Supplements in Metabolic Disease Flashcards
Integrative Health and Medicine (IHM)
a. Healing-oriented practice that incorporates the relationship between the provider and whole person (mind, body, and spirit).
b. It emphasizes the evidence and makes use of all appropriate therapeutic approaches to achieve optimal health and healing.
Why People Use IH
Dissatisfied with the results of conventional therapy
Lack of disease curing of conventional therapy
Dramatic reports from media
Patient empowerment
Focused on spiritual and emotional wellbeing
What Patients Believe…
Natural is better than synthetic
Patients don’t consider herbs as “drugs”
Herbs don’t have side effects
Herbs are regulated, standardized, and safe
Used for thousands of years
Evidence of IH
a. Efficacy
Folklore
Anecdotes
Small studies
b. Mainstream Medicine
i. Poppies = Morphine
ii. Foxglove = Digoxin
iii. Willow bark = Aspirin
iv. Pacific yew tree = Tamoxifen®
c. Safety
i. Inherent toxicity
ii. Interaction with conventional therapy
Dietary Supplement and Health Education Act (DSHEA) 1994
a. Regulate the evaluation of vitamins, herbals, amino acids and other botanicals
b. Regulates herbal supplements more like food rather than medication
c. Products cannot be put on the same shelf as OTC or meds
d. Prior to 1994 – all products were grandfathered
DSHEA
a. Manufacturers
i. Do not need to register or get FDA approval
ii. Responsible to ensure product is safe
iii. Ensure product label information is truthful and not misleading
b. US Food and Drug Administration (FDA)
i. Takes action if product is unsafe once on the market
Monitors safety (ADR MedWatch reporting)
ii. Monitors product information
-Labeling
-Claims
-Package inserts
-Accompanying literature
Adverse Event Reporting
a. FDA MedWatch Reporting System- FDA 3500 (http://www.fda.gov/medwatch/report/hcp.htm)
b. Voluntary
c. Submitted on line or mail
d. What can be reported? Regulated drug Biologic Medical device Dietary supplement
White House Commission on CAM Policy (WHCCAMP)
a. Goal
i. Provide the President with recommendations to ensure public policy maximized the potential benefits of CAM to all citizens
b. Final Report of March 2002
i. Coordination of research to increase knowledge about CAM products
ii. Educate and train the health care practitioners in CAM
iii. Provide reliable and useful information about CAM practices and products to professionals
iv. Guidance regarding appropriate access to the delivery of CAM
Labeling Requirements
*Required Disclaimer
-Structure-function
claim
“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”
Good Manufacturing Practices (GMPs)
a. Food and Drug Administration (FDA) and Federal Trade Commission (FTC)
b. June 2010
c. More stringent practices
- Record keeping
- Quality control
- Testing
- Production
- Verify quality of raw materials
- Increase inspecting of facilities by FDA inspectors
d. 483 inspection report
Major breaches is due to record keeping
Supplement Seals of Approval
Good Manufacturer Practices (GMPs)
Examples: Nature’s Way, Country Life, Twin
Consumer Labs (CL) Examples: Good Neighbor Pharmacy, Sundown
United States Pharmacopoeia (USP)
Example: Nature Made
National Sanitation Foundation (NSF)
Example: GNC Nutritional Supplements
Things to keep in mind
with Supplements
a. Start low and go slow
b. Discontinue if ineffective or unsafe
c. Herbs interact with prescription and OTCs
d. Best to use single active ingredients vs combinations
e. Purchase product from a reliable source
f. Use extra caution in:
Pregnancy
Nursing patients
Elderly
Children
Patients with serious health problems
Fish Oil / Omega 3
a. Indications:
Hypertriglyceridemia
b. Mechanism of action:
i. Decrease in hepatic secretion of VLDL-C, increase VLDL-C clearance, reduces TG transport
