Negative Vitamin E Study, 2004
Below is commentary on the negative Vitamin E study that told people not to take full potencies of Vitamin E (400 IU or more per day) that could support optimal long-term health, including the following from James Gormley and the Linus Pauling Institute. I particularly love the comments from the biostatistician (Alex Schauss)
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Comments from James J. Gormley regarding the meta-analysis.
James J. Gormley
Policy Advisor
Citizens for Health
http://www.citizens.org
Dear Editor,
As you know, a paper on vitamin E by Miller et al. was just released on November 10th in the Annals of Internal Medicine
The authors of this paper pooled numbers from 19 studies, 18 of which were statistically insignificant. This, however, didn't discourage the authors from concluding that their number-crunching yields an increased risk of mortality from vitamin E.
The authors, significantly, admitted that they cannot "evaluate the generalizability of our findings to healthy adult populations." Nevertheless, that did not stop them from stating that, "On the basis of our study, high-dosage vitamin E supplementation is clearly unjustified. Policymaking bodies, which currently do not recommend antioxidant vitamin supplement use to the general population should also caution the public against the use of high-dosage vitamin E supplementation."
It is shocking how, on the basis of such flimsy findings, such sweeping and definitive pronouncements are being made. It is likewise unfortunate that so many media outlets (print and broadcast) have seen fit to uncritically provide a platform for misplaced hysteria over interpretation of this weak data.
What does the established body of research on vitamin E really show?
A number of landmark epidemiological studies have, in fact, established that vitamin E supplementation reduces cardiovascular disease progression and reduces mortality.
In the Cambridge Heart Antioxidant Study (CHAOS) (Lancet, 1996), investigators wanted to see if supplementation with 400 or 800 I.U. of vitamin E for roughly 510 days would reduce risk for myocardial infarction (MI) and cardiovascular death in 1,035 patients with ischemic heart disease (967 more received a placebo). The findings were that so-called high-dose vitamin E supplementation significantly reduced the risk of cardiovascular death and non-fatal MI.
In a study by Boaz et al. (Lancet, 2000), hemodialysis patients with cardiovascular disease (aged 40 to 75 years) received either 800 I.U./day of vitamin E or a placebo for approximately 519 days. The results? There was a significant decrease in cardiovascular disease (endpoints) and myocardial infarction.
In another study from 2000 (Salonen et al., J Int Med), a combined supplement of both vitamin E and slow-release vitamin C reduced the progression of atherosclerosis in men by 74 percent over a three-year period of supplementation.
In the Nurses' Health Study (Stampfer, 1993) of 87,000 female nurses over eight years, among the 13 percent of women who regularly used vitamin E supplements (of at least 100 I.U. per day), there was a 31 percent reduction in relative risk for nonfatal myocardial infarction and death from cardiovascular disease compared with women who did not take vitamin E.
In a study by Rimm (1993), in which 39,000 male health professionals were studied for four years, 17 percent of the men took vitamin E supplements. Of those who took the highest doses (median of 419 I.U. per day) had a 40 percent reduction in the relative risk for nonfatal myocardial infarction or death from coronary hearth disease.
That's what the science really shows.
Responsible media outlets will (1) run a follow-up story on this putting the Annals interpretation of data into perspective - and with as much fanfare as the original "story" received from certain outlets and will (2) in the future work hard at not following the example of the outlets which "blew it" with this story in the first place in not critically looking at what the real story was behind the hype.
Thank you.
James J. Gormley,
Policy Advisor,
Citizens for Health (www.citizens.org);
Editor-in-Chief, Better Nutrition, 1995 – 2002
Former managing editor, American Journal of Surgery & American Journal of Medicine Health book author, journalist and consumer advocate
Phone: 914-701-4511
james_gormley@msn.com
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Vitamin E Supplementation and All-Cause Mortality
Linus Pauling Institute
A recent meta-analysis that combined the results of 19 clinical trials of vitamin E supplementation for various diseases, including heart disease, end-stage renal failure and Alzheimer's disease, reported that adults who took supplements of 400 IU/day or more were 6% more likely to die from any cause than those who did not take vitamin E supplements (52).
However, further breakdown of the risk by vitamin E dose and adjustment for other vitamin and mineral supplements revealed that the increased risk of death was statistically significant only at a dose of 2,000 IU/day, which is higher than the UL for adults.
