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8/13/2019 Aigul Baigazieva Common Herbs and Supplements
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COMMON HERBS AND
SUPPLEMENTS:A REVIEW OF SAFETY AND EFFICACY
Marina Shkayeva, PharmD
Natural Standard, PGY-1 Pharmacy Resident
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Natural Standard: Webinar Disclaimer
This webinar is intended for informational purposes only, and should not beinterpreted as specific medical advice. A qualified healthcare providershould be consulted before making decisions about therapies and/or healthconditions.
While some complementary and alternative techniques have been studiedscientifically, high quality data regarding safety, effectiveness, andmechanism of action are limited or controversial for most therapies.
Whenever possible, it is recommended that practitioners be licensed byrecognized professional organizations that adhere to clearly publishedstandards. In addition, before starting a new technique or engaging a
practitioner, it is recommended that patients speak with their primaryhealthcare providers.
Potential benefits, risks (including financial costs), and alternatives should becarefully considered. The following webinar is designed to providehistorical background and an overview of clinically oriented research, andneither advocates for or against the use of a particular therapy.
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Natural Standard evidence-based validated grading rationale
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Aa
An antioxidant berry from tropical Central and
South America
Reddish-purple fruit, tastes like a blend of berry
and chocolate
Variety of aa products are available: Juices, powders, tablets, and capsules
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Natural Standard: Dosing Disclaimer
The following doses are based on scientific research,publications, traditional use, or expert opinion.Many herbs and supplements have not been
thoroughly tested, and safety and effectiveness maynot be proven. Brands may be made differently,with variable ingredients, even within the same
brand. The below doses may not apply to allproducts. You should read product labels, anddiscuss doses with a qualified healthcare provider
before starting therapy.
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Aa
Evidence grade B:
Antioxidant
Evidence grade C:
Metabolic syndrome
Suggested:
1 oz. of powder mixedwith 10-12 oz. of
water once or twice
daily
Freeze-dried aa incapsules or tablets at
1-2g daily
INDICATIONS DOSE
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Natural Standard: Safety Disclaimer
The U.S. Food and Drug Administration does notstrictly regulate herbs and supplements. There is noguarantee of strength, purity or safety of products,
and effects may vary. You should always readproduct labels. If you have a medical condition, orare taking other drugs, herbs, or supplements, youshould speak with a qualified healthcare provider
before starting a new therapy. Consult a healthcareprovider immediately if you experience sideeffects.
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Natural Standard: Interactions Disclaimer
Most herbs and supplements have not beenthoroughly tested for interactions with other herbs,supplements, drugs, or foods. The interactionslisted below are based on reports in scientific
publications, laboratory experiments, or traditionaluse. You should always read product labels. If youhave a medical condition, or are taking other drugs,herbs, or supplements, you should speak with aqualified healthcare provider before starting a newtherapy.
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Aa
Likely safe in food
amounts
May reduce blood sugarlevels, caution with
diabetic agents
May block the effects ofimmunosuppressantagents
May increase potassiumlevels
ADVERSE EFFECTS INTERACTIONS
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Coenzyme Q10
CoQ10, ubiquinone Endogenously produced, fat-soluble
A co-factor in oxidative respiration for the Krebs cycle andthe electron transport chain
Levels decrease with age & in patients with: Cardiovascular disease, muscular dystrophy, Parkinson's
disease, cancer, diabetes, human immunodeficiency virus(HIV)
Standard therapy for congestive heart failure in Europe,Russia and Japan
