Title: Herbal and Natural Medicines: What You Should Know
1Herbal 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
2Objectives
- 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.
3Introduction
- 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
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5Top-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.)
6Top-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.)
7Herbal versusConventional Medication
- Disappointment with current conventional
therapies - Fear of safety and long-term effects
- Lack of effective treatments/cures
8Herbal 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
9Safety 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)
10Safety 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
11Unsafe 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
12Ephedra
- 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
13Kava (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
14FDA 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
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17United States Pharmacopeia (USP) Dietary
Supplement Verification Program (DSVP)
18ConsumerLab.com
19NSF International
20Potential 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
21Consumer 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
22Laws 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
23Structure/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
24Ginkgo (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)
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26Ginkgo 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.
27Ginkgo Adverse Effects Drug Interactions
- Adverse Effects
- Hypersensitivity reactions, gastrointestinal
disturbances - Spontaneous bleeding (few case reports)
- Drug Interactions
- Anticoagulants (Coumadin)
- Antiplatelets (aspirin, Plavix, Ticlid)
- Insulin
28Ginkgo 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
29Ginkgo 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
30Ginseng
- 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
31Panax 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
32Panax 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)
33St. 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
34St. 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)
35St. 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
36St. 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
37Echinacea (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
38Echinacea 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.
39Echinacea 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
40Echinacea 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
41Echinacea 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)
42Dietary SupplementsImmune-Stimulating Properties
- Alfalfa
- Panax ginseng
- Astragalus
- Cats claw
- Coenzyme Q10
- DHEA
- Echinacea
- Garlic
- Goldenseal
- Grape seed extract
- Melatonin
- Siberian ginseng
43Dietary Supplements-Potential Interaction with
Steroids
- Aloe
- Asian (Panax) ginseng
- Bayberry
- Licorice
44Herbal 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
45Discontinuation 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
46Herbal 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
47Natural Medicines Comprehensive Database
48The Review of Natural Products
49Herbal Medicine Expanded Commission E Monographs
50PDR for Herbal Medicines
51American Botanical Council (ABC)
52Herbal 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
53Herbal References
- The Herbal Internet Companion
- Herbs and Herbal Medicine Online
- 20 (ISBN 0-7890-1052-6)
54IBIDS 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
55CARDS 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
56Summary
- 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)
57Conclusions
- 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
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