Researchers stress view: HRT should be restricted - Workshop served to clear up confusion on study of treatment.

At an international meeting last week, the authors of the most comprehensive study to date on hormone replacement therapy made crystal clear their view that use of the medical treatment should be severely restricted.  Controversy over HRT arose when a large U.S. study of Prempro, the most popular estrogen-progestin combination hormone treatment, was halted in July five years after it began. Researchers and doctors met at a two-day workshop organized by the National Institutes of Health in Bethesda, Md., to discuss the future of HRT.

Investigators with the study, known as the Women's Health Initiative (WHI) study, found that Prempro raised slightly the risk of heart attacks, strokes, blood clots and breast cancer that were not balanced by its benefits — slight decreases in hip fractures and colon cancer.

For individual women, the risks are small: For every 10,000 women who took the pills for a year, there were eight more breast cancers, eight more strokes and seven more heart attacks compared to 10,000 women who didn't. However, when you multiply those figures by the millions of women worldwide who take these hormones, there are tens of thousands of additional cases of heart attack, stroke, breast cancer and pulmonary embolism linked to HRT.

And if you are a woman who ends up in a wheelchair for the rest of your life because of a stroke or dies prematurely after suffering a heart attack, for you the risk is 100 per cent, cautioned Women's Health Initiative co-investigator Dr. Susan Hendrix of Wayne State University. "It's all or nothing," she said.  Keep in mind this was no ordinary study, but gold-standard research. It was a large randomized, double-blind controlled trial of 16,000 women aged 50 to 79. Half the women took HRT, while the other half got a placebo, though neither the women nor the researchers knew which group was which until the trial ended.

Many doctors at the meeting in Bethesda criticized the study's design and said the investigators did a disservice to millions of women. Critics said there are quality of life issues involved, because without hormones many women will suffer hot flashes, vaginal dryness and night sweats.

National Institutes of Health director Dr. Elias Zerhouni said: "The reaction to a new scientific finding is really in proportion to the dogma it is upending."

"We had a strong dogma" about HRT, he added, so perhaps it's not surprising that reaction was swift and heated.

Researchers are currently doing further analyses on the massive amount of data collected in the study to better differentiate the risks of HRT and ultimately help women decide whether to take it.

These analyses will look at a host of factors such as age, body mass index, ethnicity and prior hormone use, to determine how they affect the risk of taking HRT. The hormones' effect on quality of life will also be examined.

The women in the study will be followed up for three years to see whether the risks and benefits of HRT persist, and also to evaluate the effect of stopping hormone use.

The results of those analyses are expected in the next six to nine months.

In the meantime, it's best to take a conservative approach to HRT, advised the study investigators.Unequivocally, HRT should no longer be used to treat or prevent heart disease.

HRT has been shown to reduce the risk of hip fractures, which are one of the leading causes of disability and death in older women. There are alternatives to prevent bone loss, such as bisphosphonates. But for the one in 10 women who can't tolerate them and are at significant risk of osteoporosis, HRT may make sense.

According to the investigators, the only real indicated use for HRT now is in women with severe, debilitating menopausal symptoms, which is the only use for which it is approved by the U.S. Food and Drug Administration.

But even in these cases, HRT should be used in the lowest dose possible for the shortest duration necessary to relieve symptoms.