Dietary Supplements Flashcards
How common is the use of dietary and herbal medications in the US?
- 50% >20 used dietary supplemets, alternative stuff
- 33% take TOGETHER with prescription meds
- 30 billion spent
What is a dietary supplement?
- supplements diet
- contains (concentrate, metabolite, constituent, extract):
- vitamins
- herbs or other botanicals
- amino acids
- COMBO
Dietary Supplement Health and Education (DSHE) Act 1994
- 1994 Act of Congress
- restricted FDA’s ability to regulate the industry…as long as manufacturers made NO CLAIMS a/b their products:
- treating
- preventing
- curing dz
- restricted FDA’s ability to regulate the industry…as long as manufacturers made NO CLAIMS a/b their products:
- supplements=food supplements NOT drugs
- places burden on FDA to prove that supplement is unsafe/ineffective
Regulation and Role of FDA…Wild Wild West
- makers NOT required to prove EFFICACY and SAFETY of a product prior to marketing
- just need adequate evidence…which they dont have to give to the FDA
Safety?
- ingredient sold pre-Oct 15 1994 is considered to be safe based upon their prior use by humans
- post 10/15/94 safety testing is not reliably enforced
What are the three types of claims that the DSHE act allows regarding dietary supplements and herbal medications?
- Nutrient claim
- health claim
- structure-function claim
DSHE-allowed: Nutrient Claim (1/3)
- relative amt of a nutrient or dietary ingredient in a product
- limite to nutrients that have FDA-established DC:
- vitamins, minerals, dietary fiber, AA
DSHE-allowed: Health Claim (2/3)
- VERY restrictive
- ability of dietary supplement ingredient to reduce r/o dz or health condition
- must be:
- pre-approved by FDA
- Ex: vit/folate/mineral/fish oils
- based on significant scientific agreement
- evidence-based w/ strong evidence (RCT)
- Ex: folate-NTD; Ca/Vit D-osteoporosis
- Ex text: “adequate ca as pt of a healthy diet MAY help REDUCE the r/o osteroporosis”
- pre-approved by FDA
DSHE-allowed: Structure-Function Claim (3/3)
- most dietary supplements and herbals
- how the dietary supplement may affect or maintain nml body structure/fxn:
- CANNOT imply that supplement will affect a dz or condition
- claim does NOT need FDA approval, BUT claim must be provided within 30 days of marketing
- Ex good: antioxidants help maintain cell integrity
- Ex good: Echinea supports the bodys immune system
- Ex bad: antioxidants prevent the onset of ca
- Ex bad: Echinea is useful in preventing colds
- ***product label must contain the following statement: “this product has not been evaluated by the FDa. This product is no tintended to diagnose, treat, cure or prevent any diseases”
DSHE modification in 2007
- companies must now inform the FDA of any serious SE
- Manufacturers responsible for Good Manufacturing Practices (GMP)
- ensure QUALITY of manufacturing PROCESS
- supplements shouldn’t contain contaminants or impurities
- supplements should be accurately labeled
- lies, fairytales, and fallicies
- >70% supplements are mislabeled
- 50% dx recalls due to dietary supplements
Why are dietary supplements basically useless in the genpop (3)?
- body only needs LOW LEVELS
- typically in HEALTHY DIET
- supplements dont replace fresh fruit/veggies (balanced diet)
Who may benefit from vitamin and mineral supplements?
