The Truth About Supplements

The Truth About Supplements
Recommending Quality Products to Improve Health
Alyson Roby, PharmD, RPh
Medica Pharmacy and Wellness Center
Disclosures
The presenter has no relevant financial relationships to disclose.
Objectives
• Identify what makes good quality supplements.
• Describe the opportunity to counsel patients on using supplements to improve health outcomes.
• Describe the impact on patient care by addressing drug‐nutrient depletion.
• Identify areas of revenue to the business by addressing drug nutrient depletion
Standard American Diet • Comprehensive studies sponsored by U.S. government
– NHANES I and II
– Ten State Nutrition Survey
– USDA Nationwide food consumption study
• Marginal nutritional deficiencies exist in approximately 50% of U.S. population
• More than 80% of certain age groups consume less than the RDA
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Nutrient Content of Food
• In the past 80 years
– Iron in apples has decreased 96%
– Calcium in lettuce has decreased 92%
– Magnesium in cabbage has decreased 77%
– 1 bowl spinach 1970 = 12 bowls today (iron)
– 1 orange 1970 = 8 oranges today (vitamin A)
– Not only is our food less nutrient dense, prescription use is depleting us further. Dietary Supplementation
• Address foundational nutrient essentials – According to Large US Nutrition and Health Examination studies certain populations can fall under the category of deficient in the daily essentials vitamins and minerals • Recommended Daily Allowance (RDA)
– The amount needed to maintain health, NOT restore a deficiency
Know your Supplements
• Patients want more than diet and lifestyle changes to improve health
• Patients may not have access to medications due to disease state or intolerance
• Patients are looking for alternatives when they don’t see improvement in symptoms
• Patients want to use safe and efficacious products/ingredients
Dietary Supplement GMPs vs. Drug GMPs
• Dietary supplement ~250 SOPs (inspected every 2 yrs)
• Drug 650+ SOPs annually inspected
Less Strict
Food GMPs
More Strict
Dietary
Supplement
GMPs
Drug
GMPs
Common supplement uses
1. Digestion
Probiotics
Magnesium and vitamin C
Digestive Enzymes, Betaine HCl
2. GERD
DGL (deglycyrrhizinated licorice root extract)
Zinc Carnosine
Probiotics
Melatonin
3. Bone Support
Calcium Magnesium Vitamin D3 – micro crystallized calcium hydroxyapatite
Comprehensive formula (calcium, mg, zinc, K2, silicon +)
Common supplement uses
4. Stress/Anxiety
B Complex
Vitamin C & Magnesium
phosphatidylserine
Botanicals l‐theanine lavender, ashwagandha)
5. Sleep
melatonin
Magnesium
Botanicals (magnolia, valerian)
See also stress
6. Fatigue
Iron (if deficient) – ferrous succinate with liver fractions, vitamin C
Vitamin C
B Complex
Magnesium
Botanicals/adrenal adaptogens ‐Rhodiola, Ginseng, licorice, ashwaganda
Common supplement uses
7. Inflammation (general)
Fish oil
curcumin
Correct digestion!!!
8. Joint cartilage
MSM (sulfur)
Glucosamine & chondroitin sulfate
Curcumin
9. Cold/Viral
EPS 7630 (perlagonium sidoides)
Black Elderberry
Echinacea purpurea and pallida, baptisia, thuja
Common supplement uses
11. Blood glucose/insulin resistance
chromium
botanicals (myricetin, berberine)
12. UTIs
probiotic (lactobacillus rhamnosus GR‐1 and reuteri RC‐14)
cranberry
13. Muscle energy
Magnesium
Coenzyme Q10 (ubiquinol form)
Common supplement uses
14. Eye health
Night vision, or clarity ‐ bilberry
macula‐ lutein, zeaxanthin, curcumin
retina‐ fish oil (DHA)
15. Prostate
WS1473 WS1031
16. Liver/ Detox
milk thistle‐ fat soluble
Comprehensive Detox formula (vitamins, minerals, botanicals, fiber)
Drug‐Nutrient Depletion
• Almost 70% of Americans take one prescription and more than ½ of them take two.*
• 20% of Americans take 5 or more prescription medications.*
• Drugs inhibit nutrient absorption, synthesis, transport, storage, metabolism, or excretion
• *Mayo Clinic June 2013
Drug Induced Depletions
• NSAIDS
– Folic acid, Iron, Vitamin C, amino acids
• Sulfonylureas
– CoQ10
• Biguanides
– CoQ10, B12, folic acid
Drug Induced Depletions
Statins
• CoQ10, Vitamin D, Vitamin E, Omega 3, Carnitine, Zinc, Selenium, Copper
Fibrates
• Vitamin B12, Vitamin E, Copper, Zinc
Gemfibrozil
• CoQ10, Vitamin E
Bile Acid Sequest.
