Herbal and Natural Medicines
اسلاید 1: www.tabaye.ir
اسلاید 2: Herbal and Natural Medicines: What You Should KnowMandy Leonard, R.Ph., Pharm.D., BCPSDrug Information SpecialistDepartment of PharmacyThe Cleveland Clinic FoundationApril 2004
اسلاید 3: ObjectivesReview the reasons why people are using herbal/ alternative medicines.Describe risks from the consumption of herbal/ alternative medicines.Describe briefly changes in law regarding dietary supplements.Discuss commonly used dietary supplements, including herbal medicines.Review reputable sources of information regarding herbal/alternative medicines.
اسلاید 4: IntroductionDefinitionsFood and Drug Administration (FDA)World Health Organization (WHO)HomeopathyOver 20,000 herbal and other natural products available in the United States.EconomicsWidespread use
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اسلاید 6: Top-Selling Herbs in Mainstream Market in U.S. 2001 Gingko ($46)Echinacea ($40)Garlic ($39)Ginseng($31)Soy($28)Saw Palmetto ($25)St. John’s wort($24)Valerian($12)Cranberry ($11)Black cohosh ($10)Kava kava ($ 9)Milk thistle ($ 7)Evening primrose ($ 6)Grape seed ($ 4)Bilberry ($ 4)Yohimbe ($ 2)($ in millions; Herbalgram 2002;55:60.)
اسلاید 7: Top-Selling Herbs in Mainstream Market in U.S. 2002 ( 13.9%)Garlic ($34)Ginkgo ($32)Echinacea ($32)Soy ($28)Saw Palmetto ($23)Ginseng ($21)St. John’s wort($15)Black cohosh($12)Cranberry ($11)Valerian ($ 8)Milk thistle ($ 7)Evening primrose ($ 7)Kava kava ($ 6)Bilberry ($ 3)Grape seed ($ 3)Yohimbe ($ 2)($ in millions; Herbalgram 2003;58:71.)
اسلاید 8: Herbal versus Conventional MedicationDisappointment with current conventional therapiesFear of safety and long-term effectsLack of effective treatments/cures
اسلاید 9: Herbal versus Conventional MedicationBelief that herbal products are safe because derived from naturePeer influenceDesire to have control of one’s own healthFalse claims from manufacturers
اسلاید 10: Safety ConsiderationsForty to 70% of patients do not inform physicians about use of alternative therapiesAdverse reactionsOne or more chemical component of the plantInappropriate or incorrect manufacturing processFDA does not require reporting of adverse reactions from alternative therapies (MedWatch and SN/AEMS)Examples: L-tryptophan, ephedra (ma haung)
اسلاید 11: Safety ConsiderationsStandardizationNomenclature and chemical constituents varyMixtures are NOT standardizedLack of Good Manufacturing Practices (GMPs)Examples: ginseng, ephedraDifficult to identify ingredientsLack of active ingredientContamination
اسلاید 12: Unsafe Herbal TherapiesLicoriceGlycyrrhiza glabraPeptic ulcersHigh doses (pseudoaldosteronism)Use no longer than 6 weeksContraindicationsDrug interactionsDigoxin, furosemideEphedra (ma haung)Ephedra sinicaAnorexiant, decongestant1% ephedrinePalpitations, MIs, deathMaximum recommended dose: 100 mg/24 hoursContraindicationsDrug interactionsTheophylline, digoxin, caffeine
اسلاید 13: EphedraProducts containing ephedra account for 64% of all adverse reactions to herbs in the USLess than 1% of herbal product salesFDA announced ban on 12/30/2003After Mid-March 2004, illegal to manufacture or sell dietary supplements that contain ephedrine and related alkaloidsDoes not include teas
اسلاید 14: Kava (Piper methysticum)Anxiety, stress, sleep disorders (kavapyrones)May be effective for short-term treatment of anxiety (similar to Valium® and Ativan®)Hepatoxicity: liver failure and liver transplantationFDA warning; Canada and some European countries- market removal Kava dermopathyUse no > 4 weeks; no alcohol/sedating medications; caution when driving or operating heavy machinery
اسلاید 15: FDA Proposed Labeling and Manufacturing Standards Designing/construction of physical plantsEstablishing quality control proceduresTesting manufactured dietary ingredients and supplementsFive out of 18 soy or red clover-containing productsOnly 50 to 80% of declared isoflavonesNiacinAlmost 10 times more niacinFolic acidOnly 35% of what was stated on label
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اسلاید 18: United States Pharmacopeia (USP) Dietary Supplement Verification Program (DSVP)
اسلاید 19: ConsumerLab.com
اسلاید 20: NSF International
اسلاید 21: Potential Warfarin-Herb InteractionsGingerAdditive effectAvoid supplements, but small amount in diet should not be problematicGarlicAdditive effectAvoid supplements, but small amount in diet should not be problematicFeverfewAdditive effectMonitor or avoidSt. John’s WortIncreased metabolism & decreased effect of warfarinMonitor or avoid
اسلاید 22: Consumer SurveyHerbal use, products, and willingness to inform health care practitioners 794/1300 surveys returned42% (n=330): Herbal product useCommon herbal products (aloe, garlic, ginseng, echinacea, and St. John’s wort)Women (majority)Higher education (75%)Herbal users = more prescription medicationsHerbal users = negative perception of prescription medicationsPharmacother 2000;20(1):83-7
اسلاید 23: Laws and Regulations1994- Dietary Supplement Health and Education Act (DSHEA)Definition (dietary supplements not categorized as food additives) Premarketing approvalBurden of proof that product is adulterated or unsafe rests on the FDA (e.g., ephedra)“Third-party Literature” Balanced view of available dataStructure/Function Statements
اسلاید 24: Structure/Function Statements“This product is not intended to diagnose, treat, cure or prevent a disease.”Change in definition of diseaseExamples: Absentmindedness and hair loss associated with aging Hot flashesPremenstrual syndromeHerbalgram 2000;48:32-8
اسلاید 25: Ginkgo (Ginkgo biloba)Leaves of the ginkgo biloba treeDistinct chemical componentsWork synergisticallyImproves blood flow (brain and heart)Protects against oxidative damage from free radicals (antioxidant)Inhibits effects of platelet activating factor (PAF)
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اسلاید 27: Ginkgo: EfficacyData demonstrate ginkgo leaf extract can stabilize or improve some measures of cognitive function and social functioning in patients with multiple types of dementia.No direct comparisons to conventional medications for dementia.Modestly improve visual memory and speed of cognitive processing in non-demented patients with age-related memory impairment.
