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Herbal Supplements: The Hype vs. the Evidence Arthur Dominguez, Pharm.D. Kaiser Permanente Baldwin Park Medical Center Herbal Remedies • Growing by 18% a Year • $16 Billion in Sales Annually • Classified as Dietary Supplements • Sold in Health Food Stores, Markets, Pharmacies Legislation • 1993 - FDA Advanced Notice of Proposed Rulemaking • Dietary Supplement and Health Education Act of 1994 Dietary Supplement and Health Education Act of 1994 (DSHEA) • No Testing for Efficacy • No Manufacturing Standards • Claims Permitted on Package • Label Statements Not Required to be Proven Dietary Supplement and Health Education Act of 1994 • Label Must State that Claims Not Approved by FDA Concerns • Does the active ingredient actually end up in pill? • What else is in the pill? • Are ingredients in a form the body can use? • Does the dose make sense? • Is it safe? New Regulations Planned • Methods of Determining Potency • Quality Assurance • Packaging • Expiration Dates • Lot Numbers New Regulations Planned • Statement of Identity – “Dietary Supplement” – “Vitamin C Supplement” – “Herbal Supplement” • Herbals Must be Identified by Common or Usual Name and Part of Plant Used “Much of what surrounds herbal medicine in the U.S. is a minefield of hyperbole and hoax” Varro E. Taylor Purdue University DHEA Dehydroepiandrosterone • Hormone Excreted by the Adrenal Gland • Only Available as a Compounded Prescription Due to an FDA Loophole • “Precursor” Made from Mexican Yams Available in Health Food Stores DHEA • DHEA “is cheap, convenient and makes you feel like a kid again” • NEJM 1986 Study Showed: – 48% Decrease in Heart Disease – 36% Decrease in Death by Any Cause • New Larger Study Shows Less Impressive Results Melatonin Claims • Fights Insomnia • Fights Jet Lag • Slows Aging • Fights Disease • Enhances Sex Life Melatonin Studies Suggest • Can Hasten Sleep • May Strengthen Immune System • May Fight Cancer Melatonin No Data on • Long-Term Effects • Drug Interactions May Worsen Existing Depression Kombucha “Immuno-Stimulatory Mushroom” • Yeast Culture • Concerns About Bacterial or Fungal Contamination Ginkgo Biloba “The Thinking Persons Supplement” Ginkgo Biloba Dilation of Arteries, Capillaries, Veins Inhibits Platelet Aggregation (Ginkgolide B) Antioxidant Ginkgo Biloba Possibly Effective • Alzheimer’s, vascular or mixed dementias • Peripheral arterial occlusive disease • Vascular vestibular disorders Ginkgo Biloba Adverse Reactions • Mild GI upset • Head ache • Dizziness • Constipation • Allergic Skin Reactions • Increased bleeding St. John’s Wort (Hypericium perforatum) Depression More effective than placebo, possibly as effective as low- dose tricyclics and SSRI’s St. John’s Wort (Hypericium perforatum) Side Effects: Gastrointestinal Tiredness Restlessness Allergic Reaction Insomnia Vivid Dreams May induce hypomania in depressed patients St. John’s Wort (Hypericium perforatum) Safety •Short term (8 weeks) •May increase muscle tone of uterus •Colic and lethargy in nursing infants Dose •300 mg TID extract standardized 0.3% hypericin St. John’s Wort (Hypericium perforatum) Drug Interactions •Theoretically, may cause serotonin syndrome with SSRI’s •Avoid within 14 days of MAOI’s •Decrease cyclosporine levels by 60% •Reduce serum digoxin levels •Decrease protease inhibitor levels possibly NNRTI’s SAMe S-Adenosyl Methionine • Uses – Osteoarthritis – Depression – Fibromyalgia – Liver disease – Slowing down aging process • Most studies conducted with intravenous route SAMe • Naturally occurring molecule • May be as effective as NSAIDS for arthritis – possible analgesic and anti-anflammatory effects • Several studies indicate superior to placebo for treatment of depression – may increase serotonin turnover and norepinephrine levels SAMe • Possible interaction with antidepressants • Dose – Depression: 400 to 1600 mg per day