- pregnant/nursing
- vegetarians/vegan
- crash dieters/chronic low-cal diet (bariatric sx)
- elderly (disabled or chronically ill)
- malabsorption problems (diarrhea, celic dz)
- food allergies (lactose intolerant)
Excessive intake of vitamins and minerals can be toxic
- U-shaped curve for micronutrients and health
- risk assoc w/ BOTH insufficient and xs intake
- Vit D/Ca insufficiency=INC r/o osteoporosis
- Vit D/Ca overconsumption=INC r/o CVD & overall mortality
Vit A <nah></nah>
- Deficiency: uncommon
- Supplementation (other than deficiency): not recommended
- Toxicity (PC CHAT):
- painful joints
- coma
- chronic: INC ICP
- hyper-vitaminosis A
- acute: nausea/vision
- Teratogenic
Vit D <nd></nd>
- Deficiency:
- overt-rare: rickets.osteomalacia
- some SUBclinical deficieny (po folk)
- Supplementation (other than deficiency): <biologi>
</biologi><ul>
<li>blk</li>
<li>institutionalized</li>
<li>obese</li>
<li>limited sunlight</li>
<li>old</li>
<li>Gi d/o</li>
</ul></biologi> - Toxicity <hv>:
</hv><ul>
<li>damage: heart, blood vessels, kidney</li>
<li>N/V/weight loss</li>
<li>HYPERcalcemia</li>
<li>vascular tissue calcification</li>
</ul></hv>
Vit E
- Deficiency: uncommon
- Supplementation (other than deficiency): not recommended
- Toxicity:
- INC all causes of mortality
- INC bleeding with anticoagulants
Vit K <babies></babies>
- Deficiency: common in NBN (VKDB)
- Supplementation (other than deficiency):
- NBN given IM Vit K @ birth to prevent hemorrhagic dz of the NBN
- Toxicity: rare
Vit C
- Deficiency: uncommon
- Supplementation (other than deficiency): not recommended
- Toxicity: GI issues + kidney stones
Vit B1
- Deficiency: poor countries Beriberi
- Supplementation (other than deficiency):
- chronic alcholics: WKS (psychotic encephalopathy)
- vision changes/ataxia/memory loss
- chronic alcholics: WKS (psychotic encephalopathy)
- Toxicity:
Vit B12 <gvape></gvape>
- Deficiency: common: 2-15%
- Supplementation (other than deficiency):
- elderly (poor absorption)
- vegan/veggies
- alcoholics
- pernicious anemia
- GI malabsorption d/o
- Toxicity:
Folate
- Deficiency: uncommon
- Supplementation (other than deficiency): childbearing women, prevent NTD
- Toxicity:
Melatonin
- Purported Use:
- insomnia/jet lag: +/-
- sleep patterns: +/-
- cognitive impairment: NO
- Clinical Evidence
- Toxicity: dont combine w/ anti-seizure meds or warfarin
Glucosamine/Chondroitin
- Purported Use: osteoarthritis
- Clinical Evidence: NOOOOO
- Toxicity
**FISH OILS**
- Purported Use:
- DECCCC:
- CVD
- CHD death
- sudden Cardiac death
- BP/HR
- DECCCC:
- Clinical Evidence: YASSSSS
- Toxicity
Co-enzyme Q10
- Purported Use <mhhc>:
</mhhc><ul>
<li>heart conditions</li>
<li>CHF/angina</li>
<li>high BP/diabetes</li>
<li>migraine</li>
</ul></mhhc> - Clinical Evidence: +/-
- only for rare genetic deficiency in CoQ10 biosynthetic enzymes
- Toxicity
Multivitamins
- each constituent: 100%-150% RDA
- benefit those with:
- poor nutrition
- low cal diet
- v/v+age>50-Vit B12
- PM women-Vit D & Ca
Historical use of Herbal medications
- 3000BC sumerian clay tablets
- 2700 BC Han dynasty
- 1900 BC turmeric (anti-inflamm/anti-microbial) India
- 1500 BC saw palmetto, garlic, junier: Egypt
- 500 BC St Johns Wort: Hippocrates
Modern Use of Herbal Meds
- health promotion, dz prevention (*chronic dz: RA, memory, fatigue, energy, immune system)
- shit outcomes with conventional for serious illness
- limited availability of conventional
- SE/risks of conventional
- thoughts natural “safer”/superior
Physicians attitude to dietary supplements and herbal meds
- 50% physicians never ask pts about herbal med use
- 70% think public havemisplace faith in herbal meds
Pt attitudes to dietary supplements and herbal meds
- MAJORITY of pts DO NOT TELL their doc:
- no reason for doc to know
- doc never asked
- embarassed
- think safe/effective
Reasons physicians should discuss dietary supplement usage with their patients
