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Dietary Supplements: How Safe and Effective are They?

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1 Dietary Supplements: How Safe and Effective are They?
Carrie N.Georgion Pharm D, BSPS, BA, RPh La Porte Hospital, La Porte, IN 46350 Introduction Valpo, Goshen, Dominican Republic, London, Greece, Portland, and full circle to Valpo Friday began this MONSTER so bare with me Seinfeld bit static.howstuffworks.com/gif/herbal-remedies

2 I present to you: Porkchop!
In December Now According to his dog trainers, “The most controlling puppy they have ever met”, “You two have your hands full”

3 The Herbal Supplement Revolution
Grown from a 2.6 billion dollar industry to a 20 billion dollar industry since 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 Another INTERESTING note and a possible dangerous side of Herbals is that 3 out of 4 people who use herbal remedies do NOT admit it to their physicians or when admitted to the hospital

4 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 Not defined until 1994 by DSHEA (will talk more about DSHEA) later in presentation Intended to supplement the diet or as #4 states provide nutrients that may be missing or not consumed in a person’s diet Please pay special attention to the 2nd and 3rd bullet points and the implications of what the general public’s view of what an herbal supplement is and what it’s designed to be or defined as

5 Homeopathy I am going to take the time to briefly describe homeopathy and vitamins and minerals and herbals since they all differ

6 What is Homeopathy? Princeton University defines homeopathy as “a method of treating disease with small amounts of remedies that, in large amounts in healthy people, produce symptoms similar to those being treated”. 7 The National Institute of Health (NIH) further describes Homeopathy as having the intention of giving very small doses of highly diluted substances to stimulate the 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 I have to be honest, in beginning this presentation (on Thurs when informed) I’m not even sure I knew what homeopathy was! It derives from the Greek words Homeo meaning SAME and Pathos meaning disease/suffering from Hippocrates theorized that like treated like ( you should use red things to cure bleeding problems) Hahnemann began diluting substances used a remedies believing the essense or imprint of the healing substance still remained.

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

8 Homeopathic Potency Scales
This chart represents a standard dilution scale for most homeopathic regimens As a general rule, most chronic illnesses use dilution numbers between 30c and 200 c (level at which most of Hahnemann treatments were diluted).8 For acute illness, dilutions were used in the 6c range and above. 8 Just as an example, a 6c treatment would only have 1 part homeopathic treatment substance in 1000 parts liquid dilution Chronic illness 30c and 200c = and dilutions Acute illnesses 6c = 10-4 dilutions

9 Vitamins A vitamin is defined as “an organic compound required as a nutrient in tiny amounts by an organism” 9 Vitamins are classified by their chemical activity on biological systems in the body. 9 Functions of Vitamins include: Hormone-LIKE activity Aid in metabolism Antioxidants Enzyme Cofactor involvement 9 In 1905 English scientist, William Fletcher determined that if certain substances (vitamins) were removed from food, different disease states occurred. 10 Vitamins 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 Our bodies REQUIRE vitamins vs. herbals that may just supplement other things that our bodies need We DON’T need herbals to survive

10 Role of Vitamins

11 Suggested Daily Dietary Intake of Common Vitamins
Vitamin C Example

12 Minerals Dietary Minerals are “the chemical elements required by living organisms, other than the four elements carbon, hydrogen, nitrogen, and oxygen present in common organic molecules.”11 made these charts but there are similar charts on the website Office of dietary Supplements intake guidelines for elements/dietary minerals

13 History of Herbal Remedies
Shennong, a “mythical personage” is believed to have tested hundreds of herbs passing his knowledge to farmers about plants and poisons over 2,000 years ago.3 The Shennong Bencao Jing is the first written material listing over 300 medicines, 252 of which are herbs dating back during the first century C.E. during the Han dynasty.4 As small societies began growing, knowledge of using plants to attempt to treat illness grew. The Egyptians first codified herbal remedies and plant indices. 5 The Naples Dioscorides is an early seventh century Greek Herbal based on the De materia Medica written by the first century Greek military physician Dioscorides. The Naples Dioscorides contains an alphabetical list of plants and their uses. 6 In the Americas, herbalism began and was spread via word of mouth from various Indian tribes. Thus, it was deeply tied with spiritualism from American Indian cultures. 5 China 2000 years ago. Shennong mythical god then book Shennong Bencao Jing Han Dynasty Egyptians codified it India’s herbalism was called Ayurvedic focused on herbs, metals, and animal parts previously considered inedible prepared them in solutions and used them for ills and ointments Greek physician also wrote book in the first century Americas influence was from American Indians historyofscience.com/G2I/timeline/images/naplesdioscorides

