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Over-the-Counter Adrenal Supplements: More Than Meets the Eye

      A large number of patients (some estimates are as high as 115 million people) are currently consuming over-the-counter (OTC) dietary supplements to relieve symptoms of chronic disease and illness.
      • Jiang T.
      Re-thinking the dietary supplement laws and regulations 14 years after the Dietary Supplement Health and Education Act implementation.
      Sales of OTC supplements have exceeded $20 billion per year.
      • Jiang T.
      Re-thinking the dietary supplement laws and regulations 14 years after the Dietary Supplement Health and Education Act implementation.
      Despite this widespread use, OTC supplements remain largely unregulated. The Dietary Supplement Health and Education Act of 1994 classified dietary supplements as being exempt from having to prove safety or efficacy as long as the product does not claim to prevent, treat, or cure a specific disease. Product labels can still make general claims such as “This supplement is an important part of a healthy immune system.” In addition to lack of efficacy data, a number of additional concerns have also been raised about OTC supplements, including the presence of potentially harmful contaminants or whether the amount of intended supplement is accurate or declared on the label.
      • Edakkanambeth Varayil J.
      • Bauer B.A.
      • Hurt R.T.
      Over-the-counter enzyme supplements: what a clinician needs to know.
      • Hurt R.T.
      • Ebbert J.O.
      • Schroeder D.R.
      • et al.
      L-arginine for the treatment of centrally obese subjects: a pilot study.
      Another primary concern about these products is potential the inclusion of a “mimic drug” rather than a dietary supplement.
      • Jiang T.
      Re-thinking the dietary supplement laws and regulations 14 years after the Dietary Supplement Health and Education Act implementation.
      Mimic drugs typically have a chemical structure very similar to pure crystallized pharmacological-grade drugs. A well-known example is red yeast rice (RYR), which has been consumed in Asia for centuries and has been associated with potential cardiovascular benefits.
      • De Backer G.G.
      Food supplements with red yeast rice: more regulations are needed.
      Some RYR supplements may contain monacolin K, a mimic drug of the prescription statin drug lovastatin.
      • De Backer G.G.
      Food supplements with red yeast rice: more regulations are needed.
      A recent study of 28 commercial brands of RYR demonstrated a 60-fold variation in the quantity of monacolin K per 1200 mg.
      • Cohen P.A.
      • Avula B.
      • Khan I.A.
      Variability in strength of red yeast rice supplements purchased from mainstream retailers.
      We often see patients with dyslipidemia who prefer RYR to statins because it is “natural,” when in reality the active drug that provides benefit (monacolin K) is essentially a statin.
      The article by Akturk et al
      • Akturk H.K.
      • Chindris A.M.
      • Hines J.M.
      • Singh R.J.
      • Bernet V.J.
      Over-the-counter “adrenal support” supplements contain thyroid and steroid-based adrenal hormones.
      in the current issue of Mayo Clinic Proceedings highlights the ongoing concern about some OTC dietary supplements. The authors purchased the 12 most popular dietary supplements that patients consume for “adrenal support” or to help with “adrenal fatigue.” Their primary aim was to evaluate the presence of the actual adrenal steroid and/or thyroid hormones present in these supplements. They noted that all 12 supplements contained a detectable amount of triiodothyronine, with daily exposure of up to 1322 ng based on recommended daily doses. Additionally, a substantial number of supplements also contained a variety of adrenal hormones ranging from a daily exposure of 1231.2 ng for pregnenolone (most common) to 159.32 ng for cortisone (least common) based on recommended daily doses. None of the OTC supplements declared on their label that they contained thyroid- or steroid-based adrenal hormones, let alone the dose.
      The study by Akturk et al adds to our body of literature describing OTC dietary supplements containing bioactive hormone ingredients that are not declared on the product's label. Although the overall risk associated with most OTC products is low, many contain contaminants, bioactive ingredients that mimic hormones, or even ingredients that can affect the metabolism of prescription drugs, all of which may impose considerable morbidity. Thus, it is paramount that supplements such as the ones tested in the current study be subjected to a more thorough and rigorous evaluation of composition and strength of included ingredients. Additionally, more clinical studies are needed because there are many examples in which OTC dietary supplements have been shown to be beneficial in chronic diseases, such as vitamin D and calcium for metabolic bone disease, fish oil for hypertriglyceridemia, and probiotics for antibiotic-associated diarrhea.
      • Edakkanambeth Varayil J.
      • Bauer B.A.
      • Hurt R.T.
      Over-the-counter enzyme supplements: what a clinician needs to know.
      • Hurt R.T.
      • Ebbert J.O.
      • Schroeder D.R.
      • et al.
      L-arginine for the treatment of centrally obese subjects: a pilot study.
      • Trivedi R.
      • Salvo M.C.
      Utilization and safety of common over-the-counter dietary/nutritional supplements, herbal agents, and homeopathic compounds for disease prevention.
      Unfortunately, performing clinical studies with dietary supplements can be problematic because of the wide variation in doses in various available commercial products.
      Over-the-counter supplements should be an important part of the ambulatory clinical assessment. Physicians evaluating patients for chronic medical conditions should perform a thorough and accurate reconciliation of the OTC supplements their patients are taking, in addition to traditional prescribed medications. For patients who chose to use or try OTC dietary supplements and products, including the adrenal products tested in the current study, physicians should counsel them regarding what is known about the supplements and their potential adverse effects, including impact on clinical laboratory tests. If they choose to try OTC supplements, we recommend that patients inform their physician and choose products that have been studied and their content evaluated. For those supplements that could be potentially harmful, patients should be informed of these risks.

      References

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        Re-thinking the dietary supplement laws and regulations 14 years after the Dietary Supplement Health and Education Act implementation.
        Int J Food Sci Nutr. 2009; 60: 293-301
        • Edakkanambeth Varayil J.
        • Bauer B.A.
        • Hurt R.T.
        Over-the-counter enzyme supplements: what a clinician needs to know.
        Mayo Clin Proc. 2014; 89: 1307-1312
        • Hurt R.T.
        • Ebbert J.O.
        • Schroeder D.R.
        • et al.
        L-arginine for the treatment of centrally obese subjects: a pilot study.
        J Diet Suppl. 2014; 11: 40-52
        • De Backer G.G.
        Food supplements with red yeast rice: more regulations are needed.
        Eur J Prev Cardiol. 2017; 24 ([editorial]): 1429-1430
        • Cohen P.A.
        • Avula B.
        • Khan I.A.
        Variability in strength of red yeast rice supplements purchased from mainstream retailers.
        Eur J Prev Cardiol. 2017; 24: 1431-1434
        • Akturk H.K.
        • Chindris A.M.
        • Hines J.M.
        • Singh R.J.
        • Bernet V.J.
        Over-the-counter “adrenal support” supplements contain thyroid and steroid-based adrenal hormones.
        Mayo Clin Proc. 2018; 93: 284-290
        • Trivedi R.
        • Salvo M.C.
        Utilization and safety of common over-the-counter dietary/nutritional supplements, herbal agents, and homeopathic compounds for disease prevention.
        Med Clin North Am. 2016; 100: 1089-1099

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