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
