VITAMIN E SAFETY

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VITAMIN E: A CURE IN SEARCH OF RECOGNITION

 

" Some doctors claim that vitamin E helps many heart

cases,

but the official view is that the substance has not

been proved

of value in treating heart disease. "

 

This statement could have been taken verbatim from any

of a

number of recent news media reports. But in fact, this

 

particular quote is from a 1953 article in Maclean's

Magazine

entitled " The Fight Over Vitamin E. " (1)

 

Half a century later, it would seem that little has

changed.

 

" (W)e do not support the continued use of vitamin E

treatment

and discourage the inclusion of vitamin E in future

primary

and secondary prevention trials in patients at high

risk of

coronary artery disease.” (2)

 

This statement is from a 2003 analysis that looked at

studies

employing daily treatment dosages between 50 and 800

IU.

Yet since the 1940's, clinicians have been reporting

that

vitamin E dosages between 450 and 1,600 IU or more are

 

required to effectively treat cardiovascular disease.

I would

enjoy seeing a meta-analysis of the work of Drs.

Wilfrid and

Evan Shute, who treated coronary thrombosis with 450

to

1,600 IU; angina with 450 to 1,600 IU; and

thrombophlebitis

with 600 to 1,600 IU of vitamin E daily. (3)

http://www.doctoryourself.com/shute_protocol.html

The recent Lancet meta-analysis did not include them.

There

is nothing capricious about either study selection or

dosage

choice. Researchers and analysts know full well that

high

dosage will obtain different results than low dosage.

Statistical

analysis of meaningless studies will rarely enable a

meaningful conclusion.

 

DOUBLE STANDARD

Countless comedians have made fun of the incompetent

physician who, when called late at night during a

life-

threatening disease crisis, says, " take two aspirin

and call me

in the morning. " Now it’s no longer funny. Recently,

one of the

largest pharmaceutical conglomerates in the world ran

prime-

time national television commercials that declared:

“Bayer

aspirin may actually help stop you from dying if you

take it

during a heart attack.” The company also promotes such

use

of its product on the Internet. (4)

http://www.bayeraspirin.com/news/heart_attack.htm

This statement comes forth after a century of

widespread

aspirin consumption. Cardiovascular disease remains

the

number one killer of men and women and there are over

a

million heart attacks annually in the US alone.

 

If you produced a TV ad that said that megadoses of

wheat

germ oil, or the vitamin E in it, could save your life

by

preventing a heart attack, not only would people

disbelieve

you, you’d also be subject to arrest for breaking

federal law.

Foods and vitamins may not be advertised as treatments

for

specific diseases. " All statements of nutritional

support for

dietary supplements must be accompanied by a two-part

disclaimer on the product label: that the statement

has not

been evaluated by FDA and that the product is not

intended to

" diagnose, treat, cure or prevent any disease. " " (5)

http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm#Ap

plication

 

Yet even traditional nutrition textbooks acknowledge

the

extensive scientific proof of successful treatment of

intermittent claudication with vitamin E. " This

therapy helps

reduce the arterial blockage, " says Nutrition and Diet

Therapy,

Seventh Edition, a standard dietetics work. (6) Unless

there

be something absolutely unique about arterial real

estate

between the knee and the ankle, would not vitamin E

also

help " reduce the blockage " in other arteries? This is

rationale

the Shutes used when, 65 years ago, they employed

vitamin

E to successfully treat circulatory diseases in

thousands of

patients, using daily dosages as high as 3,200 IU. For

that

achievement, they were praised by their patients and

ostracized from the ranks of orthodox physicians.

 

By 1971, it was increasingly clear that the Shutes had

gotten it

right. Intermittent claudication, now regarded as a

reliable sign

of peripheral arterial disease, was shown by

double-blind

study to be diminished 66% with the use of vitamin E.

