صفحه 1:
oe
صفحه 2:
لان ات ۱
Medicines:
What You Should Know
Mandy Leonard, R.Ph.,
Pharm.D., BCPS
Drug Information Specialist
Department of Pharmacy
The Cleveland Clinic
Foundation
صفحه 3:
Objectives
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
ا الت سام تاق
Discuss commonly used dietary
supplements, including herbal medicines.
Review reputable sources of information
regarding herbal/alternative medicines.
صفحه 4:
Introduction
* 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
صفحه 5:
صفحه 6:
Top-Selling Herbs in
Mainstream Market in
U.S. 2001 =
* Gingko ($46) * Cranberry
۱ ($40) ($11)
* Garlic ($39) | ° Black cohosh ($10)
* Ginseng ($31) 0 4 )۵ 9(
* Soy ($28) * Milk thistle ($ 7)
* Saw Palmetto ($25) * Evening primrose ($ 6)
¢ St. John’s wort ($24) * Grape seed ($ 4)
* Valerian ($12) 0 (cy ee
* Yohimbe ($ 2)
($ in millions; Herbalgram 2002;55:60.)
صفحه 7:
Top-Selling Herbs in
Mainstream Market in
RPT AC)
[0
* Ginkgo ($32) ($11)
* Echinacea ($32) لك ($ 8)
* Soy ($28) اوا تف اننا نا ($ 7)
* Saw Palmetto ($23) * Evening primrose ($ 7)
* Ginseng ($21) * Kava kava ($ 6)
* St. John’s wort ($15) رازن ($ 3)
* Black cohosh ($12) ۰ 6۲۵۵9 0 ($ 3)
9 ($ 2)
(2003:58:710 صعدولهطعل رعدمنللنه صذ 4)
صفحه 8:
Herbal versus
Conventional
Medication
ی
5ع لهدده ی
وتو ان
effects
* Lack of effective treatments/cures
صفحه 9:
Herbal versus
Conventional
21 210011615 هطو 01 9
safe because derived from nature
الى influence
* Desire to have control of one’s
own health
* False claims from manufacturers
صفحه 10:
Safety Considerations
0 to 70% of patients do not inform
physicians about use of alternative therapies
اف
- One or more chemical component of the plant
BRC SKS MMi eK mC Tien elite
نت۱۰
- FDA does not require reporting of adverse
pure CBIR ا اك ا
(MedWatch and SN/AEMS)
SCH (MBM a aye Clima MOC MILI betep)
صفحه 11:
Safety Considerations
¢ Standardization
- Nomenclature and chemical constituents
11
۳
* Lack of Good Manufacturing Practices (GMPs)
* Examples: ginseng, ephedra
ا ل القت لل لات
- Lack of active ingredient
- Contamination
صفحه 12:
* Ephedra (ma haung)
- Ephedra sinica
- Anorexiant, decongestant
* Licorice
5 (enyeaiihz-Mellleya=t - 190 مصنعهمطوه =
- Peptic ulcers - طخدعل ,8115 رعصمتاه] أملدط
- High doses - Maximum recommended
ای تست (pseudoaldosteronism)
- Contraindications
- Use no longer than 6 0 ۳ ۷
ne - Drug interactions
Sey AD CM erste
- Contraindications مصناقده
- Drug interactions
Se Dec etemm ateaerroriv tiles
صفحه 13:
Ephedra
* Products containing ephedra account for 64% ۴
of all adverse reactions to herbs in the US
* Less than 1% of herbal product sales
* FDA announced ban on 12/30/2003
٠ After Mid-March 2004, illegal to
manufacture or sell dietary
supplements that contain الالال لتنا
ephedrine and related alkaloids
٠ Does not include teas
صفحه 14:
Kava
(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
3
- FDA warning; Canada and some European
countries- market removal
- Kava dermopathy
Use no > 4 weeks; no alcohol/sedating
medications; caution when driving or operating
لات عت
صفحه 15:
FDA Proposed Labeling
and Manufacturing
2215
* Designing/construction of physical plants
* Establishing quality control procedures
* Testing manufactured dietary ingredients and
1م511 5
=
- Five out of 18 soy or red clover-containing products
* Only 50 to 80% of declared isoflavones
ا ا
¢ Almost 10 times more niacin >
- Folic acid
* Only 35% of what was stated on label
صفحه 16:
or tablet
Testine St. John’s Wort
In a spot check of retai 1 wert suppleme:
varied, according to 4 : tent laborat
commissioned &
The potency de :
صفحه 17:
صفحه 18:
صفحه 19:
ConsumerLab.com
How to Read a ConsumerLab.com Approved
Quality Product Seal:
This seal
Product met ie is a registered
CL’s standards. certification mark.
