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Scientifically formulated and clinically tested nutritional supplements
Herbal Supplements & the Quality of Herbal Products

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was established to meet the concerns of consumers and manufacturers that safe and appropriately labeled products would remain available to all who would like to use them. The provisions of DSHEA are provided as:

1. Defining dietary supplements and dietary ingredients
2. Placing the safety of the product responsibility on the manufacturer
3. Creating guidelines for literature used in connection with sales
4. Specifying how labeling can be used in support of health benefit claims
5. Specifying labeling requirements
6. Governing regulations of good manufacturing practices

DSHEA does not require FDA authorization for OTC herbal product labeling, however, The Federal Trade Commission (FTC) typically requires claims about the efficacy or safety of dietary supplements be supported by "competent and reliable? scientific evidence. To include botanical drug substances in an OTC monograph there must be published data establishing general recognition of safety and effectiveness, including results of adequate and well-controlled clinical studies. Numerous considerations are given to guide a supplier in assessing the adequacy of the scientific support for a specific advertising claim, which is meant to aid in the assurance of product content purity, safety and efficacy.

?Scientific validity for a health claim includes two components: 1) that the totality of the publicly available evidence supports the substance/disease relationship that is the subject of the claim, and 2) that there is significant scientific agreement among qualified experts that the relationship is valid?. Herbal Products are classified by the American Herbal Products Association (AHPA) as follows:

Class 1: No restrictions to it?s use
Class 2a: External use only
Class 2b: Not to be used during pregnancy
Class 2c: Not to be used during lactation
Class 2d: Other specific contraindications
Class3: Use only under expert supervision
Class 4: Unsafe

Herbal Supplement APHA class if known Indications Actions Contraindications

Side effects

Interactions

Dosage

Echinacea

APHA class: 1

 

Treatment and prevention of the common cold and flu

Immunostimulant

Enhances phagocytosis

Autoimmune or Chronic illness

Allergy to flowers of the aster family

Minor gastrointestinal irritation

Increased urination Mild allergic reactions

Immune suppressants

i.e, Neoral

Prednisone

Imuran

Methotreaxate

As powder extract: 300mg cap/TID

Alcohol tincture (1:5): 3-4ml TID

Juice: 2-3ml TID

Whole dried root: 102g TID

Goldenseal

Topical antibiotic for wounds that are not healing well

Mouth sores and sore throats

Strong activity against a wide variety of bacteria and fungi

Pregnancy

 

Gastrointestinal distress

Increased nervousness

 

As cream, cover entire surface of the wound

Tincture: swished or gargled

Tea: .5-1g in a cup of water

Kava Kava

APHA class: 2d

 

Mild to moderate anxiety

Insomnia

Anti-anxiety

Mild analgesic

Muscle relaxant

Anti-convulsant

Pregnancy

Nursing mothers

Endogenous Depression

 

Mild gastrointestinal irritation

Drowsiness

Yellowish skin discoloration, Balance disturbance

Skin rash

Enlargement of pupils

Benzodiazepine

Buspirone

Alcohol

Barbiturates

Anti-depressants

Anti-psychotics

Standardized extract:140-240mg in 2-3 divided doses (30-70% kava-lactones)

Ginseng

APHA class: 2d

Tonic

Stimulant

Diuretic

Diabetic impotence

Physiologic effects

Lower blood pressure

Depress CNS activity

Stimulates immune system

Coagulopathy

Diabetes

Insomnia

Schizophrenia

Cardiac Disease

Hypertension

Bleeding

Hypotension

Hypoglycemia

Insomnia

Medications for:

Psychosis

Diabetes

MAO inhibitors

Stimulants

Coumadin

Caffeine

American: Root:

.25-.5po BID

Asian (Panax):

.6-3gm 1-3 times daily

Gingko Biloba

APHA class: 1

Dementia

Improve cognitive, sexual, and GI functions

Dizziness / Tinnitus

CNS blood flow

Neuroprotective

Free Radical

capillary fragility

 

If the patient is on anticoagulants

Anticoagulants

Spontaneous bleeding

 

Cyclosporin

SSRI's

MAO inhibitors

Thiazide diuretics Anticoagulant properties may induce seizures, infertility

120-480mg/day in2 ? 3   divided doses

Herbal Supplement APHA class if known Indications Actions Contraindications

Side effects

Interactions

Dosage

Saw Palmetto

APHA class: 1

Antiinflammatory

8 Urinary Flow

9 symptoms of BPH

Inhibits dihydro-testosterone

Diurectic

Anti androgenic

Do not take while on prescription BPH treatment

None

Caution with diuretics

160 mg BID

Pygeum Africanum

Symptoms of BPH

Anti inflammatory

Diuretic,

9 cholesterol

Anti poliferative effect on fibroblast

None reported

Nausea and abdominal pain

None known

50 - 200 mg stand ext/day

Guarana

Stimulant headache

8 Energy

Sympathomimetic

Caffeine like activities

Cardiac problems

Renal disease

HTN or hyperthyroidism

8 Heart rate

HTN

Anxiety

Arrythmias

Avoid other stimulants

2x as strong as caffeine

Feverfew

APHA class: 2b

Migraine

Rheumatoid arthritis

Inhibits seretonin release

Aster family allergies

Avoid during pregnancies

GI upset 6-15%

1st week of use

Anticoagulants

(inhib cycloxygenase

50 mg - 1.2 gm/d

equivalent to 0.2 - 0.6

Hawthorne

Atherosclerosis

Arythmia

Improves cardiac output and coronary blood flow

Do not use with other inotropes

Mildly sedative

Digitalis

Fox Glove

160 - 900 mg/D

Black Cohosh

Menopause

Astringent

Diuretic

Expectorant

Vertigo

Tinnitus

Estrogen like action, Oxytocic

Luteinizing hormone suppression

Binds to estogen receptors

None known

Occasional GI upset

Nausea, Headache and dizziness in high doses

None known

Extracts w/alcohol:

40-60% (v/v) corresponds to 40mg drug

 

Garlic

APHA class: 2c

Reduces levels of lipids in blood

Prevents age-dependent vascular changes

9 Cholesterol 10-12%

 

Antibacterial

Antimycotic

Lipid-lowering

Inhibition of platelet aggregation

Prolongation of bleeding time

Enhances fibrinolytic activity

None known

GI upset

Allergic reactions

Odor may pervade breath and skin

Anticoagulants

Hypoglycemics

4g fresh garlic

(minced bulb and prep is taken orally)

Pulsatilla

Sedative, headaches

Fluid in the ears

Antispasmodic

Increases circulation

 

Avoid during pregnancy

 

 

 

Herbal Supplement APHA class if known Indications Actions Contraindications

Side effects

Interactions

Dosage

St. John's Wort

APHA class: 2d

Dizziness, Tinnitus

Mild to mod depression

Viral infections

Wound healing

Antidepressant

Weak MAOI

SSRI & DA agonist

Avoid in pregnancy

Photosensitivity

Anti-depressants

MAOI

Anti seizure meds

300 mg TID

Ma Haung

Asthma

Bronchial edema

(weight loss - not an approved use)

Stimulant

Sympathomimetic Bronchodilator

Cardiac problems

Anxiety

Hypertension

Angle closure glaucoma

Pheochromocytoma

Thyrotoxicant

HTN, neurosis,insomnia, palpitations, hyperglycemia

Death

Halothane

Cardiac glycosides

MAOI

Guanethedine

Oxytocin

15-30 mg total alkaloid

or

300 mg herb/d

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