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Coenzyme Q10
Evidence grade A CoQ10 deficiency
Evidence grade B Hypertension
Evidence grade C Alzheimer's disease
Cancer
Chronic fatigue syndrome
Migraine
50-1,200mg of CoQ10
daily
INDICATIONS DOSE
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Coenzyme Q10
Mild, brief, and self-resolving:
Nausea/vomiting/diarrhea(N/V/D), stomach upset,heartburn, appetite loss
Pruritis, rash
Insomnia, headache,dizziness, irritability,fatigue
Flu-like symptoms
May reduce warfarinseffectiveness
May deplete CoQ10 levels: Diabetes drugs
Tricyclic antidepressants
Antipsychotics
Statins
Alzheimer's drugs Anticancer drugs
Immune system-alteringdrugs
Diuretics, beta-blockers
ADVERSE EFFECTS INTERACTIONS
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Omega-3 Fatty Acids (Fish Oil)
Inuit people of Greenland have low occurrence of heartdisease Diet high in fat and rich in omega-3 fatty acids
Essential fatty acids in diet are omega-3 and omega-6 fattyacids Omega-3 and Omega-6 compete for same receptors
Omega-3: decreases inflammation
Omega-6: promotes inflammation
Optimal ratio of omega-6:omega-3 fatty acids is 4:1 American diet 20:1 up to 30:1
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Omega-3 Fatty Acids (Fish Oil)
Alpha-linolenic acid (ALA) Green vegetables, canola oil,
nuts, soybeans
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Omega-3 Fatty Acids (Fish Oil)
Evidence grade A
Coronary heart diseaseHyperlipidemia
Hypertension
Rheumatoid arthritis
Secondarycardiovascular disease
prevention
Americans consume 1.6g ofomega-3 fatty acids daily
~90% from ALA, and ~10% from EPA and DHA
Clinical trials:
1g capsules of omega-3 fattyacids
GRAS: 3g of omega-3 fatty acids
from fish daily
INDICATIONS DOSAGE
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Omega-3 Fatty Acids (Fish Oil)
N/V/D, decreasedappetite, constipation,
steatorrhea, fish burp Rare:
Mild elevations in liverfunction tests
Mania in patients with
bipolar disorder or majordepression.
Restlessness andformication
May increase bleeding
with:Aspirin
Anticoagulants
Anti-platelet drugs
Non-steroidal anti-inflammatory drugs(NSAIDs)
ADVERSE EFFECTS INTERACTIONS
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Red Yeast Rice
Red yeast rice (RYR) is the product of yeast (Monascus
purpureus) grown on rice, popular in Asian countries
Sold over the counter as Cholestin (Pharmanex, Inc.)
Contains monacolins, which inhibit cholesterolsynthesis
Monacolin K, has the same chemical structure as the drugs
lovastatin and mevinolin
RYR may lead to a 10-33% reduction in low-density
lipoprotein (LDL) levels
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RYR: A Federal Case
1998: Cholestin (Pharmanex, Inc.)taken off the
market due to monacolin K or lovastatin content,
an active ingredient of Mevacor (Merck & Co.)
Now: Cholestin can be purchased in the United
States from Pharmanex or specific dealers
Pharmanex claim:Cholestin contains 12 natural
substances acting together to "support healthycholesterol levels."
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Red Yeast Rice
Evidence grade A:
Hyperlipidemia
Evidence grade C:
Coronary heart disease
Diabetes
1,200mg of RYR
capsules two timesdaily
INDICATIONS DOSAGE
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Red Yeast Rice
Limited evidence on theside effects of red yeast
Like lovastatin: Heartburn, gas, bloating
Muscle pain or damage
Dizziness, asthma, andkidney problems
Avoid in people with liverdisease
Additive effects with
drugs that increasebleeding
Like lovastatin:Alcohol and other drugs
toxic to the liver should
be avoided
ADVERSE EFFECTS INTERACTIONS
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Garlic
A culinary herb used for cardiovascular disease and
cancer
Use of garlic might date back to ancient Greek
medicine and traditional Chinese healers
Has a sulfur compound alliin, which makes allicinwhen the bulb is crushed or ground
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Garlic
Evidence grade A
HyperlipidemiaHypertension
Evidence grade BCardiovascular disease
risk
World Health
Organization (WHO)recommends daily:
2-5g fresh garlic (2-5mg of allicin)
2-5mg oil 300-1,000 mg of
extract
INDICATIONS DOSAGE
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Garlic
