Download Nutraceuticals Vs. Pharmaceuticals

Nutraceuticals vs. Pharmaceuticals:
Safety Considerations
Cope 23905-SD
Stuart P Richer, OD, PhD, FAAO
Chief, Optometry Section, DVA Medical
Center
Associate Professor, Family and
Preventative Medicine, Rosalind Franklin
University of Medicine & Science /
Chicago Medical School
North Chicago, Illinois 60064
[email protected]
Therapeutic Eyecare
The therapeutic care of chronic disease
should be and will be a major element
of both patient care and revenue for the
eyecare practice in the next decade.
J. James Thimons, OD, FAAO.
May 2005.
Vision Institute of Canada 24 October 2009
Principles of Integrative Medicine
z A partnership between patient and practitioner
in the healing process
z Appropriate use of conventional and
alternative methods to facilitate the body's
innate healing response
z A philosophy that neither rejects conventional
medicine nor accepts alternative therapies
uncritically
z Use of natural, effective, less-invasive
interventions whenever possible
Naturopath (ND)
z First, do no harm
z Employ the healing power of nature
z Identify and Tx the cause
z Treat the whole person
z The physician is a teacher
z Prevention is the best cure
z Establish health and wellness
Expedient “Symptom” or Disease Care
Highlights – Michael T Murray, ND
z US is #1 in %GDP spent on health.
z We use 40 % of all worldwide medications.
z 700,000 US physicians @ estimated $60,000
per year in marketing per physician.
z 1992 average senior used 19.6 Rx / year.
z 2005 average senior used 34.4 Rx / year.
z Simple measures:
2004
2009
What is Integrative Medicine?
z Integrative medicine is a healing-oriented
medicine that takes account of the whole
person (body, mind, and spirit), including all
aspects of lifestyle.
z It emphasizes the therapeutic relationship and
makes use of all appropriate therapies, both
conventional and alternative.
z AKA: CAM (complimentary and alternative
medicine).
z Integrative Optometry follows these same
principles.
‹ Example
- Vitamin C, D and Fish oil ignored.
What is a Nutraceutical?
zNutraceutical can be defined as, "a food (or part of a food)
that provides medical or health benefits, including the
prevention and/or treatment of a disease."
zHowever, the term nutraceutical as commonly used in
marketing has no regulatory definition.
z* “Prescription drugs are approved through the
rigorous new drug application process (NDA). In
contrast, dietary supplements are regulated as foods and
the FDA must determine that a dietary supplement
ingredient poses a "significant or unreasonable risk of
illness or injury"
•About $7 billion spent on vitamins & $31 Billion spent
annually on dietary supplements, herbal foods and products.
RDA = Recommended Daily Allowance-”prevent 97% of deficiencies”
RDI = Recommended Dietary Intake
* J Pharmacol Exp Ther. 2005 Apr 15; [Epub ahead of print]
Most Common Reasons For Visiting Doctors
Office (Adults Over Age 45)
Coutesy Bill Sardi, Knowledge of Health
Condition
Very effective and doesn’t
cause drowsiness as
drugs can
Influenza Vitamin C to point of loose stool then Many senior Americans
reduce dosage 25%; vitamin D3 to don’t develop sufficient
5000 IU 1–5 days for adults; zinc up antibodies after flu shots
to 50 mg (adults); astragalus 1–5
because of poor nutrition.
days for adults; Echinacea,
goldenseal, oregano
Don’t forget to gargle with
salt water
Heartburn HCL hydrochloric acid and
Heartburn drugs may
pancreatic enzyme are secreted less cause osteoporosis due to
with advancing age; replace with
loss of vitamin D and
supplements; if symptoms persist try fatigue due to vitamin B12
mastic gum, aloe vera
depletion.
Alternatives
Notes
Cough (bronchitis) Chewable zinc
Echinacea, propolis,
Vitamin C (3000–15000
mg), licorice root,
eucalyptus
Colds Zinc, vitamin C, olive leaf,
vitamin D, garlic
Sore throat (laryngitis) Same as above for colds
Allergy Vitamin C to point of loose stool then
cut back 25%; quercetin, stinging
nettle, Antronex, with Yakriton
Wheezing (asthma) Vitamin C up to dose that Lower doses for
causes loose stool then
prevention
cut back 25%; vitamin B6,
magnesium, coleus
forskohlii, ginkgo biloba
Nasal sinus drainage Zinc, steam inhalation,
(infection) arabinogalactin, olive leaf
extract
Chronic Our first remedy is to thin the blood
headache as increased viscosity is a primary
cause in our experience; garlic oil,
magnesium, fish oil, bromelain,
turmeric, ginkgo, ginger, ginseng,
cayenne pepper, feverfew,
nattokinase
See a health professional if
symptoms persist.
Is Diet Enough ?
