Ten years after the historic Women’s Health Initiative found that the health risks of hormone therapy outweigh its benefits for disease prevention, those findings have been confirmed by the most definitive analysis yet. Published in the New England Journal of Medicine on Oct. 3, the WHI’s final report on hormone therapy includes additional data from follow-up of many original WHI participants for, on average, another eight years.
“There is nothing new, but this latest report puts it all together,” said WHI investigator and study author Judith Ockene, PhD, MEd, MA. Dr. Ockene (at right) is the Barbara Helen Smith Chair in Preventive and Behavioral Medicine, professor of medicine and associate vice provost for gender and equity at UMass Medical School.
Launched by The National Institutes of Health in 1991 to test the effects of postmenopausal hormone therapy on heart disease, bone fractures and breast and colorectal cancer, the Women’s Health Initiative followed nearly 162,000 women who received either one of two hormone medications or a placebo. Then, in 2002 and 2004 respectively, the estrogen plus progesterone and estrogen alone arms of the study were both stopped because increased health risks outweighed the benefits for disease prevention.
Hormone use dropped by almost half within a matter of months, although the studies did not address the short-term risks and benefits of hormones for the treatment of menopausal symptoms, and the drugs are still available and used by women for temporary relief of symptoms like hot flashes, vaginal dryness, night sweats and sleeplessness. “The latest results confirm the U. S. Food and Drug Administration’s black box warning to use hormone therapy in the smallest possible dose for the shortest period of time to relieve menopausal symptoms,” Ockene noted.
This is consistent with the updated recommendation from the United States Preventive Services Task Force, which in October 2012 advised doctors to not recommend hormone therapy because there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.
“Even in the cases where hormone therapy does confer a health benefit, for example decreased hip fractures, women should consider other approaches,” said Ockene. “Knowing the risks, women should ask ‘What are others thing I can do, like take calcium and do weight-bearing exercise?’ ”
“The evidence is there. The question is how to use it,” she concluded. “Women need to discuss with their physicians ‘What is the best thing for me now, given the evidence and given me personally?’ to make the decision based on their own needs.”