Allergies:Liliaceae family Hyacinth, tulip, onion, leek,
and chives
Common:Bad breath, bodyodor
Rare: Dizziness, anorexia,
N/V/D, belching, heartburn,constipation, flushing,tachycardia, insomnia,headache, fever, chills
Serious:Bleeding
Increased bleeding risk
with:Aspirin
Anticoagulants
Anti-platelet drugs
NSAIDs
ADVERSE EFFECTS INTERACTIONS
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Ginseng
Species of the genusPanax of the Araliaceae family
Most common are American and Asian ginseng
Ginsenosides are the active components of ginseng Quantity depends on species and growth conditions
In traditional Chinese medicine used for:
Increasing appetite, blood volume, strength Enhancing physical performance and memory
Reducing fatigue and stress
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Ginseng
Evidence grade B
Hyperglycemia Immune system
enhancement
Mental performance
100-200mg daily
German pharmacopeia(DAB 10):
1-2g of dried ginseng
root or 20-30mg
ginsenosides
INDICATIONS DOSAGE
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Ginkgo
Ginkgo bilobahas been used for thousands of yearsand is a top selling herb in the United States
Traditional Chinese Medicine (TCM): Pulmonary diseases, circulatory disorders, memory
loss, and skin lesions
Europe and the United States:Dementia, memory enhancement, and claudication
Not GRAS
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Ginkgo
Evidence grade A
Claudication(peripheral vascular
disease)
Dementia
80-240mg of a 50:1standardized leaf extract
daily
30-40mg of extractprepared as a tea
Effects may take 4-6weeks to appear
INDICATIONS DOSE
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Ginkgo
Cross-sensitivity withurushiols
Mango rind, poison sumac,poison ivy, poison oak,cashews
Well tolerated at suggesteddoses up to six months
Headache, nausea, intestinal
complaints, bleeding May be unsafe in children
May increase the risk ofstroke
May increase bleedingrisk with:
Aspirin
Anticoagulants
Anti-platelet drugs
NSAIDs
May affect insulin andblood sugar levels
ADVERSE EFFECTS INTERACTIONS
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Echinacea
Echinaceaspecies are of the Asteraceae family andoriginated from North America
In Europe and the United States for upperrespiratory tract infections (URIs)
~10% of the dietary supplement market
Many positive trials published before 2001
Limited quality or combination products
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Echinacea
Evidence grade B URI treatment (adults)
Evidence grade C Cancer
Genital herpes
Immune systemstimulation
URI prevention
URI treatment (children)
URI or common cold: 500-1,000mg three times
daily
Tea: two teaspoons (4g)of herb in one cup of
water daily
Taken for up to a week
INDICATIONS DOSAGE
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Echinacea
Cross-sensitivity to theAsteraceae family
Including ragweed,chrysanthemum,marigold, and daisy
Well tolerated and fewadverse effects
GI effects and rashes
Mildly interact with
cytochrome P450enzymes
ADVERSE EFFECTS INTERACTIONS
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Question
Which of the following herbs increase the risk of
bleeding?
A. Coenzyme Q10
B. Red yeast rice C. Garlic
D. Ginseng
E. Ginkgo
F. Echinacea
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Question
Which of the following herbs increase the risk of
bleeding?
A. Coenzyme Q10
B. Red yeast rice
C. Garlic
D. Ginseng
E. Ginkgo F. Echinacea
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Summary
SUPPLEMENT INDICATION ADVERSE
REACTION
Acai Anti-oxidant Generally safe
Coenzyme Q10 Deficiency, HTN Mild GI
Omega-3 fatty acids Elevated triglycerides Mild GI, fish burp
Red yeast rice Hyperlipidemia GI, muscle pain
Garlic Hyperlipidemia, HTN Bad odor, bleeding
Ginseng Mental performance,immune stimulation Insomnia, bleeding
Ginkgo Dementia Bleeding,
hypoglycemia
Echinacea Immune stimulation Allergic reactions
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Black Cohosh
Alternative to hormonal therapy for menopause:
Hot flashes, mood disturbances, sweating, palpitations,vaginal dryness
Controlled trials and case series:
Improved menopausal symptoms for up to six months
Lacking safety and efficacy data after six months
Controversy:is there an effect on estrogenreceptors?
