Posted on 11/10/2004 7:16:06 PM PST by neverdem
People who take high doses of vitamin E to improve their health may not be getting any benefits and may, in fact, be slightly increasing their risks of dying earlier, researchers reported yesterday.
The adverse effect was tiny, however, and some experts with no connections to the vitamin industry say they are not convinced it was demonstrated. It emerged only when the researchers pooled the results from 19 clinical trials involving 135,967 participants. That led them to conclude that there were 39 additional deaths per 10,000 people who were taking vitamin E doses exceeding 400 international units a day.
The recommended daily amount of vitamin E is about 20 international units a day, and the dose in a multivitamin pill is about 30 units. People take much higher doses because they believe that at high doses the vitamin acts like a drug, protecting them from disease.
The new study, by Dr. Edgar R. Miller III, an associate professor of medicine and epidemiology at Johns Hopkins University, will be published on Jan. 4 in The Annals of Internal Medicine. Dr. Miller presented the data at the American Heart Association meeting yesterday in New Orleans, and the journal is making the paper available free on its Web site, www.annals.org.
The results, some nutrition experts said, were disconcerting because vitamin E is widely used by people who hope it will act as an antioxidant and prevent heart disease, cancer, Alzheimer's disease, and even the common cold. In fact, said Dr. William Thies, the vice president for medical and scientific affairs at the Alzheimer's Association, taking vitamin E has become "part of the standard of care" for Alzheimer's patients, even in the absence of solid evidence that it helps.
The Council for Responsible Nutrition, an industry group, says the exact number of people who take vitamin E is not known, but the vitamin is among the most popular of all nutritional supplements. In 2003, sales of the vitamin totaled $710 million and it accounted for 11 percent of all vitamin sales, behind multivitamins , B vitamins and vitamin C.
Dr. Miller said he began the study when he was asked to write a chapter on antioxidants and heart disease for a textbook on preventive cardiology. When he looked at data from clinical trials, however, he noticed that many seemed to show that vitamin users had more heart disease, not less.
"The a priori hypothesis would be that antioxidants are protective, but there hasn't been any evidence of protection and there has been a hint of harm," he said. But the evidence of harm was weak, so he and his colleagues decided to pool data from 19 studies to get more definitive answers. Their paper, however, failed to convince some statisticians, who noted that it is notoriously difficult to pool data from disparate studies with different populations and weak results.
"They may well be right, but as a statistician I find this paper unpersuasive," said Dr. David Freedman, a statistician at the University of California at Berkeley. But since there also is no evidence that the vitamin can help, he added, "I personally wouldn't recommend that you take large doses."
Dr. James Robins, a Harvard statistician, had a similar reaction.
"They may be right but they somewhat oversold it statistically," Dr. Robins said. "It is definitely true that there is no evidence that the low dose does anything for you, and a high dose may be bad. I wouldn't tell anyone to take this stuff, but this is hardly definitive evidence."
But even a hint of risk should swing scientists' reasoning, some said.
Dr. John Erdman, a professor of nutritional sciences at the University of Illinois at Urbana-Champaign, said doctors and scientists themselves were taking high doses of vitamin E.
"I remember going to meetings where they said, 'Raise your hands if you're taking vitamin E.' An awful lot of people raised their hands."
Now, he said, "The increase in risk is extremely small, but it appears to be real."
Dr. Benjamin Caballero, the director of the Center for Human Nutrition at Johns Hopkins Bloomberg School of Public Health, said the study showed the problem with assuming that vitamins at least would do no harm.
"This reaffirms what many have already said," Dr. Caballero said. "The evidence for supplementing with any vitamin, and particularly vitamin E, is just not there. This idea that people have that even if it does not have any effect, at least it will not hurt, may not be that simple."
But Dr. John Hathcock, the vice president for scientific and nutritional affairs at the Council for Responsible Nutrition disagrees. He is not convinced by the new study's conclusion that high doses of vitamin E are risky, Dr. Hathcock says, and he believes there is at least presumptive evidence that it can help.
For the past 15 years he has taken 400 international units of vitamin E a day, he says, and he does not intend to stop.
Funny, our two posts essentially contradict each other. I concluded that the study was likely done with people who were only taking d-alpha b/c that is what you normally get when you buy a bottle of vit E at the drugstore. The mixed tocopherols are much less common, so it is unlikely that that more than a small minority were supplementing with the mixed tocopherols.
