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Vitamin E
"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)
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#Application
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.
Evan Shute's autiobiography, The Vitamin E Story, was reviewed
by Andrew Saul for The Journal of Orthomolecular Medicine, Volume 17, Number 3,
Third Quarter, 2002 (p 179-181) (Reprinted with permission from the Journal of
Orthomolecular Medicine, 2003; Vol. 18, Numbers 3 and 4, p. 213-216.)