More than a decade after a massive study of hormone replacement therapy was halted due to higher rates of breast cancer, heart attack and stroke among women assigned to the drugs to treat menopausal symptoms, a new follow-up study has found those women had no higher risk of death as of 2014 than participants who took a placebo.
The latest findings are published today in JAMA by investigators in the Women’s Health Initiative, the same multi-institutional research program that conducted the original trial begun in 1993 and stopped in 2002 because of those adverse effects. The new study focuses on “all-cause mortality,” or deaths from any cause, up to 18 years after the start of therapy and 10 to 12 years after the therapy was stopped. It offers reassurance to postmenopausal women who took hormone replacement therapy during the trial that they have not increased their risk of dying.
“Mortality rates,” said lead author Dr. JoAnn Manson, chief of preventive medicine at Harvard’s Brigham and Women’s Hospital, in Boston, “are the ultimate ‘bottom line’ when assessing the net effect of a medication on serious and life-threatening health outcomes.”
Overall, the researchers found that the risk of dying from any cause through the end of the follow-up period in 2014 was the same for women who had taken hormone therapy as for women who had taken a placebo. To Manson, the study results give women and their doctors useful information when considering a complex treatment decision. They also offer comfort to younger women now contemplating hormone therapy to bring relief from hot flashes, night sweats and higher rates of bone loss or fractures due to menopause.
“We think the findings of no increase in mortality provide reassurance for women who are seeking hormone therapy for management of symptoms in early menopause,” she said.