14 Top Ten U.S. Herbal Supplements
10.) St. Johns Wort (Hypericum perforatum) 9.) Ginseng (Panax ginseng) 3 species sold in the U.S. 8.) Milk Thistle (Silybum marianum) 7.) Black Cohosh (Cimicifuga racemosa) 6.) Echinacea (Echinacea purpurea) 5.) Saw Palmetto (Serenoa repens) 4.) Ginkgo (Ginkgo biloba) 3.) Garlic (Allium sativum) 2.) Cranberry (Vaccinium macrocarpon) 1.) Soy (Glycine max)12

15 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: mg 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 Mostly used for Depression, Anxiety Several drug interactions “Milton had an interesting side effect from Taking St. John’s Wort”

16 Ginseng (Panax ginseng)
Ancient Chinese herb used for over 2000 years and known as the ‘ultimate herb’ among most herbalists12 Used by about 6 million Americans regularly13,14 Uses: aphrodisiac, sedative, sleep aid, depression, diabetes, liver problems, energizer, healing, enhancer of physical and mental performance, resists stress, improves mental concentration13,14 Interactions: Anti-hyperglycemia drugs (Insulin, Amaryl®),MAOIs, and stimulants like coffee and tea13,14 Common Dosage: mg 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 Mostly used for physical and mental energizer (ODD THAT ALSO USED AS SLEEP AID???) You will see several of these like vs. liike homeopathic ideas when using Herbals

17 Milk Thistle (Silybum marianum)
Used as a liver tonic for centuries with varying degrees of success12 Uses: Antidote for poisonous mushrooms, Hepatitis C, Liver function aid/ “cleanser”, and Liver repair13,14 Interactions: Allergic reaction to any of its parts13,14 Common Dosage: mg daily13,14 Side Effects: Laxative effects, vaginal bleeding/menstruation13,14 Gross sales of about $8,600,000 in the U.S. in Mostly used for LIVER dysfunctions

18 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: 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 THIS IS THE WOMAN’s aid for menopause symptoms (hot flashes mostly) DOSE RANGE IS HUGE 2.bp.blogspot.com/.../herbs_black_cohosh.jpg

19 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: mg 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 texasnaturalsupply.com INFECTION CONTROL COMMON COLD SEVERAL OF MY PATIENTS BELIEVE IN THIS MEDICATION INCLUDING MY FAMILY HUGE DOSAGE RANGE

20 Saw Palmetto (Serenoa repens)
First used by the Native Americans who discovered its extensive growth on sand dunes of the Midwest. 15 It was listed in The National 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 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 MOSTLY USED FOR PROSTATE HEALTH BPH MOST OF STUDIES BELIEVE IT WORKS AS WELL AS FLOMAX (TALK ABOUT THIS LATER)

21 Ginko (Ginkgo biloba) “Botanists call the Ginko Biloba tree a ‘living fossil’ since it has remained unchanged since the Paleozoic period [200 million years 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: mg 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 MOSTLY USED FOR MEMORY AS COMIC SAYS GO OVER COMIC HUGE REACTION WITH COUMADIN

22 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: mg 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 MOSTLY USED FOR CHOLESTEROL AND AS ONE MD SAYS TO WARD OFF EVIL SPIRITS-PARTICULARLY EFFECTIVE ON VAMPIRES INTERACTS WITH BLOOD DRUGS OR COUMADIN AND ANTIPLATELET DRUGS