More recent research has demonstrated that if you supplement only with Alpha, you are displacing Gamma or other forms, which are just as important. Supplementing with high doses of d-Alpha only would presumably cause an imbalance which may limit the benefits.
I'm not trying to start a debate, rather I thought your comment was interesting b/c we are all so mixed up on these matters.
I'm especially interested in your statement that Mixed Tocopherols are not stable. Even though I don't supplement with E other than in a multi, I intend to look into your statement out of sheer curiosity.
It is amazing what many in the supp. industry will try to pawn off on us. For instance, promising research on Lipoic Acid led the marketers to begin selling Alpha-Lipoic Acid. Well, the problem was that the studies were done with R-Lipoic Acid. I will spare everybody the technical difference, but suffice to say it is not necessarily the same thing. Why did they sell ALA instead of RLA? Because RLA was not stable and it was much more costly to produce. Only recently have they begun to sell the RLA as more intelligent enthusiests began to demand it and manufacturing costs have come down. The stability issue is still there, so one manuafacturer started bonding potassium to the molecule which stabilizes it. I have no idea whether this effects efficacy (they of course claim it doesn't).
Through the link in comment# 1.
Role of the Funding Sources
The funding sources had no role in the collection, analysis, and interpretation of the data or in the decision to submit the manuscript for publication.
Author and Article Information
From The Johns Hopkins School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, The Johns Hopkins Medical Institutions, Baltimore, Maryland; National Center for Epidemiology, Instituto de Salud Carlos III, Madrid, Spain; University of Edinburgh, Edinburgh, Scotland, United Kingdom; and University of Tromsø, Tromsø, Norway.
Note: J.A. Baron provided unpublished mortality data from the Polyp Prevention Study.
Grant Support: Dr. Pastor-Barriuso was supported in part by a grant from the Instituto de Salud Carlos III (EPY 1261/02).
Potential Financial Conflicts of Interest: Grants received: R.A. Riemersma (Roche).
Requests for Single Reprints: Edgar R. Miller III, MD, PhD, Welch Center for Prevention, Epidemiology and Clinical Research, The Johns Hopkins Medical Institutions, 2024 East Monument Street, Suite 2-624, Baltimore, MD 21205-2223; e-mail, ermiller@jhmi.edu.
Current Author Addresses: Dr. Miller: Welch Center for Prevention, Epidemiology and Clinical Research, The Johns Hopkins Medical Institutions, 2024 East Monument Street, Suite 2-624, Baltimore, MD 21205-2223.
Dr. Pastor-Barriuso: Division of Biostatistics, National Center for Epidemiology, Instituto de Salud Carlos III, 28029 Madrid, Spain.
Dr. Dalal: Division of Cardiology, Department of Medicine, The Johns Hopkins Medical Institutions, BRADY 604, Baltimore, MD 21205.
Dr. Riemersma: Cardiovascular Research Unit, University of Edinburgh, Hugh Robson Building, George Square, Edinburgh EH8 9XF, Scotland, United Kingdom.
Dr. Appel: Welch Center for Prevention, Epidemiology and Clinical Research, The Johns Hopkins Medical Institutions, 2024 East Monument Street, Suite 2-618, Baltimore, MD 21205-2223.
Dr. Guallar: Welch Center for Prevention, Epidemiology and Clinical Research, Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, 2024 East Monument Street, Suite 2-639, Baltimore, MD 21205-2223.
Author Contributions: Conception and design: E.R. Miller, E. Guallar.
Analysis and interpretation of the data: E.R. Miller, R. Pastor-Barriuso, D. Dalal, R.A. Riemersma, L.J. Appel, E. Guallar.
Drafting of the article: E.R. Miller, R. Pastor-Barriuso, E. Guallar.
Critical revision of the article for important intellectual content: E.R. Miller, R. Pastor-Barriuso, D. Dalal, R.A. Riemersma, L.J. Appel, E. Guallar.
Final approval of the article: E.R. Miller, R. Pastor-Barriuso, D. Dalal, R.A. Riemersma, L.J. Appel, E. Guallar.
Statistical expertise: R. Pastor-Barriuso, E. Guallar.
Administrative, technical, or logistic support: D. Dalal, E. Guallar.
Collection and assembly of data: E.R. Miller, D. Dalal, R.A. Riemersma, E. Guallar.
