Tag: HOPE-TOO

False Propaganda Against Vitamins

Niels Hertz

November 30, 2005

A frightening warning in an article in the Danish newspaper, Ekstra Bladet, claims that people will get sick from taking Vitamin B and injure their hearts by consuming Vitamin E. These claims are twisted and false.

Condescending evaluations of vitamin supplements are quite common. They rarely come from experts, but often from people who know something about something else and therefore think they know something about everything.

As a rule, it is stated that the vitamins only provide expensive urine and do not help against anything at all. Sometimes this message is spread rather too thickly.
The vitamins are poisonous! As the other day in a large published article in the newspaper Ekstra Bladet: You get sick from nutritional supplements, the headline stated. Further down, it became clear that you would not only get sick. You would die!

Whenever these kinds of statements appear, people get scared. They cannot imagine that anyone will write anything in Ekstra Bladet if it is not true. But unfortunately there are writers who don’t bother with that. This is evident from the mentioned article, which is mainly based on two gross, false claims. Here we comment on them in reverse order.

“The last new thing was the B vitamin folic acid, which should also be able to protect against heart disease. Recently, a large Norwegian study showed that folic acid did not make users less prone to heart disease. On the contrary, they got sick from the pills”.

Is that right? No. It is wrong. In the Norwegian randomised trial (it was called NORVIT), approx. 900 people who had had blood clots in the heart were supplemented with 0.8 mg of folic acid per day for 3-4 years. The table shows the relative mortality and incidence of heart clots in those who received folic acid and those who received inactive pills (placebo.)

……………………..………..……Folic acid……Placebo
Blood clot in the heart…….57,9…………….59,2
Total mortality………………….28,7…………….31,7

As seen, the overall mortality was 9% lower if folic acid was given instead of placebo. The risk of blood clots was also reduced. How does that agree with the fact that people “got sick (meaning heart disease) from the pills”? The answer is that it is not true. Admittedly, none of the differences were statistically significant. It was a trend. But that is not the same as the study showing the opposite of the trend.

And now to the first claim. It is about vitamin E. It was claimed that vitamin E should protect against heart disease, it says, but “when the major scientific studies came, it turned out that it… gave… heart failure, bleeding and an increased risk of dropping dead”.

Heart failure. That claim must come from the HOPE-TOO study, the only one of the many studies with a total of well over 100,000 participants in which heart failure has been found to be caused by vitamin E treatment.

4,000 people with severe atherosclerosis participated in HOPE-TOO. Those who received vitamin E (400 IU/day) had slightly more often weakened heart. The difference was statistically uncertain, i.e. that it could be accidental. The absence of heart failure in all the other studies suggests the same.

On the other hand, a slightly reduced risk of lung cancer was found in HOPE-TOO, and it was reliable. But since this has not been found in other studies either, it is unreasonable to mention it. It could be random anyway.

Another peculiarity of HOPE-TOO was that even though the participants were given 25 times the recommended amount of vitamin E, it could not be seen in the blood tests. On average, the participants had very little vitamin E in their blood, despite the large supplements. The concentration in the blood (17.6 mmol/l) was even at the lower end of the normal range (12-42 mol/l). Either the participants have not taken the vitamins, or they have e.g. taken them on an empty stomach so that they were not absorbed from the intestine. So where does the vitamin E study end up?

In other words: Here a single, guaranteed misleading, result from one small experiment is misused – as “fact”. It is cheating and distortion. And for the record: That you should start bleeding, let alone die from vitamin E in the mentioned doses, is out of thin air. In contrast, the vitamin prevents, in animal experiments, gastric bleeding caused by aspirin.

Professor Maret Traber, Oregon State University, is considered one of the world’s leading vitamin E researchers. She recommends vitamin E for a number of chronic health problems, including heart disease. Louis Ignarro, who received the Nobel Prize in 1998 for his research on blood vessels, unequivocally recommends vitamin E and C for the prevention of atherosclerosis. It works, he says.

Of course, what even such big celebrities think is no argument in itself. It is the substance that counts. Yet. If you are free to choose your advisers, you are likely to prefer the most knowledgeable – and the most reliable.