اسلاید 28: Ginkgo: Adverse Effects & Drug InteractionsAdverse Effects:Hypersensitivity reactions, gastrointestinal disturbancesSpontaneous bleeding (few case reports)Drug Interactions:Anticoagulants (Coumadin®)Antiplatelets (aspirin, Plavix®, Ticlid®)Insulin
اسلاید 29: Ginkgo: Dose and AdministrationStandardized: 24% flavone glycosides and 6% terpenoids (leaf extract)Dementia:120 to 240 mg ginkgo leaf extract administered orally in two or three divided doses
اسلاید 30: Ginkgo: SummaryMild-to-moderate vasoactive agentData promising in Alzheimer’s DiseaseUsed extensively in GermanyNo comparison to standard of careWell-tolerated (weeks to 1 year)Potential drug-herb interactions with anticoagulants, antiplatelets, and insulin
اسلاید 31: GinsengEach type of ginseng is uniqueAsian or Oriental ginseng (Panax ginseng)Siberian ginseng (Eleutherococcus senticosus)American ginseng (Panax quinquefolius)Active ingredients: Root (panaxosides)Ginsenoside Rb-1Central nervous system depressantLowers blood pressureGinsenoside Rg-1Central nervous system stimulant Raises blood pressure
اسلاید 32: Panax Ginseng: EfficacyData demonstrate possibly effective:Improving abstract thinking, selective memory, and mental arithmetic skills (more effective in conjunction with ginkgo biloba leaf extract)Improving resistance to stressControlling blood glucose levels in people with non-insulin dependent diabetes (Type 2)Possibly ineffective for enhancing athletic performance in healthy, young adults
اسلاید 33: Panax Ginseng: Adverse Effects & Drug InteractionsAdverse Effects:Nervousness, insomnia, excitation, palpitations, affects blood pressure, lowers blood glucose, alters immune functiomGinseng abuse syndrome? (long-term use)Drug Interactions:Antidiabetic agentsWarfarin (Coumadin®)
اسلاید 34: St. John’s Wort (Hypericum perforatum)Common forms: capsules, tablets, tincturesSource:Flowering topsNaphthodianthrones (one of many potential active components)Hypericin - Inhibits MAOA > MAOBHyperforin: Modulates effects of serotoninSerotonin inhibition at high concentrationsNorepinephrine inhibitionCatechol-O-methyl-transferase (COMT) inhibition
اسلاید 35: St. John’s Wort: EfficacyFor the treatment of mild-to-moderate depression, data demonstrate that St. John’s wort is:Superior to placeboAs effective as low-dose tricyclic antidepressants (TCAs; Elavil® and Pamelor®),Possibly as effective as selective serotonin reuptake inhibitors (SSRIs; Prozac®, Zoloft®, Celexa®, and Lexapro®)
اسلاید 36: St. John’s Wort: Adverse Effects & Drug InteractionsAdverse Effects:Sun-exposure: Photosensitivity/Phototoxicity (hypericin component; watch if taking antibiotics)Insomnia, vivid dreams, headache, dizzinessDrug Interactions:MAOIs, selective serotonin reuptake inhibitors (SSRIs), Imitrex®, tramadol (Ultram®): Increased serotoninCyclosporine (Neoral®): Decreased levelsWarfarin (Coumadin®): Decreased INR (lab test)Oral contraceptives or hormone replacement therapy: Breakthrough bleeding
اسلاید 37: St. John’s Wort: Dose and AdministrationStandardized extract0.3% hypericin5% hyperforin Mild-to-moderate depression:300 mgAdministed orally three times a dayDoses of 1200 mg/day have also been used
اسلاید 38: Echinacea (Echinacea angustifolia, pallida, purpurea)Common Forms: tablet, juice, teaPurple coneflowerSource: Applicable parts are the roots and above ground parts.Pharmacologic action [constituent(s)?] Indirect antiviral activityImmune system stimulatory effectsCytokines, monocytes, natural killer cells
اسلاید 39: Echinacea: EfficacyEchinacea is possibly effective for Reducing symptoms associated with influenza-like upper respiratory infections such as the common cold and flu. Evidence suggests reduction in duration and severity of symptoms if started when symptoms are first noticed and used for 7 to 10 days.Possibly ineffective for preventing the common cold or influenza when taken prophylactically.
