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Title: Dietary Supplements: How Safe and Effective are They?


1
Dietary Supplements How Safe and Effective are
They?
Carrie N.Georgion Pharm D, BSPS, BA, RPh La Porte
Hospital, La Porte, IN 46350
static.howstuffworks.com/gif/herbal-remedies
http//www.pharma.unibas.ch/bio/img/Humor_now_and_
then/Humor_Herbal_Medicine
2
I present to you Porkchop!
In December
Now
  • According to his dog trainers, The most
    controlling puppy they have ever met, You two
    have your hands full

3
The Herbal Supplement Revolution
http//api.ning.com/files/AF6EQJAp56iNg1fNNmX3KLU
kx2kjc8VnKtei-tk0GnnvqcfsYVLzDrBUmfTnEonb97OBye6A
UBwwtN6NUG8uhlH-6duC85/alternativemedicine.jpg
  • Grown from a 2.6 billion dollar industry to a 20
    billion dollar industry since 199717
  • In 1998 total herbal remedy sales in the U.S.
    reached 4 billion dollars 23
  • Reached over 71 of U.S. Households nationwide17
  • The World Health Organization(WHO) estimates
    that over 80 of the worlds population uses some
    form of herbal medicine 13
  • Survived over 200 million years of use some
    supplements dating back to the Paleozoic
    Period12, the Han Dynasty, Hippocrates, and the
    Native Americans in the United States. 3,5,6,7,8
  • Over the last decade more people have turned to
    herbal medicine and natural treatment options
    than to traditional forms of medical treatment13

4
What is a Dietary Supplement?
  • The term Dietary Supplement wasnt officially
    defined in the United States until 1994 when the
    Dietary Supplement Health and Education Act
    (DSHEA) was passed by Congress.1
  • DHSEA definition of a dietary supplement a
    product take by mouth that contains a dietary
    ingredient intended to supplement the dietmay
    includevitamins, minerals, herbs, botanicals,
    amino acids, enzymes, extracts 1
  • Dietary Ingredient in the above DHSEA
    definition must be one or any combination of the
    following Vitamin, Mineral, Herb or Botanical,
    Amino Acide, Enzymes, Tissues, Metabilite,
    Concentrate, Constituent, or Extract. 1
  • The National Agricultural Library defines dietary
    supplements as a preparation intended to
    supplement the diet and provide nutrients, such
    as vitamins, minerals, fiber, fatty acids, or
    amino acids, that may be missing or may not be
    consumed in sufficient quantity in a persons
    diet. 2

5
Homeopathy
http//www.pharma.unibas.ch/bio/img/Humor_now_and_
then/Humor_Herbal_Medicine_2.jpg
6
What is Homeopathy?
  • Princeton University defines homeopathy as a
    method of treating disease with small amounts of
    remedies that, in large amounts in healthy
    people, produce symptoms similar to those being
    treated. 7
  • The National Institute of Health (NIH) further
    describes Homeopathy as having the intention of
    giving very small doses of highly diluted
    substances to stimulate the bodys ability to
    heal itself. 8
  • This principle can be linked to Hippocrates and
    further developed by Samuel Christian Hahnemann,
    an 18th Century German physician who believed
    that if a substance could cause disease symptoms
    in a healthy person, small amounts could cure a
    sick person with similar symptoms. 8

http//www.ntskeptics.org/cartoons/homeopathy.gif
7
What is Homeopathy?
  • Most homeopathic substances are so dilute that
    nearly none of the original curing molecules
    remain, but it is believed that the essence of
    that substance still exists. 8 (see chart on next
    slide)
  • Most homeopathic physicians treat patients based
    on history, body shape, physical, emotional, and
    mental symptoms. 8
  • According to the 2007 National Health Interview
    Survey, about 3.9 million adults and 900,000
    children used homeopathy in the United States in
    2006.