And, the Doctors who PUSH these DRUGS.....having recently been diagnosed as PROBABLY having Rheumatoid Arthritis, but, visiting with both a Rheum. Doc, and a Wholistic type MD.....it's VERY interesting to see the differences. PLUS, doing research on the internet is SO revealing. Alliopathic doctors who push drugs probably make most of their money dealing with the side effects of those drugs.
Thank you for doing this work for us (along with your follow-up below). I was too lazy!
I would suggest that no conclusion can be reached for healthy adults as the result of this study. Somebody needed to write a paper or spend some grant money, but had little interest in coming up with meaningful answers to relevant questions.
Ah, the truth at last...
I was taking 800 daily, but I heard that flax seed oil contains E, so I cut back to 400. It's all a matter of what makes you actually feel better. For me, that's B complex, E, Ester C, CoQ-10, bee pollen, and flax seed oil. And lately I've been taking one of those little coated aspirins every other day. I feel great.
From the people who brought us the Food Pyramid, and fought like hell to deny the Atkins low carb diet.
In other words, Blue State Morons.
The "artificial" vitamin E contains the D and L isomers of which only one is useful to the body and the other one (I think L) is a waste product and as such is possibly bad.
Yes, it's trial & error. I take many other food supplements as well. Used to lecture on nutrition, wrote articles for local newspaper, arranged for other lecturers, etc.
One poster above said the mixed tocopherols are not stable, which is why the FDA suggested only d-alpha was needed. I always understood that their logic was simply that d-alpha is the only biologically active form, so no need to worry about the others.
I know the FDA well enough to suspect that their original support of d-alpha only was likely based on something else - like the needs of a specific artificial vitamin E manufacturer that can pump out all kinds of synthetic d-alph, which is not the same thing as the 7 forms of vitamin E. Think about the boon to the "vitamin E" manufacturers! It is like saying we only need bread to eat and all other forms of food are useless. The bakers would love it! This of course is simply conspiratorial speculation on my part. The FDA could have simply been overly simplistic and ignorant because that is its general nature.
I am a huge Adele Davis fan. I tend to listen to people if they have at least a Masters degree in biochemistry, which she had. She compiled many studies which were conducted over a 30 to 40 year span which proved that d-alpha was the best and that the mixed tocohperols were not to be used because of their instability. She also noted that natural vitamins were to be preferred.
Probably the drug companies and the FDA, the same people who banned red yeast rice because it safely lowered cholesterol levels.
Nothing wrong with taking Vitamin E. Actually, 400 IUs is the right amount to take.
Me three-
Btw, I thought I was the only one who knew about polar bear liver! :)
Could it be possible that the studies looked at HEART PATIENTS (already at increased risk of death) and found higher incidence of mortality due to the population studied?>>>
Yes, they looked at sick people. How about all people who DON'T get heart disease because they take vitamin e
gamma tocopherol has been studied to prevent certain types of cancers and now there are tocotrianols which are other isomers of vitamin e.
There are 8 isomers of vitamin E including tocotrianols.
Interesting. I will have to think twice before taking any Vit E. If d-alpha displaces other forms of Vit E that are critical to Vit E's benefits (more recent research), while mixed tocopherols / tocotrienols are unstable, rendering them useless, if not dangerous (Adle Davis' older research), perhaps supplementing Vit. E ISN'T wise after all. At least until I determine for myself what seems to be the better bet.
That of course depends on another question: Have manufacturing mehtods for Vit E supplements improved in any way that has resulted in greater stability for the mixed tocopherols / tocotrienols? Has the answer to Adele Davis' primary problem with the mixed form been discovered? If so, then paying attention to the newer research might make more sense then hanging on to old orthodoxy.
This is what makes supplementation so difficult. It is an ongoing process that requires constant vigilance. Staying on the cutting edge sometimes means we make mistakes.
I don't know the answer and I've remained slightly ignorant on Vitamin E, perhaps because it is big enough to cause more controverey than some of the stuff that is so new that it hasn't ganered serious debate (though often lots of research anyway).
I do know that there are many supplements now available, in a stable form, that years ago could not be produced in a cost effective manner (at least the higher quality or important form of the compound), or kept stable enough to make widescale distribution practical.
Thanks for the response. I plan to look into it.
Vitamin E does not work without taking the cofactor Selenium - flawed study
appropriate that this is the first post, so i didn't have to scroll too far to see that someone beat me to it.
in college I used the acronym F--ADEK (it's goofy but I still remember it). Fat -- A, D, E, K. I think "K" was one of those mythical vitamins...hmmm, why didn't I just use FADE? It would have had a better ring to it...ah well...
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