+
Natures MedicineAn Overview of Popular SupplementsKayla Jester, RD InternUniversity of Virginia Health SystemFebruary 27, 2013
+
“Millions of Americans take vitamins safely every day, including me.
Vitamins and mineral supplements taken in recommended doses are
safe. It's the designer supplements that are worrisome”
- Durbin
+Presentation Overview History of herbal and dietary supplements Definition Regulation of dietary supplements in the United States Common dietary supplements used today
Echinacea Evening Primrose Garlic Ginger Gingko Bilobo Ginseng Fish Oil Saw Palmetto St John’s Wort
Role of Dietitian Take Home Message
+Learning Objectives
Develop a general understanding of the difference between supplements and prescription medications
Understand how supplements can affect an individual’s overall health
Have a better understanding of the popular supplements on the market today
Kayla JesterUVAHS – 2/27/13
+
The use of natural products for medical purposes appeared in society long before the development and distribution of pharmaceuticals.
History
Kayla JesterUVAHS – 2/27/13
6,000 year old clay tablets written by the Sumerians document the use of herbs as medicine.
Hippocrates documented the use of St. John’s wort in the fifth century B.C.E.
Ancient medical texts from Egypt, Greece, Rome, China and India each contained medical uses for garlic.
+History continued…
Plant-derived supplements were the only form of medicine for thousands of years, and are still the primary source of medicine for ~80% of the population.
~25% of all modern day pharmaceutical drugs are derived from plants Aspirin – White Willow Bark Digitalis – Foxglove Birth Control Pill – Mexican yam
Kayla JesterUVAHS – 2/27/13
+ Herbs and botanical supplements accounted for 18% of
total U.S. supplement sales in 2012.
Kayla JesterUVAHS – 2/27/13
+Definition
Kayla JesterUVAHS – 2/27/13
Found in many forms: Tablets, capsules, soft gels,
liquids, powders
Herbal and dietary supplements are products that ‘supplement the diet’ and are typically taken for therapeutic reasons.
+Public Interest in Supplements
Supplements are a: “diagnosis, treatment, and/or prevention, which complements mainstream medicine…”
Easily accessible (no prescription needed) Professional care is not immediately available and
is often times costly and inconvenient Gives people a sense of control Natural = Safe
Kayla JesterUVAHS – 2/27/13
+Fun Fact 1
The word drug originated from ‘droog’, which is the Dutch word that means ‘to
dry’. This makes sense since ancient healers used dry plants as medicine.
Kayla JesterUVAHS – 2/27/13
+Dietary Supplement Health and Education Act of 1994
First legalized definition of dietary ingredients and new dietary ingredient
Kayla JesterUVAHS – 2/27/13
Dietary Ingredient New Dietary IngredientVitamin VitaminMineral MineralHerb/Botanical Herb/BotanicalAmino Acid Amino AcidSubstance that total dietary intake
Substance that total dietary intake
Concentrate, metabolite, extract
Concentrate, metabolite, extract
What’s the difference?! - A new dietary ingredient was not sold in the U.S. before October 15, 1994.
+Dietary Supplement Health and Education Act of 1994
Supplement labels are allowed to make broad health claims, but disclaimer statements must also be included. i.e. ‘This statement has not been evaluated by the FDA.