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Black Cohosh
Evidence grade C:
Arthritis painBreast cancer
Infertility
Menopausal symptoms
Migraine (menstrual)
Traditional doses
1-2g three times a day
Studies, menopausalsymptoms
20-40mg Remifemintablets twice a day for12 weeks
INDICATIONS DOSAGE
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Black Cohosh
Not GRAS
High doses:
Frontal headache, dizziness,visual disturbances
Rare:
GI effects, bone mass loss,irregular heartbeat, low blood
pressure, muscle damage
Unclear if safe in hormone-sensitive conditions
Estrogen-like effect isdebated
May interact with Tamoxifen
Raloxifine
Caution with otherhypotensive agents, foradditive effects
ADVERSE EFFECTS INTERACTIONS
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Blue Cohosh (Do Not Confuse)
Traditionally: To stimulate and ease labor
Theory: Pelvic inflammatory
disease, endometriosis,erratic menstruation
I n vitroand in vivo: Increased uterine
contractions
Sufficient data is lacking
Overdose: Nausea, vomiting,
headache, thirst, dilatedpupils, muscle weakness,tachycardia, cardiovascularcollapse, and convulsions
Cases of neonatal
myocardial toxicity andnewborn myocardialinfarction
Sufficient data is lacking
INDICATIONS SAFETY
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DHEA (Dehydroepiandrosterone)
An endogenous hormone from the adrenal gland
Precursor to androgens and estrogens
DHEA levels in the body begin to decrease afterage 30, and reported to be low in people with:
Anorexia, end-stage kidney disease, type 2 diabetes,AIDS, adrenal insufficiency, and in the critically ill
DHEA levels may be depleted by drugs
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DHEA
Evidence grade B: Adrenal insufficiency
Depression Obesity
Systemic lupuserythematosus
Evidence grade D: Memory
Muscle strength
Common
25-200mg daily up toone year
Depression in
HIV/AIDS
200-500mg daily
INDICATIONS DOSAGE
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Kava
Kava beverages, from roots of the shrubPipermethysticum
Traditionally used in the South Pacific
Pleasant mild psychoactive effects, similar to alcoholicbeverages
Preliminary evidence:
Efficacy may be equivalent to benzodiazepines
Was used as an anxiolytic in Europe and USA
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Kava
Evidence grade A:
Anxiety
Evidence grade C:
Insomnia Parkinson's disease
Start low and increaseover time
50-280mg kava lactonesat bedtime
60-120mg ofkavapyrones daily
High dose in studies 800mg daily of kava
extract (short term)
INDICATIONS DOSAGE
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Kava
Not GRAS anymore Cases of liver toxicity
and liver failure May cause kidney
damage
Natural medicineexperts: Kava is safe at
recommended doses
No clear conclusion
Acetaminophen
Additive sedation with
alcohol Worsen side effects of drugs
blocking dopamine (e.g.Haldol)
Additive with monoamineoxidase inhibitors
Prolong effects of anesthesia
Stop kava 2-3 weeks beforesurgery
ADVERSE EFFECTS INTERACTIONS (Theoretical)
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Valerian
Valeriana officinalis: Valium of the 19th Century" Restlessness, insomnia, hypnotic, sedative, antispasmodic
MOA:increase synaptasomal gamma-aminobutyric
acid (GABA) concentrations
May contain up to 150 compounds, not all of whichhave been investigated
Known compounds: valepotriates, volatile oils, kessanes,valerenal, valeranone, and valerenic acid
Bad smell: isovaleric acid
Cat attractant: actinidine
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Valerian
Evidence grade C:
AnxietyDepression
Insomnia
Menopausal symptoms
Sedation
Studies:
400-900mg of extractat bedtime
300-1,800mg capsule
Historically as tea
1.5-3g root
INDICATIONS DOSAGE
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Saw Palmetto
Traditionally used by Native Americans
Serenoa repensused in Europe and USA for benignprostatic hypertrophy (BPH)
Many studies:superior to placebo for BPH symptoms
However: Trials were short(1-6 months) and had small sample sizes
Did not use standardized outcomes measurements
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Saw Palmetto
Evidence grade A: Benign prostatic
hypertrophy