The

dosage administered was 1600 mg/day. (7)

 

A TORRID HISTORY

1922 was the year the USSR was formed and " Little

Orphan

Annie " began. Trumpeter Al Hirt and future heart

transplant

pioneer Christiaan Barnard were born. Alexander Graham

Bell

died. And vitamin E was discovered by H. M. Evans and

K. S.

Bishop. (8)

 

In 1936, Evans' team had isolated alpha tocopherol

from

wheat germ oil and vitamin E was beginning to be

widely

appreciated, and the consequences of deficiency better

 

known. Health Culture Magazine for January, 1936

said, " The

fertility food factor (is) now called vitamin E.

Excepting for the

abundance of that vitamin in whole grains, there could

not

have been any perpetuation of the human race. Its

absence

from the diet makes for irreparable sterility

occasioned by a

complete degeneration of the germinal cells of the

male

generative glands. (T)he expectant mother requires

vitamin E

to insure the carriage of her charge to a complete and

natural

term. If her diet is deficient in vitamin E . . . the

woman is very

apt to abort. . . It is more difficult to insure a

liberal vitamin E

supply in the daily average diet than to insure an

adequate

supply of any other known vitamin. " (9)

 

And that very same year, 1936, the Shutes were already

at

work employing tocopherol from wheat germ oil to

relieve

angina symptoms. (10)

 

Since the word " tocopherol " is taken from the Greek

words for

" to carry offspring " or " to bring forth childbirth, "

it is easy

enough to see how Evan Shute and other obstetricians

were

drawn into the work. As early as 1931, Vogt-Moller of

Denmark successfully treated habitual abortion in

human

females with wheat germ oil vitamin E. By 1939 he had

treated several hundred women with a success rate of

about

80%. In 1937, both Young in England and the Shutes in

Canada reported success in combating threatened

abortion

and pregnancy toxemias as well. A. L. Bacharach's 1940

 

statistical analysis of published clinical results

" show quite

definitely that vitamin E is of value in recurrent

abortions. " (11)

And also in 1940, the Shutes were curing

atherosclerosis with

vitamin E. By 1946, thrombosis, phlebitis, and

claudication.

 

Yet when the MDR's (Minimum Daily Requirements) first

came out in 1941, there was no mention of vitamin E.

It was

not until 1959 that vitamin E was recognized by the

U.S. Food

and Drug Administration as necessary for human

existence,

and not until 1968 that any government recommendation

for

vitamin E would be issued. That year, the Food and

Nutrition

Board of the US National Research Council offered its

first

Recommended Daily Allowance: 30 IU. It has been as low

as

15 IU in 1974 . In 2000, it was set at 22 IU (15 mg)

for all

persons, including pregnant women. This is somewhat

odd in

view a 70-year established research history showing

how vital

vitamin E is during gestation. It is another curious

fact that

today, when the public has been urged to increase its

consumption of unsaturated fats, the official dietary

recommendation for vitamin E is substantially lower

than it

was 35 years ago. " The requirement for vitamin E is

related to

the amount of polyunsaturated fatty acids (PUFAs)

consumed

in the diet. The higher the amount of PUFAs, the more

vitamin

E is required. " (12)

 

One reason the RDA was lowered is that " dieticians

were

having difficulty devising diets of natural foods

which had the

recommended amount (30 IU) of vitamin E. " (13) There

are

about 39 IU of vitamin E in an 8-ounce cup of olive

oil. A full

pound of peanuts yields 34 IU. Professor Max K.

Horwitt,

Ph.D., who spent 15 years serving on The Food and

Nutrition

Board's RDA committees, said in an interview that " The

 

average intake by adults, without supplements, seems

to be

about 8 milligrams of alpha-tocopherol per day, or 8

tocopherol equivalents. This is equivalent to 12

International

Units (IU). " (14) So it might be said that, in the

end, the

accommodation was not to raise the bridge but rather

to lower

the river.

 

Vitamin E is the body's chief fat-soluble antioxidant.

It is a

powerful one indeed, when you consider that 22 IU is

presumed adequate to protect each one of the tens of

trillions

of body cells in a human being. Even though there has

been a

veritable explosion in antioxidant research since

1968, the

RDA for vitamin E has been decreased.

