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Within days of the international
regulatory body called CODEX notifying the world that it
intends to establish a worldwide maximum dosage limit on
vitamin supplements, headlines news stories warned that
high-dose vitamin E supplements "increase the risk of
dying." [Washington Post Nov. 10, 2004] The report,
emanating from a meeting of cardiologists at the American
Heart Association meeting in New Orleans, falsely claims
high-dose vitamin E (400 IU or more) may increase the risk
of death by 5 percent. This false conclusion was made after
analysis of 19 studies involving 136,000 people (to be
published in the January 4, 2005 issue of the Annals of
Internal Medicine).
The 5 percent figure is a relative increase, not a
hard number (not a 5 out of 100 increase). High-dose vitamin
E does not significantly increase, nor does it decrease,
mortality rates. Furthermore, people with cardiovascular
disease are more likely to be taking vitamin E supplements,
which skews the statistics. A University of North Carolina
study of 45,748 participants, aged 50 to 75 years, found
that supplement use is higher among people who are battling
chronic health conditions and the strongest association was
for cardiovascular disease with supplemental vitamin E. [Am
Journal Preventive Medicine 24:43-51, 2003]
Council for Responsible Nutrition
CRN QUESTIONS CONCLUSIONS REACHED BY
RESEARCHERS IN RECENT VITAMIN E META-ANALYSIS
Washington.
D.C., November 10. 2004 - A meta-analysls on
vitamin E and all-cause mortality (ACM) from today's on-line
issue of Annals of Internal Medicine inappropriately
tries to draw conclusions for the whole population based on a
combination of studies of people who were already at grave risk
with existing diseases including cancer, heart disease,
Alzheimer's, Parkinson's and kidney failure, says the Council
for Responsible Nutrition (CRN).
The
researchers themselves noted limitations in their meta-analysis,
stating “the generalizability of the findings to healthy adults
is uncertain. Precise estimation of the threshold at which risk
increases is difficult." Yet they go on to make sweeping
generalizations about the use of vitamin E and all-cause
mortality (ACM) for the whole population, although they provide
NO evidence that these kinds of effects would occur in healthy
populations.
"This is an unfortunate
misdirection of science in an attempt to make something out of
nothing for the sake of headlines," comments John Hathcock,
Ph.D. vice president, of scientific and international affairs
for CRN.
The
meta-analysis combined 19 individual studies, eighteen of which
showed no statistically significant increase in mortality,
squeezing out an overall finding of risk. Combining numerous
clinical trials into a single large cohort gave greater
statistical power but failed to capture the limitations of each
study included.
Most of the
trials involved middle-aged to elderly persons who had heart
disease or other serious conditions or were at risk of disease.
The placebo groups had an ACM rate of 1002/10,000 and the
high-dose (defined by the researchers as 400 IU and up) vitamin
E subjects had an ACM increase of 39/10,000. Says Dr. Hathcock,
"The overall conclusion of this meta-analysis is driven by the
results from a few of these clinical trials, some of which are
suspect and/or dated. For example, the WAVE trial (Waters et
al., 2002) made no correction for multiple comparisons, and
found one of 22 comparisons 'significant.' This is 1/22 whereas
1/20 would have been expected on a random basis.
In other words, they found nothing.”
Dr. Hathcock added. “In reviewing the totality of evidence on
vitamin E, including all clinical trial data and several large
observational studies, CRN agrees with the
Institute of Medicine in finding vitamin E supplements safe at
levels of at least up to 1.000 mg (1,600 IU) for normal, healthy
adults.
This meta-analysis provides no convincing evidence to the
contrary."
Note
to Editor. The Council for Responsible Nutrition (CRN), founded
in 1973, is a Washington. D.C.-based trade association
representing the dietary supplement industry ingredient
suppliers and manufacturers. CRN members adhere to a strong code
of ethics, comply with dosage limits and manufacture dietary
supplements to high quality standards under good manufacturing
practices. For more information on CRN, visit
http://www.crnusa.org.
And now for an honest published Journal article reporting
Vitamin E benefits, read here:
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