Transcript 00020 - CAM in UME Project

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HERBAL DRUGS: NATURAL HEALTH
PRODUCTS TO INCLUDE
ANIMAL SOURCED MATERIALS
Kanji Nakatsu, PhD
Queen’s University
March 2005
URL: http://www.caminume.ca/drr/resources/00020.ppt
33 slides
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Herbal Drugs
Natural Health Products to include animal
sourced materials
Medical Pharmacology
March 2005
Dr. Kanji Nakatsu
© K Nakatsu, 2005
Outline
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Relevance
Definitions
Regulation
Common Herbals
© K Nakatsu, 2005
Relevance
• Over ¼ (perhaps1/2) of the Canadian adult population
have taken a natural health product in the past year.
• More than 1/2 of Canadians using complementary or
alternative medicine did not disclose this to their
physicians.
• Increasing number of natural health products for sale in
Canada. Most of these are sold through stores (including
mail order) other than pharmacies
• Estimated sales >$1 Billion
• Potential adverse interactions with conventional
treatments. The potential for this increases when the doctor
does not know that the patient is taking NHP.
© K Nakatsu, 2005
Why are people using NHPs?
• Influx of web-based information. As with other topics the
quality of the information is uneven, spanning the range
from good, useful information to misinformation.
• Concern over the safety of conventional medication
• Cost of conventional medication
• Lack of faith in conventional medication
• Hope for a cure of incurable/chronic disease- cancer
amygdalin
• Belief that natural is non-toxic
© K Nakatsu, 2005
Definitions
• Drug (conventional medicine)
– chemical substance, non-nutritive
• Traditional Herbal Medicine (THM)
– “a finished drug product intended for selfmedication that contains, as active principles,
herbal ingredients that have received relatively
little attention in world scientific literature but
for which traditional or folkloric use is well
documented in herbal references”
© K Nakatsu, 2005
Definitions
• Natural Health Product
– “a plant or its extract, a vitamin, mineral, amino
acid, probiotic or essential fatty acid whose
purpose is to prevent or treat disease, restore or
correct an organic function, or maintain and
promote health.
– Example- St. John’s Wort, chondroitin sulfate
© K Nakatsu, 2005
Scope of NHPs
1. A plant or a plant material, an alga, a bacterium, a fungus or a nonhuman animal material
2. An extract or isolate of a substance described in item 1, the primary
molecular structure of which is identical to that which it had prior to
its extraction or isolation
3. Any of the following vitamins:
biotin folate niacin pantothenic acid riboflavin thiamine vitamin A
vitamin B6 vitamin B12 vitamin C vitamin D vitamin E
4. An amino acid
5. An essential fatty acid
6. A synthetic duplicate of a substance described in any of items 2 to 5
7. A mineral
8. A probiotic
© K Nakatsu, 2005
Exclusions
• Vitamin K
• Foods
– Garlic is used by some people as a herbal
remedy but mostly it is used as food
• Prescription drugs prepared from natural
sources
• Products made by practitioners, such as
naturopathic doctors
© K Nakatsu, 2005
Spectrum of Responses from Conventional
Medicine to Complementary & Alternative
Medicine (CAM)
• Utter disdain, but they still accept that some of their patients are using
CAM
• Reluctant acceptance
• Acceptance that CAM may have a place,
depending on the form
• Participation Some doctors do some forms of CAM
© K Nakatsu, 2005
Natural Health Products,
Quackery or Quality
• Alternative 1- NHPs are dangerous,
poisonous, ineffective
• Alternative 2- NHPs are good drugs that
just haven’t received formal approval
• Alternative 3- between 1 and 2
© K Nakatsu, 2005
Position of NHPs
Poison
Aristolochic
Acid
© K Nakatsu, 2005
Real Drug
St. John’s
Wort
Artemesinin
Prescription Drugs from Natural
Sources
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Digoxin- heart failure- foxglove
Atropine-autonomic-Deadly nightshade
Ephedrine- autonomic- Ephedra
Quinidine- anti-arrhythmic- Cinchona tree
bark
• Penicillin- antibiotic- mold
• ~25% of prescription drugs have botanical
roots (no pun intended)
© K Nakatsu, 2005
Current NHP  Prescription
Drug
• Moss Extract from Traditional Chinese Medicine
Huperzia serrata used for improving memory
• Identification of huperzine A as active ingredient
• Recruiting for phase II clinical trials in USA by
NIH for Alzheimer’s Disease
http://www.clinicaltrials.gov/show/NCT00083590
© K Nakatsu, 2005
Huperzine
Huperzine A
© K Nakatsu, 2005
Huperzine R
Concerns with NHPs
• Lack of efficacy data; often information is anecdotal
• Lack of safety data- public often assume that they are safe
to use because they are “natural”
• Intentional adulteration
– Rx medications found in NHPs. See Health Canada Warnings;
NSAIDS, heavy metals, steroids etc
• Confusing literature
• Unknown active ingredients Marker molecules can be used
to standardize products. These are anticipated to either be
the active ingredient or associated with the content of
active ingredient in the product.