http//www.wavemagazine.net/arhiva/12/science/home
opathy1.jpg
8
Homeopathic Potency Scales
  • This chart represents a standard dilution scale
    for most homeopathic regimens
  • As a general rule, most chronic illnesses use
    dilution numbers between 30c and 200 c (level at
    which most of Hahnemann treatments were
    diluted).8
  • For acute illness, dilutions were used in the 6c
    range and above. 8
  • Just as an example, a 6c treatment would only
    have 1 part homeopathic treatment substance in
    1000 parts liquid dilution

http//www.marlev.com/HowItWorks_files/image002.gi
f
9
Vitamins
  • A vitamin is defined as an organic compound
    required as a nutrient in tiny amounts by an
    organism 9
  • Vitamins are classified by their chemical
    activity on biological systems in the body. 9
  • Functions of Vitamins include
  • Hormone-LIKE activity
  • Aid in metabolism
  • Antioxidants
  • Enzyme Cofactor involvement 9
  • In 1905 English scientist, William Fletcher
    determined that if certain substances (vitamins)
    were removed from food, different disease states
    occurred. 10
  • Vitamins werent named until 1912 by Polish
    scientist Cashmir Funk after vita and amine
    meaning life and from compounds in rice husks he
    was discovering. 10

10
Role of Vitamins
11
Suggested Daily Dietary Intake of Common Vitamins
http//www.nopaperpress.com/members/1289793/upload
ed/vitaminsP.jpg
12
Minerals
  • Dietary Minerals are the chemical elements
    required by living organisms, other than the four
    elements carbon, hydrogen, nitrogen, and oxygen
    present in common organic molecules.11

13
History of Herbal Remedies
  • Shennong, a mythical personage is believed to
    have tested hundreds of herbs passing his
    knowledge to farmers about plants and poisons
    over 2,000 years ago.3
  • The Shennong Bencao Jing is the first written
    material listing over 300 medicines, 252 of which
    are herbs dating back during the first century
    C.E. during the Han dynasty.4
  • As small societies began growing, knowledge of
    using plants to attempt to treat illness grew.
    The Egyptians first codified herbal remedies and
    plant indices. 5
  • The Naples Dioscorides is an early seventh
    century Greek Herbal based on the De materia
    Medica written by the first century Greek
    military physician Dioscorides. The Naples
    Dioscorides contains an alphabetical list of
    plants and their uses. 6
  • In the Americas, herbalism began and was spread
    via word of mouth from various Indian tribes.
    Thus, it was deeply tied with spiritualism from
    American Indian cultures. 5

http//www.thecamreport.com/images/Chinese_Medicin
e.JPG
historyofscience.com/G2I/timeline/images/naplesdio
scorides
14
Top Ten U.S. Herbal Supplements
  • 10.) St. Johns Wort (Hypericum perforatum)
  • 9.) Ginseng (Panax ginseng) 3 species sold in
    the U.S.
  • 8.) Milk Thistle (Silybum marianum)
  • 7.) Black Cohosh (Cimicifuga racemosa)
  • 6.) Echinacea (Echinacea purpurea)
  • 5.) Saw Palmetto (Serenoa repens)
  • 4.) Ginkgo (Ginkgo biloba)
  • 3.) Garlic (Allium sativum)
  • 2.) Cranberry (Vaccinium macrocarpon)
  • 1.) Soy (Glycine max)12

http//www.pinkraygun.com/wp-content/uploads/2009/
01/herbal-supplements.jpg
15
St. Johns Wort (Hypericum perforatum)
  • Most scientifically studied herbal supplement on
    the market over the last 20 years12
  • Uses
  • Anxiety, Bed-wetting, Bronchial inflammation,
    Burns, Cancer, Depression, Hemorrhoids, Insect
    bites, Insomnia, Kidney disease, Scabies,
    Digestive issues, Wound healing13,14
  • Interactions
  • Allergy medications, alcohol, amphetamines,
    antidepressants called MAOIs and
    tricyclics,Desyrel, and oral contraceptives/pregn
    ancy
  • Sunlight alters efficacy13,14
  • Common Dosage
  • 100-500mg by mouth three times daily13,14
  • Side Effects
  • Allergic reactions, constipation, dizziness, dry
    mouth , restlessness, sensitivity to sunlight,
    stomach upset, sleep disturbances13,14
  • In 2007 sales in the U.S. were about 8,000,00012