Bruce Ames, PhD
Percent Americans Consuming
100% of the RDA, Select Nutrients
120%
% Population
100%
80%
64%
60%
70%
74%
72%
69%
Vit. E
Vit. B6
Zn
Ca
46%
40%
20%
0%
Vit. A
Vit. C
Vitamin / Mineral
J Am J Am Coll Nutr 1994; 13:285-91
Coll Nutr, 1994
“It is a distortion of priorities for much of
the world's population to have an
inadequate intake of vitamins or
minerals—at great cost to health—when
a year's supply of a daily
multivitamin/mineral pill costs less than
a few packs of cigarettes. The poor, in
general, have the worst diets and have
the most to gain from improving their
multivitamin and mineral
supplementation and diet,” says Dr.
Ames. [European Molecular Biology
Organization) Journal (6, S20–S24,
2005]
Drug Class
Natural remedy
RDAs needs to be updated to reflect
new scientific studies
Antidepressants
Folic acid, SAMe
Blood pressure drugs, immune
suppressants, bone drugs
Vitamin D
Penicillin
Garlic clove (crushed), oil of oregano
z RDA for vitamin C was based on flawed data (half
Hormone replacement, hair drugs
Flaxseed meal, flax lignan pills
Sleeping pills
Vitamin B12, melatonin
Cholesterol drugs,
Vitamin C, vitamin D, resveratrol
Blood thinners
Fish oil DHA, magnesium, vitamin E, garlic,
resveratrol
Calcium blockers
Magnesium, vitamin D, vitamin K, arginine
Beta blockers – slows heart rate ~8 beats
per minute
Omega-3 fish oil – slows heart rate ~6
beats per minute
life of vitamin C was never calculated). Virtually all
humans on the planet are vitamin C deficient.
z Vitamin D is not toxic at relatively high doses and
major segments of the US population are suffering
from diseases related to vitamin D deficiency (cancer,
autoimmune disease, hypertension, bone loss).
Fortification of foods with vitamin D would likely
cause cancer rates to decline by as much as 30%.
z 40% of adults over age 50 experience signs of
vitamin B12 deficiency (short-term memory loss,
fatigue, nerve tingling) because of a decline in the
production of stomach acid.
KEEP IT SIMPLE
Examples of Basic economical $20 per month
multivitamin –mineral (sufficiently potent)
and fish oil combination
Stomach acid blockers (histamine blockers) Magnesium, quercetin
Anti-inflammatories, pain relievers,
cortisone
Tart cherry, resveratrol, quercetin, SAMe
Anti-allergy anti-histamine
Quercetin, vitamin C
Antivirals, vaccines
Resveratrol, quercetin, vitamin D
Basic multivitamin / mineral formulations
approx $15 per month
NSI Basic
Synergy v #3
LEF “Two per
Day” 01215
Capsules BID
MedOp
Whole Body
50% DOSE
1 each with breakfast / dinner
www.vitacost.com
www.lef.or
g
www.medop.co
m
Increasing Rx Pharmaceutical &
OTC Safety Concerns
www.vitacost.com
24/7 Customer Service 1-800-381-0759
z NSI 3005017
240 Softgels
‹
4 month supply
z 2 per day
•
•
•
z 800 EPA
z 400 DHA
z $22
Also 120
softgels
NSI #3001484
Drug Induced- Nutrient Interactions
(examples)
Chronic use of proton pump inhibitors for dyspepsia and gastroesophageal
reflex disease (GERD) can induce vitamin B12 deficiency, which may cause
secondary effects on optic nerve function.
Chronic or high dose acetaminophen use may induce glutathione deficiency,
which accelerates cataract formation and yields myriad effects on ocular
tissues.
Overuse of steroids, such as dexamethasone and prednisolone, can induce
deficiencies of vitamins C and D, folic acid, zinc, potassium, magnesium and
selenium.
COQ10 Depleters--- statins, beta blockers, metformin
•
•
•
In 2007, Americans spent around $300 Billion on FDA
approved prescription & OTC drugs
700,000 ER visits for overdoses & allergic rxns each year
(2005) 15,000+ died from drug reactions compared to 5,519
people in 1998
• fatalities linked to generic pain pills (oxycodone, fentanyl,
morphine & acetaminophen or Tylenol)
(2005) 89,482 serious side effects to the FDA
• 2.5 X the 34,966 reported in 1998
More than half of all approved drugs (like Vioxx) produce
serious side effects not detected prior to approval. [Journal
American Medical Assn. 279: 1571-73, 1998]
only 3% of prescription medicines have been withdrawn from
the American market for safety reasons over the last 20 years.'
