August 2007

NPA: Journal study on antioxidants is flawed

A report published Aug. 13 in the Archives of Internal Medicine states women who have a higher risk of heart disease might now benefit from consuming vitamins C, E, and beta carotene, but the Natural Products Association (NPA) says the study is flawed.

Daniel Fabricant, PhD, NPA vice president of scientific and regulatory affairs, issued a statement about the report “A Randomized Factorial Trial of Vitamins C and E and Beta Carotene in the Secondary Prevention of Cardiovascular Events in Women.” The report states women who have a higher risk of heart disease might not get any benefit from consuming vitamins C, E and beta carotene, either on their own in combination, because the antioxidants do not lower their risk of experiencing a cardiovascular event.

Fabricant said, “While study subjects had to be willing to forgo individual supplements of vitamins A, C, E, and beta carotene at levels beyond the U.S. recommended daily allowance during the trial to control intake levels, the study makes a critical error in that there are no controls in place for dietary intake of vitamins C and E and beta carotene through fruits and vegetables. We have no baseline of what the subjects’ nutrient status was from food, thus to draw any comparison or conclusion doesn’t really offer a complete view of the research picture.”

He continued, “Generally diet and exercise are very important components of secondary prevention, yet this study makes no mention of the exercise habits of the subjects, nor does it track some of the dietary habits like sodium (salt) intake, which are potential study confounders.

“The risk factors for eligibility in the study are rather broad and range from self-reported diagnosis of hypertension, high cholesterol level, or diabetes mellitus; parental history of premature myocardial infarction (MI) before age 60 years; obesity (body mass index [BMI] greater than 30 [calculated as weight in kilograms divided by height in meters squared]); current cigarette smoking; and inconsistent report of the subjects’ prior medical CV. This variability of subjects has the potential to introduce bias and doesn’t reflect the scientific objective of secondary prevention.”

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