• Vitamins A, D, E, K, B12, Calcium, Magnesium, Phosphorus, Zinc, Iron, Folic Acid, beta‐carotene, fat
Drug Induced Depletions
• H2 Antagonists
– B12, D, folic acid, Calcium, Iron, Zinc, protein
• PPI’s
– All the above plus Beta carotene and magnesium
– Women on PPI’s:
• 47% more likely to have a spine fracture
• 26% more likely for forearm fracture
• 25% more likely for any type fracture.
Drug Induced Depletions
• Thiazide Diuretics
– Magnesium, Potassium, Zinc, CoQ10
• Loop
– Calcium, Magnesium, Potassium, Zinc, B1, B6, C
• K Sparing
– Calcium, Zinc, folic acid
Drug Induced Depletions
• Beta Blockers
– CoQ10, melatonin
• Clonidine/methyldopa
– CoQ10
• ACE/ARB/Chlorthalidone
– Zinc
Digestion
• Probiotics
• Digestive enzymes
• Betaine HCl
Normal Gut Flora
• > 400 bacterial species in the human intestines • Functions include
– synthesis of vitamins
– metabolism & removal of xenobiotics, toxins, and hormones
– digestion of dietary fiber from which we get short‐
chain fatty acids
– prevent colonization by pathogenic organisms
– may stimulate normal immune system maturation
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Probiotics
• Babies are sterile in the womb, colonization of flora begins in the birth canal
• Flora can affect higher rates of UTI’s
• Flora regulates perisitalsis‐ rapid transit or constipation
• If flora wasn’t important fecal transplants would not cure C. Diff
Probiotics
• Control inflammatory response in the intestines
• Protect against invading bacteria
Compete for nutrients and adhesion sites
Generate adverse environments for pathogens (e.g., low pH)
• Reinforce barrier function of intestinal mucosa, preventing attachment of pathogenic microorganisms
– Increase mucin and secretion by goblet cells
– Augments secretion of B‐ defensin preventing the proliferation of pathogens
– Enhance tight junction stability
– Promotes secretory IGA into mucosal layer binding bacteria and antigens.
Adult GI Applications of
Probiotics
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Prevention of illness (general)
Antibiotic-associated diarrhea
Recurrent C. difficile
Irritable bowel syndrome
Inflammatory bowel disease
Helicobacter pylori – adjunctive use
Functional constipation
Colorectal tumors
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Indications for Probiotics in
Children
• Atopic dermatitis
• Acute respiratory
infections
• Infectious diarrhea
• Antibiotic-Associated
Diarrhea
• Recurrent C. difficile
diarrhea
• Constipation
• Colic
• Necrotizing
enterocolitis
• Ulcerative Colitis
• Prevention of Candida
spp. colonization
• Irritable Bowel
Syndrome
• Tx for Helicobacter
pylori infection
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Probiotic Stability
• Bacteria must remain alive through the shelf life of the product.
• Bacteria must survive transit through the acidic conditions of the stomach.
• Bacteria must colonize in the intestines.
• Should have multiple strains of bacteria
Low gastric acidity symptoms
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Bloating/distention after eating
Diarrhea or constipation
Flatulence after eating
Hair loss in women
Heartburn and indigestion
Malaise
Nausea after taking vitamins
Undigested food in stool
Low gastric acidity symptoms
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Chronic candidia infections
Chronic intestinal parasites
Abnormal intestinal flora
Dilated capillaries in the cheeks and nose
Iron deficiency
Acne
Multiple food allergies
Low gastric acidity diseases
Addison Disease
Asthma
Celiac Disease
Dermatitis herpetiformis
Diabetes mellitus
Eczema
Gall Bladder Disease
Gastric carcinoma
Grave’s Disease
Chronic autoimmune disorders
• Hepatitis
• Chronic hives
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Lupus erythematosus
Myasthenia gravis
Osteoporosis
Pernicious anemia
Psoriasis
Rheumatoid arthritis
Rosacea
Sjogren’s syndrome
Thyrotoxicosis
Hyper‐and hypo thyroidism
Ulcerative Colitis
Vitiligo
GERD/Reflux
• Constipation worsens symptoms
• Vitamin C and Mag help move food in right direction • Healthy intestinal environment for peristalsis
• Stomach acid closes LES and opens pyloric
GERD ‐ Zinc Carnosine
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attenuates H. pylori, increases cure rate
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Protects, stabilizes, and repairs the gastric and intestinal mucosal lining without interfering in the normal digestive process supports the body to rapidly regenerates epithelial cells in the presence of various stressors.
