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Title: Herbal and Natural Medicines: What You Should Know


1
Herbal and Natural MedicinesWhat You Should Know
  • Mandy Leonard, R.Ph., Pharm.D., BCPS
  • Drug Information Specialist
  • Department of Pharmacy
  • The Cleveland Clinic Foundation
  • April 2004

2
Objectives
  • Review 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.

3
Introduction
  • Definitions
  • Food and Drug Administration (FDA)
  • World Health Organization (WHO)
  • Homeopathy
  • Over 20,000 herbal and other natural products
    available in the United States.
  • Economics
  • Widespread use

4
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5
Top-Selling Herbs in Mainstream Market in U.S.
2001
  • Gingko (46)
  • Echinacea (40)
  • Garlic (39)
  • Ginseng (31)
  • Soy (28)
  • Saw Palmetto (25)
  • St. Johns 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 20025560.)

6
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. Johns 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 20035871.)

7
Herbal versusConventional Medication
  • Disappointment with current conventional
    therapies
  • Fear of safety and long-term effects
  • Lack of effective treatments/cures

8
Herbal versusConventional Medication
  • Belief that herbal products are safe because
    derived from nature
  • Peer influence
  • Desire to have control of ones own health
  • False claims from manufacturers

9
Safety Considerations
  • Forty to 70 of patients do not inform physicians
    about use of alternative therapies
  • Adverse reactions
  • One or more chemical component of the plant
  • Inappropriate or incorrect manufacturing process
  • FDA does not require reporting of adverse
    reactions from alternative therapies (MedWatch
    and SN/AEMS)
  • Examples L-tryptophan, ephedra (ma haung)

10
Safety Considerations
  • Standardization
  • Nomenclature and chemical constituents vary
  • Mixtures are NOT standardized
  • Lack of Good Manufacturing Practices (GMPs)
  • Examples ginseng, ephedra
  • Difficult to identify ingredients
  • Lack of active ingredient
  • Contamination

11
Unsafe Herbal Therapies
  • Ephedra (ma haung)
  • Ephedra sinica
  • Anorexiant, decongestant
  • 1 ephedrine
  • Palpitations, MIs, death
  • Maximum recommended dose 100 mg/24 hours
  • Contraindications
  • Drug interactions
  • Theophylline, digoxin, caffeine
  • Licorice
  • Glycyrrhiza glabra
  • Peptic ulcers
  • High doses
  • (pseudoaldosteronism)
  • Use no longer than 6 weeks
  • Contraindications
  • Drug interactions
  • Digoxin, furosemide

12
Ephedra
  • Products containing ephedra account for 64 of
    all adverse reactions to herbs in the US
  • Less than 1 of herbal product sales
  • FDA announced ban on 12/30/2003
  • After Mid-March 2004, illegal to manufacture or
    sell dietary supplements that contain
    ephedrine and related alkaloids
  • Does not include teas

13
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
    transplantation
  • FDA warning Canada and some European countries-
    market removal
  • Kava dermopathy
  • Use no gt 4 weeks no alcohol/sedating
    medications caution when driving or operating
    heavy machinery

14
FDA Proposed Labeling and Manufacturing Standards
  • Designing/construction of physical plants
  • Establishing quality control procedures
  • Testing manufactured dietary ingredients and
    supplements
  • Five out of 18 soy or red clover-containing
    products
  • Only 50 to 80 of declared isoflavones
  • Niacin
  • Almost 10 times more niacin
  • Folic acid
  • Only 35 of what was stated on label

15
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16
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17
United States Pharmacopeia (USP) Dietary
Supplement Verification Program (DSVP)
18
ConsumerLab.com
19
NSF International
20
Potential Warfarin-Herb Interactions
  • Feverfew
  • Additive effect
  • Monitor or avoid
  • St. Johns Wort
  • Increased metabolism decreased effect of
    warfarin
  • Monitor or avoid
  • Ginger
  • Additive effect
  • Avoid supplements, but small amount in diet
    should not be problematic
  • Garlic
  • Additive effect
  • Avoid supplements, but small amount in diet
    should not be problematic

21
Consumer Survey
  • Herbal use, products, and willingness to inform
    health care practitioners
  • 794/1300 surveys returned
  • 42 (n330) Herbal product use
  • Common herbal products (aloe, garlic, ginseng,
    echinacea, and St. Johns wort)
  • Women (majority)
  • Higher education (75)
  • Herbal users more prescription medications
  • Herbal users negative perception of
    prescription medications
  • Pharmacother 200020(1)83-7

22
Laws and Regulations
  • 1994- Dietary Supplement Health and Education Act
    (DSHEA)
  • Definition (dietary supplements not categorized
    as food additives)
  • Premarketing approval
  • Burden of proof that product is adulterated or
    unsafe rests on the FDA (e.g., ephedra)
  • Third-party Literature
  • Balanced view of available data
  • Structure/Function Statements