Product was tested
CL is independent and for ingredient quality.
a
consumer-focused.
ConsumerLab.com
GINKGOBILOBA gore about this
product, ingredient,
and testing at our
web site.
You can learn
This specific Product was
ingredient was laboratory-tested
tested. by experts.
صفحه 20:
NSF International
صفحه 21:
Potential Warfarin-Herb
11100
* Ginger ° Feverfew
Seeley Rita - Additive effect
- Avoid supplements, but - Monitor or avoid
اسه
problematic - Increased
* Garlic metabolism &
ل sii oa decreased effect of
Sa Naess 1 حنهته 1۳۲ ا
و( - Monitor or avoid
should not be
problematic
صفحه 22:
Consumer Survey
* Herbal use, products, and willingness to inform
health care practitioners
* 794/1300 surveys returned
- 42% (n=330): Herbal product use
- Common herbal products (aloe, garlic,
ginseng, echinacea, and St. John’s wort)
- Women (majority)
- Higher education (75%)
- Herbal users = more prescription
medications
- Herbal users = negative perception of
| ل
0
صفحه 23:
Laws 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
صفحه 24:
Structure/Function
Statements
* “This product is not intended to
diagnose, treat, cure or prevent a
1 "عودع
¢ Change in definition of disease
¢ Examples:
- 59و10 تتتقط ته ددع لع ستسخسصعوطم 4
with aging
- Hot flashes
Se Sauna lm at icy
Herbalgram 2000;48:32-8
صفحه 25:
- Distinct chemical component
* Work synergistically
- Improves blood flow (brain and heart)
- Protects against oxidative damage
from free radicals (antioxidant)
- Inhibits effects of platelet activating
factor (PAF)
صفحه 26:
“Eyer since she’s been taking
ginkgo biloba, she’s been remembering
all our old arguments.”
صفحه 27:
Ginkgo: Efficacy
* Data demonstrate ginkgo leaf extract can
Vie mE ROCCE if
(roles VLAN وصنصمتامص؟ لهمتع50 0صه صمتامصی؟
in patients with multiple types of
dementia.
* No direct comparisons to conventional
medications for dementia.
* Modestly improve visual memory and
ل ل ل ال
demented patients with age-related
memory impairment.
صفحه 28:
©5015 :0121200
& ع
Interactions
۰ pez ffects:
= ee رکطمن۲6۵»1
gastrointestinal disturbances
- Spontaneous bleeding (few case reports) 5
* Drug Interactions:
- Anticoagulants (Coumadin®)
- Antiplatelets (aspirin, Plavix®, Ticlid®)
صتاعط] -
صفحه 29:
0210
Dose and
را
¢ Standardized: 24% flavone
0176051065 له 690 5
(leaf extract)
* Dementia:
- 120 to 240 mg ginkgo leaf extract
administered orally in two or three
divided doses
صفحه 30:
Ginkgo: Summary
¢ Mild-to-moderate vasoactive agent
* Data promising in Alzheimer’s Disease
* Used extensively in Germany
¢ No comparison to standard of care
* Well-tolerated (weeks to 1 year)
طخت عدم تناع و تتعغصز لاتتعغط-وتحسل ٠ CsCl
anticoagulants, antiplatelets, and
۹
صفحه 31:
Ginseng
* Each type of ginseng is unique
- Asian or Oriental ginseng (Panax ginseng)
- Siberian ginseng (Eleutherococcus senticosus)
- American ginseng (Panax quinquefolius)
* Active ingredients: Root (panaxosides)
الا
ل ا للق
- Lowers blood pressure
* Ginsenoside Rg-1
۳ VBA CR matt
See ل
صفحه 32:
Panax Ginseng:
Efficacy
Data demonstrate possibly effective:
- Improving abstract thinking, selective
memory, and mental arithmetic skills (more
effective in conjunction with ginkgo biloba leaf
امو قوت
- 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
صفحه 33:
Panax Ginseng: Adverse
Effects & Drug
Interactions
° Adverse Effects:
- Nervousness, insomnia, excitation,
palpitations, affects blood pressure,
lowers blood glucose, alters immune
functiom
BRGUCC ات berm eC eat mL)
* Drug Interactions:
- Antidiabetic agents
- Warfarin (Coumadin*)
صفحه 34:
St. John’s Wort (Hypericum
perforatum)
*Common forms: capsules, tablets, tinctures=
۰: ال
- Flowering tops
- Naphthodianthrones (one of many potential active
(متمصعص موسرو =
+ Hypericin - Inhibits MAO, > MAO,
۱ C ICM tla RRO MCHC t ey
SEcCSCUK emily taCreLaeteimouaciipec Lately
© CocyeybetyiretiCm tility tary ٠
- Catechol-O-methyl-transferase (COMT)
111 ل
صفحه 35:
St. John’s Wort:
Efficacy
¢ For the treatment of mild-to-moderate
أقطا عأهوتاكططةهططعل0 وكهل ردمتددوع:1مع0
St. John’s 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®*)
صفحه 36:
St. John’s Wort:
PANG ع 5ا0ع1811 101110
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
صفحه 37:
st. John’s Wort:
Dose and ۱
RP RELIES ea Late
- 0.3% hypericin
- 5% hyperforin
* Mild-to-moderate depressifj*
- 300 mg
+ Administed orally three times a day
- Doses of 1200 mg/day have also been
used
صفحه 38:
Echinacea
(Echinacea angustifolia, pallida,
purpurea)
* Common Forms: tablet, juice, tea
* Purple coneflower
* Source: Applicable parts are the
roots and above ground parts.