 

POSTAL FRAUD

" Any claim in the labeling of drugs or of foods

offered for

special dietary use, by reason of Vitamin E, that

there is need

for dietary supplementation with Vitamin E, will be

considered

false. " (United States Post Office Department Docket

No.

1/187 (March 15, 1961)

 

On October 26, 1959, the US government charged an

organization known as the Cardiac Society with postal

fraud

for selling 30 IU vitamin E capsules through the mail.

 

Specifically, the charge was " the operation of a

scheme or

device for obtaining money through the mails by means

of

false and fraudulent pretenses, representations or

promises . .

.. that Respondent's product 'E-FEROL 30 I.U.'

(containing

vitamin E) is therapeutically effective and beneficial

in the

treatment of heart and cardiovascular diseases for any

person

so afflicted; that Respondent's said product will

prevent heart

disease; that " It (vitamin E) is the key both to the

prevention

and treatment of all those conditions in which a lack

of blood

supply due to thickened or blocked blood vessels or a

lack of

oxygen is a part or the whole story of the disease " ;

that

" Vitamin E seems to be a natural anti-thrombin in the

human

blood stream. . . It is the only substance preventing

the

clotting of blood which is not dangerous " ; that the

book " Your

Heart and Vitamin E " tells you " What Vitamin E is and

Does,

How It Treats Heart Disease, Its Success In

Circulatory

Diseases, Your Foods' Deficiency in Vitamin E " . . .

That " It

(the book) explains medical facts in every-day

language

concerning the help that is available for sufferers

from

diseases of the heart and blood vessels such as

Coronary

Heart Disease, Angina Pectoris, Phlebitis, Buerger's

Disease,

Diabetes, Strokes, etc. " (15)

http://www.usps.gov/judicial/1961deci/1-187.htm

 

A four-day hearing before the Hearing Examiner in

Washington, D.C. generated sufficient testimony to

fill " four

volumes totaling 856 pages. Seventy-six exhibits were

received in evidence. . . for the consideration of the

Hearing

Examiner. His Initial Decision covers forty-two

pages. "

 

It is an oddity of history that, at the height of the

Cuban Missile

Crisis, the United States of America found both the

reason

and the resources to prosecute such a case as this.

 

" The record here shows that the consensus of medical

opinion

is that Respondent's claims are false and that this is

the

universality of medical opinion on the subject.

Numerous tests

and experiments have been conducted to attempt to

substantiate the claims made by Respondent that

Vitamin E is

efficacious for treatment of a number of conditions

but these

have failed to substantiate the claims. It appears

perfectly

clear from the testimony of the expert witnesses that

Respondent's claims and representations are devoid of

scientific support. . . The Hearing Examiner correctly

found

that the Respondent intends to deceive by its false

representation and that actual fraud under established

law is

proven. . . A fraud order shall issue forthwith

forbidding the

delivery of mail and the payment of money orders

incident to

such scheme, to the Respondent, its agents and

representatives, all in accordance with 39 U.S.C. 259

and

732. " (15)

http://www.usps.gov/judicial/1961deci/1-187.htm

 

After this, all mail addressed to the Cardiac Society

was

returned to the sender, with " Fraudulent " stamped on

the

envelope.

 

DOSAGE AND UTILITY

Vitamin E has many clinically important and seemingly

unrelated properties. In their books (16, 17, 18, 19,

20, 21) the

Shutes discuss a number of them.

 

1) Vitamin E strengthens and regulates heartbeat, like

digitalis

and similar drugs, at a dose adjusted between 800 to

3,000 IU

daily.

 

2) Vitamin E reduces inflammation and scarring when

frequently applied topically to burns or to sites of

lacerations

or surgical incisions. Internally, vitamin E helps to

very

gradually break down thrombi at a maintained oral dose

of

between 800 IU and 3,000 IU.

 

3) Vitamin E has an oxygen-sparing effect on the

heart,

enabling the heart can do more work on less oxygen.

The

benefit for recovering heart attack patients is

considerable.

1,200 to 2,000 IU daily relieves angina very well. My

father, duly

diagnosed with angina, gradually worked up to 1,600 IU

over a

period of a few weeks. He never had an angina symptom

again.

