Nov. 19, 2002 -- New research offers still more evidence that hormone replacement therapy does more harm that good in older women with heart disease, and it also raises doubts about the safety of the antioxidant vitamins E and C.
Results from the Women's Angiographic Vitamin and Estrogen (WAVE) Trial were to be presented Wednesday at the annual meeting of the American Heart Association (AHA) in Chicago. The study appears in the Nov. 20 issue of the Journal of the American Medical Association.
"The findings from this study confirm what we have seen in previous trials evaluating both hormone replacement therapy and vitamin E," American Heart Association president Robert O. Bonow, MD, tells WebMD. "The message is certainly out there with regard to hormone therapy, but I do think a lot of people still believe that vitamin E is protective [against heart disease]."
Until recently, hormone replacement therapy (HRT) was widely prescribed to postmenopausal women for the prevention or treatment of heart disease. Millions also take antioxidant vitamins in the belief that they protect the heart. But the clinical evidence does not support a heart-disease prevention role for either. Widely publicized findings from the Women's Health Study, published last summer, found that HRT actually increased the risk of heart attack, stroke, and blood clots in older women.
In this study, researchers evaluated the role of HRT and antioxidant vitamin supplements in the treatment of postmenopausal women with heart disease. A total of 423 women received either both of the intervention treatments, one of the treatments plus placebo, or placebo alone.
Vitamin supplementation involved daily consumption of 800 international units of vitamin E and 1 gram of vitamin C. Women were given estrogen plus progesterone or estrogen alone if they had had a hysterectomy. Participants were followed for roughly three years.
The results showed women on hormone therapy had a poorer outcome than those who did not take HRT -- they continued to have narrowing of the arteries, which indicates continued progression of heart disease.
Likewise, women taking the antioxidants fared worse than women on the placebo treatment. Fourteen patients died in the HRT group, compared to eight in the group that did not receive HRT. And 16 patients died in the group receiving the vitamins, compared to six in the no-vitamin group.
The researchers concluded that postmenopausal women with coronary disease should be discouraged from using both HRT and high doses of vitamin E and C.
"Death was not a primary endpoint, but the large number of deaths in the vitamin group was a surprise," researcher David D. Waters, MD, of San Francisco General Hospital, tells WebMD. "These results could be a fluke, but they are disturbing."
A news release issued Tuesday by a vitamin industry trade association argues that the conclusions drawn by Waters and his colleagues are based on "flawed" research. The Council for Responsible Nutrition release concludes that, "the WAVE study should not be considered the final word" on the safety of vitamins E and C in patients with heart disease.
But Waters counters that while his study is one of the first to find that antioxidant vitamins may be dangerous for people with coronary disease, no well designed studies have shown them to be beneficial.
"When people hear the word vitamin, they sort of let down their defenses," he says. "After all, your mother told you to take your vitamins so they must be good for you. But there are a lot of treatments out there that have been proven effective. My plea would be that people pay more attention to the things that are proven to work and less attention to things that are of no benefit."
Bonow agrees. He tells WebMD that while it is not clear that vitamin E is harmful, he counsels his heart patients to avoid antioxidant supplements.
"There may be other reasons to take vitamin E, but I wouldn't be taking it for heart protection," he says.