May 6, 2014
News Review From Harvard Medical School -- Report: Hormone Study Returned Big Savings
A landmark study that found hormone therapy may harm rather than help women after menopause cost the U.S. government $260 million. But the study results transformed medical practice. And that saved the health care system $37 billion, a new analysis concludes. That's $140 for every dollar spent. The National Institutes of Health funded the study, called the Women's Health Initiative. Older women, average age 63, were randomly assigned to receive either hormone treatment or placebo (fake) pills. The study was halted early, in 2002. Women taking estrogen plus progesterone had higher rates of heart attack, stroke, blood clots and breast cancer than those who got the placebo. There was no effect on heart attack or breast cancer rates in a second group of women who were given estrogen only. But they also had higher risks of stroke and blood clots. Hormone use for menopause symptoms dropped by half right away. It continued to fall in later years. Cases of breast cancer, heart disease and blood clots also declined. But stopping hormone therapy may have contributed to a rise in bone fractures, the new study says. The journal Annals of Internal Medicine published the study. HealthDay News wrote about it May 5.
By Howard LeWine, M.D.
Harvard Medical School
What Is the Doctor's Reaction?
From about 1960 until 2002, doctors often prescribed hormone therapy for women as they entered menopause. This treatment replaced the estrogen and progesterone that women begin to lose in their late 40s or early 50s. And it relieved symptoms of menopause, especially hot flashes.
Studies also suggested these hormones could help protect women from the condition that kills more women than any other: heart disease.
But this link was found only in observational studies. In this case, the studies focused on women who appeared otherwise similar but had chosen to take or not take hormone therapy. Women who took hormones had lower rates of heart disease.
Scientists know that observational studies only show associations between two things. This does not prove that there is a cause and effect.
So the National Institutes of Health (NIH), at great public expense, funded a large clinical trial of hormone therapy. Clinical trials provide the best evidence for a true cause and effect. They randomly assign people who are otherwise similar to follow different treatments or behaviors.
So began the large clinical trial called the Women's Health Initiative (WHI). Researchers enrolled thousands of women. Half of the women received hormones and half received a placebo. None of them knew what they were taking. For women with a uterus, the active pills contained both estrogen and progesterone. This was the most commonly used hormone replacement therapy at the time. If a woman's uterus had been removed, she received estrogen only, without any progesterone.
The NIH was heavily criticized for spending all of this public money. Everyone assumed it would just prove what so many experts, doctors and women had already accepted as fact -- that long-term hormone therapy in menopausal women improved health.
In fact, the money was very well spent. This new analysis concludes that the results of the WHI may have saved the United States health care system as much as $140 for every dollar spent on the study.
Here's why: The results were a complete surprise. They were just the opposite of what everyone expected. In 2002, reports from the WHI began to show an increased risk of heart attack and stroke in women taking hormones, compared with those taking a placebo. Later analysis confirmed the early findings. Women taking estrogen with progesterone also had higher risks of blood clots and breast cancer.
Women rapidly stopped taking hormone therapy for menopause symptoms. During the next 10 years, there was a dramatic fall in the number of heart attacks, strokes, blood clots and breast cancers in older women. Less money was spent on a drug that had been doing more harm than good. But most of the savings came from not needing to spend money on care of these medical problems.
What Changes Can I Make Now?
The women who participated in the WHI had an average age of 63. For women that age, the risks of heart attack and stroke from hormone therapy are real.
But more recent studies indicate that hormone therapy may actually help prevent heart disease in women if they take it at the beginning of menopause. And the risk of breast cancer seems to increase only for women who stay on hormone therapy for more than five years.
So what should you do if you have symptoms related to menopause? For women up to age 59 or within 10 years of menopause, short-term hormone therapy is the most effective treatment. Short-term use means trying to wean off the hormones once symptoms are relieved. And use the lowest dose of hormones possible.
But long-term hormone replacement is still not recommended as a way to prevent heart disease or other medical conditions. This applies to menopausal women of any age.
What Can I Expect Looking to the Future?
I can think of no other study that caused such a dramatic change in medical practice as did the WHI. This current paper probably overstates the cost savings from the results. So the debate about public funding for studies of this size will continue.