Transcript Dietary Supplements:How Safe and Effective are They?

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
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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”
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 world’s
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

What is a Dietary Supplement?

The term “Dietary Supplement” wasn’t 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 diet…[may include]…vitamins, 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
person’s diet.” 2
Homeopathy
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What is Homeopathy?
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
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 body’s 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
What is Homeopathy?
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
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.
Homeopathic Potency Scales
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
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
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 weren’t named until 1912 by Polish scientist Cashmir Funk after
‘vita’ and ‘amine’ meaning life and from compounds in rice husks he was
discovering. 10
Role of Vitamins
V itam in
M ain R ole
F ood S ource
A (R etinol)
S kin, M ucous M em branes,V ision, B ones
green leafy vegetables, m elon,squash, tom atoes, fish-liver
D (C alciferol)
K ey for C alcium A bsorption, B one grow th/m aintenance
F ish-liver, sprouts, m ushroom s, sunflow er seeds
E (T ocopherol)
H elps form R ed B lood C ells (R B C ), P revents O xidation dam age
R aw or sprouted seeds, nuts, grains, green leafy vegetables
K
N eeded for B lood C lotting and Liver F unction
K elp, alfalfa, soybeans
B 1 (T hiam in)
N ervous S ystem function and C arbohydrate m etabolism
Yeast, w heat germ , w hole-grain cereals, nuts, beans
B 2 (R iboflavin)
H elps w ith E nergy R elease from food , S kin, N ails
W hole grains, yeast, w heat germ , nuts, cooked leafy vegetables
B 3 (N iacin)
N ervous and D igestive system , C arbohydrate m etabolism
Yeast, w heat germ , rice bran, nuts, brow n rice, green vegetables
B 6 (P yridoxine)
M etabolism , H elps w ith R B C form ation, P regnancy processes
Yeast, w heat germ , soybeans, cantaloupe, pecans
B 12 (C obalam in)
R B C form ation, P revention of A nem ia, G row th in P ediatrics
Yeast, seeds, kelp, bananas, peanuts, w heat germ
Folic A cid
E ssential for R B C form ation, H ealing, M etabolism , G row th
D eep green leafy vegetables, beans, spinach, nuts, broccoli
C (A scorbic A cid)
H ealthy T eeth, G um s, B ones, A drenal S ystem s, and D etoxicant
A ll fresh fruits, vegetables, citrus, turnip greens, green peppers
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
M ineral
M ain R ole
F ood S ource
C a lciu m
B one, T ooth, H eart, M uscle F unction
Leafy vegetables S eeds, oats, B eans, N uts, C anned F ish
P h o sp h o ru s
N eeded w ith C alcium for above functions
W hole-grains, seeds, nuts, legum es, dried fruit, corn
M a gn e siu m
M uscle T one, B ones, H eart
N uts, soybeans, green leafy vegetables, apples, lem ons, peaches
P o ta ssiu m
A cid-alk aline balance in blood, M uscle
G reen leaft vegetables, oranges, w hole grains, seeds, bananas
S o d iu m
F luid A cid/B ase balance, S tom ach
K elp, celery, rom aine lettuce, w aterm elon, sea salt
C h lo rin e
S tom ach, Liver detoxification
K elp, avocado, chard, tom atoes, cabbage, celery, cucum ber, oats
S u lfu r
H air, S k in, and N ails
R adish, turnip, onions, celery, soybeans, fish
Iro n
R esistance to stress, H em oglobin form ation
A pricots, peaches, bananas, prunes, w hole grain cereals, turnips
Z in c
E nzym es, Insulin, W ound, T issues
W heat bran, pum k in seeds, yeast, onions, oysters, leafy veggies
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
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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
St. John’s Wort (Hypericum perforatum)

Most scientifically studied herbal supplement on
the market over the last 20 years12

Uses:
–

Interactions:
–
–


100-500mg by mouth three times daily13,14
Side Effects:
–

Allergy medications, alcohol, amphetamines,
antidepressants called MAOIs and
tricyclics,Desyrel®, and oral
contraceptives/pregnancy
Sunlight alters efficacy13,14
Common Dosage:
–
“Milton had an interesting side effect from
Taking St. John’s Wort”
Anxiety, Bed-wetting, Bronchial inflammation,
Burns, Cancer, Depression, Hemorrhoids, Insect
bites, Insomnia, Kidney disease, Scabies,
Digestive issues, Wound healing13,14
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
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)
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
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
Black Cohosh (Cimicifuga racemosa)

It’s Latin name literally means “to drive away
bugs” and that’s 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

It’s 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. John’s Wart12

Said to stimulate the body’s immune
system12

Uses:
–

Interactions:
–


85-4000mg up to three times daily (as
tincture, capsule, tea-each with a
different dosing regimen) 13-14
Side Effects:
–

Allergic Reaction to any of its parts13-14
Common Dosage:
–
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Antibacterial, Antiviral, Blood Cleanser,
Skin wounds13-14
Fairly well-tolerated13-14
Gross sales in the United States
topped $14,400,000 in 200712
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 Formulary’s
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
– Shouldn’t take with pregnancy, or if
attempting to become pregnancy13-14

$17,000,000 in sales in the United States in
200712
Ginko (Ginkgo biloba)
http://www.liebreich.com/LDC/Images/Climbing/Ginko_Leaves.jpg