Milton had an interesting side effect from
Taking St. Johns Wort
16
Ginseng (Panax ginseng)
  • Ancient Chinese herb used for over 2000 years and
    known as the ultimate herb among most
    herbalists12
  • Used by about 6 million Americans regularly13,14
  • Uses
  • aphrodisiac, sedative, sleep aid, depression,
    diabetes, liver problems, energizer, healing,
    enhancer of physical and mental performance,
    resists stress, improves mental
    concentration13,14
  • Interactions
  • Anti-hyperglycemia drugs (Insulin,
    Amaryl),MAOIs, and stimulants like coffee and
    tea13,14
  • Common Dosage
  • 200-600mg daily of ginseng extract and 0.5-2g
    daily of dry ginseng root13,14
  • Side Effects
  • chest/breast pain, diarrhea, headache,
    hypertension(high blood pressure), insomnia,
    impotence, itching, nausea, nervousness,
    palpitations, vomiting13,14
  • Ginseng had over 8,400,000 in annual sales in
    200712

http//www.annaklein.com/div3/ginseng.jpg
http//www.lakginseng.com/ginseng56.gif
17
Milk Thistle (Silybum marianum)
  • Used as a liver tonic for centuries with varying
    degrees of success12
  • Uses
  • Antidote for poisonous mushrooms, Hepatitis C,
    Liver function aid/ cleanser, and Liver
    repair13,14
  • Interactions
  • Allergic reaction to any of its parts13,14
  • Common Dosage
  • 200-800mg daily13,14
  • Side Effects
  • Laxative effects, vaginal bleeding/menstruation13,
    14
  • Gross sales of about 8,600,000 in the U.S. in
    2007. 12

http//en.wikivisual.com/images/7/77/Milk_thistle_
flower.jpg
http//karatetraining.org/weblog/wp-content/upload
s/2008/01/green_smoothie.jpg
18
Black Cohosh (Cimicifuga racemosa)
  • Its Latin name literally means to drive away
    bugs and thats what it does for a garden12
  • It was used by Native American Women in the
    Cherokee tribe to stimulate breast milk after
    childbirth and for other menstruation problems12
  • Uses
  • Diarrhea, Fluid retention, Inflammation, and
    Menopause symptoms13-14
  • Interactions
  • Anti-hypertensive drugs13-14
  • Common Dosage
  • 8-2400 mg daily13-14
  • Side Effects
  • Nausea or vomiting, symptoms of low blood
    pressure (dizziness), nerve irritability and
    headache. If taken in high doses may cause
    miscarriage13-14
  • Its sales were about 8,600,000 in the United
    States in 200712

http//thecompounder.files.wordpress.com/2009/05/b
lack-cohosh.jpg
2.bp.blogspot.com/.../herbs_black_cohosh.jpg
19
Echinacea (Echinacea purpurea)
  • Also among the most-studied herbs with St. Johns
    Wart12
  • Said to stimulate the bodys immune system12
  • Uses
  • Antibacterial, Antiviral, Blood Cleanser, Skin
    wounds13-14
  • Interactions
  • Allergic Reaction to any of its parts13-14
  • Common Dosage
  • 85-4000mg up to three times daily (as tincture,
    capsule, tea-each with a different dosing
    regimen) 13-14
  • Side Effects
  • Fairly well-tolerated13-14
  • Gross sales in the United States topped
    14,400,000 in 200712

texasnaturalsupply.com
20
Saw Palmetto (Serenoa repens)
  • First used by the Native Americans who discovered
    its extensive growth on sand dunes of the
    Midwest. 15
  • It was listed in The National Formularys
    Medication List until questions were raised about
    its efficacy by physicians in the 1950s15
  • Uses
  • Benign prostate hyperplasia (BPH), decreased sex
    drive, decreased breast size, decreased sperm
    production, fluid retention, and other
    genito-urinary problems13-14
  • Interactions
  • Use of prescription hormone medications13-14
  • Common Dosage
  • 320mg twice daily for 3 months (or 0.5-2 grams
    dried berries) 13-14
  • Side Effects
  • Abdominal pain, back pain, constipation,
    decreased sex drive, diarrhea, headache,
    impotence, nausea, painful urination or urinary
    retention13-14
  • Shouldnt take with pregnancy, or if attempting
    to become pregnancy13-14
  • 17,000,000 in sales in the United States in
    200712

