+ Natures Medicine An Overview of Popular Supplements Kayla Jester, RD Intern University of Virginia...

+

Natures MedicineAn Overview of Popular Supplements

Kayla 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


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


+ Herbs and botanical supplements accounted for 18% of

total U.S. supplement sales in 2012.


+Definition


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


+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.


+Dietary Supplement Health and Education Act of 1994

First legalized definition of dietary ingredients and new dietary ingredient


Dietary Ingredient New Dietary Ingredient

Vitamin Vitamin

Mineral Mineral

Herb/Botanical Herb/Botanical

Amino Acid Amino Acid

Substance 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


+

Can you identify the

supplement?


+

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


+Echinacea- Efficacy


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


+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


+

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


Gamma-Linolenic Acid

+Evening Primrose – Efficacy



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 reported

Cautions/Contraindications Should avoid if pregnant or breastfeeding


+

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


Food Source Garlic Cloves Powder

+Garlic - Efficacy



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


Precautions/Contraindications Avoid at least 7 days prior to surgery


+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


+Ginger - Efficacy



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


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


+Gingko Bilobo - Efficacy



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


Precautions/Contraindications Avoid taking at least 36 hrs prior to surgery Avoid taking during pregnancy


+ 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 steroids


Food Source Root found in

Asian Markets

+Ginseng - Efficacy



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


+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


+ 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


+Fish Oil – Efficacy



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


+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 agent


+Saw Palmetto – Efficacy



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



+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


+St. John’s Wort - Efficacy



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


+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’.


+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.


QUESTIONS?


+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.

+ Natures Medicine An Overview of Popular Supplements Kayla Jester, RD Intern University of Virginia...

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