Even OTC Pharmaceuticals can induce
nutritional deficiencies which are often treated
with additional pharmaceuticals
Nutritional and Fiscal cost of
Pharmaceuticals
z
DRUGS
z 2001: $120 Billion
z 2006: $200 Billion
estimate
z 2008 $300 Billion
AVERAGE age 65 y/o
z 4 medications
z Growing % of
healthcare budget with
political aspects
Consumers Report
2008
“Prescription drugs have an intended
effect on the body but they may be
reducing vital nutrients in your cells
causing all sorts of annoying and
dangerous side effects. For example,
cholesterol-lowering statin drugs mug you
of Coenzyme Q10, which powers your
heart beat and keeps you from becoming
weak, or developing leg
cramps. Estrogen-containing drugs mug
you of certain nutrients, leaving you
hypothyroid, depressed and
tired. Diabetic medications mug a certain
B vitamin that protects you from stroke &
heart attack. There are hundreds of
medications included as well as drug-food
interactions (like grapefruit, oatmeal and
cheese interactions that could harm
you)... “
Brand name
Generic name
Class
Aspirin
Aspirin
Pain reliever
Nutrients depleted
Vitamin C, folic acid, iron, potassium
Tylenol
Acetaminophen
Pain reliever
Glutathione
Folic acid
Advil, Motrin
Ibuprofen
Pain reliever
Lipitor
Atorvastatin
Cholesterol drug
Coenzyme Q10
Tenormin
Atenolol
Beta blocker
Coenzyme Q10
Zithromax
Aizithromycin
Antibiotic
B vitamins
Furosemide
Uroside, Uritol
Diuretic, blood pressure
Minerals, Vitamin B1, vitamin C, zinc
Amoxycillin
Amoxil, Biomox, Trimox
Antibiotic
B vitamins, acidophilus, inositol, vitamin K
Hydrochlorothiazide
Hydrodiuril, Esidrix
Diuretic, blood pressure
Minerals, Vitamin B1
Prilosec
Omeprazole
Heartburn drug
Vitamin B12
Prevacid
Heartburn drug
Vitamin B12
Zocor
Simvastatin
Cholesterol drug
Coenzyme Q10
Cephalexin
Keflex
Lansoprazole
Antibiotic
B vitamins, vitamin K
Glucophage
Metformin
Diabetic drug
Folic acid, vitamin B12
Vioxx
Rofecoxib
Pain reliever
Folic acid
Zestril
Lisinopril
Blood pressure
Zinc
Prempro
Estrogen-progesterone
Hormone replacement
Folic acid, magnesium, zinc, Vitamins C,
B2, B6
Prednisone
Deltasone, Orasone, Prednicen
Anti-inflammatory
Minerals, folic acid, vitamins
C&D
Toprol XL, Lopressor
Metoprolol
Beta blcoker
Coenzyme Q10
Pravachol
Pravastatin
Cholesterol
Coenzyme Q10
Coumadin
Warfarin
Blood thinner
Vitamin K
Cipro
Ciprofloxacin
Antibiotic
B vitamins, acidophilus
Lanoxin
Digoxin
Heart drug
Minerals, vitamin B1
Flonase, Flovent
Flutacasone
Asthma
Minerals, folic acid, vitamins C & D, zinc
Teach patients about food
14 SuperFoods ®
z Spinach
z Sardines
z Turkey Breast
z Broccoli
z Walnuts
z Tomato
z Soy
Blueberries
Citrus
Pumpkin
Yogurt
Oats
Legumes
Green Tea
The FDA against the USDA
& 29 Cherry Marketers
(Oct 2006)
“Eat 9 – 13
portions of
Fruits &
Vegetables per
day”
“20 cherries reduces inflammation in a similar manner as aspirin or Cox-2
inhibiting drugs without the lethal side effects of gastric bleeding or vitamin
depletion associated with these drugs” The molecules in cherries, called
anthocyanins, work to reduce inflammation at ten times less dosage than
aspirin. [Journal Natural Products 1999 Feb; 62(2): 294–6]
Daily sunlight and/or 1000 IU vitamin D daily
also is very important for general health
BRITAIN:
Cherrios – 12 May 2009
z FDA questions General Mills' Cheerios marketing
z
Triangle Business Journal - by Joey Peters Minneapolis/St. Paul Business
Journal
z The FDA told General Mills to stop promoting Cheerios, the
country’s best-selling cereal, as a product that can lower
cholesterol levels, reduce heart disease and reduce the risk of
cancer. The agency said that claiming the cereal can lower
cholesterol levels by 4 percent in six weeks amounts to
marketing it as a drug and violates the federal Food, Drug and
Cosmetic Act.
Warning letter threatening
regulatory action if scientific
“drug like” claims are not
removed from the web.
Tea Council under fire
z
Sept 26, 2007 - The UK Tea Council has been criticized for
exaggerating the benefits of tea and banned from making
further claims about the drinks antioxidant potential after
running a series of adverts.
