THE ANTIOXIDANTS STORY CONTINUED #6

Continued from Yesterday.....

The Proof in the Research

It is on the basis of studies such as these, appearing in preeminent medical journals, that doctors and pharmacists form their collective opinion about antioxidant supplements. And time and again, scientists, doctors and pharmacists in interviews specifically cite epidemiological studies on vitamin E as significantly perking their interest in the value of the nutrient in preventing heart disease. In other words, there is precedent that members of the mainstream medical community can be convinced of the benefits of a certain antioxidant, but only if strong evidence is present.

"I think antioxidants will eventually become another option that doctors in traditional medicine will recommend when appropriate," said Jim Clark, Ph.D., research director at Henkel Nutrition and Health Groups, which supplies such antioxidant ingredients as Pycnogenol pine bark extract, Betatene natural beta carotene with mixed carotenoids, Covitol natural-source vitamin E and Lipoec alpha lipoic acid. "However, the integration will be subtle. And because of the conservative nature of traditional medicine, only antioxidants that have been studied for many, many years will be included. For example, surveys have shown that about half of all doctors take vitamin E."

While epidemiological studies of large populations have suggested the role of an antioxidant nutrient such as vitamin E, many health professionals view the epidemiological results with caution. "I feel that observational epidemiology can be very persuasive if the studies are well designed and large enough, and I am not sure that we have to demand that a randomized clinical trial be performed before we suggest an intervention," said Dr. Regina Ziegler, a nutritional epidemiologist at the National Cancer Institute. "But on the other hand, depending on the degree to which an intervention or supplementation diverges from normal dietary patterns, you have to be concerned about potential risks and benefits. Research that fruits and vegetables are protective in a dietary study of a large population are fine, but once people want to extract beta carotene or vitamin C and put them in a pill, they should be sure that those are the only important components and that other necessary things are not getting left behind. Also, it is important to make sure that the chemical form is correct, and that the dosage is not too much, etc. We shouldn't rule out the research, but we should be very prudent in terms of taking compounds in supplements and saying that they will do the same things that are shown in studies of dietary patterns."

One way to determine whether these nutrients in supplemental form offer similar benefits as they do when ingested as part of diet is to conduct clinical human studies that specifically use supplements as the therapeutic intervention. Further, while epidemiological studies definitely catch the interest of the medical community, controlled, randomized human studies close the deal in winning doctors' and pharmacists' acceptance.

Continuing with the example of vitamin E, Andreas Papas, Ph.D., senior technical associate at Eastman Chemical Co., which supplies Nutriene brand tocotrienols, said that vitamin E is well on its way to being fully scientifically validated for its antioxidant function. Papas explained that in order to meet the burden of proof that will convince the scientific community and the FDA to approve claims for an antioxidant substance, the following steps of gathering evidence is required: 1) a good working hypothesis that a benefit is likely, with a mechanism of actions that makes good biological sense; 2) evidence from basic medical laboratory research that supports at least part of the hypothesis; 3) evidence from animal studies and small human studies that some responses related to the benefit do actually occur; 4) epidemiological studies showing a strong association between the compound and the actual health benefit; and, 5) evidence from randomized, double-blind, placebo-controlled clinical trials.

"For vitamin E, evidence is available for all steps except the evidence for the last and important step is not complete," said Papas. "If ongoing major clinical trials are positive, it will achieve the burden of proof required for FDA approval."

Continued Tomorrow....

http://www.naturalproductsinsider.com/articles/1999/01/winning-the-medical-community-over-to-antioxidants.aspx

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