21
Ginko (Ginkgo biloba)
  • Botanists call the Ginko Biloba tree a living
    fossil since it has remained unchanged since the
    Paleozoic period 200 million years ago12
  • May be the most popular herbal in the world as it
    comes specifically as a standardized extract
    world-wide12
  • Uses
  • Asthma, blood vessel disease, dementia,
    inner-ear disorders, improving brain function,
    impotence treatment, poor memory, premenstrual
    syndrome, macular degeneration, Alzheimer's (via
    increased mental alertness)
  • Interactions
  • Blood thinners like Coumadin and Aspirin
  • Common Dosage
  • 120-240mg daily
  • Side Effects
  • Digestive upset (diarrhea, gas, nausea),
    headache, seizures, skin irriation, unusual
    bleeding or bruising
  • Sales in the United States were over 18,000,000
    in 200712

http//www.liebreich.com/LDC/Images/Climbing/Ginko
_Leaves.jpg
22
Garlic (Allium sativum)
  • Among the most extensively studied herbal
    supplements to date12
  • Marketed in odorless or deodorized
    formulations13
  • Uses
  • Asthma, athletes foot, bacterial infections,
    constipation, diabetes, fungal infections,
    heavy-metal poisoning, hypertension,
    hyperlipidemia (high cholesterol), wounds, to
    ward off evil spirits13
  • Interactions
  • Antiplatelet drugs (Persantine) and blood
    thinners (warfarin) 13-14
  • Common Dosage
  • 600-900mg daily or up to 4 grams of fresh garlic
    daily13-14
  • Side Effects
  • Dizziness, nausea, skin rash, sweating,
    vomitting13
  • Was the 2 selling herbal supplement in the
    United States until two, highly-publicized
    studies found garlic ineffective at lowering
    cholesterol12
  • Grossed 20,500,000 in 2007 in the U.S. 12

http//www.cambridgebuzz.com/cb_images/GarlicHarve
st.jpg
23
Cranberry (Vaccinium macrocarpon)
  • Its been used for over a century to treat
    Urinary tract infections (UTI) and disorders12
  • Uses
  • Cancer, Skin irritation, Urinary tract disorders,
    certain overdoses13-14
  • Interactions
  • No significant interaction profile13
  • Common Dosage
  • 1-2 capsules daily or 10-16oz. juice daily13-14
  • Side Effects Diarrhea but fairly well
    tolerated13
  • Gross sales in 2007 in the United States yielded
    24,000,00012
  • Sales jumped that year more than 23.512

http//vegpod.com/wp-content/uploads/2007/11/cranb
erry_small.jpg
24
Soy (Glycine Max)
  • Since soy is actually a food crop, many dont
    consider it a traditional herb, but its
    therapeutic properties within the body as a food
    often place it in this category12
  • Uses Menopausal problems (hotflashes
    especially), Cancer prophylaxis, cardiovascular
    disease, and osteoporosis14
  • Interactions Allergy to any of its parts.
    MAOIs, antibiotics, estrogens, warfarin,
    Tamoxifen, Losartan, Phenytoin, Coreg,
    Synthroid16
  • Common Dosage 2-60g daily
  • Side Effects
  • Most side effects would be seen with long term
    use
  • Endometrial Cancer, hypothyroidism,
    urinary/kidney disease16
  • Sales actually dropped 17 in 2007 but still
    topped out at 25,600,000 in the U.S. in 2007. 12

Whats this? Soy Milk?
rlv.zcache.com/soy_milk_cows_cartoon_mousepad
http//jakst.files.wordpress.com/2009/06/soy.jpg
25
Governmental Regulation of Herbal Supplements and
Pharmaceuticals
  • In 1906, the Food and Drug Administration (FDA)
    was created through President T. Roosevelts
    signing of the Food and Drug Act
  • This act prohibited under penalty of seizure of
    goods the transport and selling of food which
    had been altered adulterated. It also stated
    that the marketing of drugs that were adulterated
    or that the standard of strength or purity wasnt
    clearly written on the label and/or werent
    listed in the United States Pharmacopoeia or
    National Formulary would incur penalties by law
  • This act also banned misbranding of food and
    drugs
  • The 1906 Act DID NOT apply to false and
    fraudulent claims of curative or therapeutic
    effect. An amendment to the act in 1912
    incorporated these additions, but courts continue
    to be vague in their definitions of the above18