In this, he had the identical success that thousands

of Shute

patients had.

 

4) Vitamin E moderately prolongs prothrombin clotting

time,

decreases platelet adhesion, and has a limited " blood

thinning "

effect. This is the reason behind the Shutes' using

vitamin E

(1,000 - 2,000 IU/day) for thrombophlebitis and

related

conditions. The pharmaceutical industry and the

medical

profession are well aware of vitamin E's anticoagulant

property

and that " very high doses of this vitamin may act

synergistically

with anticoagulant drugs. " (21) However, this also

means that

vitamin E can, entirely or in part, substitute for

such drugs but

do so more safely. Perhaps this is best summed up by

surgeon

Edward William Alton Ochsner, M.D. (1896-1981) who

said,

“Vitamin E is a potent inhibitor of thrombin that does

not

produce a hemorrhagic tendency and therefore is a safe

 

prophylactic against venous thrombosis.” (23)

 

5) Vitamin E is a modest vasodilator, promotes

collateral

circulation, and consequently offers great benefits to

diabetes

patients. (24) The Shutes used a dose of about 800 IU

or

more, tailored to the patient. For this, among other

reasons,

Evan Shute, author of over 100 scientific papers, was

literally

judged to be a fraud by the United States Post Office

Department. The 1961 court decision said, " Vascular

degenerations in a diabetic are not effectively

treated in the

use of vitamin E in any dosage. . . vitamin E has been

 

thoroughly studied and that there is no doubt

whatsoever as

to its lack of utility. " (15)

http://www.usps.gov/judicial/1961deci/1-187.htm

 

This statement was premature to say the least. The

" thorough

study " of vitamin E was not quite completed by 1961.

Thirty-

eight years later, a crossover study of 36 patients

who had

Type I diabetes, and retinal blood flows that were

significantly

lower than non-diabetics, showed that those taking

1,800 IU

of vitamin E daily obtained normal retinal blood flow.

The

patients with the worst initial readings improved the

most.

" (V)itamin E may potentially provide additional risk

reduction

for the development of retinopathy or nephropathy in

addition

to those achievable through intensive insulin therapy

alone.

Vitamin E is a low-cost, readily available compound

associated with few known side effects; thus, its use

could

have a dramatic socioeconomic impact if found to be

efficacious in delaying the onset of diabetic

retinopathy and/or

nephropathy. " (25) Vitamin E also works

synergistically with

insulin to lower high blood pressure in diabetics.

(26)

 

QUANTITY AND QUALITY

The most common reason for irreproducibility of

successful

vitamin E cures is either a failure to use enough of

it, or a

failure to use the natural form (D-alpha, plus mixed

natural

tocopherols), or both. For example, in an oft-quoted

negative

study (27), researchers who gave 300 milligrams of

synthetic

vitamin E to patients who had recently had a heart

attack saw

no beneficial effect. Such failure is to be expected.

You can

set up any experiment to fail. The Shutes would have

used

only the natural form, and four times as much.

 

Natural vitamin E is always the dextro- (right-handed)

form.

On the other hand, " synthetic vitamin E is a mixture

of eight

isomers in equal proportions containing only 12.5% of

d-alpha

tocopherol. One mg of dl-alpha tocopherol has the

lowest

Vitamin E equivalence of any of the common vitamin E

preparations. " (28)

 

There may be other differences. " Vitamin E derived

from

natural sources is obtained by molecular distillation

and, in

most cases, subsequent methylation and esterification

of

edible vegetable oil products. Synthetic vitamin E is

produced

from fossil plant material (coal tar) by condensation

of

trimethylhydroquinone with isophytol. " (12)

 

While personal philosophy is the only possible basis

for a

decision to conduct a study using only the synthetic

form of a

vitamin, the use of low dosage is generally explained

away by

alleging doubts about safety.

