The Cardiovascular Promise of Vitamin E is Still Alive: Here’s Why and Here’s What to Do.
In the early 80’s, animal studies supported the idea that vitamin E can prevent heart attacks and stroke. In rodents and piglets this vitamin caused a dramatic reduction of arterial plaque size. In the early 90’s large clinical studies reported that vitamin E did indeed cause a reduction in cardiovascular events. It was believed that this effect was due to its strong antioxidant properties which reduced cholesterol’s ability to form plaque in arteries that feed the heart and brain. I wrote about these studies and was impressed by them.
Then in our early century the big, unwelcomed surprise happened. Other large clinical studies, both in men and women, reported that vitamin E had no clinical benefit in preventing heart attacks and strokes. The national impact of these negative studies was dramatic. Medical experts concluded that previous studies on its cardiovascular protection effectiveness were faulty and that the vitamin should not be taken. The media did a superb job in sending this message to the consumer- the healthy and patients- as well as to cardiologists and practicing physicians.
I was very much disturbed about this “final judgment” for two primary reasons. The first is that it was a premature one and the second was the devastating negative impact it had on the highly promising nutraceutical movement. Let’s start with the latter. Vitamin E, of much greater importance than calcium and osteoporosis, was the most important acceptable nutraceutical in modern times. (A reminder: a nutraceutical is a diet or dietary supplement that has been proven to be clinically effective). After all, cardiovascular disease is our number one killer and any therapy that will reduce this pervasive killer rapidly gains national attention. Its clinical benefit was accepted by practically everyone, including physicians who were taking it themselves. I was among them. It’s important to note that clinical studies at that time on such potential nutraceuticals as Ginkgo balboa for improvement of memory, St. John’s Wort for depression and Echinacea for the common cold were not encouraging. Though I know of no survey on this, I fear that the negative “final judgment” on vitamin E was the final nail in the coffin which has led to the exit of physicians, the critical group needed to establish a mainstream nutraceutical health sector.
Now let’s get to the clinical studies themselves and what’s my opinion regarding vitamin E’s role in preventing heart attacks and strokes: I simply do not know. Certainly the contradictory published studies themselves do not serve as a basis of certainty such as with insulin for treatment of diabetic coma or penicillin for the treatment of bacterial pneumonia. I don’t want to enter a detail analysis of both the positive and negative studies for I’m not at all qualified. But after years of experience with interpretations of the results of a large number of clinical trials I believe statisticians who are experts in probability mathematics, not many of them, will most likely agree with my judgment. They may conclude that the studies were good enough to demonstrate vitamin E’s ineffectiveness or it was effective or even increased heart attacks and strokes.
But there’s a far more critical issue when it comes to conducting clinical studies on natural substances. In order to be conceived, born and continue to live, you must eat a meal which is, by far, the greatest nutraceutical in the world. After entering the world one survives by eating a wide variety of diets from Madagascar to Manhattan. And why does this happen? Because natural substances, including vitamin E, work in combination and not primarily as single substances and nutraceutical studies should generally be studies as combination therapies and as single entities. For reasons too complicated to address here, we have a national clinical research policy based on faulty pharmaceutical ideology which generally dictates that we must study only a single substance in clinical studies. Also, as I have mentioned in previous posts we have a general national policy that blocks medical discovery in general be it a nutraceutical, pharmaceutical or medical device. That’s why I proposed the Doctornaut Act which would help solve the problem.
In 1997, FIM, The Foundation for Innovation in Medicine, held the conference, which I chaired, Cardiovascular Nutraceuticals: Their Proper Role in Health & Medicine. Experts reviewed the potential clinical benefits of vitamin E, folic acid, carnitine, magnesium (in Diabetes), CoQ10, alcohol, garlic, special diets and a salt alternative. Two major conclusions were that nutraceuticals should be clinically tested in combinations and also together with cardiovascular pharmaceuticals.
Regarding vitamin E, I would suggest two clinical studies: one in combination with, let’s say, CoQ10, carnitine and magnesium and the other, using the same nutraceutical combination, evaluate together with a cardiovascular nutraceutical. Practically speaking, because of the tremendous costs, it would be almost impossible to conduct a clinical endpoint study where a reduction of heart attacks and strokes are evaluated. But one can evaluate bio or surrogate makers such as a reduction of cardiovascular risk factors and improvement of cardiac function in patients with coronary artery disease. These are not complicated and prohibitively costly studies.
Who will sponsor at least one of these studies? Believe it or not, a major pharmaceutical company heavily invested in cardiovascular research would, by far, gain the most. Unfortunately, it is not in their culture to sponsor such studies but times are rapidly changing and hopefully a visionary leader of a company will emerge and seize this opportunity.