Dietary Supplements: How Safe and Effective are They?

Carrie N.Georgion Pharm D, BSPS, BA, RPh La Porte Hospital, La Porte, IN 46350 static.howstuffworks.com/gif/herbal-remedies http://www.pharma.unibas.ch/bio/img/Humor_now_and_then/Humor_Herbal_Medicine

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 1997 17 In 1998 total herbal remedy sales in the U.S. reached $4 billion dollars 23  Reached over 71% of U.S. Households nationwide 17  “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 Period 12 , 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 treatment 13



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?

 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 http://www.ntskeptics.org/cartoons/homeopathy.gif

 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 18 th 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?

 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 http://www.wavemagazine.net/arhiva/12/science/homeopathy1.jpg

 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 illnesses use dilution numbers between 30c and 200 c chronic (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

Vitamin Main Role Food Source

A (Retinol) D (Calciferol) E (Tocopherol) K B1 (Thiamin) Skin, Mucous Membranes,Vision, Bones Key for Calcium Absorption, Bone growth/maintenance green leafy vegetables, melon,squash, tomatoes, fish-liver Fish-liver, sprouts, mushrooms, sunflower seeds Helps form Red Blood Cells (RBC), Prevents Oxidation damage Raw or sprouted seeds, nuts, grains, green leafy vegetables Needed for Blood Clotting and Liver Function Nervous System function and Carbohydrate metabolism Kelp, alfalfa, soybeans Yeast, wheat germ, whole-grain cereals, nuts, beans B2 (Riboflavin) B3 (Niacin) B6 (Pyridoxine) Helps with Energy Release from food , Skin, Nails Nervous and Digestive system, Carbohydrate metabolism Metabolism, Helps with RBC formation, Pregnancy processes Whole grains, yeast, wheat germ, nuts, cooked leafy vegetables Yeast, wheat germ, rice bran, nuts, brown rice, green vegetables Yeast, wheat germ, soybeans, cantaloupe, pecans B12 (Cobalamin) RBC formation, Prevention of Anemia, Growth in Pediatrics Folic Acid Essential for RBC formation, Healing, Metabolism, Growth Yeast, seeds, kelp, bananas, peanuts, wheat germ 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

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 Mineral Main Role Food Source Calcium Phosphorus Magnesium Potassium Sodium Chlorine Sulfur Iron Zinc Bone, Tooth, Heart, Muscle Function Muscle Tone, Bones, Heart Acid-alkaline balance in blood, Muscle Fluid Acid/Base balance, Stomach Stomach, Liver detoxification Hair, Skin, and Nails Leafy vegetables Seeds, oats, Beans, Nuts, Canned Fish Needed with Calcium for above functions Whole-grains, seeds, nuts, legumes, dried fruit, corn Nuts, soybeans, green leafy vegetables, apples, lemons, peaches Green leaft vegetables, oranges, whole grains, seeds, bananas Kelp, celery, romaine lettuce, watermelon, sea salt Kelp, avocado, chard, tomatoes, cabbage, celery, cucumber, oats Radish, turnip, onions, celery, soybeans, fish Resistance to stress, Hemoglobin formation Apricots, peaches, bananas, prunes, whole grain cereals, turnips Enzymes, Insulin, Wound, Tissues Wheat bran, pumkin seeds, yeast, onions, oysters, leafy veggies

History of Herbal Remedies

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 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 historyofscience.com/G2I/timeline/images/naplesdioscorides

Top Ten U.S. Herbal Supplements

 10.) St. Johns Wort (Hypericum perforatum) http://www.pinkraygun.com/wp-content/uploads/2009/01/herbal-supplements.jpg

 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 years 12  Uses: – Anxiety, Bed-wetting, Bronchial inflammation, Burns, Cancer, Depression, Hemorrhoids, Insect bites, Insomnia, Kidney disease, Scabies, Digestive issues, Wound healing 13,14  Interactions: – Allergy medications, alcohol, amphetamines, antidepressants called MAOIs and tricyclics,Desyrel ® , and oral contraceptives/pregnancy – Sunlight alters efficacy 13,14  Common Dosage: – 100-500mg by mouth three times daily 13,14 “Milton had an interesting side effect from Taking St. John’s Wort”  Side Effects: – Allergic reactions, constipation, dizziness, dry mouth , restlessness, sensitivity to sunlight, stomach upset, sleep disturbances 13,14  In 2007 sales in the U.S. were about $8,000,000 12