www.rx.uga.edu
26
Governmental Regulation of Herbal Supplements and
Pharmaceuticals
  • Following an Elixir Sulfanilamide tragedy in 1937
    which killed several people because it was
    dissolved in diethylene glycol instead of
    ethanol, President F. D. Roosevelt signed the new
    Food, Drug, and Cosmetic Act (FD C) into law in
    1938.
  • The FDC finally gave significant federal
    authority over drugs and mandating pre-market
    SAFETY of all new food,drugs, and cosmetics, as
    well as banning false therapeutic claims in drug
    labeling without proving drug safety.
  • The thalidomide tragedies in Europe led to the
    1962 Kefauver-Harris Amendment to the FDC
    which required all new drug applications to
    demonstrate substantial evidence of the drugs
    efficacy for its marketed indication.18 Drugs
    approved between 1938-1962 were also subject to
    this review.
  • The Dietary Supplement Health and Education Act
    (DSHEA) of 1994 mandated that the FDA regulate
    dietary supplements as FOODS rather than as
    drugs.
  • Dietary supplements are NOT subject to safety and
    efficacy testing and there are NO approval
    requirements. 18

www.rx.uga.edu
27
Governmental Regulation of Herbal Supplements and
Pharmaceuticals
  • A repeat DSHEA is the amendment passed in 1994
    that states that dietary supplements are now to
    be considered a food and need NOT be approved by
    the FDA before they can enter into the market19
  • At the time, passing of the DSHEA by president
    Clinton received much support from Consumer
    organizations and members of Congress
  • A large survey completed by AARP found that 77
    of respondents (including both users and
    non-users of supplements) believed that the
    federal government should review the safety of
    dietary supplements and approve them before they
    can be marketed to consumers 20
  • In October 2002, a Harris poll of the nation
    revealed that 59 of respondents ALREADY
    believed that supplements had to be approved by a
    government agency or some sort before they
    could be marketed 20
  • In the same poll, 68 believed that supplements
    had to list potential side effects on their
    labels and that 55 believed that supplement
    labels could NOT make claims of safety without
    scientific evidence 20
  • All of the above beliefs are INCORRECT as a
    result of the provisions of the DSHEA
  • A 2001 study published in Archives of Internal
    Medicine found broad public support for greater
    governmental regulation of dietary supplements
    than was currently permitted by the DHSEA 19

28
Governmental Regulation of Herbal Supplements and
Pharmaceuticals
  • The newest regulations on good manufacturing
    practices require a dietary supplement to
    consistently meet the established specifications
    for identity, purity, strength, and composition.
    The FDA inspectors may look at a companys
    records to prove the above requirements upon
    request 19
  • HOWEVER, the amount of FDA inspectors had
    decreased 16 from 2003-2006 and possibly more
    since. Enforcement is difficult given the number
    of supplement manufactures existing in respect to
    the number of FDA inspectors available to
    investigate their validity 19
  • ConsumerLab is a company that tests the quality
    and specifications of dietary supplements and
    vitamins. In 2008, this company reported that
    over 25 of the supplements it tests have
    problems and 50 of vitamins dont meet the
    required guidelines. 19
  • IF a drug claimed to cure, mitigate, or treat a
    disease, it would be considered an unauthorized
    new drug and in violation of the applicable
    regulations and statutes 19
  • When asked, Is it legal to market a dietary
    supplement as a treatment or cure for a specific
    disease or condition?, the FDA responded, No, a
    product sold as a dietary supplement and promoted
    on its labelas a treatment, prevention, or cure
    for a specific disease or condition would be
    considered UNAPPROVED and thus an ILLEGAL drug.
    19

29
Governmental Regulation of Herbal Supplements and
Pharmaceuticals
  • Dietary supplements are ONLY allowed to make
    structural or function claims on their labeling
    19
  • Only broad statements like glucosamine helps
    support healthy joints or melatonin helps
    establish normal sleep patterns may be made
    since the validity of these statements have NOT
    been proven in a new drug application/clinical
    trials for the FDA 19
  • Acceptable Claims
  • Helps maintain function, Promotes healthy
    cholesterol, Supports regularity, Summorts the
    immune system, Improves absentmindedness, Reduces
    stress 21
  • Unacceptable Claims
  • Protects against heart disease, lowers
    cholesterol, reduces pain of arthritis, laxative,
    prevents urinary tract infections, helps patients
    with reduced immune function 21
  • The FDA dose need to at least be notified of the
    claim within 30 days of use and under DHSEA these
    claims are required to contain merit
    scientifically. The reality is that misleading
    claims are common and poorly investigated due to
    lack of manpower within the FDA 19

