格评估，120 名参与者通过不直接参与数据收集的研究人员以 1:1 的比例随机分组。
干预措施：CBD，300 毫克（每天两次，每次 150 毫克），加标准护理或单独标准护理，共 28 天。
主要结局和测量指标：主要结局是情绪疲惫和倦怠症状，使用巴西版 Maslach 倦怠量表人力资源服务医学人员量表的情绪疲惫子量表评估 28 天。
结果：共有 120 名参与者随机接受 CBD，300 毫克，加标准护理（治疗组；n=61）或单独标准护理（对照组；n=59），共 28 天。其中，118 名参与者（每组 59 名参与者；79 名女性[66.9%]；平均年龄 33.6 岁[95%CI，32.3-34.9 岁]）接受了干预并纳入了疗效分析。在治疗组中，Maslach 倦怠量表的情绪疲惫子量表评分在第 14 天（平均差异，4.14 分；95%CI，1.47-6.80 分；部分 eta 平方[ηp2]为 0.08）、第 21 天（平均差异，4.34 分；95%CI，0.94-7.73 分；ηp2为 0.05）和第 28 天（平均差异，4.01 分；95%CI，0.43-7.59 分；ηp2为 0.04）显著降低。然而，5 名参与者（均在治疗组）出现严重不良事件：4 例肝酶升高（1 例严重，3 例轻度，轻度升高报告在最后 28 天评估）和 1 例严重药疹。在其中 2 例（1 例严重肝酶升高和 1 例严重药疹）中，停止了 CBD 治疗，参与者完全康复。
结论和相关性：在这项研究中，CBD 治疗减轻了 COVID-19 大流行期间与患者一起工作的医护人员的倦怠和情绪疲惫症状。然而，有必要平衡 CBD 治疗的益处与潜在的不良或不良反应。未来需要进行双盲安慰剂对照临床试验来证实目前的发现。
试验注册：ClinicalTrials.gov 标识符：NCT04504877。