23
Structure/Function Statements
  • This product is not intended to diagnose, treat,
    cure or prevent a disease.
  • Change in definition of disease
  • Examples
  • Absentmindedness and hair loss associated with
    aging
  • Hot flashes
  • Premenstrual syndrome
  • Herbalgram 20004832-8

24
Ginkgo (Ginkgo biloba)
  • Leaves of the ginkgo biloba tree
  • Distinct chemical components
  • Work synergistically
  • Improves blood flow (brain and heart)
  • Protects against oxidative damage from free
    radicals (antioxidant)
  • Inhibits effects of platelet activating factor
    (PAF)

25
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26
Ginkgo Efficacy
  • Data 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.

27
Ginkgo Adverse Effects Drug Interactions
  • Adverse Effects
  • Hypersensitivity reactions, gastrointestinal
    disturbances
  • Spontaneous bleeding (few case reports)
  • Drug Interactions
  • Anticoagulants (Coumadin)
  • Antiplatelets (aspirin, Plavix, Ticlid)
  • Insulin

28
Ginkgo Dose and Administration
  • Standardized 24 flavone glycosides and 6
    terpenoids (leaf extract)
  • Dementia
  • 120 to 240 mg ginkgo leaf extract administered
    orally in two or three divided doses

29
Ginkgo Summary
  • Mild-to-moderate vasoactive agent
  • Data promising in Alzheimers Disease
  • Used extensively in Germany
  • No comparison to standard of care
  • Well-tolerated (weeks to 1 year)
  • Potential drug-herb interactions with
    anticoagulants, antiplatelets, and insulin

30
Ginseng
  • Each type of ginseng is unique
  • Asian or Oriental ginseng (Panax ginseng)
  • Siberian ginseng (Eleutherococcus senticosus)
  • American ginseng (Panax quinquefolius)
  • Active ingredients Root (panaxosides)
  • Ginsenoside Rb-1
  • Central nervous system depressant
  • Lowers blood pressure
  • Ginsenoside Rg-1
  • Central nervous system stimulant
  • Raises blood pressure

31
Panax Ginseng Efficacy
  • Data demonstrate possibly effective
  • Improving abstract thinking, selective memory,
    and mental arithmetic skills (more effective in
    conjunction with ginkgo biloba leaf extract)
  • Improving resistance to stress
  • Controlling blood glucose levels in people with
    non-insulin dependent diabetes (Type 2)
  • Possibly ineffective for enhancing athletic
    performance in healthy, young adults

32
Panax Ginseng Adverse Effects Drug
Interactions
  • Adverse Effects
  • Nervousness, insomnia, excitation, palpitations,
    affects blood pressure, lowers blood glucose,
    alters immune functiom
  • Ginseng abuse syndrome? (long-term use)
  • Drug Interactions
  • Antidiabetic agents
  • Warfarin (Coumadin)

33
St. Johns Wort (Hypericum perforatum)
  • Common forms capsules, tablets, tinctures
  • Source
  • Flowering tops
  • Naphthodianthrones (one of many potential active
    components)
  • Hypericin - Inhibits MAOA gt MAOB
  • Hyperforin Modulates effects of serotonin
  • Serotonin inhibition at high concentrations
  • Norepinephrine inhibition
  • Catechol-O-methyl-transferase (COMT) inhibition

34
St. Johns Wort Efficacy
  • For the treatment of mild-to-moderate depression,
    data demonstrate that St. Johns
    wort is
  • Superior to placebo
  • As effective as low-dose tricyclic
    antidepressants (TCAs Elavil and Pamelor),
  • Possibly as effective as selective serotonin
    reuptake inhibitors (SSRIs Prozac, Zoloft,
    Celexa, and Lexapro)

35
St. Johns Wort Adverse Effects Drug
Interactions
  • Adverse Effects
  • Sun-exposure Photosensitivity/Phototoxicity
    (hypericin component watch if taking
    antibiotics)
  • Insomnia, vivid dreams, headache, dizziness
  • Drug Interactions
  • MAOIs, selective serotonin reuptake inhibitors
    (SSRIs), Imitrex, tramadol (Ultram) Increased
    serotonin
  • Cyclosporine (Neoral) Decreased levels
  • Warfarin (Coumadin) Decreased INR (lab test)
  • Oral contraceptives or hormone replacement
    therapy Breakthrough bleeding

36
St. Johns Wort Dose and
Administration
  • Standardized extract
  • 0.3 hypericin
  • 5 hyperforin
  • Mild-to-moderate depression
  • 300 mg
  • Administed orally three times a day
  • Doses of 1200 mg/day have also been used

