A patient recently came to my office seeking antibiotics for her viral URI symptoms. After a shared decision-making discussion on using Echinacea (an immunostimulant with antiviral, anti-inflammatory, and antimicrobial effects) instead, we were able to forgo the unnecessary antibiotic. Approximately 25 percent of U.S. adults report concurrently taking a dietary supplement with a prescription medicine. As a resident physician in primary care, I regularly receive questions from patients regarding the safety and efficacy of supplements in various forms. While some on the market make unfounded claims — e.g., protecting neurons from normal age-related degeneration — many do have research-backed efficacy. For example, red yeast rice has been shown to lower LDL cholesterol and myo-inositol can improve metabolic profile in polycystic ovarian syndrome. Therefore, it becomes a patient safety issue when physicians or other clinicians do not acknowledge commonly used botanicals.
It is prudent to be wary of interactions between supplements and prescription medications when prescribing and monitoring use. 80 percent of prescribed medications are metabolized through six cytochrome P450 enzymes; supplements may induce or inhibit enzymatic actions. For example, St. John’s Wort, while shown to be more efficacious than standard antidepressant therapy in patients with mild-to-moderate depression, is a CYP450 inducer and should, therefore, be avoided if other drugs metabolized by CYP450 are used. Garlic, which is most used for its blood pressure and cholesterol-reducing properties, may act as a blood thinner by inhibiting platelets and negating the effects of anticoagulants. Ashwagandha, a substance often recommended to mediate stress and anxiety, should be avoided in patients with hyperthyroidism as it has been shown to boost T3 and T4 levels. Physicians can avoid these pitfalls by utilizing resources such as the NatMed database and research articles from the National Institutes of Health or PubMed. Clinicians seeking additional training in the use of botanicals and other dietary supplements can find CME courses in integrative medicine.
Many modern medicines are derived from plants, including aspirin, morphine, and even some chemotherapy drugs. So why are other naturally derived compounds considered “alternative medicine?” The answer lies in U.S. Food and Drug Administration (FDA) approval. The medications we prescribe have been deemed safe and effective by the U.S. government. In contrast, many supplements and vitamins on pharmacy shelves or marketed online lack the assurance of vigorous screening by the FDA, and current dosing guidelines are woefully vague. Increased regulation of botanicals on the market is imperative to improve patient safety on a national level. Currently, the FDA is unable to regulate dietary supplements as it can with medical devices and pharmaceuticals. Under the Dietary Supplement Health and Education Act of 1994, supplement manufacturers can establish their own specifications (e.g., purity, strength, composition) for which their supplements must adhere to current good manufacturing practices. The manufacturers also can implement their own analytical methods for testing products at their discretion. These lax requirements result in significant variations in quality amongst products that are not routinely tested by the FDA. Unfortunately, many patients assume that since these products are sold alongside FDA approved over-the-counter medications, they also underwent similar screening and verification.
While manufacturers are required to report adverse events to the FDA, active surveillance is not required. Supplements can be marketed under the presumption that they are safe and effective as deemed by the manufacturers. Because of this loophole, the FDA relies on physicians to voluntarily report suspected adverse events and concerns about product quality to MedWatch. Investigations are initiated from submitted reports. While this enables physicians to work with the FDA to prevent further patient harm from dietary supplements, a more appropriate solution would be to prevent insufficiently tested botanicals from being sold in the first place. The American Medical Association (AMA) supports FDA verification of all supplements on the market and advocates for post-marketing surveillance by manufacturers. However, such regulation would require new Congressional legislation. Physicians need to work with the AMA, medical specialty groups, and state medical societies to bring these patient safety issues to the attention of Congress and the public.
While remaining cognizant of the inadequate vetting process, it is important to know how to find good quality botanicals. The U.S. Pharmacopeia (USP) Dietary Supplement Compendium provides research into the identity and strength of a supplement, quality control/quality assurance, and ingredient safety data for supplement manufacturers and ingredient suppliers. Consumer Lab provides up-to-date compositional testing of herbs, vitamins, and supplements both on and off the market with direct comparisons and dosage recommendations for consumers. Completion of virtual courses by the Andrew Weil Center for Integrative Medicine at the University of Arizona and/or the National Center for Complementary and Integrative Health are ways clinicians can become familiar with botanicals and their uses.
Whether you’re recommending valerian root, melatonin, or eszopiclone for insomnia, herbalism has a place in medicine that is not going away. Therefore, physicians should utilize reputable resources to remain up-to-date on the safety and efficacy of supplements and their interactions with prescription medicines. Because many patients may not initially divulge their use, it is important to approach the topic in a nonjudgmental manner to facilitate honest discussion. Advocating for patient safety through lobbying for stricter regulatory standards is the best way to ensure that manufacturers are held responsible for the effects of products they sell to patients seeking more natural approaches to medicine.
Jillian Dawson is a family medicine resident.
