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Women's Health Study

Vitamin E Is Safe and Shows Big Reduction in Heart Risk for Older Women

Largest study ever says cardiovascular deaths declined for boomers 24%, seniors 49%

July 5, 2005 - The Women's Health Study, to be published tomorrow in the Journal of the American Medical Association (JAMA), found 600IU vitamin E is safe and significantly reduces the risk of cardiovascular death in older, healthy women.

Conducted from 1992-2004 on 39,876 healthy women over the age of 45, the Women's Health Study found a "significant 24% reduction" in cardiovascular death in participants taking vitamin E. The study also "observed no significant effect of vitamin E on total mortality."

The Council for Responsible Nutrition (CRN) said today it was encouraged by the results of a new study involving nearly 40,000 healthy women -- the longest and largest trial ever conducted on vitamin E.

"The benefits shown in this study are very encouraging and should come as welcome news to everyone," said Andrew Shao, Ph.D., CRN's vice president of regulatory and scientific affairs. "The data clearly show that vitamin E can help healthy women, especially older women. They can continue to take vitamin E with confidence and expect to derive substantial benefit."

The WHS finding on safety is consistent with a recent review of scientific literature published in the American Journal of Clinical Nutrition, which found vitamin E is safe at daily intakes of 1600 IU. (Vitamin E supplements most commonly contain 400 IU.)

"Most Americans don't get enough vitamin E from diet alone," Dr. Shao said. "Supplements fill that gap and provide higher levels of vitamin E that have been shown to be beneficial in promoting health and protecting against some diseases."

"The good news coming out of the Women's Health Study is that healthy women receive heart health benefits from taking vitamin E, and older women may reap even greater benefit,” commented Dr. Ishwarlal Jialal, M.D., Ph.D., Robert E. Stowell Endowed Chair in Experimental Pathology, Director of the Laboratory for Atherosclerosis and Metabolic Research and Professor of Internal Medicine and Pathology at UC Davis School of Medicine.

“In women 65 and older, who never took estrogen and were on E, the study found an even greater reduction in the cardiovascular death rate. Had all these women not taken estrogen, one might surmise that the reduction in cardiovascular events among elderly women would have been even larger,” he added.

The study's objective was to test whether vitamin E supplementation decreases the risk of cardiovascular disease and cancer among healthy women. Women participating in the study randomly received 600IU natural source vitamin E or placebo every other day and 100 mg aspirin or placebo every other day.

Strikingly, women over the age of 65 in the vitamin E group experienced a 26% overall reduction in major cardiovascular events, due to a 34% reduction in heart attack and a 49% reduction in cardiovascular death. However, researchers noted the overall reduction in cardiovascular deaths among all participants was possibly due to chance.

"A weakness of this study like previous anti-oxidant trials is the failure to report an objective assessment of compliance by measuring vitamin E levels in the blood. Vitamin E was given on alternate days with a compliance rate of 72% in the vitamin E group and an 11% drop-in rate in the placebo group," added Dr. Jialal.

The study elaborates "the single largest contribution to the reduction in cardiovascular deaths was fewer sudden deaths among women on vitamin E." Still the WHS researchers appear to downplay these "significant" findings by concluding vitamin E supplementation offers no harm or benefit. Moreover, they note their research indicates healthy women should not take it for the prevention of cardiovascular disease or cancer. Yet, the researchers acknowledged their findings of a decreased risk in cardiovascular death in participants as well as the significant benefit to women over age 65 contradict the study's overall findings and "should be explored further."

The Women's Health Study is the largest and longest randomized trial of vitamin E to date on healthy people. It addition to reducing the risk of heart disease, the study concluded vitamin E is safe and did not increase the risk of death in healthy women, refuting recent findings in the Miller meta-analysis (Miller, ER, Ann. Intern. Med. 2005), which that reviewed studies of people already ill with cancer, heart disease or other serious medical conditions and suggested a contrary conclusion.

The Women's Health Study observed that while the Miller meta-analysis "raised the question of possible adverse effects on total mortality with high doses," it is important to recognize that the Miller trial was conducted on gravely ill participants "with cardiovascular risk factors and/or CVD, or at high risk for cancer." Therefore, one cannot apply its findings to the general healthy population. In contrast, the Women's Health Study conducted on nearly 40,000 healthy women with no risk factors found 600IU of vitamin E every other day "did not increase total mortality in healthy women."

The Women's Health Study was a randomized trial, considered more clinically sound than a meta-analysis. The Miller meta-analysis relied upon published summary statistics from 19 previously conducted trials, considered to be a distinctly inferior methodology when conducting a meta-analysis, making the results of the Miller study inconclusive at best. More research should be conducted on vitamin E in healthy people to better understand the scope of this nutrient's benefit.

Professor Maret Traber, Ph.D., a principal investigator at the Linus Pauling Institute at Oregon State University and a leading expert on vitamin E, said the WHS offers exciting new information, particularly for older women who have a greater risk of heart disease. "Vitamin E has clear value in helping to reduce the risk of heart and other serious degenerative diseases," she said. "This is especially important for people who smoke, have high blood pressure, or who don't eat properly, habits which can leave them with inadequate levels of this essential vitamin."

Sources:

The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing dietary supplement industry ingredient suppliers and manufacturers. CRN members adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices. For more information on vitamin E visit the CRN website http://www.crnusa.org/vitaminEissafe.html.

Founded in 1973, Leiner Health Products, headquartered in Carson, California, is America's largest manufacturer of store brand vitamins, minerals, and supplements. The company also is a leading store brand supplier in the rapidly growing over-the-counter (OTC) pharmaceutical market. Selling products exclusively to the nation's leading retailers, Leiner provides nearly 40 food, drug, mass, club and dollar store merchants with over 3,000 products, creating extraordinary, high quality store brands at a great value. Leiner markets a full line of vitamins, minerals and supplements under its YourLife(R) brand, which is the leading brand worldwide in the US military. The company also markets over-the-counter drugs under its Pharmacist's Formula(R) brand. In 2004, Leiner produced 29 billion doses. Leiner Health Products (http://www.leiner.com/)

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