The group came under fire after five people complained to the
Advertising Standards Authority (ASA) about a media campaign
which recommended drinking four cups a day as part of a
healthy diet.
z In a prepared statement, General Mills (NYSE: GIS) said the complaint
doesn’t question whether the cereal actually lowers cholesterol levels
and said the dispute is over language, not science.
z “The scientific body of evidence supporting the heart health claim was
the basis for FDA’s approval of the heart health claim, and the clinical
study supporting Cheerios’ cholesterol-lowering benefit is very strong,”.
“We look forward to discussing this with FDA and to reaching a
resolution.”
z Cheerios boxes say that two, one-and-a-half-cup servings of the cereal
every day have been clinically proven to lower cholesterol. The
message has been on the box for more than two years.
z ……despite the UK Tea Council (UKTC) submitting nearly 100
scientific studies backing up tea's health potential, the ASA said
it had not seen evidence to "firmly substantiate" any health
benefit in drinking four cups of tea per day and said the
campaign "exaggerated" the health benefits.
z …..under regulation (EC) No 1924/2006, which came into force
in the UK from 1 July 2007, any food product claiming to have a
health benefit must meet a list of European Commission
approved wording and be supported by scientific evidence.
Patients need better nutrition and higher
doses of vitamins as they age *
z
z
z
z
Mal-absorption including gastric hypo-chlorhydria
occurs with age, disease and use of acid blockers.
As we age, the ubiquitin system (Nobel Prize 2004)
becomes less efficient due to free radical attack
and glycosylation.
We have accumulated more free radical DNA hits
with less efficient repair.
We become increasingly cross-linked and rigid due
to carbonyl and glycosylation end products.
CODEX 2005
z The international “harmonization” of foods including vitamin and
mineral dosage in supplements. The FDA will abide unless it
breaks US law.
z United Nations Codex Alimentarius Commission
z Several committees
z Codex Committee on Nutrition and Foods for Special Dietary
Uses (CCNSFDU).
z The meetings are open to delegations from all over the
world and as well as non-governmental organizations such as
the Council for
Responsible Nutrition (CRN), the National Health Federation
(NHF) and the
American Holistic Health Association (AHHA).
* Vitamins for chronic disease prevention in adults: scientific review. (JAMA.
2002 Jun 19;287(23):3116-26.)
While the media creates “nutri-phobia”
Multivitamins
Oral Contraceptives
Insulin
Diuretics
Cough & cold preps
Review 145 (3) Issue 3/14/08
Aspirin
Acetaminophen
Antidepressants
Adverse
Reports
2811
9948
1686
7710
97710
5249
28991
92675
# of deaths
0
1
8
10
14
14
63
255
Comparative Safety of Multivitamins Am J Emergency Med 20: 391-452, 2002
Taking an aspirin every day is nearly
as risky as working as a firefighter.
z For 50-y/o men, taking a daily aspirin (which many do to help
prevent heart disease and strokes) increases the risk of death
by the equivalent of 10.4 deaths per 100,000 men per year.
z Similar to the added risk that professional firefighters face.
Firefighters have an added risk of 10.6 deaths per 100,000
people per year, compared to 3.9 for all occupations and 0.4 for
office workers.
z In comparison, drugs that have been withdrawn from the market,
such as the painkiller Vioxx and the multiple sclerosis drug
Tysabri, increased the risk of death by 76 deaths per 100,000
people per year and 65 deaths per 100,000 people per year,
respectively. Tysabri may be reintroduced to the market if the
FDA deems it worth using despite the risks.
z Adverse drug events harm more than 1.5 million people and
kill several thousand a year, costing at least $3.5 billion
annually. (Institute of Medicine 2006)
Anti-Dietary Supplement
Propaganda Campaign
Witch hunt (definition):
An investigation
carried out
ostensibly to uncover
subversive activities
but actually used to
harass and
undermine.
“often unsafe ?”
Health Affairs, Vol. 26, No. 3, May/June 2007: 636-646
Government Sources on Herbs and
Vitamins
All 29,000 dietary supplement products
American Association of Poison Control Centers data
z 600 US manufacturers
z 1000 more products each year
z Use in older patients: 44% in 1980; 55% by 1994, and 63% by
2000.
z In Europe, supplements like ginkgo biloba, kava kava, bilberry
and even a citrus fruit extract for hemorrhoids, are all
prescription drugs.
z 23 yrs of poison control center adverse events: 1.6 million
adverse rxns & 230 deaths (approx 12 per year).
