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Saptarshi Bhattacharya, Sanjay Kalra, Lakshmi Nagendra

Very few trials in the history of medical science have altered the treatment landscape as profoundly as the UK Prospective Diabetes Study (UKPDS). Even 44 years after its inception, the trial and post-study follow-up findings continue to fascinate and enlighten the medical community. The study was conceived at a time when there was uncertainty about […]

An Evidence-based Approach to the Clinical Use of Dietary Supplements and Nutraceuticals

Jeffery Mechanick
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Published Online: Nov 18th 2011 US Endocrinology, 2005;(1):14 DOI: http://doi.org/10.17925/USE.2005.00.01.14
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Dietary supplements are defined by the US Dietary Supplement Health and Education Act (DSHEA) as a vitamin or mineral, a herb or other plant-derived chemical, an amino acid, a dietary supplement by increasing the total dietary intake (including enzymes or tissues from organs or glands), or a concentrate, metabolite, constituent, or extract of these.

Dietary supplements are defined by the US Dietary Supplement Health and Education Act (DSHEA) as a vitamin or mineral, a herb or other plant-derived chemical, an amino acid, a dietary supplement by increasing the total dietary intake (including enzymes or tissues from organs or glands), or a concentrate, metabolite, constituent, or extract of these.

Nutraceuticals are dietary supplements that contain a concentrated form of a presumed bioactive substance derived from a whole food. These now present in a non-food matrix and are used to enhance health in doses exceeding those obtainable from whole foods. Evidence-based recommendations require a technical review of the pertinent clinical literature in which publications are rated according to their level of scientific substantiation.

The American Association of Clinical Endocrinologists’ (AACE’s) Nutrition Guidelines Task Force published their evidence-based findings on the clinical use of dietary supplements and nutraceuticals (DS/N) in endocrine practice; some of the findings are summarized throughout this article. DS/N with a recommendation grade A (strong evidence of benefit greater than risk), suitable for first-line treatment, include:

  • calcium and vitamin D for osteoporosis;
  • choline for pregnancy and breast-feeding;
  • glutamine for use in critical illness;
  • omega-3 fatty acids and flavonoids for cardiovascular (CV) risk reduction; and
  • phytosterols for hypercholesterolemia and secondary prevention of atherosclerosis.

DS/N with a recommendation grade B (intermediate evidence of benefit greater than risk) are suitable for second-line treatments, including:

  • chondroitin and glucosamine for osteoarthritis;
  • omega-3 fatty acids for hyper-triglyceridemia;
  • probiotics for pouchitis, saw palmetto for benign prostatic hypertrophy, flavonoids for osteoporosis;
  • taurine for alcoholism; and
  • α-lipoic and γ-linolenic acid for diabetic neuropathy


Physicians may have no objection to the continued use of DS/N with a recommendation grade C (weak evidence of benefit greater than risk).These DS/N include:

  • carnitine for secondary deficiency, performance enhancement, cardiac and renal disease, and concurrent valproate use;
  • choline for hyperhomocysteinemia and parenteral nutrition-induced hepatopathy;
  • coenzyme Q10 for mitochondrial disorders, congestive heart failure (HF), and ischemiareperfusion injury;
  • creatine for McArdle’s disease;
  • glutamine for stomatitis;
  • melatonin for sleep disorders or jet lag;
  • omega-3 fatty acids for inflammatory bowel disease;
  • probiotics for antibiotic-related diarrhea; and
  • taurine for parenteral nutrition hepatopathy.

Various DS/N have been used in alternative medicine for unproven uses or situations with excessive risk (grade D). Examples include androstenedione and dehydroepian-drosterone (DHEA) for body composition or performance, choline for memory, chondroitin for cognition, coenzyme Q10 for antiaging, creatine for congestive HF, glutamine for cancer, or taurine, chromium, vanadium, or vitamin E for diabetes. The AACE recognizes that as emerging scientific data become available, these recommendation grades will change.The routine use of unproven therapies with DS/N should be discouraged by physicians. Many DS/N have adverse interactions with other DS/N and with certain medications. In addition, many patients who take DS/N fail to disclose this to their physicians. It is hoped that with continuing education regarding DS/N, physicians will be able to communicate more effectively with their patients.â– 

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