otc’s&&supplements& in&the&management · pdf...

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OTC’s & Supplements in the Management of Metabolic Disease: Complementary or Confusion?”Monika Nuffer, PharmD

Skaggs School of Pharmacy and Pharmaceutical Sciences

May 19, 2017

DisclosureNothing to disclose

Learning ObjectivesÍBecome familiar with the most commonly used supplements for treatment of different aspects of the metabolic syndrome

ÍIdentify products that have safety concerns when used in metabolic syndrome

ÍAppraise the potential benefits that a product may have in a patient with metabolic syndrome

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DefinitionÍ 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.

StatisticsÍ Utilization

• Adult American population 33.2% • Children American population 11.6% • Women more then men• Patient with higher education and income

• 72 % patients didn’t report IHM use to health care provider *

Í Cost in 2014• $ 6.4 billion US dollars• Estimated $115 billion globally by 2020

Why People Use IHMÍDissatisfied with the results of conventional therapy

ÍLack of disease curing of conventional therapy

ÍDramatic reports from media

ÍPatient empowerment

ÍFocused on spiritual and emotional wellbeing

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What Patients Believe…ÍNatural is better than synthetic

ÍPatients don’t consider supplements as “drugs”

ÍSupplements don’t have side effects

ÍSupplements are regulated, standardized, and safe

ÍUsed for thousands of years

ÍPush back from providers*

http://www.cartoonstock.com/directory/v/vitamin_supplement.asp

Obesity

toonpool.com

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Obesity – Level of Evidence

www.naturaldatabase.com

Ephedra, Bitter orange, Usnea, DMAA, Aristolochia, Guar gum, and GarciniaBlond psyllium, Calcium, Conjugated linoleic acid, Phaseolus vulgaris, Barley, chromium, St. John’s wort 5-HTP, 7-keto-DHEA, Chitosan, Garcinia, glucomannan, Green coffee extract, Irvingia gabonensis, Pyruvate, Cha de bugre, Hoodia, Raspberry ketone,

NA

Ephedra (Ephedra sinica)

http://www.naturephoto-cz.eu/pic/bilek/ephedra-0134.jpg

ÍEfficacy:• Weight loss of 0.9 kg/month up to 6 months with ≤ 30 % of dietary fat intake with moderate exercise

ÍAdverse reactions:• Dizziness, anxiety, insomnia, HA, dry mouth, N/V, heartburn, tachycardia, palpitations, & áBP

• Seizures, cardiomyopathy, MI, arrhythmias & sudden death


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ÍHistory:• June 1997• Proposed restriction & 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

Í Potential risk outweighs the benefit!


Dietary Calcium

4pack.wordpress.com/.../

Dietary CalciumÍPatients will low calcium intake often gain more weight and have a higher BMI and maybe overweight or obese

ÍEfficacy: • 800-1200 mg/qd dietary calcium had been shown to á weight reduction & body fat loss

• 900-1000 mg/qd has been shown weight loss of 8-9 kg

ÍAdverse reactions: belching & flatulenceÍClinical pearl: supplement calcium alone ≠ low fat dietary intake

Am J Clin Nutr. 2004 May;;79(5):907S-912S, , Obes Res. 2005 Jan, 13(1)191 ,J Clin Endocrinol Metab. 2000 Dec;;85(12):4635-8,

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Green Coffee

Green CoffeeÍEfficacy: Possible Effective • 80-200 mg qd = 2.5 kg weight loss• 700-1050 mg qd = 1.5-2 kg ↓ 6 wks

ÍSafety: possibly safeÍAdverse reactions: caffeine & stimulates

ÍDosage: 200 mg bid – 5x dailyÍStandardized: 30 - 54% chlorogenicacids

Hypertension

http://www.cartoonstock.com

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Hypertension – Level of Evidence


