Dietary Supplements: How Safe and Effective are They?

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Dietary Supplements How Safe and Effective are
They?
Carrie N.Georgion Pharm D, BSPS, BA, RPh La Porte
Hospital, La Porte, IN 46350
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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

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The Herbal Supplement Revolution
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• 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

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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

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Homeopathy
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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

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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.

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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

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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

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Role of Vitamins
11
Suggested Daily Dietary Intake of Common Vitamins
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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

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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

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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

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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
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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

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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

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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

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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

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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

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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

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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

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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

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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?
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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
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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
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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

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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

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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

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Governmental Regulation of Herbal Supplements and
Pharmaceuticals
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Governmental Regulation of Herbal Supplements and
Pharmaceuticals
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Governmental Regulation of Herbal Supplements and
Pharmaceuticals
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Governmental Regulation of Herbal Supplements and
Pharmaceuticals
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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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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

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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

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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

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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

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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

http//www.cambridgebuzz.com/cb_images/GarlicHarve
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

http//vegpod.com/wp-content/uploads/2007/11/cranb
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

http//jakst.files.wordpress.com/2009/06/soy.jpg
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

http//www.associationtimes.com/images/articles/li
mitations.gif
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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