٠ Pharmacologic action
[constituent(s)?]
٠ اأتتتقاعة لمستتحتاصة أمعع11ل0م1
ار ل ال نا للك
- Cytokines, monocytes, natural killer cells
صفحه 39:
Echinacea: 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.
صفحه 40:
Echinacea: 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
صفحه 41:
Echinacea:
م1005 30
و( 1 1 1
* 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
صفحه 42:
Echinacea: Summa
¢ Formulation/species that offer mos
benefit is unclear. co
¢ E. purpurea pressed j تكلا or E. pallida
root extracts at first sign of cold
٠ 11 taken greater than 8 weeks
- Reduced immunostimulatory effects?
- One week drug holiday (not
substantiated)
* Well-tolerated (up to 12 weeks)
صفحه 43:
Dietary Supplements:
Immune- تست
AeA
* Grape seed
extract
* Melatonin
* Siberian ginseng
lacus
Alfalfa
Panax ginseng
ا vhs)
Cat’s claw
Coenzyme Q10
DHEA
Echinacea
[ef-ab Tor
صفحه 44:
صفحه 45:
Herbal 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
01
صفحه 46:
Discontinuation of Use
Before Surgery
¢ Echinacea * Ginseng
- مهل ولح - 7 days
Be nen Cy errant - Hypoglycemia; Bleeding
0 . 2
huang) - 24 hours
- 24 hours Sector
- Cardiac cautions * St. John’s Wort
¢ Garlic aa PNT
- 7 days ۳ عممتاع هوم مامد
~ Biceding * Valerian
هاهه 0 - تایه
0 0
- Bleeding JAMA 2001;2860):219
صفحه 47:
Herbal References
* Natural Medicines Comprehensive
ععوطم]ا2
- $92/year (book or web version)
- $132/year (book and web version)
* The Review of Natural Products
- $160/year (bimonthly updates)
* The Professional’s Handbook of
Complimentary and Alternative Medicine
۳ لك
صفحه 48:
Natural Medicines
Comprehensive
_ Database _
NATURAL MEDICINES (/7P>\
ات لیات نت Te J]
00
fags
2272
صفحه 49:
۴۲ اك
Natural Products
Lat a ey
رخ نتملا
۹
2000
صفحه 50:
صفحه 51:
PDR for Herbal
Medicines
صفحه 52:
American Botanical
Council (ABC)
Ginseng’s Good Name + Herb Baths + Aromatherapy « St. John’s Works
|
|
ا
7
95
5
صفحه 53:
Herbal 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
Peel rte ty
صفحه 54:
11121 26 5
* The Herbal Internet Companion
- Herbs and Herbal Medicine Online
- $20 (ISBN 0-7890-1052-6)
صفحه 55:
IBIDS Databasy
* 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
111 لان
٠ عكدطهغهل 18125 للدظ
* Peer-Reviewed Citations Only database
* IBIDS Consumer database
صفحه 56:
CARDS Database
* Computer Access to Research on
[ممنا5 كتداع نآ 5
- Office of Dietary Supplements (ODS) at
the NIH
- Specific mandates from the DSHEA
9 تفت رتیت
pertaining to dietary supplements
- Free of charge
- www.ods.od.nih.gov
صفحه 57:
Summary
٠ غ215 تتتهطم 220 ,21115 برسملءأووطم لاع]'
about herbal therapy use (documentation)
¢ “Natural” does not mean safe
¢ Herbal-pharmaceutical interactions do
Clete i a
* Lack of standardization (variability in
herbal content and efficacy among
manufacturers)
* Lack of quality control and regulation
(contamination and misidentification)
صفحه 58:
Conclusions
* 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 3
of judgment.
* Base advice on available knowledge that
is congruent with your needs and the
OCC MMM mente
* Majority of recommendations are NOT
evidence-based
صفحه 59:
PHARMACY
“My husband hasn’t been himself lately. Do
you have any pills to keep him that way?”