23 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 MOSTLY USED FOR UTIS DOSING VERY NORMAL MUCH CLNICAL DATA THAT IT PREVENTS THEM BY BLOCKING THE E COLI MOST COMMON INFECTION CAUSER FROM ADHERING TO THE KIDNEY CELL LINING

24 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 What’s this? Soy Milk? rlv.zcache.com/soy_milk_cows_cartoon_mousepad SOY ACTUALLY A FOOD CROP BUT OFTEN GROUPED WITH HERBALS WIDE RANGE OF USES WIDE DOSE RANGE POSSIBLY JUST A HEALTHIER ALTERNATIVE TO RED MEATS ETC

25 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 1906 FDA FORMED TEDDY ROOSEVELT ALWAYS THINK OF ARSENIC AND OLD LACE 1906 FD&C CAN’T SELL ALTERED FOOD OR DRUGS CAN’T MARKET DRUGS WHERE THE STANDARD, PURITY WASN’T CLEARLY WRITTEN ON LABEL DIDN’T ENFORCE/COULDN’T ENFORCE LAW WAS VAGUELY WRITTEN GOOD INTENTION JUST DIDN’T REALLY PRODUCE ALERT DID NOT APPLY TO THE FALSE OR FRAUDULENT CLAIMS OF CURATIVE EFFECFTS UNTIL 1912

26 Governmental Regulation of Herbal Supplements and Pharmaceuticals
Following an Elixir Sulfanilamide tragedy in 1937 which killed several people because it was dissolved in diethylene glycol instead of ethanol, President F. D. Roosevelt signed the new Food, Drug, and Cosmetic Act (FD &C) into law in 1938. The 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 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 Interesting to note that the law was still so juvenille even only years ago that the only LEGAL way the FDA could even seize the Sulfanilimide elixir was due to a loo-pole that elixir is defined as disolved in ethanol not the lethal solvent THIS IS WHERE SAFETY FINALLY COMES IN 1962 EFFICACY 1994 FOODS VS DRUGS NOW EFFICACY OUT THE WINDOW NO APPROVAL REQUIREMENTS

27 Governmental Regulation of Herbal Supplements and Pharmaceuticals
A repeat: DSHEA is the amendment passed in 1994 that states that dietary supplements are now to be considered a food and need NOT be approved by the FDA before they can enter into the market19 At the time, passing of the DSHEA by president Clinton received much support from Consumer organizations and members of Congress A large survey completed by AARP found that “77% of respondents (including both users and non-users of supplements) believed that the federal government should review the safety of dietary supplements and approve them before they can be marketed to consumers” 20 In October 2002, a Harris poll of the nation revealed that “59% of respondents [ALREADY] believed that supplements had to be approved by a government agency [or some sort] before they could be marketed” 20 In the same poll, “68% believed that supplements had to list potential side effects on their labels [and that] 55% believed that supplement labels could NOT make claims of safety without scientific evidence” 20 All of the above beliefs are INCORRECT as a result of the provisions of the DSHEA ‘A 2001 study published in Archives of Internal Medicine found broad public support for greater governmental regulation of dietary supplements than was currently permitted by the DHSEA’ 19 PRESIDENT CLINTON IS RESPONSIBLE FOR PASSING THE AMMENDMENT NO APPROVAL BY FDA READ QUOTES

28 Governmental Regulation of Herbal Supplements and Pharmaceuticals
The newest regulations on good manufacturing practices require a dietary supplement to consistently meet the established specifications for identity, purity, strength, and composition. The FDA inspectors may look at a company’s records to “prove” the above requirements upon request 19 HOWEVER, the amount of FDA inspectors had decreased 16% from 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 GOOD MANUFACTURING PRACTICES DO REQUIRE BY LAW THAT A DIETARY SUPPLEMENT MUST MEET ESTABLISHED SPECS FOR PURITY STRENGTH AND COMPOSOITION (LIKE 1906/1912) HOWEVER, THE COMPANIES ARE RARELY INSPECTED AND EVEN LESS SO NOW WITH BUDGET STAFF CUTS WITHIN THE FDA 50% HAVE BEEN PROVEN TO NOT MEED THE REQUIRED GUIDELINES

