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Vitamin E Study Asserts More Heart Failure Risk for
Seniors
Storm of controversy surrounds HOPE trials saying
Vitamin E failed to prevent cancer, cardiovascular problems
 March
16, 2005 – The battle over the benefits of Vitamin E raged on today with
an article saying the supplement – used long-term – may increase the
risk for heart failure and does not prevent cancer or major
cardiovascular problems in older people who already have vascular
disease or diabetes. A dietary supplement industry group fired back
urging caution because the “isolated findings applied only to an older
group of patients with a history of heart disease, stroke or diabetes.”
And, the American Cancer Society issued a news release on the study that
began with “Taking regular vitamin E supplements probably won't protect
you from cancer or heart disease.”
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Related Story |
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Vitamin E: Popular with Seniors But Mired in
Controversy
Harvard Medical Pulls Back Support, Supporters Going Full
Blast include Industry Group, National Eye Institute
By Tucker Sutherland, editor
Feb.
20, 2005 - Vitamin E is one of the most widely used
supplements, taken regularly by nearly a quarter of senior adults ages 55 and
over. But recent research suggests that it may not do as much good in
preventing cancer and other diseases as once thought, and it might
actually cause harm. But this popular vitamin still has plenty of
supporters. (See links to related stories.)
Read
more...
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The studies that started this battle was the HOPE
(Heart Outcomes Prevention Evaluation) conducted between December 21,
1993, and April 15, 1999) of patients at least 55 years old with
vascular disease or diabetes mellitus, and HOPE-TOO, which was an
extension from April 16, 1999, and May 26, 2003.
The initial 267 centers participating in HOPE had
9541 enrolled patients. HOPE-TOO had 174 centers. Of 7030 patients
enrolled at these centers, 916 were deceased at the beginning of the
extension, 1382 refused participation, 3994 continued to take the study
intervention, and 738 agreed to passive follow-up. Median duration of
follow-up was 7.0 years.
The trial was a randomized, double-blind,
placebo-controlled international trial. Study participants received a
daily dose of natural source vitamin E (400 IU) or matching placebo over
a median of 7.0 years.
The researchers concluded, “In patients with
vascular disease or diabetes mellitus, long-term vitamin E
supplementation does not prevent cancer or major cardiovascular events
and may increase the risk for heart failure.”
There specific results were:
“Among all HOPE patients, there were no significant
differences in the primary analysis:
> for cancer incidence, there were 552
patients (11.6%) in the vitamin E group vs 586 (12.3%) in the placebo
group;
> for cancer deaths, 156 (3.3%) vs 178
(3.7%);
> and for major cardiovascular events, 1022
(21.5%) vs 985 (20.6%).”
“Patients in the vitamin E group had a higher risk
of heart failure and hospitalization for heart failure.” (12.1 percent
in the placebo group to 13.5 percent in the vitamin E group)
“Similarly, among patients enrolled at the centers
participating in the HOPE-TOO trial, there were no differences in cancer
incidence, cancer deaths, and major cardiovascular events, but higher
rates of heart failure and hospitalizations for heart failure,” they
said.
Critics, like Annette Dickinson, Ph.D., president
of the trade group Council for Responsible Nutrition, focused on the
advanced age and poor health of study participants, as well as the
multiple medicines they were taking. She noted that the “HOPE-TOO” study
involved people who already had heart disease or very strong risk
factors and who were taking numerous medications. The average age of
the study participants was over 70. “Since these results have not been
seen in other studies, this very well may be a chance effect,” she
said. “There is certainly no evidence that these kinds of effects would
occur in healthy populations.”
"There was not a definitive conclusion to this
study, except to state that more studies were needed, so the claim is a
bit of a leap at best," said David Seckman, executive director and CEO
of the National Nutritional Foods Association (NNFA).
"I understand why the public may find this study
concerning, but let's not overreact to one study. Numerous scientific
studies have attested to vitamin E's great health benefits and safety,
not only for cardiovascular health, but also for immune function, DNA
repair and to help protect the body against the effects of free
radicals. Vitamin E continues to be a safe and effective part of a
healthy diet, and the suggested findings are incomplete and misleading,"
he added.
In an editorial
published with the study, University of Washington professors B. Greg
Brown, MD, PhD, and John Crowley, PhD, say the work "effectively closes
the door" on the idea that vitamin E will be of major benefit in
preventing cancer or heart disease.
Brown is a professor in
the division of cardiology at the university's medical school. Crowley
is a professor of biostatistics at the university's School of Public
Health and Community Medicine and a member of the department of cancer
research and biostatistics at Fred Hutchinson Cancer Research Center, in
Seattle.
The new research, they
said, will give patients a definitive answer to questions about vitamin
E:
"In nearly 68,000
patients studied to date, there is no compelling evidence that higher
doses of vitamin E reduce cardiovascular risk or cancer," they wrote.
"You may hear that vitamin E is a 'natural,' yet effective way to
prevent heart disease or cancer, but this has proven to be a false
hope."
Despite the
disappointing results of this study for cancer and heart disease
overall, Brown and Crowley note that vitamin E hasn't been ruled out
completely as a helpful substance for some very specific conditions,
including certain cancers.
CRN agrees with the Institute of Medicine’s finding
that vitamin E supplements are safe within a wide range, up to 1,000 mg
(1,000 IU of synthetic vitamin E, or
1,500 IU natural vitamin E) per day for normal, healthy adults.
(Vitamin E supplements most commonly contain 400 IU.) At a recent forum
at the University of Southern California, medical and scientific experts
concluded that vitamin E and other antioxidant supplements “are safe and
appear to confer a health benefit in certain individuals.”
“Vitamin E is essential for life and health, and
most Americans don’t get enough from diet alone. Supplements can fill
that gap as well as provide the higher levels of vitamin E that have
been shown to be beneficial in promoting health and protecting against
some diseases,” said Dr. Dickinson.
“It would be a disservice to the public to discount
the scientific evidence pointing to the benefits of vitamin E and to
sensationalize the HOPE-TOO findings,” she said.
The ongoing and highly
visible SELECT trial, will help answer whether vitamin E and selenium
can protect men against prostate cancer.
Vitamin E may also help
people with age-related macular degeneration, a condition that can cause
blindness, and with a specific type of kidney problem.
The results of the HOPE studies is published today
in the Journal of the American Medical Association (JAMA).
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