‹ Most are ephedra diet products
‹ Guilt by association in aging Americans ?
z Supplement Manufacturers are now required By Law to notify
the FDA of adverse events (not drug manufacturers)Spanking the Wrong child ?
z National Library of Medicine Medline Plus
‹ http://www.nim.nih.gov/medlineplus/druginformation.html
z National Center Complementary / Alternative
Medicine
‹
http://ncam.nih.gov
z Office of Dietary Supplements
‹ http://dietray-supplements.info.nih.gov
z The Center for Disease Control & Prevention
‹ http://www.cdc.gov/nutrition/everyone/basics/vitamins
Certification Services
zwww.usp.org
zwww.nsf.org
zwww.informed-choice.org
zwww.ConsumerLab.com
USA Dietary Patterns
(1890-2009)
z High simple carbohydrate consumption
z
z
z
z
z
Soda -3.5 cans/day (only 25 % diet) - started in 1890
White Flour Baked goods - started in 1890
Potatoes - French Fries as #1 “vegetable”
Low Fruit & Vegetable (micronutrient/fiber) consumption
20:1 imbalance W6:W3 fatty acids
5-10 % calories from trans fats
Grain-fed & fattened cows, pigs, chickens -and stable,
(perhaps slightly lower %) saturated fat consumption
Progressive increase in calories to 3700/capita in 1990s
(fast food , meal super-sizing and nocturnal 24/7 eating)
Herbs et al
z Ginkgo biloba is associated with bleeding
but researchers could not reproduce these same
side effects in animals or humans even at blood
concentrations 100 times greater than the
recommended dosage for ginkgo. (Phytomedicine
12:10-6 2005; Blood Coagulation Fibrinolysis 15:
303-09, 2004).
z Glucosamine triggers a rise in blood sugar among
healthy adults in two separate studies
‹ Couldn’t reproduce this problem. (Osteoarthritis
Cartilage 12: 506-11, 2004; Archives Internal
Medicine163:1587-90, 2003).
‹
United States: The Revis family of North Carolina
Food expenditure for one week: $341.98
“Modern Nutrition” and Ocular Disease
Bhutan
z Excess Macronutrients & Low Micronutrients
Obesity and increased risk of CVD, HTN and +/- CANCER
Obesity and increased risk of AMD & CATARACT
‹ Obesity, Diabetes and increased risk of RETINOPATHY
‹ Obesity and increased inflammation
Insufficient Nutrition
‹ induced by average plant food consumption of only 3
servings/day
‹ induced by individual pharmaceuticals & poly pharmacy
‹ induced by an RDA for ascorbic acid that is too low
‹ induced by recommendations to avoid fish – omega III
‹ induced by recommendations to avoid sunlight – vitamin D
‹ Induced by mixed media messages and “nutri phobia”
Mal-nutrition examples
-- TRANS fats from corn & vegetable oils
-- high fructose corn syrup (methylglyoxal)
-- aspartame
-- MSG
‹
‹
z
z
z
z
z
z
Anatomy of www.MyPyramid.gov
History of USDA’s Food Guidance
Food for
Young
Children
2005 for Americans (over age 2)
One Size Doesn’t Fit All
1992
z Activity
1916
1940s
z Moderation
1970s
z Personalization
z Proportionality
2005
z Variety
z Gradual Improvement
Age ; Gender ; Activity; 12 tailored diet plans
1950s-1960s
Supplements
Common Misconceptions
z Herbs/Vitamins are completely safe
z Herbs/Vitamins are ineffective
z More is better – potential high dose issues
‹ Vitamin
E
‹ Beta Carotene
‹ Calcium
‹ Selenium
‹ Omega III
Subconjunctival Hemmorhage
10 Questions
z ValSalva ?
‹ Constipation
‹ Vomiting
‹ Coughing
‹ Straining
z ASA or Coumadin ?
z High Dose Vitamin E ?
z High Dose Fish Oil ?
z Ginkgo Biloba, Ginseng ?
Reversible Minor Side effects
z Diarrhea from vitamin C
z Loose stools from magnesium
z Finger tingling from megadose Vitamin B6
z Flushing from niacin
z Reversible discoloration of skin from B
carotene
Caution Required
z Vitamin K with Coumadin ?
z Combining blood thinning agents
‹ Coumadin, Heparin
‹ ASA
‹ Vitamin E (above 1100IU)
‹ Fish oil above 2 grams
‹ Ginkgo biloba, ginseng
z Riboflavin above 10mg (photosensitizer)
z FE++ (iron)
z Herbal Steroids / Body Building Supplements
Discriminately READ Scientific Studies
z Types of Studies – don’t discount multiple
z
z
z
z
z
z
observations, but look at Power Calculation
Bias – “follow the $”
* Absolute Risk - pay close attention to this one
Relative Risk – “ where’s the beef ”
Odds Ratios - look for statistical significance
Significance - is p = 0.06 worthy of our attention?
Meta-analysis – was there selective inclusion ?
‹ Bias is still possible
z Do conclusions understate or overstate the data ?
z “Made in America” bias
Is academic medicine for sale ?
“No, the current owner is very happy
with it”
1. Why are you prescribing this drug?
2. Are there older & safer less
expensive drugs ?