ii. ω-3 fatty acids compete with arachidonic acid in the cyclooxygenase & lipoxygenase pathways
Fish Oil / Omega 3 Efficacy
a. Omega-3 Polyunsaturated Fatty Acids and Cardiovascular Diseases
b. Effects:
i. TG 20 - 50%
ii. If TG are > 500 mg/dl = 45%
iii. Combo with statin in TG levels of 200 - 499 mg/dl = 30%
iv. LDL-C neutral effects
c. Recommend treatment per AHA:
i. Primary prevention: 500 mg qd or 2 fishy meals a week
ii. Secondary prevention (CHD): 1000 mg qd
Fish Oil / Omega 3
Dosing and Adverse reactions
a. Adverse reactions:
i. Fish taste, GI upset, heartburn, and belching
b. Drug interactions:
ii. Antihypertensive, Anticoag, contraceptives, and orlistat (moderate)
c. Herb interactions:
i. Garlic, Ginger, Ginkgo, and Ginseng
d. Dosage:
i. 1 – 4 g qd of DHA and EPA
ii. Most fish oil capsules are 120 mg DHA and 180 mg EPA
Fish Oil / Omega 3
Summary Points
a. Indications:
Hypertriglyceridemia
b. Mechanism of action:
i. Decrease in hepatic secretion of VLDL-C, increase VLDL-C clearance, reduces TG transport
ii. ω-3 fatty acids compete with arachidonic acid in the cyclooxygenase & lipoxygenase pathways
c. Omega-3 Polyunsaturated Fatty Acids and Cardiovascular Diseases
d. Effects:
i. TG 20 - 50%
ii. If TG are > 500 mg/dl = 45%
iii. Combo with statin in TG levels of 200 - 499 mg/dl = 30%
iv. LDL-C neutral effects
e. Recommend treatment per AHA:
i. Primary prevention: 500 mg qd or 2 fishy meals a week
ii. Secondary prevention (CHD): 1000 mg qd
f. a. Adverse reactions:
i. Fish taste, GI upset, heartburn, and belching
Fibers- FDA and sources
a. FDA permits health claims
i. 51% whole grain reduce risk of heart disease
ii. Whole Wheat, Whole oats, Barley and Corn
b. Blond Psyllium
i. 10-12 grams daily
ii. TC 3-14% and LCL-c 5-10%
iii. MVI 1 hr before of 4 hrs after
iv. More effective with food
c. Oat Bran
i. Beta-glucan (soluble fiber)
ii. Delay food absorption
Niacin
a. Dose: 1200-1500 mg TG & 2-3 g LDL daily
b. Clinical Effect
i. Decrease LDL 5-25% & TG 20-50 %, ↑ HDL 15- 35%
ii. Decrease Apolipoprotein B 29%
c. Efficacy
Might have a risk of secondary MI but no significant in all cause mortality.
AIM HIGH study
d. Side effects: HA, GI, flushing, increase blood glucose and uric acid
e. Monitor: LFT due to Hepatotoxic risk
f. Products: IM Niacin >LA Niacin >ER Niacin Inositol Nicotinate (“no-flush” niacin)
Fish Oil / Omega 3
Clinical pearls
Clinical pearls:
Decrease the fishy taste
Generally recognized as safe (GRAS)
Pregnancy limit consumption of 12 oz per week
Avoid shark, swordfish, and tilefish
Use caution in patients allergic to shellfish
Treatment option for patients who can not take niacin due to gout and flushing reaction
Omega Quant HS–Omeg-3 Index test
Krill Oil – Dr. Oz
Plant Sterols and Stanols
a. Plant Sterols
i. Mechanism of action:
Inhibits about 50% intestinal absorption of cholesterol
ii. Efficacy:
Decrease TC, decrease LDL-C, no effect on HDL
iii. Adverse reactions:
Nausea, indigestion, diarrhea, constipation & gas
iv. Dosage: 800 mg – 6 g qd 30 min. prior low fat meals
b. Plant Stanols
i. Mechanism of action:
Inhibits dietary and biliary cholesterol
ii. Efficacy: 10-15% decrease LDL-C With Statin therapy 3-11% decrease TC 7-16% decrease LDL-C
iii. Adverse reactions:
Diarrhea & steatorrhea
iv. Dosage: 800 mg – 4 g qd
Comparing Mechanism and Efficacy between Plant Sterols and Stanols
a. Plant Sterols
i. Mechanism of action:
Inhibits about 50% intestinal absorption of cholesterol
ii. Efficacy:
Decrease TC, decrease LDL-C, no effect on HDL
b. Plant Stanols
i. Mechanism of action:
Inhibits dietary and biliary cholesterol
ii. Efficacy: 10-15% decrease LDL-C With Statin therapy 3-11% decrease TC 7-16% decrease LDL-C
Plant Sterols & Stanols
Interaction and Clinical Pearls
a. Interactions:
i. Herbs: Beta carotene and Vit. E.
