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PT 2 > Block 10 - L8-L9 > Flashcards

Block 10 - L8-L9 Flashcards

1
Q

What is a dietary supplement?

A

A product that is intended to supplement the diet, contains one or more of the following ingredients (vitamins, minerals, herbs/other botanicals, amino acids, and/or a concentrate, metabolite, constituent, extract, or combination of any of the above), is intended to be taken by mouth as a pill, capsule, table, or liquid, is not represented for use as a conventional food, and is labeled on the front as a dietary supplement.

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2
Q

True or false - dietary supplements do not include topicals, creams, or suppositories.

A

True

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3
Q

The 1994 Dietary Supplement Health and Education Act restricted the ability of the FDA to regulate the industry, as long as manufacturers met what conditions?

A

Made no claims about their products treating, preventing, or curing disease (supplements are not considered drugs, but rather food supplements)

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4
Q

True or false - makers of dietary supplements are required to prove efficacy and safety of a product prior to marketing.

A

False - they are not required to prove efficacy and safety of a product prior to marketing

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5
Q

What three claims can be made when advertising dietary supplements and herbal medications?

A
  1. Nutrient claim
  2. Health claim
  3. Structure-function claim
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6
Q

What is a nutrient claim?

A

Describes the relative amount of a nutrient or dietary ingredient in a product; can claim that the supplement addresses a nutrient deficiency, but is limited to those nutrients that have an FDA-established DV

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7
Q

What is a health claim?

A

Characterizes the ability of the dietary supplement ingredient to REDUCE THE RISK of a disease or health condition; must be pre-approved by the FDA (<25 are approved), requires a high standard of evidence, based upon significant scientific agreement, evidence-based review system supported by strong evidence includes high quality observation and intervention studies

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8
Q

What is a structure-function claim?

A

A statement reflecting how the dietary supplement may affect or maintain normal body structures or functions; cannot imply that a supplement will affect a disease or condition, including classic signs or symptoms of disease

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9
Q

What modifications have been made to the The 1994 Dietary Supplement Health and Education Act?

A

Companies must now inform the FDA of any serious AE (death, life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect)

Manufacturers are now responsible for Good Manufacturing Practices (ensures quality of the process, supplements should not contain contaminants or impurities, supplements should be accurately labeled)

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10
Q

There is little justification for widespread use of dietary supplements in the general population unless there is evidence of a symptomatic nutrient deficiency - why?

A

The body only needs low levels of vitamins and minerals, and these are typically provided by a healthy diet. Supplements do not replace or add to the benefits of eating fresh fruits and vegetables as part of a balanced diet.

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11
Q

List some populations that may benefit from vitamin and mineral supplements.

A
  1. Pregnant women/nursing mothers (especially folic acid)
  2. Some vegetarians and vegans (vitamin B12)
  3. Crash dieters or people on chronic low-calorie diets
  4. The elderly
  5. Those with malabsorption problems
  6. Those with food allergies
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12
Q

Excessive intake of vitamins and minerals can be toxic - explain.

A

There is a U-shaped curve for many micronutrients and health. There is risk associated with both insufficient and excessive intake.

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13
Q

Vitamin D and Ca2+ insufficiency increase risk of ___. Over-consumption increase risk of ___.

A

Osteoporosis; CVD and overall mortality

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14
Q

Supplementation of which vitamins (A, D, E, K, C, B1, B12, Folate) is not recommended except in deficiency?

A

A, E, C

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15
Q

When is Vitamin D supplementation recommended (beyond deficiency)?

A
  1. Older adults/people who are institutionalized
  2. Exposure to limited sunlight
  3. Dark-skinned individuals
  4. Obese individuals
  5. Individuals with G disorders
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16
Q

When is Vitamin K supplementation recommended (beyond deficiency)?

A
  1. All newborns at birth to prevent hemorrhagic disease of the newborn
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17
Q

When is Vitamin B1 (thiamine) supplementation recommended (beyond deficiency)?

A
  1. People with chronic alcohol use

2. Wernick-eKorsakoff Syndrome (vision changes, ataxia, memory loss, can be fatal if untreated)

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18
Q

When is Vitamin B12 supplementation recommended (beyond deficiency)?

A
  1. The elderly (poor absorption)
  2. Vegans and vegetarians
  3. Alcohol use
  4. Pernicious anemia
  5. GI malabsorption disorders
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19
Q

When is Folate supplementation recommended (beyond deficiency)?

A
  1. Women of childbearing age to prevent neural tube defects
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20
Q

Describe the toxicity of Vitamin A.

A
  1. First trimester birth defects
  2. Increased risk of CVD/osteoporosis
  3. Increased risk for lung cancer in smokers
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21
Q

Describe the toxicity of Vitamin D.

A
  1. Hypercalcemia
  2. Vascular tissue calcification
  3. Damage to heart, blood vessels, and kidney
  4. N/V, weight loss
22
Q

Describe the toxicity of Vitamin E.

A
  1. Increased in all cause mortality

2. Increased bleeding with anticoagulants

23
Q

Describe the toxicity of Vitamin C.

A
  1. GI issues

2. Kidney stones

24
Q

Multivitamins are of little benefit in otherwise healthy individuals with a varied diet. Who may benefit from use?

A

People with poor nutrition, low calorie diet, vegetarians/vegans (B12), post-menopausal women (Vitamin D and Ca2+), 50+ y/o (poor absorption of B12)

25
Q

What is the purported use of melatonin, and is there clinical evidence to support this?

