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Background
Researchers at Johns Hopkins University recently released
data from a meta-analysis of 19 studies conducted on patient
groups taking vitamin E. The researchers have interpreted
their results to suggest that high doses of vitamin E
may be associated with a slightly increased risk of mortality.
The ensuing publicity and resulting media stories have
been highly alarmist in nature, unduly causing widespread
confusion and safety concern among consumers currently
taking supplements that contain vitamin E.
What consumers should know
and do
- There are a great number of problems with the Johns
Hopkins study and the way it has been reported in the
media.
- The vast body of scientific evidence supports the
continued safe use of supplements containing vitamin
E.
- Vitamin E has been associated with a number of health
benefits, including reduced risk of heart disease, reduced
risk of age-related macular degeneration, delayed progression
of Alzheimers disease, and reduced rates of several
types of cancer, including prostate cancer.
- Consumers who already are using vitamin E should continue
to use it with confidence.
Issues
The major issue is three-fold:
- The studys results are being misinterpreted
and misrepresented.
- The larger body of science is being ignored.
- Consumers arent getting the solid advice they
need.
Problems with the study and
its reporting
- The meta-analysis found no increase of all-cause
mortality risk, overallOf the 19 clinical
trials analyzed for the meta-analysis, 18 found no statistically
significant increase in total mortality for those using
vitamin E. When combining all 19 clinical trials, the
study found no significant increase in total mortality.
In authors own words, "Overall, vitamin E
supplementation did not affect all-cause mortality."
- The meta-analysis sample was not representative
of the populationThe meta-analysis looked
at studies that included many patient groups who already
had increased risk factors for mortality, such as Alzheimers
disease, Parkinsons disease, kidney failure, or
heart disease.
- The meta-analysis findings may not apply to healthy
adultsWhile the study did find that low doses
of vitamin E slightly decreased total mortality and
high doses (400 IU or more) of vitamin E slightly increased
total mortality, it is questionable whether this finding
has any practical meaning. Most of the high-dose studies
sampled populations already having various diseases,
leading the authors to note "generalizability of
the findings to healthy adults is uncertain."
- The meta-analysis used questionable methodology
for identifying high dosesThe researchers
decision to select 400 IU as the cutoff between the
low-dose and high-dose groups is arbitrary and lacks
a clear scientific basis. Two studies used 330 IU
which is not significantly lower than the 400 IU cutoff
and therefore very easily could have been included in
the high-dose group. Had the researchers done so, the
results may have been different.
- Reports on the meta-analysis have ignored the
sample studies intentionsThe fact that
the studies sampled were conducted for other reasons
and differ greatly from each other has been overlooked.
For example, the studies were originally published over
the course of a decade all over the world. Also, vitamin
E was given in the studies for a variety of reasons,
including reducing the risk of heart disease, cancer,
and macular degeneration, as well as delaying the progression
of cataracts, kidney disease, and Alzheimers and
Parkinsons diseases at doses ranging from 16.5
to 2000 IUs.
- Reports on the meta-analysis have ignored the sample
studies other findingsIn focusing on
the shaky suggestion of increased mortality, the researchers
and news media have omitted the fact that several of
the studies sampled actually found vitamin E to be beneficial.
- One study in England showed that vitamin E at
levels of 400 and 800 IU reduced the risk of heart
attack by 75% in men who already had symptoms of
heart disease.
- A study in patients with kidney failure found
a reduced risk of heart attacks and of death from
heart disease in people who were given 800 IU of
vitamin E.
- A study found that vitamin E at levels of 400
IU reduced the risk of age-related macular degeneration,
when administered in combination with other nutrients.
What the science
really says
- Vitamin E has been found to be safeThe
Institute of Medicine, a scientific advisory body, has
concluded that vitamin E is safe for chronic use in
the general population at levels up to 1000 mg (1000
IU synthetic vitamin E, 1500 IU natural vitamin E).
- Vitamin E has been found to be beneficialThe
larger body of epidemiological studies has shown benefits
from vitamin E.
- A Harvard study of more than 80,000 nurses found
a 41% reduction in the risk of heart disease in
nurses who had used vitamin E supplements for at
least two years.
- A study of almost 40,000 male health professionals
found that men who took vitamin E supplements for
more than two years experienced a 37% reduced risk
of heart disease.
- A National Institute of Aging study in 11,000
elderly persons found that those who used supplements
of vitamins C and E had a 53% reduction in mortality
from heart disease and a 42% reduction in all-cause
mortality, compared to non-users.
- Consumers do not get enough vitamin E from diet aloneThe
Recommended Dietary Allowance of vitamin E is 15 mg,
and most people do not achieve that level from diet
alone. Supplements and multi-vitamins help fill that
gap.
- More studies are under wayA number of new clinical
trials are being conducted to reconfirm the safety and
efficacy of high-dose vitamin E. In the wake of recent
media alarmism, researchers are working to reassure
participants that vitamin E is safe, and that the research
should continue. Research includes:
- The Womens Health Study, involving over
40,000 female health professionals;
- The Physicians Health Study, involving thousands
of U.S. doctors;
- The Womens Antioxidant Cardiovascular Disease
Study; and
- The National Cancer Institutes Selenium
and Vitamin E Chemoprevention Trial (SELECT), which
is evaluating the effects of these two nutrients
in protecting against prostate cancer in more than
30,000 men.
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