Term
| complementary medicine usage |
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Definition
• According to 2012 National Health Survey Interview, 33% of all American adults used some form of complementary or alternative medicine (CAM).
• More common: • Women
• Higher education status
• ~$30 billion annually in the U.S. |
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Term
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Definition
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Term
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Definition
• Dietary Supplement Health and Education Act of 1994
• Dietary supplements:
• Taken by mouth
• Intended to supplement the diet
• Includes vitamins, minerals, herbs, amino acids, and other organic substances
• Must be formulated similar to a drug (tablet, capsule, etc.) |
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Term
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Definition
• FDA Center for Food Safety and Applied Nutrition regulates supplements and reviews supplement labels prior to marketing
• Manufacturers cannot make a disease claim (e.g., “reduces risk of stroke”)
• Can make structure/function, nutrient, health claims (e.g., “supports immune health”)
• Must include disclaimer:
“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. |
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Term
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Definition
• Manufacturer responsible for making sure
product is safe but...
• No requirement to demonstrate safety or
efficacy to FDA before going to market
• FDA can remove from the market if: • FDA can demonstrate harm
• Product contains prescription drug |
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Term
| Regulation of supplements |
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Definition
• 2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act: required to report serious adverse events to the FDA
• 2007 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements: required to comply with Good Manufacturing Practice (GMP)
• Limited FDA resources to audit and enforce compliance with GMP
• 2011 Food Safety Bill: manufacturers must register with FDA annually and FDA can recall supplements it deems dangerous |
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Term
| Dietary Supplements: Quality extrinsic factors |
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Definition
• Contamination (heavy metals, pesticides, microbes, mycotoxins)
• Adulteration (intentional addition of extraneous, improper, or inferior products)
• Misidentification |
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Term
| Dietary Supplements: Quality intrinsic factors |
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Definition
• Single plant may contain hundreds of chemicals
• Non-uniform ingredients |
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Term
| Drug Interactions w supplements |
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Definition
• Common and numerous
• Herbal products may contain hundreds of active and inactive compounds
• Common names may refer to multiple compounds |
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Term
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Definition
• Compared 44 products from a dozen companies to samples obtained from horticultural greenhouses
• >50% contained plant species not listed on the label
• ~1/3 did not contain the stated ingredient
• No standards for authenticating herbal products |
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Term
| United States Pharmacopeia |
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Definition
- Voluntary program through USP
- Stringent testing and auditing criteria:
• Onsite audit assessing compliance with USP general chapter <2750> and FDA current Good Manufacturing Practices
• Review manufacturing and quality control product documentation
• Laboratory testing of sample from manufacturer for compliance to standards of quality
• Off-the-shelf testing of randomly sampled dietary supplements to confirm that USP Verified product also meets standard |
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Term
| Supplements: Hepatotoxicity |
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Definition
• Many dietary supplements, especially those marketed for muscle-building and weight loss, associated with significant hepatotoxicity
• ~20% of drug-related liver injuries that led to hospitalization in 2010–2012
• May be due to unlisted steroids, green tea extract |
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Term
| How are dietary supplements regulated differently than drugs? |
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Definition
Manufacturers cannot make a disease claim (e.g., “reduces risk of stroke”).
Must include disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
No requirement to demonstrate safety or efficacy to FDA before going to market. |
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Term
BC recently purchased an herbal weight loss product online. She has struggled with weight loss and is excited that she finally found a product that can help. The website says that this replaces the need to diet and exercise and that this natural product has no side effects.
How would you counsel BC? |
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Definition
| Bodybuilding, weight loss, and sexual enhancement products are particularly high risk. Many weight loss products contain various forms of caffeine or ephedra-like compounds. There are multiple red flags in this case—no weight loss product eliminates the need to control the diet and exercise and no product is without side effects. The FDA website should be consulted to identify any product-specific safety issues. |
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Term
| Supplements: Significant Toxicity |
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Definition
• Aristolochia: nephrotoxic, carcinogen
• Kava: hepatotoxicity
• Ephedra: associated with increased risk of myocardial infarction, death
• Heavy metals: varies by compound, commonly found in products imported from Asia |
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Term
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Definition
• Echinacea purpurea, Echinacea pallida,
Echinacea angustifolia
• Active compound(s) unknown, not standardized against a specific compound
• Enhance immune function: mixed results, studies generally of poor design
• Large meta-analysis in 2014 found no statistically significant benefit in the prevention or treatment of colds
• Dose varies by formulation
• Adverse effects: flu-like symptoms, unpleasant taste, dizziness, GI upset, rash, hepatitis, blood dyscrasias
• Avoid use in patients with abnormal immune system (both immunosuppressed and patients with autoimmune disease)
• Drug interactions: none reported |
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Term
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Definition
• Standardized to allicin or alliin content
• May have minimal positive cardiovascular effects that are similar to dietary interventions
• Large NCCIH trial failed to show significant LDL-lowering effects
• Dose: 900 mg/day powdered garlic or 4 g raw garlic
• Adverseeffects:headache,nausea, hypotension, allergy, odor, asthma, rare antiplatelet effects
• Avoid use in patients with bleeding problems or who are receiving anticoagulants
• Drug interactions: may reduce bioavailability of
saquinavir, increased hypoglycemia with
chlorpropamide |
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Term
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Definition
• No consistent benefit in treatment of peripheral vascular disease, cognitive decline, hypertension
• Did not slow rate of cognitive decline or lower blood pressure in large 2009 NCCIH-sponsored RCT in older adults
• Did not reduce progression to Alzheimer’s disease in large RCT published in 2012
• Dose: 120–240 mg in divided doses
• Adverseeffects:nausea,headache,dyspepsia, diarrhea, allergic reactions, anxiety, insomnia, rare antiplatelet effects, seizures
• Avoid use in patients with bleeding problems or history of seizures
• Drug interactions: increased risk of bleeding with anticoagulants, increased blood pressure with thiazide diuretics, increased sedation with trazodone |
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Term
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Definition
• Standardized 4–10% ginsenosides
• Adulteration/misidentification is common
• Marketed as “adaptogen”
• Limited human data, but possibly effective in preventing colds, preventing cancer, or decreasing blood glucose
• Dose: 500 mg–2g ginseng root or 200–600 mg ginseng extract
• Adverse effects: edema, headache, nausea, vomiting, vaginal bleeding, mastalgia, central nervous system stimulation, hypertension, hypotension, hypoglycemia
• Avoid use in patients on psychiatric, estrogenic, or hypoglycemic medications or who have bleeding problems or an abnormal immune system
• Drug interactions: decrease in international normalized ratio (INR) with warfarin, insomnia, headache, tremors, and mania with phenelzine |
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Term
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Definition
• Standardized to 70–80% silymarin
• May limit hepatic injury through reduction of lipid peroxidation, scavenging of free radicals, and enhancement of glutathione and superoxide dismutase levels
• Dose: 420 mg in three divided doses
• Adverseeffects:dyspepsia,rash,headaches,at high doses laxative effects
• Drug interactions: none reported |
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Term
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Definition
• Hypericum perforatum
• Hypericin 2–5% used to standardize, but may not be responsible for clinical effect
• Probably effective in treatment of mild to moderate depression, may not be effective for severe depression
• Dose: 900 mg in three divided doses
• Adverse effects: photosensitivity, hypomania, mania, autonomic arousal
• Avoid use in patients on other serotonergic medications or interacting medications
• May induce CYP enzymes 3A4, 2C9, 1A2, and P-glycoprotein
• Drug interactions: reduces levels of amitriptyline, cyclosporine, digoxin, indinavir, oral contraceptives, theophylline, warfarin, some anticonvulsants; risk of serotonin syndrome when used in combination with other serotonergic agents, decreased INR with warfarin |
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Definition
• Standardized to 85–95% fatty acids and sterols
• Large review of randomized, placebo-controlled trials observed no difference in urinary symptom scores, urinary flow, prostate size
• Similar actions to tamsulosin and finasteride
• Dose: 160 mg twice daily
• Adverse effects: abdominal pain, nausea, diarrhea, fatigue, headache, decreased libido, rhinitis, rare pancreatitis, hepatotoxicity, bleeding problems
• Avoid use in patients with liver, pancreas, or bleeding problems
• Drug interactions: none reported |
