AMA’s Archives study omits key research factors of dietary intake and exercise levels
WASHINGTON, D.C (August 14, 2007) –The Natural Products Association issued the following statement by Daniel Fabricant, Ph.D., vice president of scientific and regulatory affairs, in response to a study released on August 13, 2007, in the Archives of Internal Medicine (Journal of the American Medical Association) According to the report, "A Randomized Factorial Trial of Vitamins C and E and Beta Carotene in the Secondary Prevention of Cardiovascular Events in Women," 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; the antioxidants do not lower their risk of experiencing a cardiovascular event.
“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.
“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.”
For more information, please contact Daniel Fabricant at (202) 223-0101, extension 102. Dr. Fabricant is available for interviews.
The Natural Products Association is the nation's largest and oldest non-profit organization dedicated to the natural products industry. The association represents nearly 10,000 retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids.