Major Women's Health Study Paid Big Dividends

By Barbara Bronson Gray HealthDay Reporter Latest Womens Health News

MONDAY, May 5, 2014 (HealthDay News) -- A comprehensive look at the decade-old "estrogen study" -- the U.S. government-sponsored trial that turned the tables on assumptions about hormone replacement therapy -- suggests there can be a billion-dollar upside to the millions spent on research.

The research, published May 6 in the Annals of Internal Medicine, shows the public has received a high return on its tax-funded investment in the Women's Health Initiative (WHI).

"Everything we do in medicine comes with a level of uncertainty," said Dr. Scott Ramsey, the study's lead author and director of the Hutchinson Institute for Cancer Outcomes Research, in Seattle. "The question is whether it's worth the investment in research to be sure we're not making a mistake."

The results of his research, he said, showed that, even though the WHI cost $260 million, the net economic return was $37 billion, or $140 for every dollar spent on the trial.

"Even if we only focus on medical care costs, the study saved $27 billion, a huge savings and, I think, quite a conservative estimate because we didn't assume all the decline in hormone replacement therapy was due to the study," said Ramsey.

Before the WHI study, almost 6 million menopausal American women took a pill called combined hormone therapy, which paired the hormones estrogen and progestin, to reduce hot flashes and cut their risk of cardiovascular disease and the bone-thinning disease osteoporosis.

But the WHI's Estrogen Plus Progestin clinical trial, a huge, randomized and controlled trial, which is considered the gold standard for research, produced shocking results. Rather than cutting the risk of serious disease, combined hormone-replacement therapy (HRT) actually increased the chances women would develop cardiovascular disease, blood clots and breast cancer, according to the evidence produced by the study. The trial was stopped in 2002, after investigators found that the associated risks of HRT outweighed the benefits.

As a result of the $260 million research, funded by the U.S. National Institutes of Health, many physicians stopped prescribing combined hormone therapy. Hormone use among menopausal women decreased almost immediately by about 50 percent and continued to decline by 5 percent to 10 percent each year, according to the researchers.

In the years following the drastic drop in hormone use, the number of cases of breast cancer, cardiovascular disease and blood clots declined significantly.

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Major Women's Health Study Paid Big Dividends