A

Use - insomnia, jet lag, changing sleep patterns, cognitive impairment

Not really

26
Q

Melatonin should not be combined with what medications?

A

Anti-seizure medications, warfarin

27
Q

What is the purported use of glucosamine/chondroitin, and is there clinical evidence to support this?

A

Use - osteoarthritis

No

28
Q

What is the purported use of fish oils, and is there clinical evidence to support this?

A

Use - decreased CVD, BP, HR, CHD death, sudden cardiac death

Mixed - early studies said yes, more recent are inconclusive

29
Q

What is the purported use of Co-Enzyme Q10, and is there clinical evidence to support this?

A

Use - heart conditions, CHF/angina, high BP, diabetes, migraine, cancer

Mixed - only for rare genetic deficiency in CoQ10 enzymes

30
Q

List some reasons individuals take herbal medications.

A
  1. Health promotion and disease prevention (especially chronic diseases such as RA, memory loss, fatigue; feel better, boost energy, improve immune system)
  2. Experience of poor outcomes with conventional drugs for serious illnesses
  3. Limited availability of conventional drugs for some serious illnesses
  4. Concerns over significant AE/risk associated with conventional therapies
  5. Belief that “natural” products are safer than conventional drugs
  6. Belief that herbal products are superior to manufactured drugs
  7. Cost
31
Q

True or false - evidence shows that the majority of patients taking dietary supplements and herbs do not tell their doctor.

A

True

32
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Aloe vera

A

Use - wound healing, laxative, osteoarthritis
Evidence - some for laxative effect
AE - stomach cramps (oral)
DDI - none

33
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Bitter orange (adrenergic agonists)

A

Use - nausea, constipation, weight loss
Evidence - n/a
AE - increased HR/BP, stroke, MI (especially with caffeine
DDI - MAOI (contains tyramine metabolites), inhibits gut 3A4

34
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Black cohosh

A

Use - menopausal symptoms
Evidence +/-
AE - estrogenic, may worsen breast cancer
DDI - n/a

35
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Cranberry

A

Use - UTI
Evidence +/-
AE - n/a
DDI - n/a

36
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Echinacea

A

Use - colds/flu, immune booster
Evidence: n/a
AE: potentially exacerbates AI diseases
DDI - inhibits 3A4

37
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Ephedra (banned in US)

A

Use - colds, fever, flu, weight loss
Evidence: n/a
AE: increased risk of CVD, stroke, death
DDI - additive effects with stimulants

38
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Feverfew

A

Use - fevers, headaches, migraines
Evidence +/-
AE: withdrawal syndrome with chronic use, rebound headache/joint pain, contraindicated in pregnancy (early contractions)
DDI - inhibits 1A2, 2C9, 2C19

39
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Garlic

A

Use - high cholesterol, high BP
Evidence +/-
AE - increased bleeding risk
DDI - anticoagulants, decreases isoniazid, saquinavir, HIV NNRTIs, oral contraceptives

40
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Ginger

A

Use - GI upset, nausea, CVD, inflammation, RA
Evidence - yes for nausea
AE - increased bleeding risk (may inhibit COX-1)
DDI - anticoagulants

41
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Gingko

A

Use - memory loss, sexual dysfunction, headache, fatigue, tinnitus
Evidence - n/a
AE - increased bleeding risk, unsafe in pregnancy, uncooked gingko contains a seizure toxin
DDI - anticoagulants

42
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Ginseng

A

Use - increase mental/physical performance, immune booster, ED, lower blood glucose
Evidence +/-
AE - estrogenic, contraindicated in breast cancer, pregnancy
DDI - increases effects of insulin/sulfonylureas, antagonizes anticoagulants

43
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Hawthorn

A

Use - heart disease, CHF, high BP, angina
Evidence - yes for mild HF
AE - n/a
DDI - digoxin,nitrates, BP meds

44
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Horse chestnut

A

Use - chronic venous insufficiency, varicose veins, hemorrhoids
Evidence - yes
AE - raw seed contains poisonous esculin toxin; may exacerbate kidney disease
DDI - anticoagulants

45
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Kava

A

Use - insomnia, anxiety, depression, ADHD
Evidence - yes
AE - liver damage (potent, serious), muscle spams
DDI - additive effects with sedatives, increased acetaminophen toxicity

46
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Milk thistle

A

Use - liver protection, jaundice, cirrhosis, high cholesterol, diabetes
Evidence - n/a
AE - n/a
DDI - inhibits UGT

47
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Saw Palmetto

A

Use - BPH
Evidence - n/a
AE - n/a
DDI - inhibits UGT, 3A4, 2D6, 2C9

48
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

St. John’s Wort

A

Use - depression, anxiety, sleep disorders, heart palpitations, wound healing, chronic fatigue migraine
Evidence - yes
AE - photosensitiziation, serotonin syndrome with SSRI, MAOI, TCA, may induce mania in BD, depressed/psychotic, potential for birth defects
DDI - antidepressants, increased expression of 3A4/2C19, decrease OCs, cyclosporin, statins, HIV PIs, many drugs

49
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Valerian

A

Use - sleep disorders, anxiety, depression
Evidence +/-
AE - drowsiness
DDI - additive effects on other sedatives, (benzos, barbs, kava)

50
Q

For each supplement, list the common use, clinical trial evidence, major AE, and drug interactions.

Yohimbe

A

Use - sexual dysfunction, ED, athletic performance, weight loss
Evidence - n/a
AE - increased BP, HR, anxiety, insomnia, kidney failure
DDI - increases side effects of MAOIs

PT 2 (15 decks)

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