Supports healthy gastric microbial balance and intestinal permeability.
Relieves mild gastric discomforts: occasional heartburn, nausea, bloating, and upset stomach.
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Zinc supplementation in Crohn's disease.
Small intestinal permeability is often increased in patients with Crohn's disease and may be pathogenic for clinical relapses.
Iflammatory Bowel Dis. 2001 May; 7(2):94‐8 CONCLUSIONS: Our findings show that zinc supplementation can resolve permeability alterations in patients with Crohn's disease in remission. Improving intestinal barrier function may contribute to reduce the risk of relapse in Crohn's disease.
References
Zinc Carnosine
GI Health‐DGL
Deglycyrrhizinated liquorice in aphthous ulcers.
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Twenty patients with aphthous ulcers were advised deglycyrrhizinated liquorice
(DGL) mouth wash and were followed for two weeks. Fifteen patients experienced 50‐75% improvement within one day followed by complete healing of the ulcers by third day.
Source: Das SK, Das V, Gulati AK, Singh VP. J Assoc Physicians India. 1989 Oct;37(10):647.
Effect of deglycyrrhizinated liquorice on gastric mucosal damage by aspirin.
• Gastric mucosal damage induced by giving 60 mg aspirin orally to rats was reduced by simultaneous administration of 100‐500 mg deglycyrrhizinated liquorice. Human fecal blood loss induced by 975 mg aspirin orally three times a day was less when 350 mg deglycyrrhizinated liquorice was given with each dose of aspirin.
• Source: Rees WD, Rhodes J, Wright JE, Stamford LF, Bennett A. Scand J Gastroenterol. 1979;14(5):605‐7.
Anxiety / Sleep
Lavender oil (oral)
• Several clinical studies have demonstrated the benefit of lavender extracts in decreasing symptoms of anxiety and depression.
• The best‐controlled studies with the best results utilized an extract of lavender known as Silexan (WS® 1265)
Anxiety/Sleep ‐ WS® 1265
• Indication: patients with anxiety disorder NOS
• Study design: placebo‐controlled, multi‐centric, randomized, 10 week treatment, 228 patients
• Results
– Anxiolytic efficacy, very clear effects already after 2 weeks of treatment
– Improvement of sleep disturbances, clear effects after 4 to 6 weeks
– Improvement in Quality of life (SF‐36, CGI)
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WS® 1265 vs Lorazepam for GAD
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Multi‐center, DBPC, Phase III study N= 77 subjects with Generalized Anxiety Disorder (GAD), 18–65 years of age
WS1265 80 mg per day in comparison to low‐dose lorazepam 0.5 mg for for 6 weeks.
HAMA‐total score decreased by 45% in the WS® 1265 group and by 46% in the lorazepam group.
Remission rates: 40% of the WS® 1265 group and 27% of the lorazepam
group.
Response rates: WS® 1265 group had a response rate of 52.5% compared to only 40.5% taking lorazepam. 39
Phytomedicine 2010;17:94–9. Epub 2009 Dec 3.
WS® 1265 improves anxiety
as well as low‐dose benzo
Mean change in HAMA total score from baseline during the active treatment period
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Lavender oil
Lorazepam
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week 1
week 2
week 4
week 6
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A multi‐center, double‐blind, randomised study of the Lavender oil preparation Silexan
in comparison to Lorazepam for generalized anxiety disorder “In conclusion, our results demonstrate that silexan is as effective as lorazepam in adults with GAD. The safety of silexan was also demonstrated. Since lavender oil showed no sedative effects in our study and has no potential for drug abuse, silexan appears to be an effective and well tolerated alternative to benzodiazepines for amelioration of generalized anxiety.”
