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Herbal Products with
Human Health Risk
Il-Moo CHANG
Natural Products Research Institute
College of Pharmacy
Seoul National University
[email protected]
Preface
A Global Trend: Uses of Herbal Products
Definition of Herbal Products
Derived from Medicinal Plants Materials including some
animals/insects, and minerals
Traditional medicines (e.g. Chinese, Ayurveda, etc)
Dietary supplements (functional/health foods)
Botanical drugs (herbal medicines)
Functional cosmetics including essential olis
Natural pesticides/insecticides
What & How made such booming?
W.H.O.’s Program on TM
since 1978, Alma-ata
Declaration
Introduction of CAM into
Mainstream Medicine
since early ’90, NIH (U.S.A)
Dietary Supplement
Education Act (1994)
Public Interests in TM/CAM Practices* and
Herbal Products
Limitation of Modern Medical Therapy for the
treatments of inveterate/fatal diseases
Cancer, Alzheimer, HIV, Chronic arthritis, etc.
Some Successful Examples
Anti-malaria drugs; Artemisine derived from TCM
Ginseng, St. John, Echinaceae, Shizandrin, Silymarin,
Ginko flavones
In addition, acupuncture has been widely used to
control pain
* Complementary and Alternative Medicine are used interchangeably with
Traditional Medicine in some countries; e.g. Acupuncture & herbal therapy
% of population which has used CAM at least once in
selected developed countries
100%
80%
70%
60%
48%
49%
42%
40%
31%
20%
0%
Belgium
USA
Australia
France
Canada
GDP (Income) vs Uses of TM/CAM Therapies
3.0
GDP<Int $ 15,000
GDP=Int $ 15,000
2.5
2.0
1.5
1.0
0.5
0.0
Acupuncture Homeopathy
Chiropractic
Herbal/Trad.
excerpt from WHO Global Atlas of Traditional, CAM, Kobe, Japan (2005)
GDP vs Uses of TM Therapies (Indian and Chinese TM)
2.5
2.0
GDP<Int $ 15,000
GDP=Int $ 15,000
1.5
1.0
0.5
0.0
Indian Medicine
TCM
Herbal/Trad
excerpt from WHO Global Atlas of Traditional, CAM, Kobe, Japan (2005)
Increase in sales of the most popular
herbal products in the USA 1997-1998
Herb
Sales in US$ million
1997
Total
1998
% increase
In sales
292
587
101
Echinacea
33
64
96
Garlic
66
81
24
Ginkgo
biloba
52
126
143
Ginseng
76
96
26
1
103
102
64
118
85
St. John’s
wort
Other
herbs
Do we have good evidence of
Quality,
Efficacy,
and Safety
of Herbal Products?
They are most likely prepared on
the basis of “Previous Human Uses”
Efficacy of TM Herbal Medicines??
18%
Same as compared
to placebo
34%
benefit as compared
to placebo
48%
report benefit unlikely –
due to design or analytic flaw
excerpt from WHO Traditional Medicine Strategy 2002-2005
How about Quality and Safety of
Herbal Products?
Problems arisen from
Misuse of herbs
wrong plant materials
without safety assessment
accidental contamination with similar species
Adulteration
add synthetic drugs
personal formulae without records on medical
classics/literature
Examples of Misuses
An incidence of a Slimming Pill containing
Aristolochia species
which were used long as herbs with a diuretic action,
stimulating urination
Early ’90, sold in Belgium, then expanded to Europe,
Asia and North America
Now all regulatory agencies over the world banned many
*genera of herbs and formulae containing
Aristolochic acid as a constituents
* Aristolochia, Akebia, Clematis, Cocculus, and Stephania
馬兜鈴
Aristolochiae Fructus
Aristolochia contorta Bunge (Aristolochiaceae)
木通
Aristolochia caulis
Aristolochia manchuriensis Nakai (Aristolochiaceae)
excerpt from www.tradimed.com
Toxic constituents in Aristolochia species
Impairment of Kidney function
Causes Urinary tract/Bladder Cancer
O
COOH
O
COOH
O
NO2
O
NO2
OCH3
Aristolochic Acid I
Aristolochic Acid II
“Previous Human Use” is not always render the Safety
These herbs had been listed in Chinese, Japanese and
Korean Pharmacopoeias until such a ban was undertaken
Poisonous Mushrooms of Importance
Destroying Angel / Death Cap
Lethal Mushrooms
Agaricus (Edible)
Amanita virosa
A. phalloides
excerpt from Dr. Daniel Okagaki, George Washington University(2001)
misidentification (accident)
mix with edible ones
Toxic Amanita
Liver and Renal Failure
A single piece causes deaths of several adults 3 days later
after ingestion
- Amatoxin; bicyclic octa-peptide
Inhibition of RNA polymerase II
Adulteration
Addition of Synthetic Drug Ingredients
In U.S.
Liqiang 4 Dietary Supplement Capsules
contains Glyburide (a drug for diabetes) made
in China and sold in U.S.
Risk for low sugar patients
Remark
Herbs are Natural, but many herbs contain
toxic compounds
Many dietary supplements and herbal products are
derived from TM herbs
“Previous Human Uses” as TM herbs does not always
render the Safety
Caution should be exercised for taking herbal products,
especially dietary supplements made of TM herbs without
the evidence of safety data available
Thank U
a lot ?
謝 謝 !