3. Is a drug needed at all for this mild
case?
Marcia Angell, MD former Chief
Editor , NEJM "The Truth About
the Drug Companies: How They
Deceive Us and What to Do About
It" (Random House, 2004).
How do we avoid “Disease Mongering” ?
Relative risk or “Sleight of Hand”
includes turning ordinary ailments into medical problems, seeing mild symptoms as serious, treating personal
(i.e. Headline “Cholesterol-lowering statin drugs lower the risk
for a heart attack by 30%”)
problems as medical, seeing risks as diseases & framing prevalence estimates to maximize potential markets.
A recent report in the Columbia
Journalism Review of the news
media’s complicity in drug
marketing
http://www.cjr.org/issues/2005/4/
lieberman.asp notes that noted
medical journalists chose not to
warn the American public of the
potential dangers posed by
Vioxx because pharmaceutical
advertising is now a primary
source of income for television
and newspapers.
Selling sickness: the pharmaceutical industry and disease mongering:
British Medical Journal, Volume 324: 886-91, April 13, 2002
z A naïve reader would get the false impression that these drugs will result in 30
fewer heart attacks per 100 statin drug users
z Let’s say heart attacks occur among 3% of 1000 patients over 5 years -- that
would amount to 30 heart attacks.
z A 30% relative risk reduction of 30 would be 9 less heart attacks (21 total over
5 years).
z That’s 2 heart attacks that were prevented every year among 1000 statin drug
users, or just 0.2% difference (2/10ths of one percent) between users and
non-users of statin drugs.
z Some 1,825,000 statin pills would be consumed to prevent 9 heart attacks –
but not 9 lives saved.
z 4 statin drug trials
67 of 7065 (0.948%- 9/10ths of one-percent) statin drug users died
102 of 7054 (1.446% - nearly 1½ of one percent) who did not take the drug
*An absolute difference of 0.498% (1/2 of one percent, absolute difference).
[British Medical Journal 323: 1-5, 2000]
Figure 2a. Observational Studies
HOPE (Heart Outcomes Prevention Evaluation)
Vitamin E Meta analysis
Odds Ratios,
Vitamin
C studies
C and
Nuclear
on Vitamin
Cataract
OR or RR
1.31
1
1.00
0.48
0.56
0.62
0.70
1.00
NA
NA
0.75
NA
0.90
0.70
0.54
0.80
0.54
0.40
0.32
0.31
0.30
INTAKE
Lyle et al. (1999a), Beaver Dam Eye Study
SUPP
Leske et al. (1998), Longitudinal Study of Cataract
INTAKE, SMOKERS
Lyle et al. (1999a), Beaver Dam Eye Study
Supplement duration, FEMALE; No association
Jacques et al. (2005), NVP
Intake form food and supplement, FEMALE; No association
Jacques et al. (2005), NVP
SUPP, FEMALE
Jacques et al. (2001), NVP
SUPP, NON-DIABETICS
Mares-Perlman et al. (1994), Beaver Dam Eye Study
0.10
SUPP, FEMALE
Jacques et al. (1997), NVP
SUPP, FEMALE
Jacques et al. (1997), NVP
PLASMA, FEMALE; No association
Jacques et al. (2005), NVP
PLASMA
Ferrigno et al. (2005), Italian-American Clinical Trial of
Nutritional Supplements and Age-Related Cataract (CTNS)
PLASMA
Vitale et al. (1993), Baltimore Longitudinal Study on Aging
PLASMA
Gale et al. (2001)
PLASMA
Italian-American Cataract Study (1991), Italian-American
Cataract Study
BLOOD
Valero et al. (2002)
PLASMA, FEMALE
Jacques et al. (2001), NVP
INTAKE, FEMALE
Mares-Perlman et al. (1995a), Beaver Dam Eye Study
INTAKE
Cumming et al. (2000), Blue Mountains Eye Study
INTAKE
Valero et al. (2002)
INTAKE, MALE
Mares-Perlman et al. (1995a), Beaver Dam Eye Study
INTAKE, FEMALE
Jacques et al. (2001), NVP
INTAKE
Leske et al. (1991), Lens Opacities Case-Control Study
0.22
0.1
JAMA 293:1338-47, 2005
prospective
retrospective
10
Chiu CJ & Taylor A, Nutritional antioxidants and age related
cataract and maculopathy, Exp Eye Res July 2006.
Safety: “Dose is the poison”
z 19 studies, 135,000 people
z “400 IU increased risk of dying by 4%”
z What researchers claimed was that high-dose
vitamin E increased the risk of heart failure by a
whopping absolute 1% risk among people who
took three drugs that induce heart failure
(diuretics, statin drugs and beta blockers). The
vitamin E got blamed for the problem & worse yet
the researchers eliminated studies where there
were no deaths and 2 studies with 2000 IU that
showed a decrease!
z 12% reduction in death in AREDS
z 34% reduction in MIs & 49% reduction for high risk
females over age 65 in the Womens Health Study,
JAMA 294: 56-65, 2005
Antioxidants & All Cause Mortality
Meta-analysis of 68 randomized trials, n=232,606
Goran Bjelakovic, MD, Copenhagen University Hospital in Denmark.