ii. Drugs: Zetia®
b. Clinical pearls:
i. Takes 2-3 weeks to be effective
ii. When discontinued, cholesterol levels rise back to baseline in 2-3 weeks
iii. Sterols and stanols appear to be equally effective
Ephedra
a. Mechanism of action:
i. Alkaloid constituents of the plant: ephedrine, pseudoephedrine, and small amount of phenylpropanolamine
ii. Ephedrine and pseudoephedrine are non-selective alpha and beta receptors agonist which stimulate nervous system
b. Efficacy:
i. Weight loss of 0.9 kg/month up to 6 months with ≤ 30 % of dietary fat intake with moderate exercise
c. Adverse reactions:
i. Dizziness, anxiety, insomnia, HA, dry mouth, N/V, heartburn, tachycardia, palpitations, & BP
ii. Seizures, cardiomyopathy, MI, arrhythmias & sudden death
Ephedra
History and Important Clinical pearl
Clinical pearls:
Potential risk outweighs the benefit!
History: June 1997 Proposed restriction and new warning labels 2002 Health Canada ban all ephedra products December 30, 2003 Announce the ban of ephedra products in US effective April 2004 April 2005 Federal judge in Utah challenged the ban Low does was not proven to be harmful August 2006 Appeals court reversed the Utah judge's decision
Bitter Orange
used for weight loss
a. Mechanism of action:
i. Contains 1-6% of synephrine which is related to ephedrine
b. Adverse effects: same as ephedra
i. Dizziness, anxiety, insomnia, HA, dry mouth, N/V, heartburn, tachycardia, palpitations, & BP
ii. Seizures, cardiomyopathy, MI, arrhythmias & sudden death
c. Caution: in HTN and cardiovascular patients
d. Clinical pearl:
i. Due to FDA ban on ephedra, manufactures switch to bitter orange
ii. Often products contain caffeine
iii. Generally recognized as safe (GRAS)
e. No evidence that this supplement is safer than Ephedra!!
Calcium
a. Patients will low calcium intake often gain more weight and have a higher BMI and maybe overweight or obese
i. Calcium can be used for weight loss
b. Efficacy:
i. 800-1200 mg/qd dietary calcium had been shown to weight reduction & body fat loss
ii. 900-1000 mg/qd has been shown weight loss of 8-9 kg
c. Adverse reactions: belching & flatulence
d. Clinical pearl: supplement calcium alone ≠ low fat dietary intake
Alli™ (Orlistat)
a. Mechanism of action:
i. Reversible inhibitor of pancreatic & gastric lipase
b. Efficacy:
i. Drew B et al. 2007 meta-analysis review: patient with BMI ≥ 27 saw a significant reduction of weight loss ~ 3 % then diet alone
ii. FDA approve for long term weight loss (Rx)
c. Adverse reactions:
i. HA, oily spotting, abdominal discomfort, gas, fecal urgency, steatorrhea & liver related events
ii. Psyllium/Fibers 6g with dose or 12 qhs
Alli™ (Orlistat)
Drug interaction and clinical pearls
a. Dosage:
60 mg tid with each meal that contains fat
b. Drug Interactions:
Anticoagulants, amiodarone, levothyroxine, & vitamins
c. Clinical pearls:
i. Take a MVI qd 2 hours before or after dose
- multivitamin is helpful since there will be loss of fat vitamin absorption
ii. Due to risk of liver injury inform patient signs and symptoms
Chromium
Diabetic Supplement
a. Mechanism of action:
i. Might reduce oxidative stress
ii. Low levels are associated with impaired glucose & insulin
iii. Chromium 0 has no activity
iv. Chromium III found in food and supplements
v. Chromium VI used in welding industries & carcinogenic
b. Adverse reactions:
i. HA, insomnia, irritability, mood changes & sleep disturbance
ii. Vomiting, diarrhea, & hemorrhage
c. Dosage:
i. 200-1000 mcq divided doses
ii. About 0.4-2.5% is absorbed and rapidly excreted in the urine
Chromium Study