This product is not intended to diagnose, treat, cure or prevent disease’
Manufacturers are not required to: Prove safety and effectiveness of the dietary
supplement before it hits the market Ensure standardization of products
Kayla JesterUVAHS – 2/27/13
+
Can you identify the
supplement?Kayla JesterUVAHS – 2/27/13
+
St. John’s Wort
Fish Oil
Gingko Bilobo
EchinaceaKayla JesterUVAHS – 2/27/13
+Echinacea Uses
Boosts the immune system Protects against the common cold/flu
Forms: teas, extracts, capsules, and tablets
Pharmacological action Acts as an antioxidant Stimulates the immune system by:
Increasing T-cell and natural killer cell proliferation and activity
Kayla JesterUVAHS – 2/27/13
+Echinacea- Efficacy
Kayla JesterUVAHS – 2/27/13
Study Design Objectives Limitations Results
Shah – 2007
Meta-analysis (14 randomized placebo controlled trials)
Determine the effect of Echinacea on treating the duration and risk of developing the common cold
- Possible publication bias- Focused on efficacy and not safety
duration of the common cold by 1-4 days and risk of developing cold by 58%
Barrett – 2010
Blinded/Unblinded randomized control trial of 713 pts
To investigate the safety and efficacy of Echinacea purpurea extract in the prevention of common cold episodes
-All participants from same area and had community-acquired colds-No attempt to base inclusion on viral cause-Racial/ethnic diversity limited
No significance between groups given placebo or Echinacea
+Echinacea continued… Adverse Reactions
Potential allergic reactions (rash) Potential GI upset
Drug/Supplement Interactions Decrease the effectiveness of immune-suppressing drugs
Cyclosporine, corticosteroids Negative interaction with hepatotoxic medications
Anabolic steroid, amiodarone, methotrexate, ketoconazole
Food Interactions None reported
Kayla JesterUVAHS – 2/27/13
+Echinacea Continued… Precautions/Contraindications
Pts with asthma/allergy to grass pollen have an increased risk of having an allergic rxn
Do NOT use > 8 weeks May cause hepatotoxicity or immunosuppression
Avoid in pts with immune disorders HIV/AIDs Multiple Sclerosis Lupus
Kayla JesterUVAHS – 2/27/13
+
Uses Decreases cholesterol levels Alleviates symptoms associated with:
Rheumatoid arthritis Mastalgia Atopic Dermatitis
Forms: capsules Pharmacologic Action
Gamma-linolenic acid (GLA) is thought to replace essential fatty acids that are typically reduced during disease states
Evening Primrose
Kayla JesterUVAHS – 2/27/13
Gamma-Linolenic Acid
+Evening Primrose – Efficacy
Kayla JesterUVAHS – 2/27/13
Study Design Objectives Limitations Results
Kawamura- 2011
Double-blind, controlled trial (n=112)
Safety and efficacy of food high in GLA for treating dry skin
-Participants kept own food records-Symptoms based on participants report of severity of itching
GLA-rich foods appear safe and improve skin barrier function in people with dry skin
Cameron – 2011
Review – 22 randomized controlled trials
To update an existing systematic review of herbal therapies in RA
-Poor reporting of important information in the included trials
No clear benefits of evening primrose oil with treating atropic dermatitis and/or mastalgia
+ Evening Primrose
Adverse Reactions Belching, bloating, and nausea
Drug/Supplement Interactions Lowers seizure thresh old when used with tricyclic
antidepressants/anticonvulsant medications Avoid when taking anticoagulant drugs
Food Interactions: None reportedCautions/Contraindications
Should avoid if pregnant or breastfeeding
Kayla JesterUVAHS – 2/27/13
+
Uses Helps control blood pressure Improves circulation Lowers cholesterol Cancer Prevention/Treatment
Forms: raw, powder, tablets, and capsules
Pharmacologic Action Vasodilation Inhibit platelet aggregation Lipid lowering effect
Garlic
Kayla JesterUVAHS – 2/27/23
Food Source Garlic Cloves Powder
+Garlic - Efficacy
Kayla JesterUVAHS – 2/27/13
Study Design Objectives Limitations Results
Alder – 2003
Meta-analysis of 10 studies
To determine effects of garlic on lipid levels
-Poor method of blinding subject (some could smell garlic pill)- Different methods for controlling for diet
Garlic should not be recommended as a antihyperlipidemic agent
Nakasone- 2013
Double-blind, randomized, placebo-controlled study
Effects of garlic on hypertension
Study was small in size and record keeping was the responsibility of the participant
Garlic has a hypotensive effect on pts with mild HTN, but not those with preHTN.