Stress
Success Story
55 year old female that came in from another pharmacy due to them not having her medicine – she wanted brand name zoloft and they failed to order it for her. She was extremely anxious, irritable, and tearful. She had lost her father 5 weeks prior and was not handling things well. She had tried alprazolam and buspirone and hated both. Now her MD wanted her to try an SSRI and she didn’t want to. I spent time talking about how stress effects you, why I didn’t think brand name zoloft
would help better than generic anyway, and gave her information on lavendar oil, another adrenal stress supplement that lowers cortisol, and a sample of the lavendar
oil capsules with written instructions on how to use them. She came in the next day after lunch, gave me a hug so big I wasn’t sure she would let go and said that she couldn’t explain how much better she felt and her husband was so impressed that he gave her $100 and told her to come back here and buy whatever I suggested.
Inflammation‐ Curcumin
Properties of curcumin
• Antioxidant
• Hepatoprotective
• Anti‐mutagenic
• Anti‐carcinogenic
• Anti‐tumor
• Antibacterial/Fungistatic
• Wound‐healing
• Anti‐inflammatory (multiple pathways affected‐
next slide)
HerbalGram 2009;84:1‐3.
Signalling pathways modulated by Curcumin
Curcumin, cholesterol and LDL receptors
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10 healthy volunteers consumed 500 mg of curcumin per day for 7 days
– not only did their blood levels of oxidized cholesterol drop by 33%
– total cholesterol dropped 11.63% – HDL (good cholesterol) increased by 29%! (Soni KB, Kuttan R).
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Curcumin communicates with genes in liver cells, directing them to increase the production of mRNA (messenger proteins) that direct the creation of receptors for LDL cholesterol. With more LDL‐receptors, liver cells are able to clear more LDL‐cholesterol from the body.
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LDL‐receptor mRNA increased sevenfold in liver cells treated with curcumin at a concentration of 10 microM, compared to untreated cells. (Peschel D, Koerting R, et al. J Nutr Biochem)
Cancer prevention by curcuminoids
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Breast
Colorectal
Gastrointestinal
Genitourinary
Lung
Leukemia
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Lymphoma
Melanoma
Ovarian
Pancreatic
Prostate
Sarcoma
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Curcumin absorption
• Studies on curcumin over the past three decades show curcumin:
– is not well absorbed • low blood levels after oral dosing
– has limited tissue distribution • does not accumulate in tissues
– is rapidly metabolized and eliminated • the body gets rid of it quickly
• Water soluble form – 27x more bioavailable
Water soluble curcumin
• NIH funded clinical trials
– UCLA‐ Alzheimer's Disease
– MD Anderson – Cancer
• Short‐term effects of highly‐bioavailable curcumin for treating knee osteoarthritis
– Journal of Orthopedic Science in Vol. 19 No. 6 2014
• Muscle fatigue recovery
• Effects of curcumin supplementation of exercise‐
induced oxidative stress in humans
– Accepted by Int. J Sports Med. 35:469‐475, 2013
Curcumin ongoing research
• Pancreatic Cancer
• Chronic Obstructive Pulmonary Disease (COPD)
• Osteoarthritis
• Crohn’s Disease
• Ulcerative Colitis
• Hypertension
• Periodontitis
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• Chronic Kidney Disease
• Schizophrenia
• Diabetes (Decreased Triglycerides and Gamma GTP)
• Cognition
• Advanced Cancers
• PSA After Surgery
• Phase I for Lung Cancer
Immune Support
• EPS 7630
– From the plant perlagonium sidoides
• Over 20 Double blind placebo controlled studies – Common cold
– Bronchial irritations
– Sinusitis
– tonsillopharyngitis
Fatigue
• Body requires fuel (nutrition)
MY TANK IS EMPTY
– Vitamin C
– B Complex (not just B12)
– Magnesium
1. Use a multivitamin‐mineral, amino acids
2. Add Vitamin C, Magnesium
3. Probiotic‐ to digest the B vitamins
Magnesium
• Symptoms of Deficiency
– Muscle cramps and spasms, including vasospasm, twitching, migraines, anxiety, nervousness, insomnia, depression, low energy/fatigue, increased BP, arrhythmia/palpitations, kidney stones, osteoporosis, constipation, blood sugar disturbances
– 75% of U.S. population deficient
Coenzyme Q10
• An essential component to the Electron transport chain in the mitochondria
• Deficiencies have been correlated to obesity and Type II Diabetes
• CoQ10 can increase fast twitch muscles, influence genetic expression of fast twitch muscles, and protect against aging of muscle tissue.