- herbs are pharmalogically active
- certain dietary supplements have well-established toxic effects:
- heptatotoxiity: comfrey/kava
- nephrotoxic: aristolochic acid (chinese herbs)
- CV (+ death): ephedra/bitter orange
- uncover unspoken medical concerns
-
***Potential for serious herb-drug interactions:
- St. JW induces CYP450 enzymes=DEC levels of certain drugs
- =clinical failure of HIV PI, OCP, cyclosporin (transplant rejection)
Quality and Efficacy of Herbal Meds
- diff pharm with diff plant parts
- closely related may have diff ingredients/contaminants
- harvest/storage/processing techniques may be diff
- many cases of mislabeling
-
recent study using fingerprinting:
- 2/44 herbal supplements had 100% authentic, rest were contaminated, had filler, mislabeled
Problems with Herbal Standardization, Purity, Efficacy
- diff prep=diff activity
- contamination: lead, mercury, arsenic
- few high quality clinical trials
Aloe Vera
- Common Use <low>:
</low><ul>
<li>laxative (some)</li>
<li>OA</li>
<li>wound healing</li>
</ul></low> - CTE:
- SE: stomach cramps
- DDI:
**BITTER ORANGE**
(Pseudophedrine and ephedrine same)
- Common Use:
- N
- constipation
- weight loss
- CTE:
- SE:
- INC HR/BP
- stroke/MI (espec w/ caffeine)
- DDI: MAOI (contains tyramine metabolites); inhibits gut 3A4
Black cohosh
- Common Use: menopausal s/s
- CTE:+/-
- SE: estrogenic-may worse breast ca
- DDI:
Cranberry
- Common Use: UTI
- CTE: +/-
Echinacea
- Common Use: colds/flu; immune booster
- SE: exacerbate a/i/d
- DDI: inhib 3A4
**EPHEDRA (banned in US)**
- Common Use:
- cold/fever/flu
- **weight loss
- SE: INC reisk CVD/stroke/death
- DDI: additive effects with stimulants
Fever-few
- Common Use: fever/HA/MA
- CTE:+/-
- SE:
- withdrawal syndrome w/ chronic use: rebound HA/jt pain
- Ci in pregnancy (early contractions)
- DDI: inhib 1A2, 2C9, 2C19
Garlic
- Common Use: high cholesterol, high BP
- CTE:=+/-
- SE:INC bleeding risk
- DDI:
- ANTIcoagulants
- DEC:
- Saquinavir
- Isoniazid
- NNRTI
- OCP
Ginger
- Common Use: upset tum, N, morning sickness
- CTE: +/- N
- SE: INC bleeding risk
- DDI: anticoagulants
Ginkgo
- Common Use:
- memory loss
- sex dysfunction
- HA/fatigue
- tinnitus
- CTE: +/-
- SE:
- INC bleeding risk
- unsafe preg
- uncooked: seizure toxin
- DDI: ANTI coags
Ginseng
- Common Use:
- INC mental/physical performance
- immune booster
- erectile dysfunction
- lower BG
- CTE:+/-
- SE:
- Teratogenic
- contraindic in Breast ca
- estrogenic
- birth defects
- DDI:
- INC effects of insulin/sulfonylureas
- ANTagonize ANTicoags
**HAWTHORN**
- Common Use:
- heart dz
- CHF/high BO
- angina
- CTE: yes for mild HF
- DDI:
- digoxin/nitrates
- BP meds
**HORSE CHESTNUT**
- Common Use:
- chornic venous insufficiency
- varicose veins
- hemorrhoids
- CTE: YES
- SE:
- raw seeds: poisonous ESCULIN toxin
- may exacerbate kidney dz
- DDI: ANTIcoags
**KAVA**
- Common Use:
- insomnia/anxiety
- depression
- ADHD
- CTE: YES
- SE:
- liver damage
- muscle spasms
- DDI:
- additive effects with sedatives
- INC acetominophen toxicity
Milk Thistle
- Common Use:
- liver protection; jaundic/cirrhosis
- high cholesterol
- diabetes
- DDI: inhibits UGT
Saw Palmetto
- Common Use: BPH
- CTE:+/-
- DDI: inhibits UGT, 3A4, 2D6, 2C9
***SJW***
- Common Use:
- Wound healing
- heart palpitations
- anxiety/depression
- sleep d/o; chronic fatigue
- MA
- CTE: YES
- SE:
- photosensitization
- SEROTONIN SYNDROME (w/ SSRI, MAOI, TCA)
- induce mania in bipolar
- depressed/psychotic
- teratogenic
- DDI:
- Anti-depressants (serotonin syndrome)
- INC expression 3A4/SC19
- DEC:
- Statins/HIV PI
- OCP
- Cyclosporin
***VALERIAN***
- Common Use (SAD):
- sleep d/o
- anxiety
- depression
- CTE: +/-
- SE: drowsiness
- DDI: additive effets on other sedatives (BZ/barbs/Kava)
Yohimbe (congo and maui)
- Common Use:
- sexual dysfxn
- erectile dysfxn
- athletic performance
- weight loss
- CTE: +/-
- SE:
- INC: BP/HR/anxiety
- insomnia
- kidney failure
- DDI: INC SE MAOIs