+Garlic Adverse Reactions
GI discomfort (heartburn, flatulence, etc)
Drug/Supplement Interactions May increase bleeding if taken with other blood thinning
drugs (anticoagulants, antiplatalets) May decrease concentration of protease inhibitors
HIV drug saquinavir
Food Interactions None reported
Precautions/Contraindications Avoid at least 7 days prior to surgery
Kayla JesterUVAHS – 2/27/13
+Ginger Uses
GI Issues (stomach aches, nausea, diarrhea) Osteoarthritis Joint/Muscle Pain Lowers blood pressure
Forms: dried, powder, crystallized, capsule, raw root Pharmacological Action
Inhibition of antiinflammatory agents such as thromboxanes and/or prostaglandins
Calcium-channel blocker Components of ginger act on 5-HT3 receptors in the ileum
Kayla JesterUVAHS – 2/27/13
+Ginger - Efficacy
Kayla JesterUVAHS – 2/27/13
Study Design Objectives Limitations Results
Ding – 2012
Review of 4 RCT
To examine the evidence for the safety and effectiveness of ginger for pregnancy-induced N/V
-Studies were time limited (no trials developed treatment >3wks-2 studies recruited women up to 20 wks gestation
Ginger is a safe and effective treatment for PNV; however, max safe dose is uncertain
Drozdov – 2012
Randomized control trial with 43 patients
To study the influence of GI health in an osteoarthritis population receiving ginger or diclofenac
-Small population size-Not blinded
Ginger is as effective and safer than diclofenac in treating OA
+Ginger Adverse Reactions
GI upset Bloating Diarrhea
Drug/Supplement Interactions Anticoagulants/Antiplatelets
i.e. coumadin, warfarin Diabetes medications Calcium channel blocker
Food Interactions None reported
Precautions/Contraindications Pregnancy Breast feedingKayla Jester
UVAHS – 2/27/13
+Fun Fact 2
The first medical schools were based off the use of herbs, and
today over half of medical schools offer an alternative medicine
course.
+ Gingko Bilobo
Uses Enhances/improves memory and concentration Treats depression, anxiety and dizziness
Forms: tablets, capsules, teas Pharmacologic Action
Increases neurotransmission Vasodilator Reduces blood viscosity
Kayla JesterUVAHS – 2/27/13
+Gingko Bilobo - Efficacy
Kayla JesterUVAHS – 2/27/13
Study Design Objectives Limitations Results
Birks – 2009
Review of 36 trials
Determine the effect of gingko on cognitive function
Pts had differing levels of dementia
Evidence was ‘inconsistent and unreliable’ concerning the use of gingko for treating cognitive impairment
Brinkley- 2010
3,069 participants (mean age 79 yrs)
To determine the effects of gingko on HTN
- Specific age group- Could not completely control for antiHTN meds
Gingko bilobo does not reduce BP or HTN in the elderly
+Gingko Bilobo Adverse Reactions
GI upset (nausea/vomiting) Prolonged bleeding Headache Allergic Reactions
Drug/Supplement Interactions May increase bleeding if taken with blood thinning medications
i.e. warfarin, coumadin, aspirin Increase the effect of MAOI drugs
Food Interactions None reported
Precautions/Contraindications Avoid taking at least 36 hrs prior to surgery Avoid taking during pregnancy
Kayla JesterUVAHS – 2/27/13
+ Ginseng
Uses Energy/Mood booster Improves cognitive function Cardiovascular benefits
Forms: dried, extracts, capsules, and tablets Pharmacologic Action
Decreases adrenal stress hormones Bioactive compounds (ginsenosides) have similar structure
to steroidsKayla JesterUVAHS – 2/27/13
Food Source Root found in
Asian Markets
+Ginseng - Efficacy
Kayla JesterUVAHS – 2/27/13
Study Design Objectives Limitations Results
Vogler- 1999
16 double-blind, randomized controlled trials
To study the efficacy of Ginseng related to physical performance, cognitive function, DM and herpes
-Only ½ the studies were of good methodological quality- Small sample size, varying dosages, and unclassified preparation
More research is needed concerning the safety and effectiveness of Ginseng.
