Cannabidiol (CBD) has become a widely used health supplement for relieving anxiety, easing aches and pains, and supporting sleep. However, it is not regulated by the Food and Drug Administration (FDA) to ensure safety or efficacy, and commercial CBD products are not approved for any medical use. This disconnect lead researchers to study the safety and effectiveness of commercial CBD products and publish their findings in the 2022 paper “The Safety and Effectiveness of Commercially Available Cannabidiol Products for Health and Well-Being: A Randomized, Multi-Arm, Open-Label Waitlist-Controlled Trial” (Clinical Trial Registration number: NCT05003882).
Thirteen orally ingested commercial CBD products were evaluated using an open-label, randomized, waitlist controlled study design. This study consisted of over 2800 participants that were 94% female and had symptoms of anxiety, sleep disturbance, or chronic pain. The CBD products used in the study varied in form and potency. They included products like CBD capsules, tinctures, CBD gummies, and oral sprays. Some products were CBD isolate versus full spectrum CBD formulations, and ranged from 10mg to 100mg CBD per serving.
The study found that many participants felt a significant improvement to general well-being, anxiety (46.6%), sleep (47.9%), and pain symptoms (35.2%). While these benefits were felt by less than 50% of the participants, the benefits were statistically significant. This data suggests that commercial CBD products can be effective in a wide variety of formulations and doses. As far as safety is concerned, no severe side effects were reported. However, 9.5% of participants did experience CBD side effects that included gas/flatulence (1.6%), headache (1.4%), diarrhea (1.2%), and bloating (1.2%).
While this clinical trial does not prove that every commercial CBD product is safe and effective, it suggests that in general these products can benefit consumers with mild risks of side effects. This study was a bit unusual in having 94% female participants and also noted that 47% of participants were obese and 25% were overweight. 90% of participants were non-Hispanic, and 83% were white. Most of the participants had prior experience using CBD and/or marijuana and the study also allowed participants to determine their own CBD dose (which can be impacted by weight). These factors could all contribute some bias to the study’s findings, so it will be important for future studies to consider more participant diversity along with controls for dosing.
References
Saleska, J. L., Pauli, E. K., Rezvan, P., Cobb, O., Chen, J., Thorogood, P., … & Laird, K. T. (2022). The Safety and Effectiveness of Commercially Available Cannabidiol Products for Health and Well-Being: A Randomized, Multi-Arm, Open-Label Waitlist-Controlled Trial. Integrative Medicine Reports, 1(1), 215-226.
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