 

SAFETY

The most elementary of forensic arguments is, where

are the

bodies? Poison control statistics report no deaths

from vitamin

E. (29) There is a reason for this. Vitamin E is a

safe and

remarkably non-toxic substance. Even the 2000 report

by the

Institute of Medicine of the National Academy of

Sciences,

which actually recommends against taking supplemental

vitamin E, specifically acknowledges that 1,000 mg

(1,500 IU)

is a " tolerable upper intake level . . . that is

likely to pose no

risk of adverse health effects for almost all

individuals in the

general population.” (30) The Shutes observed no

evidence of

harm with doses as high as 8,000 IU/day. In fact,

" toxicity

symptoms have not been reported even at intakes of 800

IU

per kilogram of body weight daily for 5 months "

according to

the Food and Nutrition Board. (31) This demonstrated

safe

level would work out to be around 60,000 IU daily for

an

average adult, some 2,700 times the RDA!

 

In addition to an awareness of anticoagulation

medications,

" Dr. Shute advises starting with small doses for

patients who

have rheumatic heart disease. He starts with 90 IU.

and very

slowly works up the dose. The reason for this is that

if too

much is given at the beginning the increased strength

of the

heartbeat may create some difficulty. The same applies

to

heart failure. The initial dose should be small and

gradually

increased. If this is done the final dose can safely

reach 800

to 1200 IU. " (31)

 

SAFETY IN THE ELDERLY

A Columbia University study reported progression of

Alzheimer's disease was significantly slowed in

patients taking

high daily doses (2,000 IU) of vitamin E for two

years. (32)

The vitamin worked better than the drug selegiline

did. The

patients in the Alzheimer's study tolerated their

vitamin E

doses well. Perhaps the real story is that 2,000 IU

per day for

two years is safe for the elderly.

 

SAFETY IN CHILDREN

Children using anti-epileptic medication have reduced

plasma

levels of vitamin E, a sign of vitamin E deficiency.

So doctors

at the University of Toronto gave epileptic children

400 IU of

vitamin E per day for several months, along with their

 

medication. This combined treatment reduced the

frequency

of seizures in most of the children by over 60

percent. Half of

them “had a 90 to 100 percent reduction in seizures.”

(33)

This extraordinary result is also proof of the safety

of 400 IU of

vitamin E per day in children (equivalent to at least

800 to

1,200 IU/day for an adult). " There were no adverse

side

effects, " said the researchers. It also provides a

clear example

of pharmaceutical use creating a vitamin deficiency,

and an

unassailable justification for supplementation.

 

SAFETY IN INFANTS

Overexposure to oxygen has been a major cause of

retrolental fibroplasia (retinopathy of prematurity)

and

subsequent blindness in premature infants. Incubator

oxygen

retina damage is now prevented by giving preemies 100

mg E

per kilogram body weight. That dose is equivalent to

an adult

dose of about 7,000 IU for an average-weight adult.

" There

have been no detrimental side effects " from such

treatment,

said the New England Journal of Medicine, Dec. 3,

1981. (34)

Nevertheless, the 1989 (sixth) edition of the textbook

Nutrition

and Diet Therapy (6) advised that " healthy persons

stand the

chance of developing signs of toxicity with the

megadoses

that are recommended in these studies. " (p. 225) That

incorrect statement was dropped in the book's next

edition.

Instead, the 7th edition (1993) said under " Toxicity

Effects "

that " Vitamin E is the only one of the fat-soluble

vitamins for

which no toxic effect in humans is known. Its use as a

 

supplement has not shown harmful effects. " (p 186)

 

IMMUNE FUNCTION

“Worst Pills, Best Pills” is a monthly newsletter

published by

Public Citizen, Ralph Nader’s “Health Research Group.”

The

October, 2002 issue (Vol 8, No 10) contained this

statement

by editor Sidney M. Wolfe, M.D.: “You should not take

dietary

supplements. These products have not been tested or

shown

to be effective for any use, and their safety is

unknown. The

only exception to this advice is an inexpensive

vitamin or

mineral preparation.” (p 80) On page 77, the doctor

presents a

JAMA study (35) alleging that a mere 200 mg of vitamin

E is

somehow detrimental to patients over the age of 60

with

respiratory tract infections.