30
Governmental Regulation of Herbal Supplements and
Pharmaceuticals
www.extension.iastate.edu/.../images/label_1.jpg .

31
Governmental Regulation of Herbal Supplements and
Pharmaceuticals
www.extension.iastate.edu/.../images/label_1.jpg
32
Governmental Regulation of Herbal Supplements and
Pharmaceuticals
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re20-20label.png
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Governmental Regulation of Herbal Supplements and
Pharmaceuticals
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990-f1.gif
34
International Regulation of Herbal Supplements
  • The European Union (EU) requires that dietary
    supplements be DEMONSTRATED to be safe in
    quantity and quality. And, ONLY those
    supplements that are proven to be safe may be
    sold without a prescription. This makes
    obtaining dietary supplements much more difficult
    and controversy from consumers has arisen.
    Several petitions have been signed to change this
    law process. 19
  • In Russia, Dietary Supplements are defined as
    Biologically Active Dietary Supplements (BADS).
    BADSs are foodstuffs with clinically proven
    effectiveness. They are recommended
    prophylactically and included into a complex
    therapy for the prevention of pharmaceutical
    therapys side effects and for the achievement of
    complete remission. The focus in Russia is
    based more on preventive medicine for chronic
    disease rather than as a daily part of a persons
    regimen. 19
  • In China, PRIOR TO MARKET ENTRY, manufactures
    must register dietary supplements with the
    SFDA-Chinas equivalent to our FDA. These
    registrations are valid for 5 years and then must
    be renewed. This process involves a strict
    testing protocol, including ANIMAL AND HUMAN
    STUDIES in comparison to the U.S. process for
    pharmaceutical approval. 19

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an-union-eu.gif
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35
Reviewing the Safety and Efficacy of Dietary
Supplements
  • Some of the research suggests that St. Johns
    Wort has value in treating mild forms of
    depression13
  • In Spring, 1998, the National Institutes of
    Health began a 3-year long study to determine if
    St. Johns Wort is effective in treating major
    depression. It is one of the first studies of
    its kind to actually compare selective serotonin
    reuptake inhibitors (SSRIs) like Prozac, Celexa,
    etc. to St. Johns Wort and placebo (Double Blind
    study) 13
  • 340 participants were in the trial and averaged
    42 years old. 2/3 were female 22
  • The trial found no statistically significant
    difference between St. Johns Wort and Placebo on
    improvement with their depression 22

Milton had an interesting side effect from
Taking St. Johns Wort
36
Reviewing the Safety and Efficacy of Dietary
Supplements
  • Physical Performance Seven trials investigated
    this result and the four most recently performed
    studies found no improvement of physical
    performance. The other three studies actually
    found decreased heart rate increased oxygen
    uptake compared to placebo23
  • Psychomotor performance/Cognitive function Five
    studies investigated the effects of ginseng on
    these two endpoints. Three of the five studies
    found statistically significant improvements
    while two did not23
  • Immunmodulation Two studies tested effects of
    ginseng on the immune system. One study found
    improvements in T-lymphocyte counts and the other
    found no significant differences23

http//www.annaklein.com/div3/ginseng.jpg
37
Reviewing the Safety and Efficacy of Dietary
Supplements
  • Among 18 compared trials, six studies
    investigated milk thistle in chronic alcoholic
    liver disease and 4 of them reported improvement
    in 1 of the liver function measurements (about
    20) 20
  • Two trials included patients with alcoholic or
    nonalcoholic cirrhosis. The milk thistle groups
    showed a trend toward improved survival20
  • Two trials showed improvement in 1 liver function
    endpoint in patients with viral hepatitis20
  • Two recent studies in Europe suggest milk thistle
    may be effective in prevent damage to the liver
    in hepatotoxic drug use or in exposure to
    hepatotoxic substances13

