anesjc.com - October, 2021

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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

October, 2021

Journal: JAMA Network Open
PMID: 34387679
Type of study: Randomized, controlled trial
Hypothesis: Oral CBD plus standard care administered daily for 28 days will be superior to standard care alone for the prevention or reduction of emotional exhaustion and burnout symptoms among health care professionals working with patients with COVID-19
Methods
- Prospective, single-site, randomized clinical trial
  - Ribeirão Preto Medical School University Hospital, São Paulo, Brazil
- Evaluators blinded
- Participants and investigators unblinded
  - Initial placebo-controlled, double blinded design rejected by local ethics committee
- Exclusion criteria
  - Currently using medication that may interact with CBD
  - Patients with active marijuana use were not excluded
  - History of adverse/undesirable reactions to CBD or other cannabinoids
  - Belonged to a “COVID 19 risk group”
    1. DM, HTN, lung disease, hematological disease, CKD, immunosuppression
  - Currently pregnant or male with pregnant partner
- Standard Care
  - Motivational/instructional videos on low-impact physical exercise
  - Weekly consultations with psychiatrists
  - Repeatedly offered PPE, modifications to work schedules,
- Intervention
  - Standard Care + 300mg CBD daily
- Primary outcome: emotional exhaustion and burnout symptoms
  - Validated Brazilian version of the emotional exhaustion subscale of the Maslach Burnout Inventory-Human Services Survey for Medical Personnel
- Secondary Outcomes:
  - Anxiety (GAD-7)
  - Depression (PHQ-9)
  - PTSD (PCL-5)
- Weekly labs: IL-1β, TNF-α, CBD plasma levels, basic labs
Results
- Subjects in the CBD + standard care group had decreased emotional exhaustion at 14 days (mean difference, 4.14 points; 95% CI, 1.47-6.80 points) and 21 days (mean difference, 4.34 points; 95% CI, 0.94-7.73).
- 5 subjects in the CBD + standard care group experienced serious adverse events
  - 4 subjects with elevated liver enzymes
  - 1 subject with severe pharmacodermia
Strengths
- Randomized, prospective study design
- Use of validated scoring systems
- Weekly results
- Relevance to current issues among physicians
Weaknesses
- Unblinded
- Lack of placebo group
- Short follow up period
- Single intervention dose
- Single center design
- Small n
- Exclusion criteria
- Standard of care
Key Point: Healthcare workers randomized to CBD therapy experienced reduced symptoms of burnout and emotional exhaustion but had more adverse events than the standard care group.

JAMA Netw Open. 2021 Aug 2;4(8):e2120603

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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

Journal: JAMA Network Open

PMID: 34387679

Type of study: Randomized, controlled trial

Hypothesis: Oral CBD plus standard care administered daily for 28 days will be superior to standard care alone for the prevention or reduction of emotional exhaustion and burnout symptoms among health care professionals working with patients with COVID-19

Methods

Prospective, single-site, randomized clinical trial

Ribeirão Preto Medical School University Hospital, São Paulo, Brazil

Evaluators blinded

Participants and investigators unblinded

Initial placebo-controlled, double blinded design rejected by local ethics committee

Exclusion criteria

Currently using medication that may interact with CBD

Patients with active marijuana use were not excluded

History of adverse/undesirable reactions to CBD or other cannabinoids

Belonged to a “COVID 19 risk group”

DM, HTN, lung disease, hematological disease, CKD, immunosuppression

Currently pregnant or male with pregnant partner

Standard Care

Motivational/instructional videos on low-impact physical exercise

Weekly consultations with psychiatrists

Repeatedly offered PPE, modifications to work schedules,

Intervention

Standard Care + 300mg CBD daily

Primary outcome: emotional exhaustion and burnout symptoms

Validated Brazilian version of the emotional exhaustion subscale of the Maslach Burnout Inventory-Human Services Survey for Medical Personnel

Secondary Outcomes:

Anxiety (GAD-7)

Depression (PHQ-9)

PTSD (PCL-5)

Weekly labs: IL-1β, TNF-α, CBD plasma levels, basic labs

Results

Subjects in the CBD + standard care group had decreased emotional exhaustion at 14 days (mean difference, 4.14 points; 95% CI, 1.47-6.80 points) and 21 days (mean difference, 4.34 points; 95% CI, 0.94-7.73).

5 subjects in the CBD + standard care group experienced serious adverse events

4 subjects with elevated liver enzymes

1 subject with severe pharmacodermia

Strengths

Randomized, prospective study design

Use of validated scoring systems

Weekly results

Relevance to current issues among physicians

Weaknesses

Unblinded

Lack of placebo group

Short follow up period

Single intervention dose

Single center design

Small n

Exclusion criteria

Standard of care

Key Point: Healthcare workers randomized to CBD therapy experienced reduced symptoms of burnout and emotional exhaustion but had more adverse events than the standard care group.

JAMA Netw Open. 2021 Aug 2;4(8):e2120603

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