a. Design: Type 2 non-insulin dependent elderly patients in rehabilitation for stroke or hip fracture, N = 78
b. Dose: Chromium picolinate 200mg bid x 3 weeks
c. Results:
i. Fasting blood glucose (190 mg/dL vs 150 mg/dL, p < 0.001)
ii. HbA1c (8.2% to 7.6%, p < 0.01)
iii. Total cholesterol (235 mg/dL to 213 mg/dL (p < 0.02)
Chromium
Interactions and Clinical Pearls
a. Interactions:
i. Herbs: bilberry, brewer yeast, iron, Vit. C & zinc
ii. Drugs: insulin, levothyroxine, NSAIDs & corticosteroid
iii. Disease: diabetes, renal and hepatic dysfunction
b. Clinical pearls:
i. Several salt forms
- Picolinate, nicotinate, polynicotinate and chloride
ii. Chromium picolinate most often used in studies
iii. No reliable method to diagnoses deficiency
Vanadium
Diabetes Supplement
a. Mechanism of action:
i. Activates insulin receptor proteins, stimulates glucose oxidation & transport
ii. Liver: stimulates glycogen synthesis
iii. Adipose: inhibits lipolysis
ivSkeletal muscle: promotes glucose uptake
b. Efficacy:
i. High does of 100 mg qd may improve insulin sensitivity and possibly reduce blood glucose levels
ii. Effective in Type 2 but not Type I diabetes
c. Adverse reactions:
i. GI upset, kidney toxicity, fatigue, lethargy & tongue discoloration
Vanadium
a. Dosage: 50 mg bid of the sulfate form
b. Interactions:
i. Herbs: garlic, ginger, ginkgo & ginseng
ii. Drugs: anticoagulants & antiplatelet
iii. Disease: diabetes & renal dysfunction
c. Clinical pearls:
i. Average diet contains 6-18 mcq qd
ii. Only 5% is absorbed
Dietary/Culinary Herbs
a. Bitter Melon - Asian and Indian cuisine
b. Cassia Cinnamon - Caution in history of liver disease
c. Magnesium
i. 100 mg daily 15% risk reduction for T2DM
- ¼ cup nuts, 3 bananas, 4 slice whole grain bread, 1c beans
d. Prickly pear cactus (Opuntia streptacantha)
e. Stevia – Sweeteners more purified
f. Chia (Salba)– “Super food”
g. Fruit (Blueberries, Grapes, Apples)
Garlic (Allium sativum)
a. Indications:
i. Hypertension
- Systolic Bp 8% or 16 mmHg
- Diastolic Bp 7% or 9 mg Hg
ii. Hyperlipidemia - Mix results
b. Mechanism of action:
i. Allicin is the active ingredient
ii. Inhibits hepatic cholesterol synthesis
iii. Activates production of endothelium-derived relaxation factor to relax smooth muscle and vasodilation
Garlic (Allium sativum)
Adverse and DD reactions
Supplement for HTN
a. Adverse reactions:
i. Halitosis, body odor, heartburn, and GI upset
b. Drug interactions:
i. Anticoagulant
ii. Antiplatelet
iii. CYP3A4
iv. CYP2E1
c. Herb interactions:
i. Ginger, ginkgo, fish oil and vitamin E
Garlic (Allium sativum)
Dosage and Clinical Pearls
a. Dosage:
i. DL 600 mg – 1200 mg/day in tid doses
ii. HTN – 300-1500 mg qd in divided doses
iii. 1 fresh clove (4 g)
iv. Standardized to 0.65 - 1.3 % allicin
b. Clinical pearls:
i. When using fresh product needs to sit for 10 minutes chopped up prior to use for best results
ii. Generally recognized as safe (GRAS)
iii. Discontinue 2 - 3 weeks prior to surgery
iv. Products marketed as odorless, may not contain allicin
Coenzyme Q-10
Indication and Mechanism
a. Indications:
i. Congestive heart failure
ii. Preventing statin-induced myopathy
b. Mechanism of action:
i. Has antioxidant properties to stop damage and give energy to cells
ii. Cofactor in metabolic pathways
c. Efficacy:
i. No evidence when taken as monotherapy, possibly useful with prescription treatment for HF
ii. No significant benefit for myopathy or statin tolerability
Coenzyme Q-10
Adverse and DD reactions
a. Adverse reactions: GI upset, heartburn, and appetite loss
b. Drug interactions: anticoagulants
c. Lab interactions: increase T4/T8 ratio in normal patients