http//en.wikivisual.com/images/7/77/Milk_thistle_
flower.jpg
38
Reviewing the Safety and Efficacy of Dietary
Supplements
  • A study was published in the Journal of Clinical
    Oncology in May of 2001.
  • It studied the use of Black Cohosh for treatment
    of hot flashes among women with a history of
    breast cancer
  • Of the 85 patients studied (half on placebo, half
    given black cohosh), BOTH groups reported
    improvements of menopausal symptoms and blood
    levels of hormones effecting hot flashes like FSH
    and LH were unchanged
  • Black cohosh was NOT significantly more
    efficacious statistically than placebo in number
    or intensity of hot flashes24
  • It is important to note that most of the studies
    (including this one) have been done on a very
    small group of women and further study is
    necessary

2.bp.blogspot.com/.../herbs_black_cohosh.jpg
39
Reviewing the Safety and Efficacy of Dietary
Supplements
  • The theory behind echinacea is that it prevents
    the adhesion of the E.coli bacteria to the lining
    of the kidney cells
  • Once studys conclusion was that echinacea does
    not prevent or treat the infection, but it may
    decrease the time to resolution of symptoms25
  • Another study conducted in 1999 observed
    INCREASED frequency of upper respiratory
    infections for those who continuously used
    echinacea as compared to those who did not13

texasnaturalsupply.com
40
Reviewing the Safety and Efficacy of Dietary
Supplements
  • Most studies agree that their findings support
    the use of Saw Palmetto to treat BPH
  • Many clinical trials, one of which studies over
    300 males, found that saw palmetto and its
    component LSESR treats BPH as effectively as
    commonly prescribed pharmaceuticals
  • More studies comparing saw palmetto and BPH
    medications in head-to-head competitions need to
    be completed before specific statements about its
    efficacy can be made and trusted by health care
    professionals13

41
Reviewing the Safety and Efficacy of Dietary
Supplements
  • In 2002, a long study of Ginkgo was published in
    the Journal of the American Medical Association
    concluded that NO measurable benefit in memory or
    related cognitive function was found with use of
    ginkgo25
  • However, in a clinical trial published in
    Psychopharmacology in 2005, evidence supported
    the potential efficacy of Ginkgo in enhancing
    certain neuropsychological memory processes of
    cognitively intact older adults gt60 years of age
    25 and had exactly the opposite effects as the
    2002 study
  • It also concluded that ginkgo improved
    performance in tests of attention and memory
    acutely, but NO effects were seen after 6 weeks
    of continuous treatment25

42
Reviewing the Safety and Efficacy of Dietary
Supplements
  • In comparing several of the clinical trials
    that investigated the efficacy of garlic in
    treating cardiovascular outcomes, most concluded
    that garlic may have small, positive, short-term
    effects on lipids20
  • The study could NOT conclude the effects of
    taking garlic supplements for beyond 3 months
  • Using ANY of the garlic supplements for less
    than 3-5 years did NOT show improvements in
    cancer patients
  • Multiple adverse effects including bad breath,
    dermatitis, bleeding, and abdominal disturbances
    led to several non-compliances by patients
    enrolled in the studies 20

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st.jpg
43
Reviewing the Safety and Efficacy of Dietary
Supplements
  • In one clinical trial investigating the ability
    of cranberry juice to prevent urinary tract
    infections, 60 patients were observed
  • After 12 weeks of cranberry juice administration,
    this particular study found that it can
    effectively reduse the risk of urinary tract
    infections (UTIs) of long-term care facility
    residents
  • This study only studied the effect of cranberry
    juice in PREVENTION but not treatment of UTIs 20

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erry_small.jpg
44
Reviewing the Safety and Efficacy of Dietary
Supplements
  • Across most studies, high concentrations of soy
    intake reported suggestion in decreased LDL and
    triglycerides
  • Over all the studies analyzed, none reported a
    change in blood pressure with soy use
  • The results are spread across the board for soys
    effect to decrease the frequency and intensity of
    hot flashes 20

