Transcript Promises or Poisons: Herbal Medicines

Herbal Supplements:
The Hype vs. the Evidence
Arthur Dominguez, Pharm.D.
Kaiser Permanente
Baldwin Park Medical Center
Herbal Remedies
• Growing by 18% a Year
• $16 Billion in Sales Annually
• Classified as Dietary Supplements
• Sold in Health Food Stores, Markets,
Pharmacies
Legislation
• 1993 - FDA Advanced Notice of
Proposed Rulemaking
• Dietary Supplement and Health
Education Act of 1994
Dietary Supplement and Health
Education Act of 1994 (DSHEA)
• No Testing for Efficacy
• No Manufacturing Standards
• Claims Permitted on Package
• Label Statements Not Required to be
Proven
Dietary Supplement and Health
Education Act of 1994
• Label Must State that Claims Not
Approved by FDA
Concerns
• Does the active ingredient actually end
up in pill?
• What else is in the pill?
• Are ingredients in a form the body can
use?
• Does the dose make sense?
• Is it safe?
New Regulations Planned
• Methods of Determining Potency
• Quality Assurance
• Packaging
• Expiration Dates
• Lot Numbers
New Regulations Planned
• Statement of Identity
– “Dietary Supplement”
– “Vitamin C Supplement”
– “Herbal Supplement”
• Herbals Must be Identified by Common
or Usual Name and Part of Plant Used
“Much of what surrounds
herbal medicine in the U.S. is a
minefield of hyperbole and
hoax”
Varro E. Taylor
Purdue University
DHEA
Dehydroepiandrosterone
• Hormone Excreted by the Adrenal
Gland
• Only Available as a Compounded
Prescription Due to an FDA Loophole
• “Precursor” Made from Mexican Yams
Available in Health Food Stores
DHEA
• DHEA “is cheap, convenient and
makes you feel like a kid again”
• NEJM 1986 Study Showed:
– 48% Decrease in Heart Disease
– 36% Decrease in Death by Any Cause
• New Larger Study Shows Less
Impressive Results
Melatonin
Claims
• Fights Insomnia
• Fights Jet Lag
• Slows Aging
• Fights Disease
• Enhances Sex Life
Melatonin
Studies Suggest
• Can Hasten Sleep
• May Strengthen Immune System
• May Fight Cancer
Melatonin
No Data on
• Long-Term Effects
• Drug Interactions
May Worsen Existing Depression
Kombucha
“Immuno-Stimulatory
Mushroom”
• Yeast Culture
• Concerns About Bacterial or Fungal
Contamination
Ginkgo Biloba
“The Thinking Persons Supplement”
Ginkgo Biloba
Dilation of Arteries,
Capillaries, Veins
Inhibits Platelet
Aggregation
(Ginkgolide B)
Antioxidant
Ginkgo Biloba
Possibly Effective
• Alzheimer’s,
vascular or mixed
dementias
• Peripheral arterial
occlusive disease
• Vascular vestibular
disorders
Ginkgo Biloba
Adverse Reactions
• Mild GI upset
• Head ache
• Dizziness
• Constipation
• Allergic Skin
Reactions
• Increased bleeding
St. John’s Wort
(Hypericium perforatum)
Depression More effective than placebo, possibly as
effective as low- dose tricyclics and
SSRI’s
St. John’s Wort
(Hypericium perforatum)
Side Effects:
Gastrointestinal
Tiredness
Restlessness
Allergic Reaction
Insomnia
Vivid Dreams
May induce hypomania in depressed
patients
St. John’s Wort
(Hypericium perforatum)
Safety
•Short term (8 weeks)
•May increase muscle tone of uterus
•Colic and lethargy in nursing infants
Dose
•300 mg TID extract standardized 0.3%
hypericin
St. John’s Wort
(Hypericium perforatum)
Drug Interactions
•Theoretically, may cause serotonin
syndrome with SSRI’s
•Avoid within 14 days of MAOI’s
•Decrease cyclosporine levels by 60%
•Reduce serum digoxin levels
•Decrease protease inhibitor levels
possibly NNRTI’s
SAMe
S-Adenosyl Methionine
• Uses
– Osteoarthritis
– Depression
– Fibromyalgia
– Liver disease
– Slowing down aging process
• Most studies conducted with
intravenous route
SAMe
• Naturally occurring molecule
• May be as effective as NSAIDS
for arthritis
– possible analgesic and anti-anflammatory
effects
• Several studies indicate superior to
placebo for treatment of depression
– may increase serotonin turnover and
norepinephrine levels
SAMe
• Possible interaction with
antidepressants
• Dose
– Depression: 400 to 1600 mg per day po
– Arthritis: 200 mg TID po
SAMe
• Side effects
– nausea, diarrhea
– anxiety, hypomania in patients
bipolar disease
with
• No cases of toxicity or drug interaction
reported
Kava
Used for anxiety, stress and insomnia.