+Ginseng Adverse Reactions
Insomnia Nervousness Hypertension Headaches GI distress (nausea, diarrhea)
Drug/Supplement Interactions May interfere with MAO inhibitor, corticosteroids,
digoxin, blood sugar medications Avoid taking with anticoagulates/antiplatelets
Kayla JesterUVAHS – 2/27/13
+Ginseng
Food Interactions Use with caffeine may stimulate hypertension
Precautions/Contraindications Do not take longer than 3 months Don’t use if you have
Renal Failure Acute infection Active bleeding
Kayla JesterUVAHS – 2/27/13
+ Fish Oil
Uses Cardiovascular benefits Decrease or inhibit the development of inflammatory
diseases
Forms: oil, capsules Pharmacologic Action
Omega-3 fatty acids (EPA & DHA) are precursor to eicosanoids, which have anti-atherogenic and anti-inflammatory effects
Food SourceFatty Fish: mackerel,
salmon, herring, tuna, anchovy
1 serving 2-3 times per week provides ~3g fish oil
Kayla JesterUVAHS – 2/27/13
+Fish Oil – Efficacy
Kayla JesterUVAHS – 2/27/13
Study Design Objectives Limitations Results
Kromhout - 2010
Multicenter, double-blind, placebo-controlled trial with 4837 pts
Examined the effect of EPA, DHA and ALA on the rate of cardiovascular events in pts with previous MI
- Mostly men (78%) of pts- Many pts on statin medications (85%)
Low-dose supplementation with EPA-DHA or ALA did not significantly reduce rate of major cardiovascular events
Bucher – 2002
11 randomized, controlled trials with over 16,000 participants
Determine the effects of dietary and non-dietary intake of n-3 FAs on CHD
-Publication bias -Types of n-3 used varied widely
n-3 FAs decrease the overall mortality and sudden death in pts with CHD
+Fish Oil
Adverse Reactions Prolong bleeding time
Food Interactions: Garlic
Drug/Supplement Interactions Should not be taken with blood-thinning drugs
Coumadin, warfarin
Kayla JesterUVAHS – 2/27/13
+Saw Palmetto
(Seronoa repens)
Uses Prevents prostate cancer Increases sperm production Improves symptoms related to enlarged
prostate
Forms: dried berries, extracts, tablets, capsules, and tea
Pharmacologic Action Inhibits 5a-reductase Antiandrogen Antioxidant/anti-inflammatory agentKayla Jester
UVAHS – 2/27/13
+Saw Palmetto – Efficacy
Kayla JesterUVAHS – 2/27/13
Study Design Objectives Limitations Results
Barry – 2011
Double-blind, multicenter, placebo controlled trial with 365 men
Studied the effect of saw palmetto on UTI infections
Used only one extract so findings may be generalized
Extract did not reduce UTI symptoms
Boyle - 2004
14 randomized clinical trials and 3 open-label trials (4,280 pts)
To determine the effects of permixon on BPH symptoms
Some of the information provided by the clinical trials was unclear
Permixon, the extract from saw palmetto, had a beneficial impact on treating individuals with BPH
+Saw Palmetto Adverse Reactions
Mild GI discomfort (nausea, vomiting, constipation, diarrhea)
Drug/Supplement Interactions Contraceptive drugs Estrogen pills Anticoagulants/Antiplatelets
Food Interactions None reported
Kayla JesterUVAHS – 2/27/13
+St. John’s Wort
(Hypericum perforatum)
Uses Promotes emotional well-being Alleviates mild depression
Forms: teas, tablets, and capsules Pharmacologic Action
Inhibits reuptake of serotonine, dopamine and norepinephrine
Reduces cortisol levels
Kayla JesterUVAHS – 2/27/13
+St. John’s Wort - Efficacy
Kayla JesterUVAHS – 2/27/13
Study Design Objectives Limitations Results
Lecrubler – 2002
Double-blind, randomized, placebo control trial of 375 pts
Studied the efficacy of SJW on depression
-Only recruited pts with mild/moderate depression
SJW extract was safe and more effective than placebo in treating depression
Fava – 2005
Double-blind, randomized, placebo-controlled trial with n=135
Compared antidepressant efficacy and safety of standardized SJW with both placebo and fluoxetine
-Small sample size-Sole use of fluocetine
SJW was more effective than fluoxetine and placebo
+St. John’s Wort(Hypericum perforatum)
Adverse Reactions May cause photosensitivity Lethargy
Drug/Supplement Interactions Do NOT combine with antidepressant meds (tricyclics,
serotonin reuptake inhibitors) Decreases effectiveness of drugs metabolized by cytochrome
P450 Ex: theophylline (bronchodilator), protease inhibitor indinavir
(HIV drug), digoxin Negative interaction with immunosuppressant cyclosporine
Food Interactions Tyramine containing foods
Kayla JesterUVAHS – 2/27/13
+Dosage Information
+Fun Fact 3
It is thought that the use of herbs is a more holistic approach to bringing
harmony and balance back to the body. Today, synthetic chemical compounds are used with the inclination that the body is a ‘broken machine that needs
to be fixed’.