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Ginseng (Panax ginseng)

 Ancient Chinese herb used for over 2000 years and known as the ‘ultimate herb’ among most herbalists 12  Used by about 6 million Americans regularly 13,14  Uses: – aphrodisiac, sedative, sleep aid, depression, diabetes, liver problems, energizer, healing, enhancer of physical and mental performance, resists stress, improves mental concentration 13,14  Interactions: – Anti-hyperglycemia drugs (Insulin, Amaryl ®),MAOIs, and stimulants like coffee and tea 13,14   Common Dosage: – 200-600mg daily of ginseng extract and 0.5-2g daily of dry ginseng root 13,14 Side Effects: – chest/breast pain, diarrhea, headache, hypertension(high blood pressure), insomnia, impotence, itching, nausea, nervousness, palpitations, vomiting 13,14 http://www.lakginseng.com/ginseng56.gif

 Ginseng had over $8,400,000 in annual sales in 2007 12

Milk Thistle (Silybum marianum)

 Used as a liver tonic for centuries with varying degrees of success 12  Uses: – Antidote for poisonous mushrooms, Hepatitis C, Liver function aid/ “cleanser”, and Liver repair 13,14  Interactions: – Allergic reaction to any of its parts 13,14 http://en.wikivisual.com/images/7/77/Milk_thistle_flower.jpg

 Common Dosage: – 200-800mg daily 13,14  Side Effects: – Laxative effects, vaginal bleeding/menstruation 13,14  Gross sales of about $8,600,000 in the U.S. in 2007. 12 http://karatetraining.org/weblog/wp-content/uploads/2008/01/green_smoothie.jpg

Black Cohosh (Cimicifuga racemosa)

   It’s Latin name literally means “to drive away bugs” and that’s what it does for a garden 12 It was used by Native American Women in the Cherokee tribe to stimulate breast milk after childbirth and for other menstruation problems 12 Uses: – Diarrhea, Fluid retention, Inflammation, and Menopause symptoms 13-14 http://thecompounder.files.wordpress.com/2009/05/black-cohosh.jpg

 Interactions: – Anti-hypertensive drugs 13-14  Common Dosage: – 8-2400 mg daily 13-14  Side Effects: – Nausea or vomiting, symptoms of low blood pressure (dizziness), nerve irritability and headache. If taken in high doses may cause miscarriage 13-14  It’s sales were about $8,600,000 in the United States in 2007 12 2.bp.blogspot.com/.../herbs_black_cohosh.jpg

Echinacea (Echinacea purpurea)

 Also among the most-studied herbs with St. John’s Wart 12  Said to stimulate the body’s immune system 12  Uses: – Antibacterial, Antiviral, Blood Cleanser, Skin wounds 13-14  Interactions: – Allergic Reaction to any of its parts 13-14 texasnaturalsupply.com

 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-tolerated 13-14  Gross sales in the United States topped $14,400,000 in 2007 12

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 1950s 15 Uses: – Benign prostate hyperplasia (BPH), decreased sex drive, decreased breast size, decreased sperm production, fluid retention, and other genito-urinary problems 13-14 Interactions: – Use of prescription hormone medications 13-14    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 retention 13-14 – Shouldn’t take with pregnancy, or if attempting to become pregnancy 13-14 $17,000,000 in sales in the United States in 2007 12

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-wide 12  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 2007 12 http://www.liebreich.com/LDC/Images/Climbing/Ginko_Leaves.jpg

Garlic (Allium sativum)

 Among the most extensively studied herbal supplements to date 12  Marketed in ‘odorless’ or ‘deodorized’ formulations 13 http://www.cambridgebuzz.com/cb_images/GarlicHarvest.jpg

     Uses: – Asthma, athlete’s foot, bacterial infections, constipation, diabetes, fungal infections, heavy-metal poisoning, hypertension, hyperlipidemia (high cholesterol), wounds, to ward off evil spirits 13 Interactions: – Antiplatelet drugs (Persantine) and blood thinners (warfarin) 13-14 Common Dosage: – 600-900mg daily or up to 4 grams of fresh garlic daily 13-14 Side Effects: – Dizziness, nausea, skin rash, sweating, vomitting 13 Was the #2 selling herbal supplement in the United States until two, “highly-publicized” studies found garlic ineffective at lowering cholesterol 12  Grossed $20,500,000 in 2007 in the U.S. 12  Is found to be safe by the FDA 13

Cranberry (Vaccinium macrocarpon)

 It’s been used for over a century to

treat

Urinary tract infections (UTI) and disorders 12 http://vegpod.com/wp-content/uploads/2007/11/cranberry_small.jpg

 Uses: – Cancer, Skin irritation, Urinary tract disorders, certain overdoses 13-14  Interactions: – No significant interaction profile 13  Common Dosage: – 1-2 capsules daily or 10-16oz. juice daily 13-14  Side Effects: Diarrhea but fairly well tolerated 13  Gross sales in 2007 in the United States yielded $24,000,000 12  Sales jumped that year more than 23.5% 12

Soy (Glycine Max)

What’s this? Soy Milk?