EPA, Oats, Vitamin E and Black tea

Alpha-lipoic acid, Blond psyllium, Calcium, Cocoa, Coenzyme Q-10, Fish oil,Garlic, Potassium, Sweet orange, Vitamin C, Wheat bran,Hibiscus, L-arginine, DHA, English walnut, Flaxseed, Green tea, Magnesium, Oolong tea, Pomegranate, Soy, Vitamin D, Beet, Pycnogenol, tomato extract, and Casein petidesNA

Coenzyme Q-10

www.drugstore.com

Coenzyme Q-10ÍEfficacy:• In combination with standard therapy might have some benefit in lowering BP

ÍAdverse reactions:• GI upset• Heartburn• Appetite loss

ÍDosage: • Isolated systolic HTN 60 mg bid• HTN 60-100 mg bid• Max daily dose of 300 mg daily

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Coenzyme Q-10Í Interactions:• Herbs: Fish oil, Stinging Nettle, & Red Yeast Rice

• Drugs: antihypertensives & anticoagulants• Labs: increase T4/T8 ratio in normal patients

• Disease: cigarette smoking may deplete body stores

Í Clinical pearls:• Some medications can lower Co Q 10 levels (e.g. Statins, Beta Blockers, and Diuretics)

Flavonoids

allaboutresveratrol.org/

Healthly-holistic-living.com/

Flavonoids

Í N = 150,000 • Women - Nurse Health Study I & II • Men - Health Professional follow up study

Í Anthocyanin • Flavonoid from strawberries & blueberries

Í 8% lower risk of HTN over 14 years

Í COSMO study results are coming

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Dyslipidemia

Dyslipidemia – Level of Evidence


Evening primrose oil and GarlicGreen tea, red yeast rice, English walnuts, Flaxseed,Guar gum, Soy, Artichoke, Pectin, Alpha-linolenic acid, Black currant, Boarage see oil, Chitosan, Gamma Linolenicacid, Guggulipid, Inositol nicotinate, Krill oil, Policosanol

EPA, Fish Oil, Barley, Beta-glucans, Blood psyllium, Niacin, Oat bran, Plant Stanols and sterols

Fish Oil / Omega 3

http://www.healthhype.com/wp-content/plugins/omega-3-fish-benefits.jpg

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Fish Oil / Omega 3 EfficacyÍEffects: • TG â20 - 50%• If TG are > 500 mg/dl = â 45%• Combo with statin in TG levels of 200 -499 mg/dl = â 30%

• LDL-C neutral effects

ÍRecommend treatment per AHA:• Primary prevention: 500 mg qd or 2 fishy meals a week

• Secondary prevention (CHD): 1000 mg daily

J. Am. Coll. Cardiol. 2009 54: A24

Fish Oil / Omega 3ÍAdverse reactions:• Fishy taste, GI upset, heartburn, and belching

ÍDrug interactions: • Antihypertensive & Anticoagulants

ÍHerb interactions: • Garlic, Ginger, Ginkgo, and Ginseng

ÍDosage: • 1 – 4 g qd of DHA & EPA• 120 mg DHA &180 mg EPA

• Catfish = 0.15-2 grams • Cod = 0.13-0.24 grams • Flounder/Sole = 0.42 grams • Halibut = 0.4-1 grams • Herring = 1.71-1.81 grams • Mackerel = 0.34-1.57 grams • Rainbow trout = 0.84-0.98 grams • Salmon (Atlantic, Farmed) = 1.09 - 1.83 grams • Salmon (Atlantic, Wild) = 0.9 - 1.56 grams • Salmon (Chinook) = 1.48 grams • Salmon (pink) = 1.09 grams • Salmon (sockeye) = 0.68 grams • Sardines = 0.98-1.70 grams • Tuna (light, canned) = 0.26 grams