Kayla JesterUVAHS – 2/27/13
+Our Role as Registered Dietitians Ask, ask, ask the patient if they are taking
anything on the side other than what his/her doctor prescribes.
Communicate with MD and other health care professionals concerning the patients use of dietary supplements.
Continue to learn as much about herbal supplements as possible, and that the information you obtain comes from trustworthy sources.Kayla Jester
UVAHS – 2/27/13
+Take Home Message
Even though a supplement may be ‘natural’ does not mean that it
should be considered safe and free of harm.
Kayla JesterUVAHS – 2/27/13
QUESTIONS?
Kayla JesterUVAHS – 2/27/13
+References Alder R, Lookinland S, Berry J, Williams M. A systematic review of the effectiveness of garlic as an anti-hyperlipidemic agent. J Am Acad Nurse Pract. 2003;15(3):120-9.
American Botanical Council. St. John’s wort. The ABC Clinical Guide to Herbs. 2002.History of Dietary Supplement. Available at: http://iml.jou.ufl.edu/projects/spring2000/kimpel/history.html. Accessed January 20, 2013. Barrett B, Brown B, Rakel D, Mundt M, Bone K, Barlow S, Ewers T. Echinacea for treating the common cold: A randomized trial. Ann Intern Med. Dec 2012; 153(12):769-777. Barry M, Meleth S, Lee J, Kreder K, Avins A, Nickel J, Roehrborn C, Crawford E, Foster H, Kaplan S, McCullough A, Andriole G, Naslund M, Williams O, Kusek J, Meyers C, Betz J, Cantor A, McVary K. Effect of increasing doses of saw palmetto extract on lower urinary tract symtoms: a randomized trial. JAMA. 306(12):1344-51.
Bayles B, Usatine R. Evening primrose. Am Fam Physician. 2009;80(12):1405-8.
Birks J, Grimley Evans J. Gingko bilobo for cognitive impairment and dementia. Cochrane Database Syst Rev. 2009;(1):CD003120. Boyle P, Robertson C, Lowe F, Roehrborn C. Updated meta-analysis of clinical trials of serenoa repens extract in the treatment of symptomatic benign hyperplasia. BJU Int. 2004;93(6):751-6.
Brinkley TE, Lovato JF, Arnold AM, et al. Effects of ginko biloba on blood pressure and incidence of hypertension in elderly men and women. American Journal of Hypertension. 2010;23(5):528-533.
Bucher H, Hengstler P, Schindler C, Meler G. N-3 polyunsaturated fatty acids in coronary heart disease: a meta-analysis of randomized controlled trials. AM J Med. 2002;112(4):298-304.
Coon J, Ernst E. Panax ginseng: a systematic review of adverse effects and drug interactions. Drug Saf. 2002;25(5):323-44.
Ding M, Leach M, Bradley H. The effectiveness and safety of ginger for pregnancy-induced nausea and vomiting: a systematic review. Women and Birth. 2013;26(1):e26-e30.