Evidence grade C Androgenetic alopecia
Hypotonic neurogenic
bladder Prostate cancer
Prostatitis
BPH studies:
320mg daily
Reports:
160mg daily may be
as effective as 160mg
twice a day
INDICATIONS DOSAGE
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Saw Palmetto
Common:
Gastrointestinaleffects, bad breath,
constipation
Increases bleeding risk with:
Aspirin
Anticoagulants Anti-platelet drugs
NSAIDs
Should not be taken withdrugs that affect androgenlevels:
Finasteride (Proscar)
Flutamide (Eulexin)
ADVERSE EFFECTS INTERACTIONS
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Peppermint
Mentha x piperitais a hybrid of spearmint and watermint
Products: peppermint oil, menthol
GRAS in food amounts
MOA: reduces gastrointestinal smooth muscle motility,perhaps by calcium channel antagonism
Food and pharmaceutical industries use for coolingproperty, scent, and flavor
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Peppermint
Evidence grade A Irritable bowel
syndrome (IBS)
Evidence grade B Antispasmodic
Breast tenderness Dyspepsia
Headache (topical)
Recommend not usingpeppermint oil topically morethan 3-4 times daily
Intestinal/digestion disorders:
0.2-0.4mL of peppermint oilin enteric-coated capsules orliquid preparations TID
For sore throat
2-10mg of peppermint oil in alozenge
INDICATIONS DOSAGE
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Peppermint
Topically: allergic reactions,mouth ulcers, chemical burn
Orally: dizziness, heartburn,slow heart rate, dental caries,gingivitis, or muscle tremor
Use cautiously in hiatalhernia, achlorhydria,gastroesophageal refluxdisease
May moderately inhibit CYP1A2, 2E, and 3A4
May cause synergistic effectswith anti-hypertensives andanti-hyperglycemics
Menthol may enhanceabsorption of steroids,salicylates
ADVERSE EFFECTS INTERACTIONS
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St. Johns Wort
Extracts ofHypericum perforatumis not on GRASlist
Treatment of mild-moderate major depression:More effective than placebo and equally effective as
tricyclic antidepressant drugs for 1-3 months
Controversy about the trials, problems in design
Serious interactions with prescription drugs, herbs,and supplements
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St. Johns Wort
Evidence grade A Depression
Evidence grade B Somatoform disorders
Evidence grade D Depressive disorder
Human immunodeficiencyvirus (HIV)
Trials:
0.17-2.7mg ofhypericin daily
150-1,800mg of St.
John's wort extractdaily
INDICATIONS DOSAGE
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St. Johns Wort
Well tolerated atrecommended doses for up to1-3 months
Common (1-3%):
GI upset, fatigue, sedation,anxiety, sexual dysfunction,dizziness, headache, dry
mouth
May cause suicidal andhomicidal thoughts
CYP 450 inducer
Studies had smallpopulations, bias, variableduration and dose
Carbamazepine,cyclosporine, midazolam,simvastatin, warfarin
FDA: patients on medicationsfor HIV should not take St.John's wort
Antidepressants: serotoninsyndrome and mania
ADVERSE EFFECTS INTERACTIONS
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Summary
SUPPLEMENT INDICATION ADVERSE EFFECTS
Black cohosh Menopausal symptoms GI effects, bradycardia,
hypotension
**Blue cohosh Stimulate labor Toxic to mother &
fetusDHEA Adrenal insufficiency Fatigue, tachycardia
Kava Anxiety Liver toxicity
Valerian Anxiety, insomnia Sedation
Saw palmetto BPH BleedingPeppermint Irritable bowel
syndrome
Dyspepsia, topical
irritation
St. Johns Wort Depression GI effects, anxiety
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Conclusions
Many herbs and supplements lack quality studies
Supplements/herbs are generally well tolerated in
recommended doses with no contraindications
Be aware of interactions and safety information
that is available
f
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References
Information is based on a systematic review of scientific literatureedited and peer-reviewed by contributors to the Natural StandardResearch Collaboration (www.naturalstandard.com)
Dietary Supplements. Food and Drug Administration. October 14,
2012.
Kimpel , Paul. The Cholestin Case: Drug vs. Supplements. InteractiveMedia Lab at University of Florida. October 12, 2012.