© K Nakatsu, 2005
Concerns with NHPs (cont’d)
• Lack of quality control.
• Unknown active ingredients. Marker molecules can be
used to provide some consistency.
• Poorly designed studies
• Toxicities poorly defined. Some are mild, but some can be
lethal. Aristolochic acid is carcinogenic and nephrotoxic
• Drug interactions with prescription drugs
© K Nakatsu, 2005
Regulation
• Little attention until 1990s
• Creation of Natural Health Products Directorate, NHPD
• New Regulations- implementation started January 2004.
– Expect evolution as this is new work for Health Canada
• Affect manufacturers, distributors, importers, packagers
and labelers
• All products that fit under the NHP definition must obtain
their product licenses by December 31, 2009
• Future Regulations:
– Claims: structure-function, risk-reduction, and
treatment
– Standards of Evidence: varies with type of claim
© K Nakatsu, 2005
Application for license
• An application for a product license must include
specific information about the NHP, for example,
the quantity of the medicinal ingredients it
contains, the specification it complies with, the
recommended use or purpose for which the NHP
is intended to be sold, and the supporting safety
and efficacy data. The NHPD is developing a
standards of evidence framework and guidance
documents
© K Nakatsu, 2005
Safety and Efficacy
• performance standard, applies to an application which
references a monograph in the Compendium of
Monographs developed by the NHPD. Medicinal
ingredients are the focus of the monographs, and are
developed based on public literature. The Compendium of
Monographs will ease the administrative burden on
industry and ensure more efficient processing of product
license applications. Development of single-medicinal
ingredient monographs is ongoing. The monographs
provide support for the safety and the claim of the NHP,
and therefore additional safety and efficacy data are not
required in the application for a product license.
© K Nakatsu, 2005
USA Regulations
• Covered by Dietary Supplement Health and
Education Act, 1994
• NHPs are considered to be food supplements and
not regulated as drugs
• Affords less control than Canadian Regulation
– Androstendione has just been
ruled as not being a food
supplement in USA
– Makes people like baseball
players famous
© K Nakatsu, 2005
NHPs and Health of Population
• Include consideration of NHPs as part of the drugs
that people are taking- interactions & toxicities
• General knowledge of extent of NHP usage
• Knowledge of source of information Good
reliable web sites and books.
• Evidence based medicine should be applied to
NHPs
– a challenge because there is so little evidence for the
basis of judgment
© K Nakatsu, 2005
Evidence-based Medicine
• Standards of evidence
• Prospective, double-blind controlled trial is
desirable
• Not all current conventional practice is
based on such evidence
• Hormone replacement therapy
– started well
– currently evidence against original
© K Nakatsu, 2005
Where to find information
• Natural Health Products Directorate
– http://www.hc-sc.gc.ca/hpb/onhp This is anticipated to be a stable
site with valuable information.