29 Governmental Regulation of Herbal Supplements and Pharmaceuticals
Dietary supplements are ONLY allowed to make “structural or function” claims on their labeling 19 Only broad statements like ‘glucosamine helps support healthy joints’ or ‘melatonin helps establish normal sleep patterns’ may be made since the validity of these statements have NOT been proven in a new drug application/clinical trials for the FDA 19 Acceptable Claims: Helps maintain function, Promotes healthy cholesterol, Supports regularity, Summorts the immune system, Improves absentmindedness, Reduces stress 21 Unacceptable Claims: Protects against heart disease, lowers cholesterol, reduces pain of arthritis, laxative, prevents urinary tract infections, helps patients with reduced immune function 21 The FDA dose need to at least be notified of the claim within 30 days of use and under DHSEA these claims are required to contain merit scientifically. The reality is that misleading claims are common and poorly investigated due to lack of manpower within the FDA 19 DIETARY SUPPLEMENTS MAY ONLY MAKE BROAD STATEMENTS AS ABOVE SINCE NOT PROVEN NOR APPROVED BY THE FDA

30 Governmental Regulation of Herbal Supplements and Pharmaceuticals
LABEL MUST HAVE STATEMENT OF IDENTITY SUPPLEMENT NAME MUST STATE THAT IT’S A DIETARY SUPPLEMENT QUANTITY OF PRODUCT .

31 Governmental Regulation of Herbal Supplements and Pharmaceuticals
LABEL MUST ALSO HAVE DIRECTIONS: HOW TO TAKE OR DOSAGE MUST STATE IF CAN BE HAZARDOUS TO HEALTH POTENTIAL HARM OR INTERACTIONS MUST HAVE A FACTS PANEL LIKE OTHER FOODS BASED ON 2000 CALORIE DIET

32 Governmental Regulation of Herbal Supplements and Pharmaceuticals

33 Governmental Regulation of Herbal Supplements and Pharmaceuticals
PRE CLINICAL PHASE/RESEARCH: SYNTHESIZED, PRODUCED ACCORDING TO GMP AND ANIMAL STUDIES DONE ----SORRY TO ANIMAL LOVERS CLNICAL PHASES – done on healthy pts first just use it to prove pharmacokinetics (adsorption, metabolism, excretion) and confirm mechanism of action as done in animal research Phase II –pt with actual disease state or symptoms Phase III longer studies FDA might weigh benefits over risks and approve then IV phase often post marketing

34 International Regulation of Herbal Supplements
The European Union (EU) requires that dietary supplements be DEMONSTRATED to be safe in quantity and quality. And, ONLY those supplements that are proven to be safe may be sold without a prescription. This makes obtaining dietary supplements much more difficult and controversy from consumers has arisen. Several petitions have been signed to change this law process. 19 In Russia, Dietary Supplements are defined as “Biologically Active Dietary Supplements” (BADS). BADSs are “foodstuffs with clinically proven effectiveness. [They are] recommended prophylactically and included into a complex therapy for the prevention of pharmaceutical 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 EU has MUCH MORE STRICT REGIMEN than US infact all do China’s process is much like our process for actual drug

35 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”

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

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

38 Reviewing the Safety and Efficacy of Dietary Supplements
A study was published in the Journal of Clinical Oncology in May of 2001. It studied the use of Black Cohosh for treatment of hot flashes among women with a history of breast cancer Of the 85 patients studied (half on placebo, half given black cohosh), BOTH groups reported improvements of menopausal symptoms and blood levels of hormones effecting hot flashes like FSH and LH were unchanged Black cohosh was NOT significantly more efficacious statistically than placebo in number or intensity of hot flashes24 It is important to note that most of the studies (including this one) have been done on a very small group of women and further study is necessary Both Placebo and Cohosh groups reported improved positive results 2.bp.blogspot.com/.../herbs_black_cohosh.jpg

39 Reviewing the Safety and Efficacy of Dietary Supplements
The theory behind echinacea is that it prevents the adhesion of the E.coli bacteria to the lining of the kidney cells Once 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 Mixed Results but one of the most popular in my pharmacy experience texasnaturalsupply.com