po – Arthritis: 200 mg TID po SAMe • Side effects – nausea, diarrhea – anxiety, hypomania in patients bipolar disease with • No cases of toxicity or drug interaction reported Kava Used for anxiety, stress and insomnia. • Likely effective for short-term use • Similar to low dose BZD’s • Absence of cognitive impairment Kava • At least 24 documented cases liver failure at normal doses • As little as two months use • Transplant and death Green Tea • Unfermented form of black tea – retains many chemicals of the fresh leaf • Uses – antioxidant – lower cholesterol – Treat nausea and diarrhea – prevent cancer Green Tea • Side effects – Heart burn, stomach irritation – Contains caffeine • Drug interactions – may decrease effect of warfarin No proof of claims Morinda “Noni Juice” Uses • Diabetes • Migraine • Kidney disorders • Reduce signs of aging Dose • One to ten ounces daily • Imported from French Polynesia Morinda “Noni Juice” Drug interactions • Potassium diuretics Side effects • Discolor urine pink to rust HerbsThat May Be Useful Chamomile Saw Palmetto Feverfew Valerian Ginger Garlic Hawthorn Milk Thistle Echinacea HerbsThat May Be Useful Chamomile HerbsThat May Be Useful Feverfew HerbsThat May Be Useful Ginger HerbsThat May Be Useful Hawthorn HerbsThat May Be Useful Echinacea HerbsThat May Be Useful Saw Palmetto HerbsThat May Be Useful Valerian HerbsThat May Be Useful Garlic HerbsThat May Be Useful Milk Thistle Herbs That Are Harmful Chaparral Comfrey Ephedra (Ma-Huang) Lobelia Yohimbe Herbs That Are Harmful Chaparral Herbs That Are Harmful Comfrey Herbs That Are Harmful Ephedra (Ma-Huang) Herbs That Are Harmful Lobelia Herbs That Are Harmful Yohimbe Phytoestrogens “Plants do not produce chemicals that possess chemical structures which allow them to serve as hormone replacement drugs” James E. Robbers, Ph.D. Tyler’s Herb’s of Choice Phytoestrogens • The ability of a hormone to react with its particular receptor is very specific – “Lock and Key” • The estrogen receptor accommodates a diverse array of chemical structures – No hormonal effect – Estrogen-like effects Mexican Wild Yam (Dioscorea villosa) Marketed as a Supplement to: • Decrease the symptoms of premenstrual syndrome • Help treat urinary/ kidney disorders • Increase libido No Proof of Claims Available Mexican Wild Yam (Dioscorea villosa) • Adverse effects: – Emesis (large amounts) – Recent proof of damage to cells lining the kidney • No known drug interactions • Diosgenin is a starting material for the chemical synthesis of progesterone – Conversion does not occur in the body Black Cohosh (Actaea racemosa) Marketed as a Supplement to: • Decrease the symptoms of menopause, dysmenorrhea • Induce labor • Rheumatism, fever, sore throat • Insect repellent Black Cohosh (Actaea racemosa) Possibly effective: • Decrease the symptoms of menopause – reduce hot flashes – four weeks treatment necessary Black Cohosh (Actaea racemosa) Adverse effects: •GI upset •nausea •vomiting •weight gain No evidence of drug interactions at this time Soy Isoflavonoid genistein • Binds weakly to estrogen receptor (0.4%) • Large doses may result in estrogenlike effects Soy Percentage of Soy in Total Diet Japan 40% USA 3% Soy Nationality African-American Osteoporosis Risk Factor 20% Latin 30% White 50 – 65% Japanese 85% Chromium Picolinate Promoted for Weight Loss • Targets Fat • Spares Muscle • Increases Strength Possible Benefit in Type II Diabetes Chromium Picolinate • Commonly marketed as picolinate • Mechanism of Action – Glucose Tolerance Factor (GTF) contains Cr atom » increases insulin receptor sensitivity » enhances glucose transport into cells – Brain » appetite suppression » down regulation of insulin secretion Chromium Studies • 1997 180 Chinese Type 2 diabetics received 1000 mcg/d, 200 mcg/d or placebo for 4 months • HbA1C improved after 2 months in 1000 mcg group, and in 4 months in 200 mcg group • Fasting glucose lower