The widespread rejection of estrogen therapy after the 2002 Women's Health Initiative (WHI) study has most likely led to almost 50,000 unnecessary deaths over the last 10 years among women aged 50 to 69 who have had a hysterectomy, Yale School of Medicine researchers reveal in a study published in the July 18 issue of the American Journal of Public Health.
Led by Philip Sarrel, M.D., emeritus professor in the Departments of Obstetrics, Gynecology & Reproductive Sciences, and Psychiatry, the researchers analyzed United States census data, hysterectomy rates, and estimates of decline in hormone use in women aged 50 to 59 between 2002 and 2011.
Before 2002, it was standard practice for doctors to recommend estrogen therapy for this slice of the population, and more than 90% of these women used it to treat symptoms such as hot flashes, and to prevent osteoporosis and other diseases related to menopausal hormone deficiency. Today, about 10% of these women use estrogen.
This sharp decline in estrogen usage was linked to results from one part of the large, federally funded WHI study in 2002. Women and their doctors became frightened of the dangers of post-menopausal hormones. But according to Sarrel and his colleagues, this was a report about women with a uterus, who took pills that combined estrogen and a progestin. Women who have a uterus must take a second hormone (a progestin) to avoid a risk of uterine cancer. But these results did not apply to women with no uterus who use estrogen-only therapy.
"Sadly, the media, women, and health care providers did not appreciate the difference between the two kinds of hormone therapy," Sarrel said. "As a result, the use of all forms of FDA-approved menopausal hormone therapy declined precipitously."
Sarrel added that for the women taking combined hormone therapy (at least the particular drug, Prempro, used in the WHI study), it was probably a good decision to avoid it because the WHI study showed a significant increase in breast cancer, heart disease, stroke, and blood clots in women who used this drug compared to placebo. However, for the women taking estrogen-only therapy, avoiding treatment does not appear to have been a good decision.
Results from the second part of the WHI study, which followed women who had no uterus and who took either estrogen-only or placebo, were very different. A series of papers published by the WHI between 2004 and 2012 showed that estrogen-only therapy had mostly positive health outcomes. For example, in 2011 and 2012 the WHI reported that women who received estrogen compared to those who received placebo had fewer deaths each year for 10 years and were less likely to develop breast cancer and heart disease. For each of the 10 years the death rate among those not taking estrogen was 13 more per 10,000. Most of these women died from heart disease while breast cancer accounted for almost all the other deaths.
"Estrogen avoidance has resulted in a real cost in women's lives every year for the last 10 years -- and the deaths continue," said Sarrel. "We hope this article will stir an overdue debate and raise consciousness about the health benefits of estrogen-only therapy for women in their 50s with no uterus."
Other authors on the study are valentine Y. Njike, M.D., Valentina Vinante, M.D., and David L. Katz, M.D. Sarrel is a consultant with Noven Therapeutics.
Citation: American Journal of Public Health (Published online ahead of print July 18, 2013)