People seeking relief from everything from social anxiety and addiction to chronic pain and cancer have looked to Cannabidiol (CBD) products to heal. It's also a product market that's largely unregulated and not FDA approved. Here's what you need to know to help keep patients safe.
Posted in ND Insights Newsletter on Thursday, June 20, 2024
Cannabidiol, commonly referred to as CBD, is marketed as a “miracle drug.” People seeking relief from everything from social anxiety and addiction to chronic pain and cancer have looked to CBD products to heal.
It’s a booming market. In 2023, the global market was valued at 7.7 billion1 and experts predict its continued growth. It’s also a product market that’s largely unregulated. From false claims of efficacy to poor quality, buyers of CBD products should be cautious.
A Forbes Health survey found that 60% of respondents had used CBD. The survey indicated that CBD is used by people seeking to alleviate anxiety (47%), reduce stress (60%), relieve pain (56%), and to improve sleep quality (55%).2
As CBD usage rises, so does misinformation. What’s factual and what’s unsubstantiated? Here’s what we know so far.
Facts and Myths
FACT: Clinical Research Has Found Benefits of CBD Use
Clinical studies have confirmed that CBD reduces the levels of proinflammatory cytokines, inhibits T cell proliferation, induces T cell apoptosis and reduces migration and adhesion of immune cells.3
A 2019 literature review found evidence of the value of CBD, showing it to have a “calming effect” on the central nervous system in neuropsychiatric disorders such as epilepsy, anxiety, and schizophrenia.4
There is also evidence to suggest that nausea and vomiting can be lessened through the use of CBD,5 which is especially valuable when it comes to relieving cancer pain and the side effects associated with chemotherapy.6
Pre-clinical and clinical evidence also supports a role for CBD as a novel treatment for anxiety disorders. A study demonstrated “the potential of CBD to produce anxiolytic-like effects in pre-clinical models and the potential of CBD to induce acute anxiolytic effects when administered as a single dose in healthy volunteers and individuals with SAD.”7
MYTH: There Are No Side Effects or Adverse Events Associated with CBD
Although CBD is known to be non-intoxicating and non-habit forming, there are known side effects. One-third of CBD users report non-serious side effects, including dry mouth, euphoria, hunger, irritated eyes and fatigue.7
Adverse events have also been reported. In animals, CBD adverse events included developmental toxicity, embryo-fetal mortality, central nervous system inhibition and neurotoxicity, hepatocellular injuries, spermatogenesis reduction, organ weight alterations, male reproductive system alterations and hypotension, although at doses higher than recommended for human pharmacotherapies.8
In addition, animal studies have shown the potential for elevated liver enzymes, though at higher doses than typical human consumptions. In humans, adverse events include the potential for drug-drug interactions. CBD acts like grapefruit, by inhibiting the cytochrome P450 system.
Tacrolimus is an immunosuppressive drug used with heart, liver, and kidney transplant patients. In a research study, it was deemed to have clinically significant negative outcomes due to CBD’s interference with the ability to metabolize it.9
Studies also suggest an interaction between blood thinners (warfarin) and CBD, which are also metabolized by the cytochrome P450 system.10
A 2021 review found evidence of CBD interacting with anti-epileptic drugs, antidepressants, opioid analgesics, and THC. Additionally, it’s been shown to interact with acetaminophen.11
FACT: Lack of Regulation Could Lead to Patient Harm
The general lack of regulation is making it increasingly difficult to determine what’s safe.
- Mislabeling. A study by Penn Medicine found mislabeling of 70% of CBD products sold online. Marcel Bonn-Miller, PhD, an adjunct assistant professor of Psychology in Psychiatry and the lead author on the study, believes the mislabeling of cannabidiol products is a direct result of inadequate regulation and oversight. “The big problem, with this being something that is not legal at the federal level, is that the needed quality assurance oversight from the Food and Drug Administration is not available.”12
- False Medical Claims. The FDA and Federal Trade Commission (FTC) have sent warning letters to many CBD companies about false claims for medical use, including its efficacy in treating “alcoholism, Alzheimer’s disease, arthritis, autism, blood pressure and heart rate, cancer, chronic traumatic encephalopathy, cardiovascular disease, chemotherapy-induced hearing loss, colitis, concussions, depression, diabetes, leukemia, liver inflammation, lupus, Lyme disease, neurological damage, Parkinson’s disease, stroke, schizophrenia, traumatic brain injury (TBI), and tumors.”13
- Dosage. Due to a lack of clinical studies, it’s difficult for doctors to confirm safe, beneficial dosage levels. Researchers have studied oral dosaging ranging from 100-800mg per day.
MYTH: CBD Oil is legal
CBD can be derived from hemp or marijuana. At the federal level, only CBD derived from hemp (with THC of less than 0.3 percent) is legal. However, CBD oil, even if derived from hemp, is not legal in all states.14 Some states require a license for medical use, or have conditional legality based on the percentage of THC in the oil. It’s essential to consider the regulations in your own state. Contact your state board for questions or guidance.
FACT: Encouraging Patients to Be Savvy Consumers is Important
It’s always important to check the label to understand what you’re purchasing; this can be difficult when labels are intended as product marketing. Some general guidance includes:
CBD oil can be derived from hemp or from marijuana. If you live in a state where marijuana is legal, you may be able to purchase CBD oil with higher levels of THC which may cause a psychoactive effect and/or cause THC to show up on a drug test.
Ensure the label mentions “cannabidiol” or hemp extract. Some products marketed as CBD may only list hempseed oil, hemp seeds, or cannabis seed oil. While they may each have their own set of health benefits, CBD and its benefits are not present in these products.
Always check the product for any known allergies and follow the manufacturer’s dosage recommendations.
Even if you are not prescribing medical cannabis or CBD products, your patients may be using it. As a provider, understanding medical cannabis and CBD products is beneficial, regardless of the laws in your state. This includes knowledge of the potential uses, adverse effects, and risks associated with using. Document and discuss the pros and cons of use, monitor for improvements and/or potential adverse effects and consider how medical cannabis and CBD products could affect medications you are prescribing and adjust them accordingly.
References
[1] https://www.grandviewresearch.com/industry-analysis/cannabidiol-cbd-market
[2] https://www.forbes.com/health/cbd/cbd-statistics/#:~:text=On%20CBDfx's%20Website-,CBD%20Statistics%20at%20a%20Glance,it%20offers%20some%20medicinal%20benefits.
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7023045/
[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6326553/
[5] https://news.unm.edu/news/cannabis-offers-mmediate-relief-from-symptoms-of-nausea-but-product-use-matters
[6] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9220307/
[7] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6043845/
[8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7052834/
[9] https://pubmed.ncbi.nlm.nih.gov/31012522/
[10] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5789126/
[11] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8298645/#:~:text=tacrolimus%20concentrations61.-,Acetaminophen,hepatic%20injury%2C%20such%20as%20acetaminophen.
[12] https://www.pennmedicine.org/news/news-releases/2017/november/penn-study-shows-nearly-70-percent-of-cannabidiol-extracts-sold-online-are-mislabeled
[13] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7723146/
[14] https://www.forbes.com/health/cbd/cbd-legalization-by-state/