Herbal Products
اسلاید 1: www.tabaye.ir
اسلاید 2: Herbal Products
اسلاید 3: Medicinal Chemistry 525 (2 credits) Alternative and Complementary Medicines Thursdays 1:30-3:20 Room T747http://courses.washington.edu/medch420/Gary Elmer, H172j Health Sciences, 543-2055, elmer@u.washington.edu
اسلاید 4: Lecture TopicsSept 25Introduction Gary Elmer Oct 2Herbal Products 1 (M-Z)Gary ElmerTour of the Medicinal Herb Garden (A-L) Doug EwingOct 9Herbal Products 1 (A-L)Gary Elmer Tour of the Medicinal Herb Garden (M-Z) Doug EwingOct 16Herbal Products 2 Gary ElmerOct 23Herbal Products 3Gary ElmerOct 30Herbal Products 4Gary Elmer Other Dietary SupplementsNov 6Herbal-Drug InteractionsGary ElmerNov 13ProbioticsGary Elmer Homeopathic ProductsGary ElmerNov 20Toxic HerbalsSid NelsonNov 27Thanksgiving Holiday Dec 4Effective Herbal Counseling Darleen Wilson
اسلاید 5: Requirements for CreditResearch paperShort (4-6 double spaced pages, not including references) and up-to-dateWrite on an herbal or other dietary supplement NOT covered in class. We will cover the “top 20” herbals (see slides for list), probiotics, fish oil, glucosamine, chondroitin, melatonin, CoQ10,and homeopathic products.If taking Pharm 500, the guidelines specified for the research paper for this course and a 3.0 grade or better on the paper will be accepted. See http://courses.washington.edu/pharm500.If not taking 500, write the paper following guidelines for the paper for Pharm 500 (see above) except you do not need to indicate the database search source location of your cited references. You will need to read and cite results from the PRIMARY literature for credit for the paper. SOME secondary citations are OK to use. Due date will be Nov 21.
اسلاید 6: Weekly Quiz Every week there will be a brief (~5 questions) quiz. The time allowed will be 10-15 min.quiz will be based on lecture material presented in the previous class.You can drop one quiz with the lowest score.There will be no “make-up” quiz if you are absent.At least a 70% on all possible quiz points and a “pass” on the research paper will be needed to get credit for this credit/no credit course.
اسلاید 7: General References on Herbal Products (comprehensive monographs)The Review of Natural Products. Facts and Comparisons Publishing Group, St. Louis MO. 2004. Available at the UW Bookstore. Also available online through the UW at (http://healthlinks.washington.edu/)Natural Medicines Comprehensive Database Excellent database, the “gold standard”, available in print version ($92/yr) or online ($92/yr). Online updated “daily”. Available online at UW at (http://healthlinks.washington.edu/)Natural Standard. Excellent database with an expert editorial board. $99/year. Online available at UW at http://healthlinks.washington.edu/
اسلاید 8: BooksDesk Reference to Nature’s Medicines Stephen Foster and Rebecca L. Johnson. National Geographic 2006 $40Essential Guide to Herbal Safety Simon Mills and Kerry Bone.. 2005 Elsevier – excellent. $65The ABC Clinical Guide to Herbs By M. Blumenthal, et al. 2003. ABC Press. $70.
اسلاید 9: Books (continued)Rational Phytotherapy: A Reference Guide for Physicians and Pharmacists. Schulz, Hansel, Blumenthal and Tyler. Springer Verlag. 2005. Emphasis on therapeutics with herbals. Excellent. $60Natural Therapeutics Pocket Guide, 2nd edition. Krinsky, DL et al. APhA. 2003. Very well done. Has disease conditions as well as monographic information. $32
اسلاید 10: Periodicals and Newsletters on Herbal Products“HerbalGram” published by the American Botanical Council and the Herb Research Foundation; PO Box 201660, Austin TX 78720www.herbalgram.org. A must read.
