- The Washington Times - Monday, June 28, 2004

LONDON — The American study that triggered a worldwide scare over the risks of hormone-replacement therapy was fundamentally flawed and not applicable to most women going through menopause, according to a group of leading researchers.

The Women’s Health Initiative appeared to show that hormone-replacement therapy (HRT) increased the risk of heart disease and breast cancer.

Last year, the study, which involved 16,000 women, was abandoned early after five years because the results were so disturbing.

Millions of women taking HRT to relieve the unpleasant symptoms of menopause and prevent brittle-bone disease stopped taking the drug. Millions more were discouraged from starting the therapy.

The same study was used last week to show that HRT increases the risk of dementia.

But a report in the journal Fertility and Sterility says women recruited to the study were not representative of those taking the drug and the results were wrongly interpreted.

Most subjects were in their 60s, some were in the early 70s and almost all had long since gone through menopause, the authors say.

Because the study was set up to test the effects of HRT on heart disease, most had heart problems when it started.

Dr. Frederick Naftolin, of the department of obstetrics, gynecology and reproductive medicine at Yale University is the lead author of the paper. He said: “It’s a very sad outcome from a very important study. But this was a study on aging women who very likely already had some level of cardiovascular disease when they started.

“People interpreted them as having implications for younger women. That was the real tragedy.

“This meant women who would have been on hormones were frightened away from starting. Women who were older and had been doing well, stopped being protected. The result was misinterpreted.

“It is likely that even the younger women in the [study] were still beyond menopause, which could preclude the evaluation of the cardiovascular effects of hormone therapy,” said Dr. Naftolin.

The study had shown that HRT reversed bone loss in osteoporosis. It found a slight, but not statistically significant, increase in breast cancer for women taking estrogen and progestin, but a slight fall in women taking estrogen only.

The largest-ever study of HRT and breast cancer was carried out by scientists at Cancer Research UK’s Epidemiology Unit at Oxford and published last year. It found the single pill moderately increases the risks of breast cancer, but that the combined pill doubles the risk.

The study estimated that HRT may have been responsible for an extra 20,000 cases of breast cancer in Britain in the past decade.

About 1.5 million British women took HRT before the scare, but that number has dropped.

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