Furthermore, three other meta-analyses that combined the results of randomized controlled trials designed to evaluate the efficacy of vitamin E supplementation for the prevention or treatment of cardiovascular disease found no evidence that vitamin E supplementation up to 800 IU/day significantly increased or decreased cardiovascular disease mortality or all-cause mortality (53-55).
At present, there is no convincing evidence that vitamin E supplementation up to 800 IU/day increases the risk of death from cardiovascular disease or other causes.
1. Tolerable Upper Intake Level (UL) for Alpha-Tocopherol Age
Group mg/day (IU/day d-alpha-tocopherol) Infants 0-12 months Not Possible to Establish* Children 1-3 years 200 mg (300 IU) Children 4-8 years 300 mg (450 IU) Children 9-13 years 600 mg (900 IU) Adolescents 14-18 years 800 mg (1,200 IU) Adults 19 and older 1,000 mg (1,500 IU) *Source of intake should be from foods or formula only.
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From Alex Schauss about your (Ms. Corbett-Dooren) vitamin E story in the WSJ Alex Schauss, PhD, FACN (Fellow of the American College of Nutrition)
Dear Ms. Corbett-Dooren:
You have committed a terrible disservice to the public by your article on vitamin E in today’s Wall Street Journal. I read the report from the AHA meeting from Johns Hopkins. Didn’t you see that they did not take benefits into consideration in their meta-analysis?
I used to teach biostatistics and epidemiology. A good example of
statistical violation can be made by one illustration. You may fly a lot. I do. If we looked at the risk of dying from flying we could reasonably predict that those who fly the most are at greatest risk of dying in an
airplane.
But unless you compare flying to other modes of transportation you can't see the benefit per mile of flying and its incredibly lower risk of dying compared to any other form of transportation, including walking. Getting even more absurd, I could argue that walking is extremely dangerous. Walking is nothing more than not falling. We are actually catching ourselves from falling every time we take a step! So if I calculated how many people have heart attacks while walking (or standing - but they had to walk to get to where they were standing), I could argue that walking is very dangerous to health, and should be avoided if you don't want to get a heart attack. I could then prove my point by showing how many fewer deaths from a heart attack occur in bed lying down than standing up or walking.
Hence, exercise of any form that involves standing on my feet would be a significant risk factor for heart attacks. I am sure that my findings would be invited for a presentation at the next American Mattress Manufacturers Association meeting.
Please, as a journalist, look at the evidence for the benefits of vitamin E, before scaring people based on this one selective meta-analysis that depended on a study on synthetic (not natural) beta-carotene, an isolated carotene, in long term smokers to reach its conclusion.
What is with all this supplement bashing lately? I don't see people in emergency rooms for supplement overdoses according to data from the Center for Disease Control or the American Poisoning Control Centers, both of which monitor emergency room visits nationally. Couldn't it possible that millions of Americans who quit smoking are now afraid that they could die from their long-term habits and have begun taking supplements to try to ameliorate the risk? So what killed them - smoking or vitamin E?
Good statistical analysis is putting data in perspective. I thought good journalism was suppose to be the same thing.
Alex Schauss, PhD, FACN
(Fellow of the American College of Nutrition)
Tacoma, Washington
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Renowned Researchers, Doctors Challenge Recent Study and Say 'Keep Taking Vitamin E'
New Web Site Provides Clarity for Consumers on Vitamin E's Proven Health Benefits
November 18, 2004 - "To E or not to E," a question prompted by a controversial analysis released last week, is addressed by leading researchers and physicians who recommend that Americans keep taking vitamin E supplements in recommended amounts for overall health benefits. These researchers, physicians and health officials have voiced concern and even outrage regarding a "meta-analysis" suggesting that high-dose vitamin E supplements "may increase risk of dying" among older, high-risk patients.
The Dietary Supplement Information Bureau (DSIB) has launched a new Web site - www.vitaminEfacts.org - to help consumers obtain accurate information on vitamin E. Visitors will find referenced materials to help them understand the analysis generating news
headlines and facts on why vitamin E is safe and beneficial.
DSIB Scientific Advisory Board members were quick to respond to the issues raised in the study:
"This meta-analysis, a study of other studies published during the last 11 years, concludes there may be a very small increase in mortality associated with high dose vitamin E supplements. However, these results were generated from clinical trials of patients sick with chronic diseases or at very high risk of such conditions and cannot be extrapolated to generally healthy people looking to promote their health and prevent disease. It is important to appreciate that these researchers examined only 19 clinical trials comprised of 135,000 patients and did not investigate at all dozens of observational studies involving millions of people that show vitamin E supplementation can be beneficial and completely safe," explains Dr. Jeffrey Blumberg, a professor of nutrition at Tufts University.