اسلاید 11: Useful Internet Web sites Consumerlab.com. Consumerlab is evaluating dietary supplements for quality, a worthy goal. To see the complete evaluations, there is a subscription fee of $29/yr. The subscription will also provide you access to The Natural Products Encyclopedia, an excellent database of monographs on herbals and other dietary supplements. www.consumerlab.com NIH Nat Center for Complementary and Alternative Medicine (NCCAM). Programs and information of this important NIH program. http://nccam.nih.gov UW Healthlinks-Alternative Medicine. Links to many useful sites. http://healthlinks.washington.edu/clinical/alt_med.html University of Washington Medicinal Herb Garden. Home page includes access to photos of selected medicinal plants and a map of the garden. http://www.nnlm.nlm.nih.gov/pnr/uwmhg/index.html Association of Natural Medicine Pharmacists web site. Natural medicine information for the health professional. CE programs. http://www.anmp.org/ American Botanical Council home page. Links to many sites of interest. http://www.herbalgram.org
اسلاید 12: Useful Internet Web sites Office of Dietary Supplements, NIH. Mandated by DSHEA, their mission is to promote research and provide objective information on dietary supplements. Link to IBIDS database on scientific literature on dietary supplements and other databases. Use is free to all. . http://ods.od.nih.gov American Herbal Products Association. Trade Association with links to member companies and publications. Also access to HerbMed database providing some references on herbals. Not always up to date, however. Useful general site. http://www.ahpa.org/ Dr. Duke’s databases. Database on plants and their chemical constituents with biological activities. Dr. James Duke is a well known authority on ethnobotany. http://www.ars-grin.gov/duke
اسلاید 13: Free Electronic NewlettersDietary Supplement/Food Label News from the FDA http://www.cfsan.fda.gov/~dms/infonet.htmlNutrition News Focus http://www.NutritionNewsFocus.comArbor Clinical Nutrition Updates (Dr. Tony Heilman) http://arborcom.com
اسلاید 14: 1000 year old “Patterson Bundle”, a Native American bundle of medicinal herbs. HerbalGram 2002;55:35-41
اسلاید 15: Herbal Productssales of about $14 billion $ in USA for dietary supplementssales of about 5 billion $ in USA for botanicalsMass market herbal sales increased dramatically in the 1990s but have dropped in recent years. Total sales from all channels have generally shown a slow increase.In 1990 5.8% used “alternative medicines”In 2002, 25.2% used “alternative medicines”most do not tell their “traditional” provider what they are taking and many take alternative and complementary products together with alopathic drugs ref. Eisenberg et al. JAMA 1998;280:1569-1575; HerbalGram 2006;71:64.
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اسلاید 17: Dietary Supplement Education Alliance Survey (Harris Interactive)July 2001N=102259% take dietary supplements on a regular basis46% take multivitamins23% take herbal and specialty products (15% botanicals, 8% non botanical supplements)95% indicate satisfaction; 75% very satisfied or extremely satisfied25% wrong about expecting immediate results from herbalsOnly 49% consult with health care providers about taking supplementsMost believe they have sufficient information on using supplements
اسلاید 18: Elmer et al. Ann Pharmacother. 2007;40:1617-24.
اسلاید 19: Elmer et al. Ann Pharmacother (in press for Oct 07)
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اسلاید 22: Most Common Uses for Herbal Products and Alternative MedicinesMusculoskeletal Complaintsarthritis (glucosamine/chondroitin)CNSfatigue (ginseng and others)insomnia (valerian)anxiety/depression (kava, chamomile, skullcap, St. John’s Wort)Colds/flu/immune (echinacea, goldenseal, atragalus, pau d’arco)Men (saw palmetto, pygeum)Women (black cohosh, soy, evening primrose)Circulation (ginkgo, garlic)
اسلاید 23: Types of Herbal and Alternative Medicines“Crude” dried herbs *“European” Phytopharmaceuticalsextractsstandardized extracts *Traditional Chinese Medicines*Ayurvedic MedicinesHomeopathic Medicines*Functional Foods/Nutraceuticals *Probiotics **“other” dietary supplements (e.g. melatonin)
اسلاید 24: Top 20 Selling Herbals for 2007- Mass Market HerbalGram 2008;78:61-62ProductM $ % change rank in 20061. soy25-1712. cranberry 24+2433. garlic 20-1324. ginkgo 18+125 5. saw palmetto17 - 646. echinacea 16- 967. black cohosh 09-0.588. milk thistle09-0.479. ginseng 08+ 31010. St. John’s wort08- 6911. Green tea 05- 71112. Evening primrose oil04- 91213. valerian03- 91314. Horny goat weed02- 214Red indicates risk for drug interactions
اسلاید 25: Top 20 Selling Herbals for 2007- Mass Market HerbalGram 2008;78:61-62ProductM $ % change rank in 200415. bilberry02- 91516. grape seed02- 91617. Yohimbe01-151718. red clover01-1318 19. Horse chestnut seed01-211920. ginger0.7-2020Total (all herbs)268+7.6Red indicates potential risk for drug interactionsNote: total herbal sales are estimated at $4.7 billionThe above figures include only sales from food stores, drug stores, and mass market retailers but with Wal-Mart figures not included. It does not include warehouse buying clubs (Costco), convenience stores, natural foods stores, multilevel marketers, health professional sales, mail order or internet sales.