d. Disease interactions: may lower blood pressure, cigarette smoking may deplete body stores
Coenzyme Q-10
a. Dosage:
i. HF 100 mg qd
ii. HTN 120-200 mg qd in bid- tid dosing
iii. Max daily dose of 300 mg daily
iv. Lower dose taken 2-3 times a day may decrease side effects
b. Clinical pearls:
i. Some medications can lower Co Q 10 levels
- Statins, beta blockers, and diuretics
ii. Take it with a fatty meal
Conclusion
a. Several OTC and supplement products have demonstrated possible efficacy in treatment of metabolic disease
b. Evidence continues to evolve regarding legitimate IHM uses
c. IHM therapies hold potential for drug/disease interactions
d. Providers should include OTCs and supplements when obtaining a medication history and providing treatment recommendations
e. Health professionals should learn where to find more information about OTCs and supplements
f. “ Do no harm” approach
Fish oil/Omega 3 Fatty Acid
Stuff to know for test
a. Decrease the fishy taste – freeze, take with food, or an enteric coated product
b. Generally recognized as safe (GRAS)
c. Pregnancy limit consumption of 12 oz. per week
d. Avoid shark, swordfish, and tilefish due to the levels of mercury
e. Treatment option for patients who cannot take niacin due to gout and flushing reaction
f. Not effective in lowering TC or LDL-c
g. Omega Quant HS–Omeg-3 Index test
h. Krill Oil – Dr. Oz
i. Increase risk of bleeding in combination with Rx, OTC’s or other supplements
j. DHA/EPA (measures potency) – amount vary in commercial products
k. Use both in primary and secondary prevention per the AHA recommendations
Plant sterols and Stanols
Pearls for test
a. Takes 2-3 weeks to be effective
b. When discontinued, cholesterol levels rise back to baseline in 2-3 weeks
c. Sterols and Stanols appear to be equally effective
d. GI side effects
e. Drug interaction with Zetia®
Higher quality supplement requirements
Pearls for Test
a. Label contains the required disclaimer – “This statement has not been evaluated by the FDA. This products is not intended to diagnosed, treat, cure, or prevent disease”
b. Label may include a structure-function claim (claim for its use) this statement is not required
c. Manufacture follows Good Manufacture Practices
d. Label contains a Supplement Seal of Approval (GMP’s, CL, USP, NSF) if applicable
Dietary Supplement and Health Education Act (DSHEA) 1994
- Evaluates the evaluation of vitamins, herbals, amino acids and other botanicals
- Regulates herbal supplements more like food rather than medication
- Products cannot be put on the same shelf as OTC or meds
- Prior to 1994 – all products were grandfathered
Two key players in DSHEA
1. Manufacturers
• Do not need to register or get FDA approval
• Responsible to ensure product is safe
• Ensure product label information is truthful and not misleading
- US Food and Drug Administration (FDA)
• Takes action if product is unsafe once on the market
• Monitors safety (ADR MedWatch reporting) www.fda.gov/medwatch/report/hcp.htm
Monitors product information - Labeling , Claims, Package inserts & Accompanying literature
Definition of Integrative Health and Medicine
a. Definition of Integrative Health and Medicine
• Healing-oriented practice that incorporates the relationship between the provider and whole person (mind, body, and spirit).
• It emphasizes the evidence and makes use of all appropriate therapeutic approaches to achieve optimal health and healing.
b. IHM Utilization
• Most often used by Elderly American Women population with higher education and income.
• 72 % patient didn’t report IHM use to health care provider!
