Term
| As defined by congress, criteria for dietary supplement is product that what? |
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Definition
- intended to supplement diet
- contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, AA's, other substances) and their constituents
- intended to be taken by mouth as pill, capsule, tablet, or liquid
- labeled on front panel as being dietary supplement
- this makes these substances FOODS, NOT DRUGS
- FDA expressly excluded from approval process unless toxicity has been rigorously proven
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Term
| Whats wrong with herbals? |
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Definition
- few controlled clinical studies supporting various claims
- complex mixtures
- what are the active principles
- are there important interactions with drugs or other herbals
- variability from lot to lot and manufacturer to manufacturer in bioavailability
- aka what dose are u getting
- contamination
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Term
| Examples the potential risk of contamination of herbals whether intended or unintended |
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Definition
- PC-SPES (mix of Chinese herbs that claimed to aid in tx prostate cancer)
- contaminated with DES and warfarin
- internet ED products- FDA study shows may contain other rx drugs, sildenafil
- other drugs found in dietary supplements
- alprazolam
- lovastatin
- indomethacin
- toxic components
- aristolochic acid in weight loss products led to renal failure and urothelial cancer
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Term
| Common misconceptions/false statements about commercial herbal products |
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Definition
- natural products are always safe
- FDA approves herbal preps before they are sold in US
- FDA ensures that herbal preps have standardized ingredients
- US has among the most rigorous standards in the world for herbal preps
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Term
| Required dietary supplement labeling |
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Definition
- this product is not intended to dx, tx, cure, or prevent any disease
- but people buy this because they believe it has such benefits
- labeling can state support for emotional health, etc., but must say these statements have not been approved by FDA
- but most Americans wrongly believe FDA must approve herbals before they are sold
- many purchase drugs across from OTC drugs that must be approved by FDA
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Term
| garlic (purported indication, active ingredient, conventional alternative) |
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Definition
- purported use
- hypolipidemic (some show reduction in total cholesterol)
- minor uses
- lower bp
- reduce platelet aggregation
- antimicrobial
- active ingredient: allicin
- alternative (both shown to be better)
- statins
- bile acid sequestering drugs
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Term
| ginseng (purported use, mechanism of action, adverse effects, drug interactions) |
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Definition
- purportive use: adaptogen and general cure all
- mechanism- increase steroid production, increase NO production
- actual data not compelling
- adverse effects
- CNS excitation
- hypoglycemia
- abnormal menstruation
- drug interaction- digoxin
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Term
| melatonin (purported use, mechanism of action) |
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Definition
- use- sedative, jet lag
- mechanism
- melatonin is normally secreted by pineal gland to enhance sleep
- recommended doses provide plasma levels well above endogenous
- possibly effective for some people
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Term
| ginkgo: proported use, conventional alternative, mechanism of action |
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Definition
- proported use- memory enhancer
- mechanism of action
- free radical scavenger
- inhibits platelet aggregation
- alternative: Donepazil
- studies showing that:
- modest improvements in small clinical trials with Alzheimer's patients
- large double blind study shows no better than placebo
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Term
| St Johns wart (proported use, adverse effects, mechanism of action, |
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Definition
- proported use: antidepressants
- mechanism- lots of active compounds that may bind to GABA or 5-HT
- adverse effects
- drug interactions
- sedation with SSRI
- increase bp, HR with MAOI
- decrease blood levels of many other drugs
- oral contraceptives
- HIV protease inhibitors
- anti leukemia drugs (imantinib mesylate)
- conventional alternative- SSRI, TCA, MAOI
- studies show:
- more effective than placebo of treating moderate forms of depression
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Term
| echinacea (proported use, studies, alternatives) |
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Definition
- purported use as immune stimulant to protect against colds and flu
- studies
- no benefit in common cold
- very little compelling data supports benefit
- alternative- no drug approved to treat common cold, but amantadine for flu
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Term
| saw palmetto: purported use, mechanism of action, studies |
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Definition
- purported use- prostate health
- mechanism- androgen antagonist and alpha 5 reductase inhibitor (decrease DHT)
- studies
- comparible to finestaride in reducing symptoms of BPH
- large study showed no improvement in BPH health over year of using saw palmiento over placebo
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Term
| glucosamine: purported use, studies, mechanism of action) |
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Definition
- purported use- pain or swelling in arthritis
- mechanism of action- principle component of GAG that form CT matrix
- need 2-4 weeks to see relief
- studies show:
- no significant clinical relief
- clinical relief when combined
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Term
| omega 3 (purported use, adverse effects, studies) |
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Definition
- purported use: hyperlipidemia, HTN, CV disease prevention, macular degeneration, ADHD
- adverse effects- increase LDL's
- at high doses, increase bleeding risk
- decrease vitamin E levels
- studies show:
- recently approved omega 3 formulation for very severe hyperlipidemia
- evidence supports significant decrease in triglycerides and modest improvement in HTN
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