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Dietary Supplements: What’s Hot, What’s Not? Rhonda Cooper-DeHoff, Pharm D, MS, FACC, FAHA, FCCP Associate Professor University of Florida College of Pharmacy and Medicine Presenter Disclosure Statement No conflicts or commercial relationships to disclose Overview • Current Trends – New Data • Content Variability- New Evidence • Adverse Reactions – New Concerns What’s going on in your practices? Current Trends • NHANES • Serial, cross-sectional analysis • 37,958 adults included in study across 7 cycles • In-home surveys • Participants were asked to show interviewer the bottle(s) 2012 - Supplement Use in Prior 30 Days by Age (n=5556) N=1957 N=2352 N=1247 2012 - Supplement Use in Prior 30 Days by Gender N=2737 N=2819 2012 - Supplement Use in Prior 30 Days by Race 2012 - Supplement Use in Prior 30 Days by Education 2012 - Supplement Use in Prior 30 Days by Health Status Trends in Use of Nonvitamin, Nonmineral Specialty Supplements Among US Adults, 1999-2000 through 2011-2012 Increased Use Decreased Use CoQ10 Echinacea Cranberry Green Tea Omega-3 FA Omega-6 FA Omega-9 FA Garlic Ginkgo biloba Ginseng Probiotics Methylsulfonylmethane (MSM) Para-aminobenzoic acid Stable Use Amino Acids Bilberry Bromelain Chondroitin Fiber Ginger Glucosamine Grape seed Quercetin Saw palmetto Soy PABA Claims: Benefit in fatigue, irritability, depression, weeping eczema, scleroderma, patchy pigment loss in skin and premature grey hair MSM Claims: Benefit in osteoarthritis, often in combination with glucosamine or chondroitin Dietary Supplement Oversight DSHEA •Dietary Supplement Health and Education Act •Statute of US federal legislation (Orin Hatch R-Utah 1993) •Signed by Clinton in Oct 1994 FDA •DS are regulated on the food side of FDA (not drug side) •Serving Size, not Dose •Supplement vs Food USP •Nongovernmental, NFP organization •USP sets standards for Rx and OTC drugs (required) •2001 USP launched verification program for DS (voluntary) Purported indication for the treatment of 1 or more of the following cardiovascular conditions • hypertension • heart failure • coronary artery disease • dyslipidemia • thromboembolic disorders • peripheral artery disease 10 Herbal Supplements Included • asian ginseng (Panax ginseng) – memory, fatigue, diabetes • astragalus (Astragalus membranaceus) - stresses, including physical, mental, or emotional stress • Flaxseed oil (Linum usitatissimum) – alpha linoleic acid • garlic (Allium sativum) – BP, lipids, cancer • ginkgo (Ginkgo biloba) – Alzheimer's, memory, antioxidant • grape (Vitis vinifera) seeds – circulation, lipids, eye sight • green tea (Camellia sinensis) – weight loss, antioxident • hawthorn (Crataegus) – HF, lipids, BP • milk thistle (Silybum marianum) – liver disease • soy (Glycine max) – fiber, protein For each herb, possible indications, biological and clinical data, and safety concerns are described CNS symptoms, major bleeding events JACC Conclusions • Use of herbal medications for the treatment of CV diseases is not supported by scientific evidence • Although most of the herbs demonstrate an effect on biological mechanisms associated with CV disease, available clinical studies are limited in sample size and appropriate controls • Physicians should be certain patients inform them regarding all supplements, particularly herbals, which can result in serious bleeding and drug interactions • Physicians should try to assess whether patients are not taking their medication as prescribed because of the preference for herbal supplements, which they perceive as safe and not “drugs.” Herbal and Dietary Supplement – Liver Injury • Herbal and dietary supplements account for 20% of cases of hepatotoxicity in the US • Major implicated agents • anabolic steroids (body building) – cholestasis, self-limiting • Green tea – acute hepatitis type injury Take Home Messages Talk to your patients about what they are taking •Add dietary supplements to intake form Content – may •Be suspicious if adulterants based on contain more (or unexpected symptoms less) than what is •Avoid products that do not specify the exact contacts listed Take Home Messages Oversight •When it comes to supplements, it’s like the Wild West, and the bad guys know they don’t have to take the JAMA, 2009;301:1427 sheriff seriously Evidence •Supporting BENIFIT is lacking •Supporting RISK is growing