“Botanists call the Ginko Biloba tree a ‘living
fossil’ since it has remained unchanged since
the Paleozoic period [200 million years ago]”12

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
Garlic (Allium sativum)

Among the most extensively studied herbal
supplements to date12

Marketed in ‘odorless’ or ‘deodorized’
formulations13

Uses:
– Asthma, athlete’s 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

Is found to be safe by the FDA13
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Cranberry (Vaccinium macrocarpon)

It’s 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
23.5%12
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Soy (Glycine Max)

Since soy is actually a food crop, many
don’t 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 osteoporosis 14

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
What’s this? Soy Milk?
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Governmental Regulation of Herbal
Supplements and Pharmaceuticals
www.rx.uga.edu

In 1906, the Food and Drug
Administration (FDA) was created
through President T. Roosevelt’s
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 wasn’t clearly
written on the label and/or weren’t
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
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 FD&C finally gave significant federal
authority over drugs and mandating premarket 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 FD&C which required all new drug
applications to demonstrate ‘substantial
evidence’ of the drug’s 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
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
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
company’s records to “prove” the above requirements upon request 19

HOWEVER, the amount of FDA inspectors had decreased 16% from 20032006 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 don’t 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 label…as a treatment, prevention, or
cure for a specific disease or condition would be considered UNAPPROVED
and thus an ILLEGAL drug.” 19
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
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 therapy’s 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 person’s regimen. 19

In China, PRIOR TO MARKET ENTRY, manufactures
must register dietary supplements with the SFDAChina’s 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.
John’s 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. John’s 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. John’s Wort and placebo
(Double Blind study) 13

340 participants were in the trial and
averaged 42 years old. 2/3 were female
“Milton had an interesting side effect from
Taking St. John’s Wort”
22

The trial found “no statistically
significant difference between St.
John’s Wort and Placebo on
improvement [with their depression] 22
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
Reviewing the Safety and Efficacy of Dietary
Supplements
http://en.wikivisual.com/images/7/77/Milk_thistle_flower.jpg

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
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
Reviewing the Safety and Efficacy of Dietary
Supplements
texasnaturalsupply.com

The theory behind echinacea is
that it prevents the adhesion of the
E.coli bacteria to the lining of the
kidney cells

Once study’s 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
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
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 >60 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
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
http://www.cambridgebuzz.com/cb_images/GarlicHarvest.jpg
Multiple adverse effects including
bad breath, dermatitis, bleeding,
and abdominal disturbances led to
several non-compliances by
patients enrolled in the studies 20
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/cranberry_small.jpg
Reviewing the Safety and Efficacy of Dietary
Supplements
http://jakst.files.wordpress.com/2009/06/soy.jpg

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 soy’s effect to
decrease the frequency and
intensity of hot flashes 20
General Studies’ Limitations for Most Herbal
Supplements
http://www.associationtimes.com/images/articles/limitations.gif

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

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
Pharmaceutical Interactions with Dietary
Supplements

St. John’s 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
References
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1.) http://www.fda.gov/food/dietarysupplements/consmerinformation/ucm110417.htm Food: Overview of Dietary
Supplements
2.) http://www.nal.usda.gov/fnic/pubs/bibs/gen/dietary 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-herbal-medicine.html History of Herbal Medicine.
6.) http://www.historyofscience.com/G2I/timeline/index. 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/mma/timeline.html
11.) http://en.wikipedia.org/wiki/Dietary_mineral Dietary Mineral
12.) http://factoidz.com/top-10-best-selling-herbal-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 Remedies:Visual Reference Guide.1st Ed. Metro Books, New York, NY. 2007.
15.) http://www.herbs2000.com/herbs/herbs_saw_palmetto.htm Saw Palmetto.
16.) http://www.webmd.com/vitamins-supplements/ingredientmono-975SOY.aspx?activeIngredientId=975&activeIngredientName=SOY Soy
17.) http://www.marketresearch.com/browse.asp?sortby=p&categoryid=189&g=1 Hartmon Group Phase III National Study
18.) http://www.fda.gov › About FDA
19.)http://en.wikipedia.org/wiki/DietarySupplement.Dietary Supplkements.
20.)http://www.assets.aarp.org Dietary Supplements and Older Consumers. February 2007
21.)http://www.extension.iastate.edu/nutrition/supplements/labeling. Supplement Facts Labeling and Health Claims
22.) http://nccam.nih.gov/news/2002/stjohnswort/q-and-a.htm A Trial of St. John’s Wort for the Treatment of Major
Depression.
23.) Vogler, B., Pittler, M.H., Ernst, E., The efficacy of ginseng. A systematic review of randomised clinical trials. Eur J Clin
Pharmacol (1999) 55: 567-575.
24.) Jacobson, J, Troxel, A, Evans, J et.al. Randomized Trial of Black Cohosh for the Treatment of Hot Flashes Among
Women With a History of Breast Cancer. Journal of Clinical Oncology 19(10)2001: 2739-2745.
25.) Elsabaugh, S, Hartley, D, Differential cognitive effects of Ginkgo biloba after acute and chronic treatment in healthy
young volunteers. Psychopharmacology 179 2005: 437-446.
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