Fish Oil / Omega 3

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Plant Sterols & Stanols

www.benecol.com

http://www.promisehearthealthy.com/Products/Default.aspx#activ

http://www.latinastyle.com/currentissue/v14-2/ima/v8.jpg

ÍEfficacy:• â TC, â LDL-C, no effect on HDL

ÍAdverse reactions: • Nausea, indigestion, diarrhea, constipation & gas

ÍDosage: 800 mg –6 g qd with low fat meals

ÍEfficacy:• 10-15% â LDL-C• With Statin therapy• 3-11% â TC• 7-16% â LDL-C

ÍAdverse reactions: • Diarrhea & steatorrhea

ÍDosage: 800 mg –4 g qd

Plant Sterols & Stanols

Red Yeast Rice (Monascus purpureus)

http://en.wikipedia.org/wiki/Red_yeast_rice

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ÍEfficacy: • Certain products contain about 6-10 mg of HMG-CoA reductase inhibitors

ÍAdverse reactions: • GI upset, heartburn, flatulence & dizziness• á liver enzymes & myopathy• Kidney failure

ÍDosage: 600 mg – 1200 mg bid

ÍInteractions: similar to Statins

ÍFDA role on adulterated product

Red Yeast Rice (Monascus purpureus)

Diabetes

thebuttercompartment.com

Diabetes – Level of Evidence


Flaxseed and Selenium

Blond psyllium, Magnesium, Oat bran, Soy, Agaricus mushroom, Alpha-lipoic acid, American ginseng, Berberine, Chromium, Fenugreek, Glucomannan, Ivy gourd, Prickly pear cactus, White mulberry, Cassia cinnamon, Coenzyme Q-10, Guar gum, Stevia, Vanadium, Banaba, Bitter melon, Chia, Gymnema, Panax ginseng, Phaseoulus Vulgaris NA

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Chromium

www.redorbit.com/modules/reflib/article_image...

ÍDesign: Type 2 non-insulin dependent elderly patients in rehabilitation for stroke or hip fracture, N = 78

ÍDose: Chromium picolinate 200mg bid x 3 weeks

ÍResults:• Fasting blood glucose (190 mg/dL vs 150 mg/dL, p < 0.001)• HbA1c (8.2% to 7.6%, p < 0.01)• Total cholesterol (235 mg/dL to 213 mg/dL p < 0.02)

Int J Vitam Nutr Res. 2004 May;;74(3):178-82.

ChromiumÍAdverse reactions:• HA, insomnia, irritability, mood changes & sleep disturbance• Vomiting, diarrhea, & hemorrhage

ÍDosage: • 200-1000 mcq divided doses• About 0.4 - 2.5% is absorbed and rapidly excreted in the urine• Several salt forms - picolinate

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Cinnamon (Cinnamomum verum)

www.greenchem.biz/.../pageproducts.php?no=25

Bitter Melon (Momordica charantia)

http://www.herbalextractsplus.com/bitter-melon.html

ÍDose: 1-6 g qd (1 tsp = 4.75 g)

ÍClinical pearls:• GRAS • Discontinue 2 wks prior to elective surgery

• Different forms available in spice shops

ÍEfficacy:• Improvement in glucose tolerance, reduce sugars and lowers HbA1C in Type 2

Í Dosing: Juice better than sun dry fruit

ÍToxicity: G6PD deficiency risk of favim from the seed

Resveratrol

allaboutresveratrol.org/

Healthly-holistic-living.com/

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Resveratrol Í Environmental factors: • Grapes, climate, & practices• Cold and humid climates higher concentrations

• Whites have only 1-5% • Cognac (oak barrels) insufficient concentrations

ÍEfficacy: ↓ fasting glucose & HbA1c by 0.79 in T2DM

ÍDose: 25-1000 mg daily

ÍAdverse reactions: noneAm J Clin Nutr. 2014 Jun;;99(6):1510-9

Online resourcesTitle Location (Access)Natural Medicine http://www.naturaldatabase.com

National Center for Complementary and Alternative Medicine (NCCAM)

http://nccam.nih.gov

Florence G. Strauss-Leonard A. Wisneski Indigenous and Integrative Medicine Collection

http://hslibrary.ucdenver.edu/strauss

American Botanical Council http://herbalgram.org/Herb Research Foundation http://herbs.org/

American Herbalist Guild http://americanherbaistsquild.com

National Center for Homeopathy http://www.homeopathy.orgUnited Plant Savers http://www.unitedplantsavers.org