 

But there are other studies that Public Citizen might

do well to

present to its readership. Emanuel Cheraskin, M.D.,

writes:

" The effect of daily vitamin E supplementation (800 IU

alpha

tocopherol for 30 days) on immune responses of 32

healthy

subjects (60+ years old) was examined in a placebo-

controlled, double-blind trial in a metabolic research

unit. The

data suggest that vitamin E supplementation improves

immune responsiveness in healthy elderly. " (36) In a

second

study, " using a double blind protocol, immune response

was

studied in a group receiving vitamin E (800 mg per

day)

versus placebo. The increased immunocompetence was

matched by blood vitamin E levels which jumped from

1.1 to

3.1 mg%. No such change in blood vitamin E occurred in

the

control group (1.1 to 1.0 mg%). " (37)

 

A recent and perhaps even more important study looked

at

patients with colon cancer " who received a daily dose

of 750

mg of vitamin E during a period of 2 weeks. Short-term

 

supplementation with high doses of dietary vitamin E

leads to

increased CD4:CD8 ratios and to enhanced capacity by

their

T cells to produce the T helper 1 cytokines

interleukin 2 and

IFN-gamma. In 10 of 12 patients, an increase of 10% or

more

(average, 22%) in the number of T cells producing

interleukin

2 was seen after 2 weeks of vitamin E

supplementation. " The

authors concluded that " dietary vitamin E may be used

to

improve the immune functions in patients with advanced

 

cancer. " That improvement was achieved in only two

weeks

merits special attention. (38)

 

Note that the doses in these positive studies were

four times

the dose used in the negative JAMA study cited by Dr.

Wolfe.

 

HYPERTENSION

Recent research has indicated that Vitamin E

normalizes high

blood pressure. (39, 40, 41) In some hypertensive

persons,

commencement of very large vitamin E doses may cause a

 

slight temporary increase in blood pressure, although

maintained supplementation can then be expected to

lower it.

The solution is to increase the vitamin gradually,

along with

the proper monitoring that hypertensive patients

should have

anyway. High blood pressure has been called the

" silent

killer, " and nearly one-third of adults have it. It is

all too

frequently unrecognized and untreated.

 

Nearly half of all deaths are due to cardiovascular

diseases,

and often the first symptom is death. Advocating daily

 

supplementation with several hundred IU's of vitamin E

would

be good public health policy. Yet vitamin E, for

decades

lampooned as a " cure in search of a disease, " remains

virtually the " silent healer " for as much as the

public has been

advised of its benefits.

 

Back in 1985, Linus Pauling wrote: “The failure of the

medical

establishment during the last forty years to recognize

the value

of Vitamin E in controlling heart disease is

responsible for a

tremendous amount of unnecessary suffering and for

many

early deaths. The interesting story of the efforts to

suppress the

Shute discoveries about Vitamin E illustrates the

shocking bias

of organized medicine against nutritional measures for

 

achieving improved health.” (10, vii)

 

Dr. Pauling would most likely have appreciated this

comment

from a recent Harvard Health Letter: " A consistent

body of

research indicates that vitamin E may protect people

against

heart disease. . . The data generally indicate that

taking doses

ranging from 100 to 800 IU (International Units) per

day may

lower the risk of heart disease by 30%-40%. " (42) Over

half a

century ago, the Shute brothers and colleagues showed

that,

with even higher doses than those, and with an

insistence on

the use of natural vitamin E, the results are better

still.

 

A bibliography of selected books and papers by Wilfrid

and

Evan Shute is posted at

http://www.doctoryourself.com/biblio_shute.html .

 

Evan Shute's autiobiography, The Vitamin E Story, was

reviewed by me for The Journal of Orthomolecular

Medicine,

Volume 17, Number 3, Third Quarter, 2002 (p 179-181)

and is

also posted online at

http://www.doctoryourself.com/estory.htm .

 

(Reprinted with permission from the Journal of

Orthomolecular

Medicine, 2003; Vol. 18, Numbers 3 and 4, p. 213-216.)

 

 

All 42 references for this article are posted at

http://www.doctoryourself.com/evitamin.htm .