JAMA. Feb 2007;297:842-857.
z Safety of antioxidant vitamins and B carotene,
Am J Clin Nutr 1995;62(suppl): 1510S-6S.
z Safety of antioxidant vitamins. Arch Intern
Med 156: 925-35, 1996.
z Meta-analysis of 68 randomized trials,
n=232,606 Goran Bjelakovic, MD,
Copenhagen University Hospital in Denmark.
JAMA. Feb 2007;297:842-857.
Relative Risk for All-Cause Mortality With Antioxidant Vitamins
Trials/Agent
All trials- all agents
Low Bias Trialsall agents
Beta carotene
Vitamin A
**Vitamin E
Relative Risk
of Mortality
1.02
1.05
95 % CI
0.98 - 1.06 ns
1.02 – 1.08
1.07
1.16
1.04
1.02 – 1.11
1.10 – 1.24
1.01 – 1.07
High dose Vitamin A and Acutane® should be
avoided by women who might become pregnant,
patients with liver disease and those who drink
heavily.
B Carotene Contraindication for
SMOKERS
ATBC Trial
z 18 % more lung
cancers were
diagnosed and 8 %
more overall deaths
occurred in
participants taking
20 mg B carotene
daily.
N Eng J Med
330:1029-35, 1994.
However vitamin A from B Carotene is produced on
an “as needed” basis.
Consider the issue of competition with D, another
fat soluble vitamin, when talking about the bone
mineralization issue.
ß-Carotene - Intervention Studies
increased
risk
increased
risk
4
a) ß-Carotene
100
50
0.01
no
effect
preventive
effect
Linxian
(20 mg/d)
+Toc/Asc
(15 mg/d)
+Toc/Se
1
10
PHS
CARET
(50 mg/2d) (30 mg/d)
+Retinol
ATBC
(20 mg/d)
150
100
50
0
0.01
0.1
1
10
Carotenoid (nmol/ mg cellular protein)
100 %= UV-induced TBARS-formation
in controls without carotenoids: 1.4 ±
0.2 nmol MDA/mg protein (n=14)
c) Lutein
95%ile
U.S.
HPS
0.1
Carotenoid (nmol/ mg cellular protein)
no
effect
2
b) Lycopene
150
0
TBARS (% control)
Carotene Plasma Levels at the
End of the Study (µmol/L)
carotox1.jnb
6
Carotenoids and UV-induced TBARS formation
in skin fibroblasts
TBARS (% control)
Slide: Helmut Sies,PhD
University of Duesseldorf
CARET
z After 4 years, there
were 28 % more
lung cancer deaths
and 17 % more
deaths in
participants taking
30 mg B carotene
daily.
N Eng J Med
334:1150-5, 1996.
TBARS (% control)
Beta Carotene
150
Eichler et al (2002) Photochem.
Photobiol 75, 503-6.
100
50
0
0.01
0.1
1
10
Carotenoid (nmol/ mg cellular protein)
Slide: Helmut Sies, University of
Duesseldorf
The predictive power of coronary
artery CA++ scores
Calcium
z Heartbeat, nerve conduction, hormone secretion,
z
z
z
z
z
z
z
z
blood clotting & skeleton (osteoporosis 4x more
common in females)
Are Americans over-calcified ?
Arterial plaques are 50% calcium but only 3%
cholesterol.
Unwanted soft tissue deposition.
Not balanced by Magnesium
Aortic valve calcification and decreased elasticity and
rising systolic BP
Kidney stones
Mitral valve defects
Bruchs membrane calcifies with age
S Seeley, International J Cardiology, 1991;33:191-8
z Among subjects whose
coronary artery CA++ score
was zero, the risk for any
adverse coronary event was
only about one-half of 1%
(0.0044), or less than 1 in
200.
z Those with a coronary
CA++ score over 300, about
8.0% experienced an
adverse event involving
coronary arteries (0.0804),
or about 8 in 100, an 18-fold
difference (1800% !), over
the 3.8 year period.