اسلاید 26: Total Estimated Herb Sales for All Channels YearM $% change Ref: HerbalGram 2008;78:61-62
اسلاید 27: Herb Sales by Channel 2007Ref: HerbalGram 2008;78:61-62
اسلاید 28: Herb Sales by Category 2007 M$% changeRef: HerbalGram 2008;78:61-62
اسلاید 29: Kaufman et al. JAMA 2002;287:337-344
اسلاید 30: Useful Herbal Products (some evidence in support of uses)Echinacea immune stimulantSaw Palmetto BPHGinkgo circulationMilk Thistle liverGinger nauseaChamomile indigestionFever Few migraineSt. John’s Wortmild/mod depressionHawthornheart/circulationSoymenopause symptomsKava anxiolyticBlack cohosh menopause symptomsGreen tea stimulant (antioxidant)CranberryUTI prevention
اسلاید 31: Possibly Useful Herbal Products (less evidence or conflicting evidence)pycnogenol vision, antioxidant usesginseng adaptogen, tonicgrape seedvision, antioxidant usesEvening primrose dysmenorrhea, otherBilberryvision, antioxidant usesGarlichyperlipidemias, hypertension, heartyohimbeerectile dysfunctionValeriansleep
اسلاید 32: Herbal Products Deemed Unsafe Aconite (Bushi)Aristolochia sp.BelladonnaBlue CohoshBorage (internal)BroomCalamusChaparralColtsfootComfreyEphedra (Ma Huang)GermanderKombucha TeaMa Huang (ephedra)LobeliaPennyroyal OilPoke RootSassafrasScullcapTansy RagwortWormwood
اسلاید 33: Complementary and Alternative Medicines “CAM”Fall under “Dietary Supplement” regulatory status (except homeopathic products)Dietary Supplements vitamins, minerals, hormones whole plant material, extracts of plants, amino acids miscellaneous “natural” products (e.g. glucosamine sulfate, melatonin)
اسلاید 34: Regulatory IssuesFederal Food and Cosmetic Act of 1938 - safeKefauver-Harris Act of 1962 - efficacyVitamin and Mineral Ammendments of 1972 - high dose OKNutrition Labeling and Education Act of 1990 - food labelsDietary Health and Education Act of 1994 (DSHEA) -
اسلاید 35: Dietary Health and Education Act of 1994 (DSHEA) not considered foods, food supplements or drugs no “therapeutic claims” unless approved by FDA no “health claims” unless approved by FDA limited “structure/function” claims allowed if there is some evidence to support themexamples of structure/function claims FDA must show product is unsafeLabel must have a disclaimer “This statement has not been evaluated by the FDA”“third party” literature regs.Advertising regulated by FTC; all else by FDA
اسلاید 36: Dietary Health and Education Act of 1994 (DSHEA) dietary supplements are not considered foods, food supplements or drugs no “therapeutic claims” unless approved by FDA no “health claims” unless approved by FDA limited “structure/function” claims allowed if there is some evidence to support themexamples of structure/function claims FDA must show product is unsafeLabel must have a disclaimer “This statement has not been evaluated by the FDA”“third party” literature regs.Advertising regulated by FTC; all else by FDA
اسلاید 37: Dietary Health and Education Act of 1994 (DSHEA) dietary supplements are not considered foods, food supplements or drugs no “therapeutic claims” unless approved by FDA no “health claims” unless approved by FDA limited “structure/function” claims allowed if there is some evidence to support themexamples of structure/function claims FDA must show product is unsafeLabel must have a disclaimer “This statement has not been evaluated by the FDA”“third party” literature regs.Advertising regulated by FTC; all else by FDA
اسلاید 38: Dietary Health and Education Act of 1994 (DSHEA) dietary supplements are not considered foods, food supplements or drugs no “therapeutic claims” unless approved by FDA no “health claims” unless approved by FDA limited “structure/function” claims allowed if there is some evidence to support themexamples of structure/function claims FDA must show product is unsafeLabel must have a disclaimer “This statement has not been evaluated by the FDA”“third party” literature regs.Advertising regulated by FTC; all else by FDA