CoQ10
1. Vital for the mitochondria and ATP energy of every cell in the body
2. Highest concentration found in the most metabolically active cells (heart, kidney, liver, brain)
3. Functions as an intracellular antioxidant 4. Inhibits LDL oxidation
5. Maintenance dose: 50 to 200 mg daily
6. Ubiquinol is the active form
7. Some taking ubiquinone cannot convert as effectiely to ubiquinol
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Elderly
Diabetics
Kidney disease
Liver disease
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Drugs that Deplete Coenzyme Q10
Amiloride
Amoxapine
Beta Blockers
Candesartan\HCTZ
Chlorpromazine
Chlorpropamide
Clonidine
Desipramine
Doxepin
Enalapril\HCTZ
Fenofibrate
Gemifobrozil
Glimepiride
Glipizide
Glyburide
Haloperidol
Hydralazine
Imipramine
Indapamide
Irbesartan\HCTZ
Losartan\HCTZ
Methyldopa
Moexipril\HCTZ
Nortriptyline
Prochlorperazine
Protriptyline
Repaglinide
Statins
Thiazides
Thioridazine
Tolazamide
Tolbutamide
Valsartan\HCTZ
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CoQ10
• 109 patients with HTN for avg of 9.2 years
• Avg dose of 225 mg CoQ10 added to HTN medications
• 51% were able to D/C 1‐3 medicines within first 6 months (avg 4.4 months)
• Only 3% required addition of 1 more drug
• LangsjoenP, et al. Molecular Aspects of Medicine. 1994; 15 Suppl: S265‐72.
Atorvastatin and CoQ10
• Brief exposure to atorvastatin causes a marked decrease in blood CoQ(10) concentration. • Inhibition of CoQ(10) synthesis could explain the most commonly reported adverse effects of statins, especially exercise intolerance, myalgia, and myoglobinuria.
Arch Neurol. 2004 Jun;61(6):889‐92
Department of Neurology, Columbia University College of Physicians & Surgeons, New York, NY 10032, USA. PMID: 15210526
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Ws1473 & WS1031 in Prostate
• No adverse effects of ED. • WS1473 Saw Palmetto
– inhibits 5‐alpha reductase (anti androgenic‐
affecting testosterone dependent growth)
– Spasmolytic and alpha‐1 receptor antagonistic activity (support urinary flow rate, normal muscle function of small muscle cells of the urethra and prostate)
• WS1031 Stinging Nettle
– Inhibits aromatase and has anti estrogenic effect
– Inhibition of leukocyte elastase – Immunomodulatory properties
– Interaction with sex hormone binding globulin WS1473 & WS1031 in Prostate
Author/Year
Design
Duration
Number of subjects
Results/Conclusion
Lopatkin et al, 2005
Double‐blind, placebo‐
controlled (DBPC). Long‐
term study.
48 weeks (24‐week DBPC; 24‐week open‐
label)
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PRO 160 | 120 was distinctly superior to placebo, with excellent tolerability. Engelmann, 2006
DBPC. Long‐term study
60 weeks
140
Efficacy and safety was demonstrated in supporting lower urinary tract health. Specific reference is made to efficacy in comparison to a related agent.
Sökeland, Albrecht, 1997
DBPC. Long‐term study.
48 weeks
543
Efficacy and safety was demonstrated with specific reference to 5‐alpha reductase inhibition and tolerability.*
Sökeland & Walther, 2000
Follow‐up evaluation.
24 weeks
543
In this follow‐up evaluation to the 1997 study,3 it was determined that efficacy did not depend on baseline prostate volumes.
Long‐term follow‐up.
After 7 years
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Prostate support persisted after 7 years of follow‐
up as compared to respective baseline values in the original study.3 Improvements in QOL† also persisted.
Metzker, 1996
DBPC. Long‐term study.
48 weeks (24‐week DBPC; 24‐week single‐
blind)
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Significantly superior to placebo for urinary flow, prostate support, and QOL.*†
Jenner, 1998
Open‐label, multi‐center
12 weeks
102
Urinary flow rate support to a highly statistically significant degree; support of normal bladder urine volume; positive subjective reports.*
Popa et al, 2005
DBPC; re‐evaluation of previous study.
24 weeks
543
Positive support of normal micturition frequency and sensation. QOL† statistically significantly supported under the well‐tolerated PRO 160 | 120 in comparison with placebo.
Sökeland et al, 2005; Sökeland & Schläffke, 2007
THANK YOU!!
Questions?
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Medica Pharmacy & Wellness Center
202 W Stephen Foster Ave
Bardstown, KY
(502) 348‐6623