Dr. Ronald Watson, professor in the College of Public Health and School of Medicine at the University of Arizona, who is currently editing an encyclopedia on vitamin E says, "We have carefully reviewed almost 100 articles about vitamin E, its benefits, activity, etc. There is almost no evidence of toxicity or adverse effects in doses used by the average American. In fact multitudinous animal and human studies proclaim it has limited toxicity and significant benefits. The huge amounts of data and studies on vitamin E suggest that it should be considered in supplement programs to promote health, especially in seniors."
When asked if consumers should continue taking vitamin E, Dr. Maret Traber, a vitamin E expert at the Linus Pauling Institute at Oregon State University stated, "Absolutely yes."
The Web site http://www.vitaminefacts.org/ provides:
1. Reviews of the meta-analysis describing major flaws in methodology and conclusions presented
2. A vitamin E safety fact sheet from the government's National Institutes of Health, Office of Dietary Supplements
3. Advice from physicians and researchers indicating that consumers can feel confident in benefiting from the typical supplement of 400 IU of vitamin E each day.
Consumers like Sharon Gross, a 57 year-old pre-school director from
Chicago, found the new Web site to be useful. "I've been taking vitamin E supplements for years and was ready to stop when I saw the reports on TV. But, when I learned that this so-called meta-analysis was done with people who were already very sick to begin with, and that the individual studies still showed health benefits, it restored my faith and I'm still going to take my E each day."
DSIB has readily available to the media a number of scientific experts to
answer questions on vitamin E's safety and benefits:
David Heber, M.D., Ph.D. - director of the UCLA Center for Human Nutrition and chief of the
division of Clinical Nutrition in the Department of Medicine at the University of California, Los Angeles.
Jeffrey Blumberg, Ph.D. - professor in the Friedman School of Nutrition Science and Policy and the associate director of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston
Kenneth Cooper, M.D., M.P.H. - president and founder, The Cooper Aerobics Center and "father of aerobics"
Michael Gaziano, M.D., M.P.H. - associate professor of Medicine, Harvard Medical School
Lester Packer, Ph.D. - one of the world's leading researchers on natural antioxidants. Research conducted in his laboratory led to the discovery of the Antioxidant Network.
Barbara Levine R.D., Ph.D. - director of the Human Nutrition Program at The Rockefeller University and the director of the Nutrition Information Center at Weill Medical College of Cornell University-New York Presbyterian Hospital and Sloan-Kettering Cancer Center.
Maret Trabor, Ph.D. - principal investigator for the Linus Pauling
Institute and professor in the College of Health and Human Sciences at Oregon State University
Ron Watson, Ph.D. - professor of Public Health and Family and Community Medicine at the University of Arizona Medical School
For more information, or to schedule an interview, call Deb Knowles at
941-349-9044 or Bree Flammini at 202.326.1763.
The Dietary Supplement Information Bureau (DSIB) was created to provide accurate information about vitamins, minerals, herbs and other supplements for consumers and the professional healthcare community. The DSIB Scientific Advisory Board comprises nationally-recognized physicians and researchers who are experts in dietary supplements. For more information, see the DSIB Web site at
http://www.supplementinfo.org/
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Annals of Internal Medicine
Rapid Responses to publication of this article
http://www.annals.org/cgi/eletters/0000605-200501040-00110v1#617
Rapid Responses to:
Reviews: Edgar R. Miller, III, Roberto Pastor-Barriuso, Darshan Dalal, Rudolph A. Riemersma, Lawrence J. Appel, and Eliseo Guallar
Meta-Analysis: High-Dosage Vitamin E Supplementation May Increase All-Cause Mortality. Ann Intern Med 2004; 0: 0000605-200501040-00110-53
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From: Michael Mooney
www.michaelmooney.net
www.medibolics.com
Another problem with this study is that the recommendations at the end of the study said:
"What are the implications of the study? Adults should avoid taking vitamin E preparations in amounts of 400 IU or more. Experts should reconsider the stated upper tolerable intake level of vitamin E. Sellers should consider removing vitamin preparations that contain 400 IU or more per dose from stores."
