Combined estrogen and progestin should not be used for the prevention of osteoporosis or other chronic conditions in postmenopausal women, according to recommendations issued by the U.S. Preventive Services Task Force.
Hormone therapy currently has Food and Drug Administration approval for use in the prevention of osteoporosis in postmenopausal women.
The task force, an independent body of volunteer experts that advises the Department of Health and Human Services, issued the recommendations Oct. 22 as an update of its 2005 statement on hormone therapy for prevention of disease in postmenopausal women.
Jan L. Shifren
Using the most recent scientific evidence available, including long-term follow-up data from the Women's Health Initiative (WHI) studies of hormone therapy use in postmenopausal women, the task force reached the same conclusions as it had in 2005, advising against combined estrogen and progestin for prevention of chronic conditions, and also against the use of estrogen alone for the prevention of chronic conditions in postmenopausal women who have had a hysterectomy.
The task force emphasized that hormone therapy was still indicated for the management of menopausal symptoms, such as hot flashes or vaginal dryness. It additionally made clear that its recommendation against hormone therapy for disease prevention does not apply to women younger than 50 years of age who have undergone surgical menopause.
Prior to the WHI studies, a series of government-funded trials that began in the 1990s, with follow-up ending in 2010, hormones had been widely used for the prevention of bone disease in postmenopausal women. Both estrogen and combined estrogen and progestin are known to reduce fracture risk.
However, both forms of hormone therapy were shown during the WHI studies to also increase the risk of serious adverse events, to the point where the trials were stopped early. In one randomized, placebo-controlled trial, estrogen alone was associated with a significantly higher risk of stroke, deep vein thrombosis, and gallbladder disease, while combined therapy was associated with an increased risk of stroke, invasive breast cancer, dementia, gallbladder disease, deep vein thrombosis, and pulmonary embolism.
Reproductive endocrinologist Jan L. Shifren of the department of obstetrics and gynecology and reproductive biology at Harvard Medical School and director of the menopause program at Massachusetts General Hospital, both in Boston, said in an interview that the task force’s updated position largely reflected the current consensus of the ob.gyn. community, "which is that HT should not be used to prevent the diseases of aging."
The task force was "very careful to point out that they are not saying HT should not be used for the treatment of vasomotor symptoms or vaginal atrophy. It’s not that hormones aren’t indicated; they’re just not indicated for prevention. They remain an appropriate treatment for otherwise healthy, very symptomatic women at the menopause transition," said Dr. Shifren, who is not a task force member.
FDA-approved indications for hormone therapy in postmenopausal women include treatment of menopausal symptoms and prevention of osteoporosis. A black box warning indicates that estrogen with or without progestin should be prescribed at the lowest effective dose and for the shortest time possible. The task force’s findings were based on the dosages and formulations used in the WHI trials: oral conjugated equine estrogen (0.625 mg/day plus medroxyprogesterone acetate, 2.5 mg/day) or estrogen 0.625 mg/day alone.
Dr. Shifren said that there are some practitioners "who believe that hormone therapy could still be appropriate for the prevention of osteoporosis in people who absolutely cannot tolerate any other therapy. But what I would argue is that it is incredibly rare that there is a patient who can’t tolerate one of the very many other FDA-approved treatments for the prevention of osteoporosis."
The task force members declared no relevant financial conflicts of interest.