dietary supplements: how safe and effective are they? static.howstuffworks.com/gif/herbal-remedies...

Dietary Supplements: How Safe and Effective are They?

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Carrie N.Georgion Pharm D, BSPS, BA, RPhLa Porte Hospital, La Porte, IN 46350

http://www.pharma.unibas.ch/bio/img/Humor_now_and_then/Humor_Herbal_Medicine

I present to you: Porkchop!

According to his dog trainers, “The most controlling puppy they have ever met”, “You two have your hands full”

In December

Now

The Herbal Supplement Revolution

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

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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

Homeopathyhttp://www.pharma.unibas.ch/bio/img/Humor_now_and_then/Humor_Herbal_Medicine_2.jpg

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 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

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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 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

Vitamin Main Role Food Source

A (Retinol) Skin, Mucous Membranes,Vision, Bones green leafy vegetables, melon,squash, tomatoes, fish-liver

D (Calciferol) Key for Calcium Absorption, Bone growth/maintenance Fish-liver, sprouts, mushrooms, sunflower seeds

E (Tocopherol) Helps form Red Blood Cells (RBC), Prevents Oxidation damage Raw or sprouted seeds, nuts, grains, green leafy vegetables

K Needed for Blood Clotting and Liver Function Kelp, alfalfa, soybeans

B1 (Thiamin) Nervous System function and Carbohydrate metabolism Yeast, wheat germ, whole-grain cereals, nuts, beans

B2 (Riboflavin) Helps with Energy Release from food , Skin, Nails Whole grains, yeast, wheat germ, nuts, cooked leafy vegetables

B3 (Niacin) Nervous and Digestive system, Carbohydrate metabolism Yeast, wheat germ, rice bran, nuts, brown rice, green vegetables

B6 (Pyridoxine) Metabolism, Helps with RBC formation, Pregnancy processes Yeast, wheat germ, soybeans, cantaloupe, pecans

B12 (Cobalamin) RBC formation, Prevention of Anemia, Growth in Pediatrics Yeast, seeds, kelp, bananas, peanuts, wheat germ

Folic Acid Essential for RBC formation, Healing, Metabolism, Growth Deep green leafy vegetables, beans, spinach, nuts, broccoli

C (Ascorbic Acid) Healthy Teeth, Gums, Bones, Adrenal Systems, and Detoxicant All fresh fruits, vegetables, citrus, turnip greens, green peppers

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Suggested Daily Dietary Intake of Common Vitamins

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

Mineral Main Role Food Source

Calcium Bone, Tooth, Heart, Muscle Function Leafy vegetables Seeds, oats, Beans, Nuts, Canned Fish

Phosphorus Needed with Calcium for above functions Whole-grains, seeds, nuts, legumes, dried fruit, corn

Magnesium Muscle Tone, Bones, Heart Nuts, soybeans, green leafy vegetables, apples, lemons, peaches

Potassium Acid-alkaline balance in blood, Muscle Green leaft vegetables, oranges, whole grains, seeds, bananas

Sodium Fluid Acid/Base balance, Stomach Kelp, celery, romaine lettuce, watermelon, sea salt

Chlorine Stomach, Liver detoxification Kelp, avocado, chard, tomatoes, cabbage, celery, cucumber, oats

Sulfur Hair, Skin, and Nails Radish, turnip, onions, celery, soybeans, fish

Iron Resistance to stress, Hemoglobin formation Apricots, peaches, bananas, prunes, whole grain cereals, turnips

Zinc Enzymes, Insulin, Wound, Tissues Wheat bran, pumkin 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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historyofscience.com/G2I/timeline/images/naplesdioscorides

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. John’s 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/pregnancy

– 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. John’s Wort”

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)

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: – 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 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) “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

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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 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

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What’s this? Soy Milk?

Governmental Regulation of Herbal Supplements and Pharmaceuticals

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

www.rx.uga.edu


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 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 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


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


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 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 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


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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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 SFDA-China’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 22

The trial found “no statistically significant difference between St. John’s Wort and Placebo on improvement [with their depression] 22

“Milton had an interesting side effect from Taking St. John’s Wort”


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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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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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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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

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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


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


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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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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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

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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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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 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-975-SOY.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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