Basically this is like saying "Do not take 400 IU of more of Vitamin E, even though 400 IU is the minimum amount of Vitamin E that the majority of dose comparison studies show provides significant health benefits.
i.e. (From a paper I wrote)
Vitamin E: Low Doses Do Not Reduce Cholesterol Oxidation, While Higher Doses Do
The Daily Value for Vitamin E is currently 30 IU. One placebo-controlled study showed that Vitamin E dosing at 60 IU or 200 IU had no significant effect on reducing the oxidation of LDL cholesterol that can precede plaque formation in arteries, but that doses of 400 IU, 800 IU and 1,200 IU had a significant effect on safely reducing the oxidization of LDL cholesterol in the blood stream.
Reference: Jialal I, et al. The effect of alpha-tocopherol supplementation on LDL oxidation. A dose-response study. Arterioscler Thromb Vasc Biol 1995;15(2):190-198.
The authors of this negative Vitamin E study, which I contend was produced to keep us from being healthy enough not to need drugs, recommended that you don't take the threshold minimum amount of Vitamin E that can help keep your arteries healthier.
Hmmm. Sounds like it fits the agenda I contend the multi-billion dollar drug companies have: to keep us sick enough that we need statins, drugs for hypertension, and other drugs that we might never need if we take an effective dose of Vitamin E regularly over the course of many years.
Michael Mooney
www.michaelmooney.net
www.medibolics.com
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Message: 4
Date: Sat, 13 Nov 2004 15:00:09 -0800
From: "Michael Mooney" <mmooney@covad.net>
Subject: Vitamin E Study Poor Design Overstated Significance Contradicts Preponderance of Scientific Literature
Very poor study in quality of design, oversight, expression to the public --- highly exaggerated significance. Just bad news to scare the public with very poor data. There is going to be a continuing campaign to scare the public about using nutritional supplements. As surely as any powerful financial group uses tactics of any kind to promoting its agenda, the big money in the pharmaceutical world does not want the public to get healthier. They want us to stay a little bit sick, but not dying, so they can make money on us. They do not want us to take supplements that make us so healthy that we don't need to buy their drugs. Sound silly? Well, it’s just as likely as not.
Here is my answer to the Vitamin E study that I sent out to another list I am on.
From: Michael Mooney
You have undoubtedly been getting questions regarding the recent press on a Vitamin E study.
Bear in mind that the editors of the journal publishing the study stated, "Trials that tested high dosages involved adults with chronic diseases..." and the authors of the study, themselves, stated, "We could not evaluate the generalizability of our findings to healthy adult populations." The studies the article referred to are studies with elderly people who have Alzheimer's, Cancer, Heart Disease, Eye Disease and Kidney Disease.
If you want to read the study go to:
http://www.annals.org/cgi/content/full/0000605-200501040-00110v1
The title of the study is "High-Dosage Vitamin E Supplementation May Increase All-Cause Mortality."
A more fully informative title would read, "High-Dosage Vitamin E
Supplementation May Increase All-Cause Mortality About 4 Percent in Elderly People with Critical Illnesses, Many of Whom Were Going To Die Anyway."
However, this is even questionable because this study had a design that excluded looking at the studies that showed that Vitamin E did increase life-spans, even for elderly people who had life-threatening illnesses.
For instance: Losonczy published a study with 11,000 elderly people that showed that Vitamin E supplementation was associated with a 44 percent reduced relative risk of all-cause mortality.(1) The Iowa Women's Health Study found a 47% reduction in cardiac mortality with higher dose Vitamin E supplementation.(2) The best known of these trials, the Cambridge Heart Antioxidant Study, found a 47% reduction in fatal and nonfatal myocardial infarction in patients with proven coronary atherosclerosis who were given 400 or 800 IU of vitamin E daily.(3)
Given the hundreds of other quality published studies that show that Vitamin E can reduce the risk of death from various causes and improve specific measures of health, this one inconclusive study appears to contradict the preponderance of scientific literature.
Michael Mooney
www.michaelmooney.net
www.medibolics.com
References:
1. Losonczy KG et al. Vitamin E and Vitamin C supplement use and risk of all-cause coronary heart disease mortality in older persons: the Established Populations for Epidemiologic Studies of the Elderly. American Journal of Clinical Nutrition. 1996;65:190-6.
2. Kushi LH, et al. Dietary antioxidant vitamins and death from coronary heart disease in postmenopausal women. New England Journal of Medicine. 1996;334:1156-62.
3. Stephens NG, et al. Randomized controlled trial of vitamin E in patients with coronary disease: Cambridge Heart Antioxidant Study (CHAOS). Lancet.
1996;347:781-786.