• Likely effective for short-term use
• Similar to low dose BZD’s
• Absence of cognitive impairment
Kava
• At least 24 documented cases liver
failure at normal doses
• As little as two months use
• Transplant and death
Green Tea
• Unfermented form of
black tea
– retains many
chemicals of the
fresh leaf
• Uses
– antioxidant
– lower cholesterol
– Treat nausea and
diarrhea
– prevent cancer
Green Tea
• Side effects
– Heart burn, stomach
irritation
– Contains caffeine
• Drug interactions
– may decrease effect
of warfarin
No proof of claims
Morinda
“Noni Juice”
Uses
• Diabetes
• Migraine
• Kidney disorders
• Reduce signs of
aging
Dose
• One to ten ounces
daily
• Imported from
French Polynesia
Morinda
“Noni Juice”
Drug interactions
• Potassium diuretics
Side effects
• Discolor urine pink
to rust
HerbsThat May Be Useful
Chamomile
Saw Palmetto
Feverfew
Valerian
Ginger
Garlic
Hawthorn
Milk Thistle
Echinacea
HerbsThat May Be Useful
Chamomile
HerbsThat May Be Useful
Feverfew
HerbsThat May Be Useful
Ginger
HerbsThat May Be Useful
Hawthorn
HerbsThat May Be Useful
Echinacea
HerbsThat May Be Useful
Saw Palmetto
HerbsThat May Be Useful
Valerian
HerbsThat May Be Useful
Garlic
HerbsThat May Be Useful
Milk Thistle
Herbs That Are Harmful
Chaparral
Comfrey
Ephedra (Ma-Huang)
Lobelia
Yohimbe
Herbs That Are Harmful
Chaparral
Herbs That Are Harmful
Comfrey
Herbs That Are Harmful
Ephedra
(Ma-Huang)
Herbs That Are Harmful
Lobelia
Herbs That Are Harmful
Yohimbe
Phytoestrogens
“Plants do not produce chemicals that
possess chemical structures which
allow them to serve as hormone
replacement drugs”
James E. Robbers, Ph.D.
Tyler’s Herb’s of Choice
Phytoestrogens
• The ability of a hormone to react with
its particular receptor is very specific
– “Lock and Key”
• The estrogen receptor accommodates
a diverse array of chemical structures
– No hormonal effect
– Estrogen-like effects
Mexican Wild Yam
(Dioscorea villosa)
Marketed as a Supplement to:
• Decrease the symptoms of
premenstrual syndrome
• Help treat urinary/ kidney disorders
• Increase libido
No Proof of Claims Available
Mexican Wild Yam
(Dioscorea villosa)
• Adverse effects:
– Emesis (large amounts)
– Recent proof of damage to cells lining the kidney
• No known drug interactions
• Diosgenin is a starting material for the
chemical synthesis of progesterone
– Conversion does not occur in the body
Black Cohosh
(Actaea racemosa)
Marketed as a Supplement to:
• Decrease the symptoms of
menopause, dysmenorrhea
• Induce labor
• Rheumatism, fever, sore throat
• Insect repellent
Black Cohosh
(Actaea racemosa)
Possibly effective:
• Decrease the symptoms of
menopause
– reduce hot flashes
– four weeks treatment necessary
Black Cohosh
(Actaea racemosa)
Adverse effects:
•GI upset
•nausea
•vomiting
•weight gain
No evidence of drug interactions at this
time
Soy
Isoflavonoid genistein
• Binds weakly to estrogen receptor
(0.4%)
• Large doses may result in estrogenlike effects
Soy
Percentage of Soy in Total Diet
Japan
40%
USA
3%
Soy
Nationality
African-American
Osteoporosis Risk
Factor
20%
Latin
30%
White
50 – 65%
Japanese
85%
Chromium Picolinate
Promoted for Weight Loss
• Targets Fat
• Spares Muscle
• Increases Strength
Possible Benefit in Type II Diabetes
Chromium Picolinate
• Commonly marketed as picolinate
• Mechanism of Action
– Glucose Tolerance Factor (GTF) contains
Cr atom
» increases insulin receptor sensitivity
» enhances glucose transport into cells
– Brain
» appetite suppression
» down regulation of insulin secretion
Chromium
Studies
• 1997 180 Chinese Type 2 diabetics
received 1000 mcg/d, 200 mcg/d or
placebo for 4 months
• HbA1C improved after 2 months in
1000 mcg group, and in 4 months in
200 mcg group
• Fasting glucose lower in high dose
group
Chromium
Studies
• Double-blind study of 30 women with
pregnancy-related diabetes
• Dose of 4 to 8 mcg/kg/day
• Improvement in control of blood sugar
Chromium
• Dose: 200 mcg TID (RDA is 200 mcg)
• Likely safe in pregnancy for
gestational diabetes, but there are still
theoretical concerns of effects on DNA
• Likely safe during lactation
• Not all studies have been positive, esp.
