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how are herbal medications marketed in the US? |
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They are marketed without FDA or other governmental premarketing review of efficacy or safety
There is also little governmental oversight of purity, variations in potency, or adverse effects |
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treatments that are not recognized by the medical community as standard or conventional medical approaches |
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controlled clinical trial |
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a clinical trial that compares a group of subjects who are receiving a treatment with a closely matched group of individuals who are not receiving a treatment |
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plants or plant extracts that people use to improve their health |
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a substance that is added to the diet to improve health and which usually containes dietary ingredients such as vitamins, minerals, amino acids, and enzymes |
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an inactive medication made to resemble the investigational formulation as much as possible |
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use:decrease duration and intensity of cold symptoms
nature: leaves and roots - contains flavonoids, polyacetylenes, and caffeoyl conjugates
Pharmacology: has cytokine activation and anti-inflammatory properties
Tox.: unpleasant taste and GI effects
- some dizziness or headache
- no drug interactions reported |
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use: treatment of respiratory ailments such as bronchitis and asthma, and as a CNS stimulant
nature: major chemical constituents = ephedrine (which is Rx drug) and pseudoephedrine (which is OTC decongestants); The FDA has banned marketing of dietary supplements containing ephedrine alkaloids (they pose cardiovascular risk); The ban not applied to Chinese herbal remedies
Pharmacology: indirect-acting sympathomimetics that release norepinephrine from sympathetic nerve endings
- ephedrine is a pressor agent
- commonly used for treatment of respiratory dysfunction, including bronchitis and asthma, and a s mild CNS stimulants
- In Chinese medicine, used for cold and flu sx, diuresis, and bone or joint pain
- ephedirine alkaloids = weight loss and enhancement of althletic performance
Toxicity: dizziness, insomina, anorexia, flushing, palpitations, tachycardia, and urinary retention
- in high doses = ↑ BP, cardiac arrhythmias, and toxic psychosis
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use: cholesterol lowering and atherosclerosis
Nature: contains organic thiosulfinates that can form allicin (this is the ODOR)
Pharmacology: - allicin inhibits hepatic hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase and angotensin-converting enzyme (ACE), blocks plately aggregation, increases nitric oxide (NO), in fibrinolytic, has antimicrobial activity, and reduces carinogen activation
- some evidence that it is more effective at lowering total cholestrol
toxicity: nausea, hypotension, and allergic reactions may occur
- antiplatelet action - so watch patients on anticoags or anti antiplatelets |
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use: treatment of intermittent claudication, and cerebral insufficiency and dementia
nature: leaves = flavone glycosides and terpenoids
pharmacology: -anti-oxidant and radical scavenging effects and increases nitric oxide formation
- animal studies: blood viscosity and changes in CNS neurotransmitters
- may reduce markers of oxidative stress associated with coronary artery bypass surgery
toxicity: GI effects, anxiety, insomina, and headache occur
- possible antiplatelet action, so monitor pts on anticoags or antiplatelet druggs
- maybe epileptogenic - don't give to those with seizure hx |
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use: improvement of physical and mental performance
nature: plants = triterpenoid saponin glycosides (except the Siberian or Brazilian plants)
pharm.: - COLD prevention and lowering postprandial glucose
toxicity: estrogenic effects = mastalgia and vaginal bleeding
- insomina, nervousness, hypertension
- use with CAUTION in pts receiving anticoags, antihypertensives, hypoglycemic meds, and psych meds |
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use: limitation of hepatic injury and as an antidote to Amanita mushroom poisoning
nature: fruit and seeds = contain flavonolignans such as silymarin
pharm.: in vitro studies = reduces lipid peroxidation, scavenges free radicals, enhances superoxide dismutase, inhibits formation of leukotrienes, and icnreases heptocyte RNA polymease activity
Tox: loose stools |
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use: treatment of mild to moderate depression
Nature: dried flowers = hypericin and hyperforin
Pharm. Hyperforin = decreased activity of serotonergic reuptake systems
- downregulation of adrenoceptors and upregulations of 5-HT receptors
- hypericin, when photoactivated, may have antiviral and anticancer effects
Tox.: mild GI effects and photosensization
- avoid in pts taking selective serotonin reuptake inhibitors or MAO inhibitors and those with history of bipolar or psychotic disorder
- formation of P450 isoforms and P-glycoprotein drug transporters
- it decreases the effectiveness of:
* birth control pills
* cyclosporine
*digoxin
*HIV protease inhibitors
*warfarin |
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use: improvement in sx of benign prostatic hyperplasia
nature: dervied from berries = contains phytosterols, aliphatic alcohols, polyprenes, and flavonoids
pharm: inhibition of 5alpha-reductase
tox: abdominal pain with GI distress, decreased libido, headache, and htn; no effect on PSA |
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use: improvement of ischemic heart disease and for Parkinson's disease
nature: ubiquinone = benzoquinone; serves as cofactor in the mitochondrial electron transport chain --> reduced to ubiquinol (an important antioxidant)
pharm: small degree of efficacy in reducing systolic and diastolic blood pressure and in treating coronary artery disease and chronic stable angina
- may have some efficacy in reducing muscle pain in patients with statin-related myopathy
tox: GI distrubances; rare effects include rash, thrombocytopenia, irritability, dizziness, and headache
- structural similarity to vitamin K and decrease the effects of warfarin |
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use: reduction of pain associated with osteoarthritis
nature: amino sugar that serves as the precursor of nitrogen-containing sugars (major constituent of CT, including the carilage in joints)
pharm: trials = mixed results
toxicity: occasionally cause diarrhea and nausea but otherwise is well tolerated
- it is prepared from crustaceans, there is some concern about cross-allergenicity in people with shellfish allergy |
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use: decrease jet lag symptoms and a sleep aid
nature: a serotonin derivative produced in pineal gland - regulates sleep wake cycles;
- other purported activities include contraception, prevention of aging, protection against oxidative stress, and the treatment of cancer, major depression, and HIV infection
pharm: FDA approved for insomnia
tox: sedation and next-day drowsiness and headache
- can suppress the midcycle susrge of luteinizing hormone (LH)
- DO NOT USE IN PREGNANCY or women attempting to conceive
- decrease prolactin levels = should not be used by nursing mothers
- can decrease sperm levels in healthy men |
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which drug protects against hepatic dysfunction? |
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which endogenous antioxidant reduces statin-induced myopathy? |
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Derivative of serotonin that may help in treating jet lag? |
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enhances immune function in vitro and used to treat sx of common cold? |
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