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45
General Studies Limitations for Most Herbal
Supplements
  • Number of participants
  • Different forms of herbal supplements (roots,
    concentrate, elixir, leafy parts, etc) used
    sometimes in the same study
  • No certification that all supplements used meet
    GMP, or are comparative to begin with
  • Different species of supplements (ie Ginseng has
    3 sold in U.S.)
  • Short-term studies done (not enough data)
  • Rarely double-blind, randomized, head-to-head

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46
Dangerous Herbal Supplements
  • Bloodroot promoted as an expectorant and for oral
    hygiene, has caused DEATH when used to induce
    vomitting
  • Chan su topical aphrodisiac, has caused DEATH
    when ingested
  • Chaparral tea claimed antioxidant and pain
    reliever, caused liver failure
  • Comfrey used to promote wound healing, has caused
    liver problems and cancer
  • Sassafras used as diuretic and rheumatoid
    treatment, has caused liver damage and
    miscarriage
  • Ephedra well-known diet pill, caused seizures,
    stroke, heart attack, and death when sold as
    Fen-Phen
  • Lobelia used to treat respiratory congestion, has
    caused respiratory failure and death13

47
Pharmaceutical Interactions with Dietary
Supplements
  • St. Johns Wort Amitryptilline,
    Anticonvulsants, Antihistamine, Benzodiazepines,
    Calcium channel blockers, Chemotherapy, Oral
    Contraceptives (OC), Digoxin, Simvastatin, SSRIs,
    Warfarin
  • Milk Thistle Metronidazole
  • Black Cohosh Iron, Hormones, Warfarin,
    Salicylates
  • Echinacea Immunosuppressants
  • Saw Palmetto Hormones (including OC)
  • Gingko biloba Tylenol, Anticonvulsants,
    Antidepressants, Aspirin, Thiazides, Haloperidol
  • Garlic Aspirin, HIV medications, Warfarin
  • Cranberry low interaction profile
  • Soy low interaction profile

48
References
  • 1.) http//www.fda.gov/food/dietarysupplements/con
    smerinformation/ucm110417.htm Food Overview of
    Dietary Supplements
  • 2.) http//www.nal.usda.gov/fnic/pubs/bibs/gen/die
    tary suppllementsconsumers06.pdf Food and
    Nutrituion Information Center, National
    Agricultural Library
  • 3.) http//www.library.thinkquest.org/taohong.
    Chinese Herbal Medicine
  • 4.) http//wn.wikipedia.org/Chnese_Herbology.
    History of Chinese Herbology
  • 5.) http//www.herbalremediesinfo.com/history-of-h
    erbal-medicine.html History of Herbal Medicine.
  • 6.) http//www.historyofscience.com/G2I/timeline/i
    ndex. History of Science, Medicine, and
    Technology.
  • 7.) http//wordnetweb.princeton.edu/perl/webwn.
    Definition of Homeopathy
  • 8.) http//nccam.nih.gov/health/homeopathy/
  • 9.) Liberman,S, Brunig, N (1990). The Real
    Vitamin and Mineral Book. NY Avery Group, 3.
  • 10.) http//library.duke.edu/digitalcollections/mm
    a/timeline.html
  • 11.) http//en.wikipedia.org/wiki/Dietary_mineral
    Dietary Mineral
  • 12.) http//factoidz.com/top-10-best-selling-herba
    l-supplements-in-the-us-1/ What are the Top 10
    Best-Selling herbal Supplements in the United
    States 2007.
  • 13.) Fetrow, Charles W., Avila, Juan R., The
    Complete Guide to Herbal Medicines 1st Ed. Simon
    and Schuster, Inc, New York, Ny. 2000.
  • 14.) Chevallier, Andrew, Herbal RemediesVisual
    Reference Guide.1st Ed. Metro Books, New York,
    NY. 2007.
  • 15.) http//www.herbs2000.com/herbs/herbs_saw_palm
    etto.htm Saw Palmetto.
  • 16.) http//www.webmd.com/vitamins-supplements/ing
    redientmono-975-SOY.aspx?activeIngredientId975ac
    tiveIngredientNameSOY Soy
  • 17.) http//www.marketresearch.com/browse.asp?sort
    bypcategoryid189g1 Hartmon Group Phase III
    National Study
  • 18.) http//www.fda.gov About FDA
  • 19.)http//en.wikipedia.org/wiki/DietarySupplement
    .Dietary Supplkements.

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