in patients with normal Cr levels
Chromium
• Adverse reactions
– 400 mcg/day: cognitive, motor and
perceptive dysfunction
– 1.2 to 2.4 mg/day: anemia,
thrombocytopenia, hemolysis, hepatic and
renal dysfunction
Coenzyme Q10
Claims
“Can strengthen the heart”
“Inhibits the aging process”
“Helps diabetics”
• Produced by cells in body
• Essential cofactor in many metabolic
pathways
Coenzyme Q10
• Possibly effective in improving
blood glucose control
• Typical dose: 150 mg qD
• Adverse effects
– Nausea
– Diarrhea, gastritis
Coenzyme Q10
Interactions
• Serum aminotransferase levels may be
elevated at > 300 mg/day
• Oral hypoglycemics and HMG-COA
reductase inhibitors may reduce
coenzyme-Q10 levels
• May reduce response to warfarin
Ginseng
• Stress
• Edema
• HTN
• Impaired Memory
• Ulcers
• Anemia
• Diabetes
• Menopause
• Atherosclerosis
• Depression
• Life Extender
• Aphrodisiac
Ginseng
• Scientific name:
Panax Ginseng
• Principle
constituents are
ginsenosides (18
subtypes)
Ginseng
• Nearly all of over 400 studies were
poorly controlled, non-standardized
• Most reliable studies used Asian
ginseng
• May possibly have a beneficial effect
on reducing fasting blood glucose and
HbA1C when used orally
Ginseng
• Adverse Reactions
– Hypertension (Long-term at > 3 Gm/day)
– Insomnia
– Nervousness
– Estrogenic effects
– Increased libido
– Possible coumarin effects
Ginseng
Typical dose
• Tea: 3 Gm root in 150 ml water. Take
TID for 3 to 4 weeks
• Oral: 0.6 to 3 Gms dried root qD to TID
Ginseng
Natural Brand
Korean
Naturally Korean
648 MG
648 MG
Ginsinosides
Ginsinosides
23.2 MG
2.3 MG
Glucosamine and
Chondroitin
• Use: Arthritis
• Glucosamine - stimulates
production of proteoglycans
• Chondroitin - component found in
glycosaminoglycans
Glucosamine and
Chondroitin
• Available separately or in
combination
• Suggested dose:
–Glucosamine 1500 mg po qD
–Chondroitin - 1200 mg po qD
• Side effects:
–gastrointestinal symptoms
How Should We Discuss Herbs
with Our Patients?
• Ask “Are you taking any herbs or
supplements?”
• Approach the discussion from the
standpoint of safety
• Stress the fact that natural doesn’t
necessarily mean safe
• Educate
Guidelines for Patients
• Research each supplement before you
take it
• Always discuss with your providers
• List the supplements you are taking
with your prescription and OTC drugs
• Discuss possible drug-supplement
interactions with your pharmacist
Guidelines for Patients
• Take a minimum of supplements
• Never discontinue prescription drugs
without discussing with your provider
• Stop the supplement if you experience
side effects. Discuss with your
provider
• Do not use if you are pregnant or
nursing
Guidelines for Patients
• Do not give supplements to infants or
young children
• Store in original container, away from
children
• Stop all supplements two weeks before
surgery or anesthesia
Guidelines for Patients
• Choose supplements manufactured by
nationally known companies
• Avoid products containing more than 2
herbs
• Look for products with USP, NF or
TruLabel symbol
• Avoid foreign products unless the
quality is known
Guidelines for Patients
Choose products with
• standardized extracts
• clearly labeled quantities of active
ingredients
• expiration dates
• lot numbers
Independent Quality Regulators
National Nutritional Foods Association
www.nnfa.org
U.S.Pharmacopeia
www.usp.org
Consumerlab.com
www.consumerlab.com
Natural Medicines
Comprehensive Database
www.naturaldatabase.com
Compiled by the Editors of
Pharmacist’s Letter
Prescriber’s Letter