The Center for Integrative Medicine at University of Colorado Hospital

http://www.uch.edu/conditions/integrative-medicine/

Online resourcesTitle Location (Access)Micromedex www.micromedex.comUpToDate www.uptodate.comPubMed www.ncbi.nlm.nih.gov/pubmed

Cochrane Collaboration www.cochrane.orgOffice of Dietary Supplements www.ods.od.nih.gov

Mayo Clinic http://www.mayoclinic.com/health/drug-information/DrugHerbIndex

Memorial Sloan-Kettering Cancer Center

http://www.mskcc.org/mskcc/html/11570.cfm

NOAH: New York Online Access to Health

http://noah-health.org/en/alternative/healing/herbal.html

Medline Plus http://www.nlm.nih.gov/medlineplus/druginfo/herb_All.html

Food and Drug Administration www.fda.gov

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ConclusionÍ Several supplements have demonstrated possible efficacy in treatment of metabolic syndrome

Í IHM therapies hold potential for drug/disease interactions

Í Providers should include OTCs and supplements when obtaining a medication history and providing treatment recommendations

ÍHealth professionals should learn where to find more information

Í “Do no harm” approach

QUESTIONS ?

References• Anderson RA, Cheng N, Bryden NA, et al. Elevated intakes of supplemental

chromium improve glucose and insulin variables in individuals with type 2 diabetes. Diabetes 1997;;46:1786-91.

• Rabinovitz H, Friedensohn A, Leibovitz A, et al. Effect of chromium supplementation on blood glucose and lipid levels in type 2 diabetes mellitus elderly patients. Int J Vitam Nutr Res 2004;;74:178-82.

• Gylling H, Miettinen TA. Effects of inhibiting cholesterol absorption and synthesis on cholesterol and lipoprotein metabolism in hypercholesterolemicnon-insulin-dependent diabetic men. J Lipid Res 1996;;37:1776-85.

• Gylling H, Radhakrishnan R, Miettinen TA. Reduction of serum cholesterol in postmenopausal women with previous myocardial infarction and cholesterol malabsorption induced by dietary sitostanol ester margarine: women and dietary sitostanol. Circulation 1997;;96:4226-31.

• Hallikainen MA, Sarkkinen ES, Gylling H, et al. Comparison of the effects of plant sterol ester and plant stanol ester-enriched margarines in lowering serum cholesterol concentrations in hypercholesterolaemic subjects on a low-fat diet. Eur J Clin Nutr 2000;;54:715-25.

• Jones PJ, Raeini-Sarjaz M, Ntanios FY, et al. Modulation of plasma lipid levels and cholesterol kinetics by phytosterol versus phytostanol esters. J Lipid Res 2000;;41:697-705.

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References• Halberstam M, Cohen N, Shlimovich P, et al. Oral vanadyl sulfate

improves insulin sensitivity in NIDDM but not in obese nondiabetic subjects. Diabetes 1996;;45:659-66.

• Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington, DC: National Academy Press, 2002. Available at: www.nap.edu/books/0309072794/html

• Aharon Y, Mevorach M, Shamoon H. Vanadyl sulfate does not enhance insulin action in patients with type 1 diabetes. Diabetes Care 1998;;21:2194-5.

• Aviram M, Rosenblat M, Gaitini D, et al. Pomegranate juice consumption for 3 years by patients with carotid artery stenosis reduces common carotid intima-media thickness, blood pressure and LDL oxidation. ClinNutr 2004;;23:423-33.

• Adapted from patient education found in the Natural Medicines Comprehensive Database www.naturaldatabe.com. Accessed March 2017.

• Office of Dietary Supplements web site. Available at: https://ods.od.nih.gov/. Accessed November 9, 2016.

• Vinson JA, Burnham BR, Nagendran MV. Randomized, double-blind, placebo-controlled, linear dose, crossover study to evaluate the efficacy and safety of a green coffee bean extract in overweight subjects. Diabetes Metab Syndr Obes 2012;;5:21-7.

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