Drozdov V, Kim V, Tkachenko E, Varvanina G. Influence of a specific ginger combination on gastropathy conditions in patients with osteoarthritis of the knee or hip. The Journal of Alternative and Complementary Medicine. 2011;18(6):583-588.
+
Echinacea. University of Maryland Medical Center. Available at: http://www.umm.edu/altmed/articles/echinacea-000239.htm. Accessed January 20, 2013. Fava M, Alpert J, Nierenberg AA, Mischoulon D, Otto MW, Zajecka J, Murch H, Rosenbaum J. A double-blind, randomized trial of St John’s wort, fluoxetine, and placebo in major depressive disorder. J Clin Psychopharmacol. 2005;25(5):441-7. FDA. Dietary supplement – Q&A. Available at: www.fda.gov. Accessed February 18, 2013. Fragakis, A. The Health Professional’s Guide to Popular Dietary Supplements 2nd ed. American Dietetic Association. Pg. 211-219
Ginger. Natural Medicines Comprehensive Database. Available at: http://faculty.ksu.edu.sa/18856/Medicinal%20Plants/Ginger.pdf. Accessed February 20, 2013. . Gorman C. Is it good medicine. Time. 1998;152(21):69. Greenwald J. Herbal Healing. Time. 1998;152(21):61-67.
Hairston, A. Common Herbs and Dietary Supplements. Duke University Health System. April 14, 2009.
Health Professional’s Guide to Popular Dietary Supplements 2nd ed. American Dietetic Association. Kawamura A, Ooyama K, Kojima K, Kachi H, Abe T, Amano K, Aoyama T. Dietary supplementation of gamma-linolenic acid improves skin parameters in subjects with dry skin and mild atopic dermatitis. J Oleo Sci. 2011;60(12):597-607. Kromhout D, Giltay E, Geleijnse J. n-3 fatty acids and cardiovascular events after myocardial infarction. The New England Journal of Medicine. 2010;363:21.
Lecrubier Y, Clerc G, Didi R, Kieser M. Efficacy of St. John’s Wort extract WS 5570 in major depression: a dobule-blind, placebo-controlled trial. AM J Psychiatry. 2002;159:1361-1366.
Nakasone Y, Nakamura Y, Yamamoto T, Yamaguchi H. Effect of traditional Japanese garlic preparation on blood pressue in prehypertensive and mildly hypertensive adults. Exp Ther Med. 2013;5(2):399-405. Paulsen S. Evening primrose. May 2003. Available at: http://www.ucdenver.edu/academics/colleges/pharmacy/Resources/OnCampusPharmDStudents/ExperientialProgram/Documents/nutr_monographs/Monograph-eve_prim.pdf. Accessed February 17, 2013. Purple Herbal. Available at: http://purpleherbal.wordpress.com/2011/02/11/10-interesting-facts-about-herbal-medicine. Accessed February 25, 2013.
Saw Palmetto. Available at: http://www.nlm.nih.gov/medlineplus/druginfo/natural/971.html. Accessed February 19, 2013.
References Continued
+References continued… Roberts, S. Alternative nutrition therapies used by oncology patients. Support Line. 1998; 20(4): 10-16 Scarbrough B. Dietary supplements: areview of united states regulation with emphasis on the dietary supplement Health and education act of 1994 and subsequent activity. April 2004. Available at http://leda.law.harvard.edu/leda/data/663/Scarbrough.html. Accessed February 17, 2013. Shah et al Lancet Infect Dis. 2007 Jul;7(7):473-80 US Department of Health and Human Services. Herbal supplements: consider safety, Too. Available at: http://img.thebody.com/nccam/safety.pdf. Accessed January 20, 2013. U.S. Food and Drug Administration. Dietary supplements – Q&A.September 2012, Available at: www.fda.gov. Accessed February 17, 2013.
Vogler B, Pittler M, Ernse E. The efficacy of ginseng. A systematic review of randomised clinical trials. Eur J Clin Pharmacol. 1999;55(8):567-75.