By: Niels Hertz  MD

References:
1. A. Astrup. Du bliver syg af kosttilskud. Sund og Slank. Ekstra Bladet. 26.11.05.
2. The HOPE and HOPE-TOO Trial Investigators. Effects of long-term vitamin E supplementation on cardiovascular events and cancer. JAMA 2005;293:1338-47.
3. Bonaa KH. NORVIT: Randomized trial of homocysteine-lowering with B-vitamins for secondary prevention of cardiovascular disease after acute myocardial infarction. Program and Abstracts from the European Society of Cardiology Congress 2005; September 3-7, 2005; Stockholm, Sweden. Hot Line II. Iflg. Linda Brooks. NORVIT: The norwegian vitamin trial. Medscape Sept. 2005. (Not published in printed media.)

The Emperor’s New Clothes: HOPE-TOO

Claus Hancke

April 5, 2005

Reputable American researchers claim that even large amounts of natural Vitamin E do not benefit established atherosclerosis. But their study do not reveal it. The participants got almost no Vitamin E.

Perhaps somebody have heard about the praised American HOPE study from 2000. It was to reveal that natural Vitamin E would not make any difference for people with atherosclerosis. This was a disappointment, and with it the issue could then have been dismissed.

That is not how it went. The HOPE study, which lasted 4,5 years and included 9,000 participants was prolonged with 2,5 years. They wanted to be absolutely sure, they said. In the follow-up study called HOPE-TOO only 4,000 people participated. Some did not want to participate, others had died, and others only wanted to be examined, but did not want any medication.

Half of the participants took 400 units natural Vitamin E daily (alpha-tocopherol), while the rest took placebo. They certainly had serious atherosclerosis: Every other one had had a heart attack, just as many suffered from angina pectoris (atherosclerosis ), and more than every third had diabetes.

The HOPE study showed that Vitamin E did not cause more or less cancer, more or less heart attacks, strokes, deaths or anything else. HOPE-TOO showed the same result, though with a single addition: Those who took Vitamin E slightly more often had heart failure; that is to say a decreased functioning of the heart.

The difference was so small that it could very well have been coincidental, even though it was statistically significant. Nevertheless the authors took the opportunity to strongly warn against dietary supplements. But yet they might as well have taken the opportunity to recommend them. They found that Vitamin E protected against lung cancer!

This finding, which was also statistically significant, was rejected, as an “error.” This conclusion was preceded by a lengthy discussion, in which reference is made to studies with beta-carotene, which as we all know, is something completely different.

No clothes on
But there is a far more serious surprise, which totally overshadows this biased opinion: During the whole study the participants did not have any more Vitamin E in their blood than all other people, who do not take supplements. The average value was 17,6 μmol/l. The normal value is 12 – 42. Despite the Vitamin E they only just managed to get their minimal need covered.

Before the study the participants actually had even lower values, averaging 10 μmol/l. This fits well with the fact that they were seriously ill, overweight heart patients who were kept on a low fat diet. A low fat diet may lead to deficiency of vitamin E.

Here we may also find the explanation of the low blood values. Vitamin E can only be absorbed from the intestine when fat is present. If you eat non-fat foods you might as well not take Vitamin E, even when you take 20 – 40 times the recommended dosage.

One is reminded of the Emperor’s New Clothes. HOPE-TOO has no clothes on. It claims to examine the effects of mega doses of Vitamin E, but the participants are only seemingly getting it. Strangely enough nobody has pointed out this almost ridiculous mistake before. In particular one wonders, why the authors themselves have not seen this mistake. Could it be that they do not know the normal values of Vitamin E in the blood?

This is not completely out of the question although it sounds strange. There are many examples of superficiality in scientific research. You do not have to look any further than the official commentary in the same issue of JAMA, which published the HOPE-TOO study. Here doctor Greg Brown by and large agrees with the conclusion of the study. He was also in charge of a similar study from 2001, which was supposed to show if antioxidants prevent atherosclerosis in the coronary arteries. This study concluded that antioxidants did not prevent atherosclerosis, even though the figures showed in black and white that the antioxidants halved the growth of atherosclerosis in the coronary arteries, compared to placebo.

By: Vitality Council

References:
1. The HOPE and HOPE-TOO Trial Investigators. Effects of long-term vitamin E supplementation on cardiovascular events and cancer. JAMA 2005;293:1338-47.
2. B Greg Brown. Is there any hope for vitamin E? JAMA 2005;293:1387-90.
3. Greg Brown et al. Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N Engl J Med 2001;345:1583-92.

jama.ama-assn.org
content.nejm.org
www.iom.dk