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Term
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Definition
• Ubiquinone
• CoQ10 levels decline in setting of heart failure and statin use, however unclear if supplementation is beneficial
• CoQ10 is not recommended in the treatment of heart failure in the American College of Cardiology/American Heart Association Guidelines
• Dose: 100–1,200 mg/day in divided doses
• Adverse effects: dyspepsia, diarrhea, nausea, heartburn, irritability, dizziness, headache, decreased appetite, rash, thrombocytopenia
• Avoid use in patients on concomitant anticoagulants
• Drug interactions: may decrease effect of warfarin |
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Term
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Definition
• Available as hydrochloride and sulfate formulations
• Two large NCCIH-sponsored RCT glucosamine hydrochloride in osteoarthritis of the knee failed to show benefit; one assessed pain and function, the other assessed knee cartilage through imaging
• Unclear if glucosamine sulfate may have benefit
• Not currently recommended by major guidelines for osteoarthritis |
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Term
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Definition
• Dose: 1,500 mg/day as single or divided doses
• Adverse effects: diarrhea, nausea, possible cross allergenicity with shellfish allergy
• Avoid use in patients on concomitant anticoagulants
• Drug interactions: may increase INR with warfarin |
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Term
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Definition
• Endogenous serotonin derivative that helps regulate sleep-wake cycle
• Release/suppression coincides with darkness/light
• May be helpful in treatment of jet lag, especially if taken close to bedtime at destination
• May be helpful in combination with a dark environment in treatment of insomnia
• Dose: 0.5–5 mg for jet lag, 0.3–20 mg for insomnia
• Adverse effects: morning drowsiness, fatigue, dizziness, headache, irritability, hypo- and hypertension, decreased sperm quality in males, lower mean luteinizing hormone in females
• Avoid use in patients who are attempting to conceive or in women who are lactating
• Substrate of CYP enzyme 1A2
• Drug interactions: may decrease effect of warfarin, nifedipine; many drugs can alter melatonin concentrations including NSAIDs, antidepressants, beta adrenergic/beta-blocking agents |
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Term
| Dehydroepiandrosterone (DHEA) |
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Definition
• Endogenous steroid hormone secreted by adrenal gland
• Precursor to androgens and estrogens
• FDA investigating DHEA for the treatment of systemic lupus erythematosus (SLE) and to improve bone mineral density in women with SLE who are on steroids
• Banned by National Collegiate Athletic Association and International Olympic Committee
• Dose:5–100mgdaily,avoidprolongedusewhen dose exceeds 50 mg daily
• Adverseeffects:fatigue,nasalcongestion, headache, acne, tachycardia, hypertension, insomnia, agitation, mania, psychosis, irritability, masculinization in women, gynecomastia and testicular wasting in men
• Avoid use in patients with liver disease,depression, mood disorders, polycystic ovary syndrome, hormone-sensitive conditions, pregnancy/lactation
• CYP3A4inhibitor=numerous drug interactions |
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Term
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Definition
• Available as FDA-approved product
• Most commonly used supplement in the U.S.
• Mainly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
• Indication: hypertriglyceridemia, secondary prevention in patients with CHD or heart failure
• May prolong bleeding time
• Dietary supplements’ FDA approved-health claim:
“Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.” |
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Term
| complementrary treatments for back pain |
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Definition
| acupuncture, yoga, massage therapy, spinal/osteopathic manipulation |
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Term
| neck pain complementary treatment |
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Definition
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Term
| knee osteoathritis complementary treatment |
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Definition
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Term
| severe headache/migrane complementary treatment |
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Definition
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Term
| fibromyalgia complementary treatment |
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Definition
| tai chi, relaxation techniques |
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Term
| JS is a 45-year-old man who has a history of chronic insomnia, but is otherwise healthy. Ambien (zolpidem), Sonata (zaleplon), and trazodone didn’t work for him; Unisom (diphenhydramine) was effective, but he experienced too much daytime sleepiness. At today’s routine checkup appointment, he asks if you would recommend melatonin. |
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Definition
All patients reporting insomnia should be counseled about good sleep practices such as a consistent bedtime, using the bedroom only for sleep, keeping the bedroom dark, avoiding caffeine, and avoiding screentime or other stimulating activities prior to bed.
Melatonin has weak evidence supporting its use in chronic insomnia, although it is generally well tolerated. If the patient chooses to trial melatonin, consider recommending USP-verified product to ensure it is stated potency and purity. |
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