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Transcript
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