اسلاید 39: Dietary Health and Education Act of 1994 (DSHEA) dietary supplements are not considered foods, food supplements or drugs no “therapeutic claims” unless approved by FDA no “health claims” unless approved by FDA limited “structure/function” claims allowed if there is some evidence to support themexamples of structure/function claims FDA must show product is unsafeLabel must have a disclaimer “This statement has not been evaluated by the FDA”“third party” literature regs.Advertising regulated by FTC; all else by FDA
اسلاید 40: New DSHEA Labeling Requirements implied claims banned also health maintenance claims OK definition of “disease” narrowed so that “life stage” symptoms (acne, hot flashes, wrinkles etc) are not considered diseases “science-based” regulatory program for dietary supplements will be in place at the FDA by 2010 just passed in 2007, the Adverse Event Requirement bill (AER Bill). Now manditory reporting to FDA of serious adverse events for supplements and OTC products
اسلاید 41: Problems with Existing Regulationsrequirements to make therapeutic claims are unrealistic herbals are not patentableno consideration for long safe useless consideration for non USA studiesdietary supplement label is inappropriatemeaningful package insert lackinginnovator companies have no protectionexample: Saccharomyces boulardii* limited “official” monographs for herbals in USA (USP)
اسلاید 42: Problems with Existing RegulationsStill huge problems in quality controlUnethical and criminal elements in industryexample: adulteration
اسلاید 43: Hypericin and Hyperforin in Eight Brands of St. John’s Wort De Los Reyes and Koda, Am J Health-syst Pharm 59:545-547.2002Product-hypericin (%)hyperforin (%)Hyperifin0.291.89PNC0.120.20Brite-Life0.221.16ShopKo0.260.05Shurfine0.170.29YourLife0.280.19Nature’s Balance0.030.01Natrol0.250.48
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اسلاید 45: Copyright restrictions may apply.Saper, R. B. et al. JAMA 2004;292:2868-2873. (Ayervedic Herbal Medicine Products)Estimated Daily Lead, Mercury, and Arsenic Ingestion for Heavy Metal-Containing HMPs Recommended for Adults and Children
اسلاید 46: Internet Marketing of Herbal Products StudyMorris and Avorn JAMA 2003;290:1505-1509Methods: Searched using 5 search engines the first page hits for 8 popular herbalsFindings: 273 of 338 (81%) made 1 or more health claimonly 12% provided references to back claimonly 39% of kava sites mentioned hepatotoxicity
اسلاید 47: Examples of Internet Health Claims (JAMA 2003;290:1505-1509)Ginkgo Biloba“Its effects in improving circulation also contribute to its use for impotency and peripheral vascular insufficiency …. Ginkgo treats depression, headaches, memory loss and ringing in the ears (tinnitus). It is also recommended for Alzheimers, asthma, eczema, heart and kidney disorders.”St Johns Wort “St Johns wort is effective in the treatment of mild to moderate depression … recent studies have shown that it could have a potent anti-viral effect against enveloped viruses.”Echinacea “Because it has natural antibiotic actions, Echinacea is considered an excellent herb for infections of all kinds. In addition, it works to boost lymphatic cleansing of the blood, enhances the immune system and has cortisone like properties which contribute to its anti-inflammatory action. It is recommended for stubborn viral infections, yeast infections and for arthritic conditions.”Saw Palmetto “The lipophilic extract of the saw palmetto (ser repens) berries is the most widely used herbal preventive and therapeutic agent for benign prostatic hyperplasia (BPH).”