37
Echinacea (Echinacea angustifolia, pallida,
purpurea)
  • Common Forms tablet, juice, tea
  • Purple coneflower
  • Source Applicable parts are the roots and above
    ground parts.
  • Pharmacologic action constituent(s)?
  • Indirect antiviral activity
  • Immune system stimulatory effects
  • Cytokines, monocytes, natural killer cells

38
Echinacea Efficacy
  • Echinacea 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.

39
Echinacea Adverse Effects Drug Interactions
  • Adverse Effects
  • Allergic reactions
  • ragweed, daisies, marigolds
  • Fever, nausea, vomiting, unpleasant taste, and
    dizziness
  • Atopy more likely to experience allergic
    reaction
  • Drug Interactions
  • Immunosuppressants Interfere with therapy
  • Medications used for transplant patients, cancer
    patients, and patients with multiple sclerosis

40
Echinacea Dose and Administration
  • Wide variety of doses depending on formulation
  • Difficulty in standardization (echinacoside,
    alkamide content)
  • Purpurea herb juice 6 to 9 mL for 8 weeks
  • Purpurea crude extract 2 tablets administered
    orally three times a day
  • Tea 5 to 6 cups on day 1 of symptoms, then 1
    cup/day for 5 days

41
Echinacea Summary
  • Formulation/species that offer most benefit is
    unclear.
  • E. purpurea pressed juice or E. pallida root
    extracts at first sign of cold
  • If taken greater than 8 weeks
  • Reduced immunostimulatory effects?
  • One week drug holiday (not substantiated)
  • Well-tolerated (up to 12 weeks)

42
Dietary SupplementsImmune-Stimulating Properties
  • Alfalfa
  • Panax ginseng
  • Astragalus
  • Cats claw
  • Coenzyme Q10
  • DHEA
  • Echinacea
  • Garlic
  • Goldenseal
  • Grape seed extract
  • Melatonin
  • Siberian ginseng

43
Dietary Supplements-Potential Interaction with
Steroids
  • Aloe
  • Asian (Panax) ginseng
  • Bayberry
  • Licorice

44
Herbal Use in Patients Undergoing Surgery
  • Approimately 26 of patients scheduled for
    surgery use herbal products
  • Cardiovascular instability
  • Prolongation of anesthesia/sedation
  • Bleeding
  • Electrolyte disturbances
  • Immunosuppression
  • Anaesthesia 200257889-99

45
Discontinuation of Use Before Surgery
  • Echinacea
  • No data
  • Immunosuppression
  • Ephedra (ma huang)
  • 24 hours
  • Cardiac cautions
  • Garlic
  • 7 days
  • Bleeding
  • Gingko
  • 36 hours
  • Bleeding
  • Ginseng
  • 7 days
  • Hypoglycemia Bleeding
  • Kava
  • 24 hours
  • Sedation
  • St. Johns Wort
  • 5 days
  • Drug-herb interactions
  • Valerian
  • No data
  • Sedation
  • JAMA 2001286(2)213

46
Herbal References
  • Natural 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 Professionals Handbook of Complimentary and
    Alternative Medicine
  • 40/edition

47
Natural Medicines Comprehensive Database
48
The Review of Natural Products
49
Herbal Medicine Expanded Commission E Monographs
50
PDR for Herbal Medicines
51
American Botanical Council (ABC)
52
Herbal References
  • The United States Pharmacopeia and The National
    Formulary (USP-NF)
  • 526/edition
  • 21 botanical monographs (since 1995)
  • Internet Reference
  • The Natural Pharmacist (www.tnp.com)
  • Conditions
  • Drug Interactions
  • Review of published articles
  • Search

53
Herbal References
  • The Herbal Internet Companion
  • Herbs and Herbal Medicine Online
  • 20 (ISBN 0-7890-1052-6)

54
IBIDS Database
  • International Bibliographic Information on
    Dietary Supplements
  • Office of Dietary Supplements (ODS) at the NIH
  • Published, international, scientific literature
  • Vitamins, minerals, and botanicals
  • Over 676,000 unique scientific citations
    abstracts
  • Three databases
  • Full IBIDS database
  • Peer-Reviewed Citations Only database
  • IBIDS Consumer database

55
CARDS Database
  • Computer Access to Research on Dietary
    Supplements
  • Office of Dietary Supplements (ODS) at the NIH
  • Specific mandates from the DSHEA
  • Federally funded research projects pertaining to
    dietary supplements
  • Free of charge
  • www.ods.od.nih.gov

56
Summary
  • Tell physician, nurse, and pharmacist about
    herbal therapy use (documentation)
  • Natural does not mean safe
  • Herbal-pharmaceutical interactions do occur
  • Lack of standardization (variability in herbal
    content and efficacy among manufacturers)
  • Lack of quality control and regulation
    (contamination and misidentification)

57
Conclusions
  • Because 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 clinicians
    best judgment
  • Majority of recommendations are NOT evidence-based

58
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