Unnaturally Natural: Complementary and Alternative Agents in Patients with Heart Failure

For over 5000 years, natural or herbal medications have been used to preserve or recover health. As late as 1890, 59% of the products in the United Sates Pharmacopoeia were derived from herbs or herbal combinations.¹ Today, thousands of herbal products are available over the counter. The herbal market constitutes a $2.6 billion industry in 2022, and is projected to reach $4.1 billion by 2027.² These products are easily obtained by patients at any local grocery or health food store, pharmacy, and through the internet, and come under many different names, including “food supplements,” “nutraceuticals,” “herbal medicines,” and “complementary and alternative medicines (CAM)”.

These products are widely available in the U.S. due in part to their limited oversight. The Dietary Supplement Health and Education Act of 1994 defined dietary supplements as products “intended to supplement the diet” that contain one or more vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances; or “a concentrate, metabolite, constituent, extract, or combination of” these ingredients. As CAM cannot claim cure or treatment of disease, the Food and Drug Administration (FDA) has no authority to regulate or approve these products before they are sold to the public under the provisions of the Federal Food Drug and Cosmetic Act (FD&C Act). To this end, the FDA does not recommend substituting these products for available prescription products with documented safety and efficacy.³

According to the National Center for Complementary and Integrative Health, the prevailing public perception is that when it comes to medicine, “natural is better, healthier, and safer than unnatural or synthetic drugs”.⁴ However, does this perception reflect reality, particularly for those with underlying cardiovascular disease? Within this issue of Circulation, Chow et al provide a robust systematic analysis of the evidence and safety for the use of CAM in the management of heart failure (HF). Based on the authors’ synthesis of the current literature, several key themes emerge. First, health care professionals need to be cognizant of the lack of federal oversight and regulation, as well as lack of well-powered prospective randomized trials. Second, of the common CAM used for supposed treatment of heart failure, only the omega-3 polyunsaturated fatty acids (PUFA, fish oil) have the strongest evidence for clinical benefit in patients with HF and can safely be used in moderation. However, certain nutraceuticals such as bitter orange, blue cohosh, devil’s claw, gossypol, licorice, lily of the valley, and oleander should either be avoided or used with extreme caution, while agents such as alcohol, vitamin D, and caffeine can be harmful in excess. Third, health care professionals who consider CAM use should employ routine pharmacovigilance, as well as a multidisciplinary approach with the inclusion of a pharmacist in the HF team. Finally, taking a non-judgmental, transparent, shared decision-making approach should be used when considering CAM.

One gap in the literature is a need to better contextualize the motivation behind the use of CAM, especially in the high-risk and medically complex population with HF. The COVID-19 pandemic highlighted the high prevalence of medical misinformation, conspiracy beliefs, and distrust of political and scientific authorities.⁵ However, the relationships between endorsement of CAM, belief in off-label use of pharmaceuticals (e.g. hydroxychloroquine, ivermectin), vaccine hesitancy, and trust in allopathic medicine are often complex.⁶ Only through a better understanding of these beliefs and behaviors can we truly engage our patients, encourage open discussions, establish trust in the medical establishment, and ultimately agree upon treatment regimens that patients will consistently take.

Recent survey data suggest that the majority of patients who do employ CAM in their medical management are highly-educated but also older with multiple chronic conditions, which is reflective of the HF population.⁷ The reality is that patients are incorporating CAM into their medication management and such use needs to be addressed at each patient encounter. As any other prescription medication, CAM can have serious side effects and potential drug-drug interactions and should be treated as such.

Finally, CAM is not a substitute for guideline-directed medical treatment (GDMT), as recommended by the 2022 AHA/ACC/HFSA HF Guidelines.⁸ When comparing the rigorous and consistent efficacy and safety data for GDMT against the potential cost and lack of data for CAM agents, health care professionals and systems must continue to emphasize the likely relative value of GDMT. At a minimum, CAM adds complexity and distraction; at its worse, CAM may be a barrier to life-saving GDMT and could contribute to the significant underuse of GDMT in routine care. Therefore, in the case of patients with HF, “natural” may be unnatural. Within this context, this Scientific Statement from the American Heart Association on “Complementary and Alternative Medicines in the Management of Heart Failure” will serve as an excellent source of reference and education for all health care professionals when having CAM discussions with their patients.