Why people use IHM
Why People Use IHM
• Dissatisfied with the results of conventional therapy
• Lack of disease curing of conventional therapy
• Dramatic reports from media
• Patient empowerment
• Focused on spiritual and emotional wellbeing
What Patients Believe…
• Natural is better than synthetic
• Patients don’t consider herbs as “drugs”
• Herbs don’t have side effects
• Herbs are regulated, standardized, and safe
• Used for thousands of years
Weight loss treatment options – Clinical pearls
1. Ephedra • Moderate weight loss benefits • FDA has received many serious or fatal case reports • Product has been band from market • Potential risk outweighs the benefit
- Bitter Orange
• Due to FDA ban on ephedra, manufactures switch to bitter orange
• Often products contain caffeine
• Generally recognized as safe (GRAS)
• No evidence that this supplement is safer than Ephedra! - Calcium – supplement alone does not equal to a low fat dietary intake of calcium
- Alli
• Take a MVI qd 2 hours before or after dose
• Due to risk of liver injury inform patient signs and symptoms
• FDA approved for long term weight loss
• Patients with BMI of 27 or more have seen benefits
Ephreda and Bitter Orange
Test Pearls
a. Ephedra
• Moderate weight loss benefits
• FDA has received many serious or fatal case reports
• Product has been band from market
• Potential risk outweighs the benefit
b. Bitter Orange
• Due to FDA ban on ephedra, manufactures switch to bitter orange
• Often products contain caffeine
• Generally recognized as safe (GRAS)
• No evidence that this supplement is safer than Ephedra!
Calcium and Alli
Test Pearls for these weight loss IHM
a. Calcium – supplement alone does not equal to a low fat dietary intake of calcium
b. Alli
• Take a MVI qd 2 hours before or after dose
• Due to risk of liver injury inform patient signs and symptoms
• FDA approved for long term weight loss
• Patients with BMI of 27 or more have seen benefits
Diabetes treatment options – Clinical pearls
- Chromium
• Several salt forms (Picolinate, nicotinate, polynicotinate and chloride)
• Chromium picolinate most often used in studies
• No reliable method to diagnoses deficiency
• Caution in renal and hepatic dysfunction
• Mix data on effectiveness
2. Vanadium • Average diet contains 6-18 mcq qd • Only 5% is absorbed • Kidney toxicity • Effective in Type 2 DM • Increase risk of bleeding when used in combination with RX, OTC or Supplements
Chromium
Test pearls
Diabetes IHM
a. Several salt forms (Picolinate, nicotinate, polynicotinate and chloride)
b. Chromium picolinate most often used in studies
c. No reliable method to diagnoses deficiency
d. Caution in renal and hepatic dysfunction
e. Mix data on effectiveness
Vanadium
Test Pearls
a. Average diet contains 6-18 mcq qd
b. Only 5% is absorbed
c. Kidney toxicity
d. Effective in Type 2 DM
e. Increase risk of bleeding when used in combination with RX, OTC or Supplements
Hypertension treatment options – Clinical pearls
- Garlic
• When using fresh product needs to sit for 10 minutes chopped up prior to use for best results
• Generally recognized as safe (GRAS)
• Discontinue 2 - 3 weeks prior to surgery
• Products marketed as odorless, may not contain allicin
• 0.65-1.3% allicin for standardization (measure potency) - Coenzyme Q-10
• Some medications can lower Co Q 10 levels (Statins, beta blockers, and diuretics)
• Increase risk of bleeding
• Increase T4/T8 labs in normalized patients
• Take with a fatty meal for best absorption
Garlic
Test Pearls
Used for HTN treatment
a. When using fresh product needs to sit for 10 minutes chopped up prior to use for best results
b. Generally recognized as safe (GRAS)
c. Discontinue 2 - 3 weeks prior to surgery
d. Products marketed as odorless, may not contain allicin
e. 0.65-1.3% allicin for standardization (measure potency)
Coenzyme Q-10
Test Pearls
a. Some medications can lower Co Q 10 levels (Statins, beta blockers, and diuretics)
b. Increase risk of bleeding
c. Increase T4/T8 labs in normalized patients
d. Take with a fatty meal for best absorption
Conclusion statements
From handout
a. Several OTC & supplement products have demonstrated possible efficacy in treatment of metabolic disease
b. Evidence continues to evolve regarding legitimate IHM uses
c. IHM therapies hold potential for drug/disease interactions
d. Providers should include OTCs and supplements when obtaining a medication history and providing treatment recommendations
e. Health professionals should learn where to find more information about OTCs and supplements
f. “ Do no harm” approach