University of Auckland Study, Sept 2007
CA++ link to heart attacks
z N=1500 postmenopausal females
z Placebo or 1000mg calcium to prevent
….For bone health, think about adding
magnesium & boron (besides vitamin D) to
simple calcium supplementation
osteoporosis over 5 years
z 36 heart attacks for calcium users’
z 22 heart attacks for placebos
z * 3 smaller international studies had
similar results
200 ug Selenium & increased risk of DM II
z N=1202; self report of DM
z National Prevention of CA trial
z The claim is that, after 7.7 years of
use, a 200 microgram selenium
supplement increased the risk for
diabetes by 50%.
z A large long-term study reported in
1994 that the same dose of
selenium resulted in a dramatic
decline in cancer incidence
z Mechanism: There is animal data
showing that selenium, which helps
to produce an antioxidant enzyme
called glutathione peroxidase, may
trigger over-expression of this
enzyme which could possibly
increase the inability of insulin to
enter cells (called insulin
resistance).
9.7%
Flaws in this 10 yr post hoc study
originally designed to look at cancer
z The NP CA study was not designed to look at
diabetes
6.5%
ABSOLUTE STATS
‹
Self-reporting of DM
z Limited data for analysis
‹ No diet or medication data
z Ignored + CA findings (1 sentence in article)
‹ SE reduced deaths from prostate cancer by 63%.
‹ SE reduced deaths from colorectal cancer by 58%.
‹ SE reduced deaths from lung cancer by 46%.
Effects of Long-Term Selenium Supplementation on the Incidence
of Type 2 Diabetes: A Randomized Trial.
Annals of Internal Medicine: 21 August 2007, 147(4).
ORGANS with FAT
Essential Fats for Thought and Health
z Intelligence and breast feeding to 4 mo; 1st born and
zBRAIN & RETINA
zBREAST
zPROSTATE
z
z
z
z
z
z
z
z
z
z
z
maternal DHA; visual acuity
ADHD
Depression: USA vs. Japanese elderly
Mental disorders i.e. schizophrenia/ 3 studies
Alcoholism- destroys DHA
Postpartum depression
Impulsive violent behavior
Type A vs. Type H (Hostility) and MI
Eczema and psoriasis
Rheumatoid Arthritis
AMD
DRY EYES
Omega 3 fatty acids
1. Diminish inflammatory tear
components & meibomian gland
dysfunction.
2. Augment the lipid component of
the tear film (prevent
evaporation).
3. Indirectly stimulate lacrimal tear
secretion.
IS THERE ANOTHER WAY TO
TX DRY EYE ?
----or---IF THE WHOLE HOUSE IS ON
FIRE, WHY SEND THE FIRE
DEPARTMENT ONLY TO THE
BARN ?
Is dry eye an
indicator of
systemic
essential fatty
acid deficiency ?
Fish oil & Coagulation Status
Warfarin is an oral anticoagulant used to control and prevent thromboembolic disorders. The dose is adjusted to maintain
the patient's prothrombin time (PT) international normalized ratio (INR) within a recommended therapeutic range.
z CASE REPORT Ann Pharmacother. 2004 Jan;38(1):50-2.
‹
Omega-3 fatty acids may lower thromboxane A(2) supplies
within the platelet as well as decrease factor VII levels.
Although controversial, this case report illustrates that fish oil
can provide additive anticoagulant effects when given with
warfarin. CONCLUSIONS: This case reveals a significant
rise in INR (2.8 to 4.3) after the dose of concomitant fish oil
was doubled (1 g to 2g) . Patients undergoing
anticoagulation therapy with warfarin should be educated
about and monitored for possible drug-herb interactions.
z STUDY: J Thromb Thrombolysis. 1998 Jul;5(3):257-261.
Effects of Marine Fish Oils on the Anticoagulation Status of
Patients Receiving Chronic Warfarin Therapy….. “Fish oil
supplementation in doses of 3-6 grams per day does not seem
to create a statistically significant effect on the anticoagulation
status of patients receiving chronic warfarin therapy”.
Current atrophic AMD intervention
z
z
z
z
z
z
z
z
z
z
z
z
Decrease smoking
Avoid obesity
Exercise
Avoid exposure to bright sunlight
(blueblockers-yellow tint)
Increase plant food (spinach) consumption
‹ Follow www. MyPyramid.Gov & SuperFoods Rx
book by Steve Pratt, MD ………
1 egg every day is a good source of lutein
Avoid or control hypertension.
Avoid high Fe(II) intake; give blood 3x/year
(Lutein based multivitamin/multimineral)
Omega 3 fatty acids
A glass of red wine and blueberries.
Soy (genistein), oranges, bananas & vitamin D
against neovascularization (wet AMD)
Intellectual Morons
1.
Admit they read only 4 journals
1.
(i.e NEJM, AMA, Annals Inter Med, Lancet)
Don’t have time to research material that
would improve a patient's care
3. Would be so obstinate and filled with so
much self-importance they would allow a
patient to die rather than try something that
had strong clinical evidence of benefit
without any complications
2.
Benefits of offering
Ocular Nutritional Counseling
z Solving the patient’s main problem
z Enhanced understanding of the
patient’s overall health
z Bringing patients back to the office
frequently
z Better from you than the health food
store clerk
z Enhanced reputation