Transcript www.med.umich.edu

Herbs and Health:
Real World Basics
Leslie Shimp, PharmD
Professor College of Pharmacy
Asst Prof of Pharm, Dept of Family Medicine
Suzanna M. Zick, ND MPH
UM Integrative Medicine
Research Invest, Dept of Family Medicine
Historical Context
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Physical evidence dates
back 60,000 years
All cultures have traditions
of herb use for healing
2000 BC - First known
materia medica in Sumeria
1st Century AD - Chinese
Materia Medica
Cultural Context
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In China, 40-50% of meds used are
traditional herbs
In Africa, 80% of population uses herbal
medicine for primary care
In Germany, 90% of adults use herbs in
lifetime
Ethnic populations in US very likely to be
using herbs
25% of prescription drugs from plants
Context
Herbalism
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Traditional Healers
– Native American, Ayurvedic, Tibb, Unani,
Tibetan, etc
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Traditional Chinese
Western Folkloric
Western Scientific
Earth-centered
Ethno-botanical
Example categories from the American Herbalist Guild
Expertise – Who has it?
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Consumer/patient
Clerk in store
Herbalist – what tradition? How certified?
Chiropractor (DC)
Nutritionist (RD)
Pharmacist (PharmD, PhD)
Naturopathic Doctor (ND)
Board Certified Holistic Physician (MD, DO)
Fellowship-trained Integrative Physician
Evidence
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Traditional use
Basic science
Clinical science
Traditional use
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Often based on
hundreds to thousands
of years of observation
60-70% of traditionally
used herbs are
pharmacologically
active
German Commission E
Traditional
preparations
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Infusion - flowers and leaves steeped
in hot water, ie, teas
Decoction - bark, roots or seeds boiled
in water
Tincture – extraction with alcohol or
vinegar or glycerin and water
More preparations
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Capsules
– dried and ground herbs in a gelatin or
vegetable capsule
– dried extract of plant part
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Salve - an oil and beeswax/lanolin
mixture used topically
Basic Science
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Mechanism of action
Pharmacokinetics, etc
Toxicity
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Often done AFTER clinical studies
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Clinical Science
Federally funded studies
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Echinacea
Ginseng
Gingko biloba
Garlic
SJW
Peppermint
Ginger
Soy
Chamomile
Kava kava
19
22
8
48
28
0
9
>200
1
6
Herbal Products -- Herbal Market
Regulated -- or -- Unregulated?
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Herbal regulations differ significantly from
drug (pharmaceutical) regulations.
Both FDA and FTC have a role in regulating
herbal products.
Major federal laws governing herb products:
– FD&C Act (1938)
– Kefauver-Harris Amendments (1962)
– DSHEA (1994)
Role of FDA
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Stop the marketing of toxic or unsanitary
products
Stop the marketing of products with false or
unsubstantiated claims
Take action against a product which poses “ a
significant unreasonable risk of illness or
injury”
Prohibit claims that a product cures or treats
a disease
Stop the marketing of a new (post 1994)
dietary ingredient if safety data is lacking
Role of FTC
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FTC governs the advertising and
promotion of herbs and dietary
supplements. It can:
– Outlaw unfair or deceptive practices
– Stop unsubstantiated advertising
– Investigate complaints and seek civil
penalties for violations of trade
regulations
Concept of Effectiveness
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Two elements
– Causation - Did the Treatment make a
difference?
– Quantification Is the degree of change
clinically important?
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80% Rule (K. B. Thomas)
– “80% of those who seek medical care get
better no matter what hand waving or pill
popping is provided”.
Concept of Risk - Adverse Reaction
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Risk is likely for any substance with
pharmacologic effects
GRAS list
Reporting an adverse reaction to an
herb
– FDA Medwatch
– 1-800-FDA-1088
– www.fda.gov/medwatch
Detecting an Adverse Reaction
Number of Persons who need to be
exposed to a drug to have a 95% chance
of detection
Frequency of
Adverse Drug
Reactions (ADR)
1 out of 100
1 out of 200
1 out of 1000
1 out of 2000
1 out of 10,000
1
300
600
3000
6000
30,000
Number of
ADR Cases
2
480
960
4800
9600
48,000
3
650
1300
6500
13,000
65,000
WB Jonas and JS Levin (eds), Essentials of Complementary and Alternative Medicine.
Lippincott Williams & Wilkins, Philadelphia, PA. 1999
Product Quality
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Genetics, growing conditions,
harvest time
Misidentification, contamination,
adulteration
Lack of Standardization
– product preparation
Quality
Solutions
Standardization
 Independent testing
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– www.consumerlab.com
– www.nsf.org
– www.usp.org
Health Care Providers Actions
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Avoid products with multiple herbs
Consider following LFT’s, BUN, CrCl
Consider herbs in differential
Obtain samples when problems
suspected
Report to MedWatch 1-800-332-1088
Health Professional’s Actions
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Honor your patients reasons for usage
Encourage open communication
Read about herbal remedies
Be honest about what you learn
Avoid criticism
List herbal remedies in the patient
chart
Weigand JM et al, FP Recertification, 22(9):45-62
The Importance of Knowledge
“Only ignorance! Only ignorance! How can
you talk about only ignorance? Don’t you
know that ignorance is the worst thing in
the world next to wickedness? -- and which
does the most mischief Heaven only knows.
If people can say, “Oh I did not know, I did
not mean any harm,” they think it is all
right.”
From the Book - Black Beauty by Anna Sewell
Lisa Vincler, JD When Ignorance isn’t Bliss: What Healthcare
Practitioners and Facilities should know about CAM, 1998