اسلاید 48: Solutions: Presidents Commission on Dietary Supplement Labels recommendations and suggestions to FDA (‘97) * set up system to review botanicals for OTC statusurge to study regulatory systems in other countriescall for surveillance of adverse effectsset up system for “traditional use claims” or the like for products that may not meet OTC data requirementscall for use of outside experts in product reviews
اسلاید 49: FDA WarningsFDA posts warnings of contaminated or harmful supplements tiratricol or TRIAC (triiodothyroacetic acid)aristolochic acid (renal toxicity)ephedra alkaloidsComfreyKava and hepatotoxicityFDA recall of PC-SPES (contamination with warfarin and maybe DES)To get email postings see www.fda.gov
اسلاید 50: SolutionsNew compendial monographs on herbals underwayUSP monographs (USP24-NF14) and label logoMicromedex and other objective “use monographs”WHO Monographs on Selected Medicinal PlantsGMPs for Dietary Supplements are now in effect
اسلاید 51: USP-NFUnited States Pharmacopoeia/National FormularyNon profit corporation that sets standards for drugs and biologicsIs in the process of creating standards for dietary supplementsLimits on heavy metals, pesticidesLimits on microbial contaminationQuality control specs for marker compounds
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اسلاید 53: USP Dietary Supplement Verification ProgramManufacturer must agree to meet standards set by USP and their monographsMust agree to inspections and random analyses of productsUSP analyzes the product and inspects the manufacturing facilityPharmavite is the first manufacturer to seek USP verification (Nature Made, Nature’s Resource) for their line of herbals and dietary supplements. The “USP” will appear on the labels.www.usp.org
اسلاید 54: Consumerlab.com A private company testing and certifying dietary supplementsMembership is $24/yr and includes access to The Natural Pharmacist database Manufacturers whose products “pass” are listed on consumerlab’s website (www.consumerlab.com)Manufacturers who do not pass are also listedA manufacturer whose product “passes” can (for a fee) include the consumerlab seal on their label
اسلاید 55: better books, journals, and literature now availablebetter education on subject in pharmacy schools and other health professions trainingmore frequent and better CE programsmore research activity in USANIH funded studiespressure is on for FDA to “adapt” to CAM
اسلاید 56: Product Selection IssuesSelect “name brands” recognized for qualityselect “standardized” products that give potency per unit of the product of an important marker compoundselect products used in the positive clinical trialsselect “standardized extracts” where appropriateselect products that have batch numbers, expiry dates, and have the new label elementsavoid complex herbal mixtures
اسلاید 57: Some “Name Brand” BotanicalsWarner Lambert Quanterra Mental® (ginkgo)Quanterra Prostate® (saw palmetto)Whitehall-Robins HealthcareCentrum® botanicals linePharmaton (Boehringer Ingelheim)Ginsana ® (ginseng)Ginkoba ® (ginkgo)Venastat ® (horse chestnut)Movana ® (St. John’s wort)SK-Beecham Alluna ® (valerian and hops)PharmaviteNature Made ®Nature’s Resource ®Phyto-PhamicaNature’s Way
اسلاید 58: What can we do?Dialog with NDs and other prescribersask patients about herbals they may be takingoffer the best productspress for regulatory reformstay informed
اسلاید 59: Choosing Herbals -Advice for patientsBe sure you have an accurate diagnosis.Select a “name brand”, quality product; If the advertising says “cure” “breakthrough” “detoxify” etc – forget it!Tell your doctor and pharmacist what you are taking to avoid interactions with Rx or other OTC medications.Use one supplement (single ingredient) at a time.Keep the container with labels in case of future adverse reactions.
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