• Camline
– www.camline.org. This site has valuable information but its
stability is uncertain. Much depends on whether good people
continue to develop and maintain it.
• Chandler, F. Herbs: Everyday Reference for Health Professionals.
Ottawa: CPhA & CMA, 2000. This is a very useful reference with
credible sponsors. It is limited in its coverage. Its continuing value
will depend on regular revisions.
• National Centre for Complementary and Alternative Medicine
– http://nccam.nih.gov
– This anticipated to be a stable site with valuable informtion.
• Bracken Library- Natural Standard
© K Nakatsu, 2005
Common Herbals
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Glucosamine
Black Cohosh
Garlic
St. John’s Wort
Echinacea
Ginsing
Ginkgo Biloba
© K Nakatsu, 2005
Glucosamine
-collagen component
Uses: osteoarthritis, prevent inflammation
C/I-none known
A/E-mild GI, drowsiness, h/a
Dosage: 1500mg po div TID, or 400 mg
IM/IV (caution in diabetics)
© K Nakatsu, 2005
Glucosamine
• Glucosamine- amino-monosaccharide
produced in humans. Used in
biosynthesis articular cartilage
components, such as
glycosaminoglycans, proteoglycans,
and hyaluronic acid.
• Reduces pain in humans, increases joint
space in rats
• Evidence indicates efficacy in osteoarthritis
of the knee
© K Nakatsu, 2005
Black Cohosh
Estrogen-like activity?
Uses: menopausal symptoms, PMS,
dysmenorrhea
C/I: preg/lact, estrogen dependent tumours,
estrogen receptor activity?.
A/E: h/a, GI
Dosage: dried extract equivalent to 160 mg of
dried root or rhizome per day
© K Nakatsu, 2005
Garlic
Allicin, diallyl sulfide, ajoene (sulfur based
compounds)
Uses: hyperlipidemia- some evidence of mild effect
-immune enhancer etc no evidence
C/I: none known
A/E: odour,  bleeding time
Dosage: fresh garlic 1-5 cloves/day, oil 0.25mg/kg
Intxns: anticoagulants
© K Nakatsu, 2005
St. John’s Wort
• Hypericin, hyperforin
• Uses: depression (comparable to TCAs and SSRIs,
SAD, anxiety)
• Evidence of effectiveness in mild-moderate
depression, but not severe depression
• C/I: none
• A/E: photosensitivity, restlessness
• Intxns: theophylline, warfarin,
indinavir,cyclosporine, SSRIs
• Induces Cytochrome P4503A4
© K Nakatsu, 2005
Echinacea
E. angustifolia (N.A.), E. purpurea (Germany)
Uses: immune stimulation, cold, flu, prevent of yeast
infections
Treatment of upper respiratory tract infections in
adults- some evidence
C/I: autoimmune diseases
A/E: hepatotoxicity,  sperm ability to penetrate egg
Intxns: cancer chemo, immunosuppressants, warfarin
© K Nakatsu, 2005
Ginseng
Panax quinquefolius (N.A.), Panax ginseng
(Oriental); white vs. red ginseng, do not confuse
with Siberian Ginseng (Eleuthero)
Uses: stress, impotence, BP
Probably useful for improving mental performance
and type 2 diabetes.
C/I: preg/lact, hyperactive children
A/E: HTN, diarrhea, insomnia, mastalgia, vaginal
bleeding
Intxns:warfarin, BP meds, estrogen, hypoglycemics,
MAOIs, caffeine, psychotherapeutics
© K Nakatsu, 2005
Ginkgo Biloba
Uses: ischemia assoc with periph arterial
disease, dementia
C/I: caution in pts on meds affecting
hemostasis
A/E:  risk of bleeds, GI upset, h/a
Intxns: anticoagulants, NSAIDs
© K Nakatsu, 2005
Important issues regarding NHPs
• Wide use in Canada
• Possibilities of useful therapies
• Possibilities of harmful effects and
interactions
• Evolving regulation
• Quality control
© K Nakatsu, 2005