in high dose group Chromium Studies • Double-blind study of 30 women with pregnancy-related diabetes • Dose of 4 to 8 mcg/kg/day • Improvement in control of blood sugar Chromium • Dose: 200 mcg TID (RDA is 200 mcg) • Likely safe in pregnancy for gestational diabetes, but there are still theoretical concerns of effects on DNA • Likely safe during lactation • Not all studies have been positive, esp. in patients with normal Cr levels Chromium • Adverse reactions – 400 mcg/day: cognitive, motor and perceptive dysfunction – 1.2 to 2.4 mg/day: anemia, thrombocytopenia, hemolysis, hepatic and renal dysfunction Coenzyme Q10 Claims “Can strengthen the heart” “Inhibits the aging process” “Helps diabetics” • Produced by cells in body • Essential cofactor in many metabolic pathways Coenzyme Q10 • Possibly effective in improving blood glucose control • Typical dose: 150 mg qD • Adverse effects – Nausea – Diarrhea, gastritis Coenzyme Q10 Interactions • Serum aminotransferase levels may be elevated at > 300 mg/day • Oral hypoglycemics and HMG-COA reductase inhibitors may reduce coenzyme-Q10 levels • May reduce response to warfarin Ginseng • Stress • Edema • HTN • Impaired Memory • Ulcers • Anemia • Diabetes • Menopause • Atherosclerosis • Depression • Life Extender • Aphrodisiac Ginseng • Scientific name: Panax Ginseng • Principle constituents are ginsenosides (18 subtypes) Ginseng • Nearly all of over 400 studies were poorly controlled, non-standardized • Most reliable studies used Asian ginseng • May possibly have a beneficial effect on reducing fasting blood glucose and HbA1C when used orally Ginseng • Adverse Reactions – Hypertension (Long-term at > 3 Gm/day) – Insomnia – Nervousness – Estrogenic effects – Increased libido – Possible coumarin effects Ginseng Typical dose • Tea: 3 Gm root in 150 ml water. Take TID for 3 to 4 weeks • Oral: 0.6 to 3 Gms dried root qD to TID Ginseng Natural Brand Korean Naturally Korean 648 MG 648 MG Ginsinosides Ginsinosides 23.2 MG 2.3 MG Glucosamine and Chondroitin • Use: Arthritis • Glucosamine - stimulates production of proteoglycans • Chondroitin - component found in glycosaminoglycans Glucosamine and Chondroitin • Available separately or in combination • Suggested dose: –Glucosamine 1500 mg po qD –Chondroitin - 1200 mg po qD • Side effects: –gastrointestinal symptoms How Should We Discuss Herbs with Our Patients? • Ask “Are you taking any herbs or supplements?” • Approach the discussion from the standpoint of safety • Stress the fact that natural doesn’t necessarily mean safe • Educate Guidelines for Patients • Research each supplement before you take it • Always discuss with your providers • List the supplements you are taking with your prescription and OTC drugs • Discuss possible drug-supplement interactions with your pharmacist Guidelines for Patients • Take a minimum of supplements • Never discontinue prescription drugs without discussing with your provider • Stop the supplement if you experience side effects. Discuss with your provider • Do not use if you are pregnant or nursing Guidelines for Patients • Do not give supplements to infants or young children • Store in original container, away from children • Stop all supplements two weeks before surgery or anesthesia Guidelines for Patients • Choose supplements manufactured by nationally known companies • Avoid products containing more than 2 herbs • Look for products with USP, NF or TruLabel symbol • Avoid foreign products unless the quality is known Guidelines for Patients Choose products with • standardized extracts • clearly labeled quantities of active ingredients • expiration dates • lot numbers Independent Quality Regulators National Nutritional Foods Association www.nnfa.org U.S.Pharmacopeia www.usp.org Consumerlab.com www.consumerlab.com Natural Medicines Comprehensive Database www.naturaldatabase.com Compiled by the Editors of Pharmacist’s Letter Prescriber’s Letter