 Since soy is actually a food crop, many don’t consider it a traditional

herb,

food often place it in this category 12 but its therapeutic properties within the body as a  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, Synthroid 16  Common Dosage: 2-60g daily rlv.zcache.com/soy_milk_cows_cartoon_mousepad  Side Effects: – Most side effects would be seen with long term use – Endometrial Cancer, hypothyroidism, urinary/kidney disease 16  Sales actually dropped 17% in 2007 but still topped out at $25,600,000 in the U.S. in 2007. 12 http://jakst.files.wordpress.com/2009/06/soy.jpg

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 www.rx.uga.edu

 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

Formulary United States Pharmacopoeia or National

would incur penalties by law  This act also banned ‘misbranding’ of food and drugs  The 1906 Act above 18 DID NOT and fraudulent’ claims of ‘curative or therapeutic effect’ apply to ‘false . An amendment to the act in 1912 incorporated these additions, but courts continue to be vague in their definitions of the

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.

www.rx.uga.edu

 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”.

this review.

18 Drugs approved between 1938-1962 were also subject to  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



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 enter into the market 19 NOT be approved by the FDA before they can  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 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

statutes”

19 “

cure, mitigate, or treat a disease, it would be considered an unauthorized new drug and in violation of the applicable regulations and

 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’ helps establish normal sleep patterns’ FDA 19 or ‘melatonin may be made since the validity of these statements have NOT been proven in a new drug application/clinical trials for the  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 prescription . And, ONLY those supplements that are proven to be safe may be sold without a . 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 http://flagsandanthems.com/media/flags/flag-european-union-eu.gif

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 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 http://www.auckbad.co.nz/shuttleexpress/images/china-flag.gif

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 depression 13 “Milton had an interesting side effect from Taking St. John’s Wort”  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

Reviewing the Safety and Efficacy of Dietary Supplements

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

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 placebo 23 

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 not 23 

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 differences 23

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 http://en.wikivisual.com/images/7/77/Milk_thistle_flower.jpg

 Two trials included patients with alcoholic or nonalcoholic cirrhosis. The milk thistle groups showed a trend toward improved survival 20  Two trials showed improvement in 1 liver function endpoint in patients with viral hepatitis 20  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 substances 13

Reviewing the Safety and Efficacy of Dietary Supplements

 A study was published in the

Journal of Clinical Oncology

in May of 2001. 2.bp.blogspot.com/.../herbs_black_cohosh.jpg

 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 flashes 24  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

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 texasnaturalsupply.com

 Once study’s conclusion was that echinacea does not prevent or treat the infection, but it may decrease the time to resolution of symptoms 25  Another study conducted in 1999 observed INCREASED frequency of upper respiratory infections for those who continuously used echinacea as compared to those who did not 13

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 professionals 13

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 ginkgo 25  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’ 2002 study 25 and had exactly the opposite effects as the  It also concluded that ginkgo improved performance in tests of attention and memory acutely, but NO effects were seen after 6 weeks of continuous treatment 25

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 lipids 20 http://www.cambridgebuzz.com/cb_images/GarlicHarvest.jpg

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

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 http://vegpod.com/wp-content/uploads/2007/11/cranberry_small.jpg

 This study only studied the effect of cranberry juice in PREVENTION but not treatment of UTIs 20

Reviewing the Safety and Efficacy of Dietary Supplements

 Across most studies, high concentrations of soy intake reported “suggestion” in decreased LDL and triglycerides http://jakst.files.wordpress.com/2009/06/soy.jpg

 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

 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.)

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  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 death 13



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

1 st Ed. Simon and Schuster, Inc, New York, Ny. 2000.

14.) Chevallier, Andrew,

Herbal Remedies:Visual Reference Guide.

1 st 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.

Pharmacol (1999) 55: 567-575.

Eur J Clin 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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