اسلاید 40: Echinacea: Adverse Effects & Drug InteractionsAdverse Effects:Allergic reactionsragweed, daisies, marigolds Fever, nausea, vomiting, unpleasant taste, and dizzinessAtopy; more likely to experience allergic reactionDrug Interactions:Immunosuppressants: Interfere with therapyMedications used for transplant patients, cancer patients, and patients with multiple sclerosis
اسلاید 41: Echinacea: Dose and AdministrationWide variety of doses depending on formulationDifficulty in standardization (echinacoside, alkamide content)Purpurea herb juice: 6 to 9 mL for 8 weeksPurpurea crude extract: 2 tablets administered orally three times a dayTea: 5 to 6 cups on day 1 of symptoms, then 1 cup/day for 5 days
اسلاید 42: Echinacea: SummaryFormulation/species that offer most benefit is unclear.E. purpurea pressed juice or E. pallida root extracts at first sign of coldIf taken greater than 8 weeksReduced immunostimulatory effects? One week drug holiday (not substantiated)Well-tolerated (up to 12 weeks)
اسلاید 43: Dietary Supplements: Immune-Stimulating PropertiesAlfalfaPanax ginsengAstragalusCat’s clawCoenzyme Q10DHEAEchinaceaGarlicGoldensealGrape seed extractMelatoninSiberian ginseng
اسلاید 44: Dietary Supplements- Potential Interaction with SteroidsAloeAsian (Panax) ginsengBayberryLicorice
اسلاید 45: Herbal Use in Patients Undergoing SurgeryApproimately 26% of patients scheduled for surgery use herbal productsCardiovascular instabilityProlongation of anesthesia/sedationBleedingElectrolyte disturbancesImmunosuppressionAnaesthesia 2002;57:889-99
اسلاید 46: Discontinuation of Use Before SurgeryEchinaceaNo dataImmunosuppressionEphedra (ma huang)24 hoursCardiac cautionsGarlic7 daysBleedingGingko36 hoursBleedingGinseng7 daysHypoglycemia; BleedingKava24 hoursSedationSt. John’s Wort5 daysDrug-herb interactionsValerianNo dataSedationJAMA 2001;286(2):213
اسلاید 47: Herbal ReferencesNatural Medicines Comprehensive Database$92/year (book or web version)$132/year (book and web version)The Review of Natural Products$160/year (bimonthly updates)The Professional’s Handbook of Complimentary and Alternative Medicine$40/edition
اسلاید 48: Natural Medicines Comprehensive Database
اسلاید 49: The Review of Natural Products
اسلاید 50: Herbal Medicine: Expanded Commission E Monographs
اسلاید 51: PDR for Herbal Medicines
اسلاید 52: American Botanical Council (ABC)
اسلاید 53: Herbal ReferencesThe United States Pharmacopeia and The National Formulary (USP-NF)$526/edition21 botanical monographs (since 1995)Internet ReferenceThe Natural Pharmacist (www.tnp.com)ConditionsDrug InteractionsReview of published articlesSearch
اسلاید 54: Herbal ReferencesThe Herbal Internet Companion Herbs and Herbal Medicine Online$20 (ISBN 0-7890-1052-6)
اسلاید 55: IBIDS DatabaseInternational Bibliographic Information on Dietary SupplementsOffice of Dietary Supplements (ODS) at the NIHPublished, international, scientific literatureVitamins, minerals, and botanicalsOver 676,000 unique scientific citations abstractsThree databasesFull IBIDS databasePeer-Reviewed Citations Only databaseIBIDS Consumer database
اسلاید 56: CARDS DatabaseComputer Access to Research on Dietary SupplementsOffice of Dietary Supplements (ODS) at the NIHSpecific mandates from the DSHEAFederally funded research projects pertaining to dietary supplementsFree of chargewww.ods.od.nih.gov
اسلاید 57: SummaryTell physician, nurse, and pharmacist about herbal therapy use (documentation)“Natural” does not mean safeHerbal-pharmaceutical interactions do occurLack of standardization (variability in herbal content and efficacy among manufacturers)Lack of quality control and regulation (contamination and misidentification)
اسلاید 58: ConclusionsBecause of lack of efficacy and toxicity information, patients and clinicians should be aware that advice about herbal therapies is not absolute and is a matter of judgment. Base advice on available knowledge that is congruent with your needs and the clinician’s best judgmentMajority of recommendations are NOT evidence-based
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