40 Reviewing the Safety and Efficacy of Dietary Supplements
Most studies agree that their findings support the use of Saw Palmetto to treat BPH Many clinical trials, one of which studies over 300 males, found that saw palmetto and its component LSESR treats BPH as effectively as commonly prescribed pharmaceuticals More studies comparing saw palmetto and BPH medications in head-to-head competitions need to be completed before specific statements about its efficacy can be made and trusted by health care professionals13 Most of the studies agreed that it works Several of the trials included treatment groups of larger quantities One of largest supported dietary supplements

41 Reviewing the Safety and Efficacy of Dietary Supplements
In 2002, a long study of Ginkgo was published in the Journal of the American Medical Association concluded that NO measurable benefit in memory or related cognitive function was found with use of ginkgo25 However, in a clinical trial published in Psychopharmacology in 2005, evidence supported ‘the potential efficacy of Ginkgo …in enhancing certain neuropsychological memory processes of cognitively intact older adults >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 TWO OPPOSITE STUDIES. LIMITATIONS

42 Reviewing the Safety and Efficacy of Dietary Supplements
In comparing several of the clinical trials that investigated the efficacy of garlic in treating cardiovascular outcomes, most concluded that garlic may have small, positive, short-term effects on lipids20 The study could NOT conclude the effects of taking garlic supplements for beyond 3 months Using ANY of the garlic supplements for less than 3-5 years did NOT show improvements in cancer patients Multiple adverse effects including bad breath, dermatitis, bleeding, and abdominal disturbances led to several non-compliances by patients enrolled in the studies 20 SMALL IMPROVEMENT FOR CARDIOVASCULAR OUTCOMES LIPIDS BP NO IMPROVEMENT FOR CANCER ADVERSE EFFECTS CAUSED SEVERAL PATIENTS TO WITHDRAW FROM THE STUDY

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

44 Reviewing the Safety and Efficacy of Dietary Supplements
Across most studies, high concentrations of soy intake reported “suggestion” in decreased LDL and triglycerides Over all the studies analyzed, none reported a change in blood pressure with soy use The results are spread across the board for soy’s effect to decrease the frequency and intensity of hot flashes 20 SUGGESTED LDL INCREASE MEANING SLIGHTLY STATISTICALLY SIGNIFICANT RESULTS, BUT ONLY IN CERTAIN ENDPOINTS NO CHANGE IN BP MIXED RESULTS

45 General Studies’ Limitations for Most Herbal Supplements
Number of participants Different forms of herbal supplements (roots, concentrate, elixir, leafy parts, etc) used sometimes in the same study No certification that all supplements used meet GMP, or are comparative to begin with Different species of supplements (ie: Ginseng has 3 sold in U.S.) Short-term studies done (not enough data) Rarely double-blind, randomized, head-to-head Haven’t really told you anything but that there are mixed results with no conclusive data-well that’s how I feel And that’s basically how it is Lack of funding no need to spend money on it

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

47 Pharmaceutical Interactions with Dietary Supplements
St. 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 SEE HANDOUT

48 References Possibly the worse reference section EVER!
1.) Food: Overview of Dietary Supplements 2.) suppllementsconsumers06.pdf Food and Nutrituion Information Center, National Agricultural Library 3.) Chinese Herbal Medicine 4.) History of Chinese Herbology 5.) History of Herbal Medicine. 6.) History of Science, Medicine, and Technology. 7.) Definition of Homeopathy 8.) 9.) Liberman,S, Brunig, N (1990). The Real Vitamin and Mineral Book. NY: Avery Group, 3. 10.) 11.) Dietary Mineral 12.) 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 14.) Chevallier, Andrew, Herbal Remedies:Visual Reference Guide.1st Ed. Metro Books, New York, NY 15.) Saw Palmetto. 16.) Soy 17.) Hartmon Group Phase III National Study 18.) › 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.) 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: 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: 25.) Elsabaugh, S, Hartley, D, Differential cognitive effects of Ginkgo biloba after acute and chronic treatment in healthy young volunteers. Psychopharmacology : Possibly the worse reference section EVER!

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