Final USPSTF Rec: Don't Use HRT to Prevent Chronic Illness

Marcia Frellick

December 12, 2017

The US Preventive Services Task Force (USPSTF) in its final statement released today recommends against using hormone replacement therapy (HRT) — estrogen alone or combined with progestin — for primary prevention of chronic conditions.

The recommendation, published in JAMA, upholds the previous 2012 guidelines.

Task force members acknowledged some benefits with HRT, but also well-established harms. For the combined therapy, the potential harms include higher risk for invasive breast cancer and venous thromboembolism, coronary heart disease, dementia, stroke, gallbladder disease, and urinary incontinence.

For estrogen alone, potential harms include greater risk for thromboembolism, stroke, dementia, gallbladder disease, and urinary incontinence.

The group also notes there is insufficient evidence to show that any subgroup studied would have a different harm/benefit relationship with HRT used for primary prevention.

The recommendation again cites as its main evidence the Women's Health Initiative (WHI) trials that found HRT was linked to serious adverse effects in postmenopausal women. Both large trials were stopped early.

HRT use dropped dramatically, from 44% in 1998 to 1994 to 4.7% in 2010, in the wake of the findings.

In an accompanying editorial, Cora E. Lewis, MD, MSPH, from the Division of Preventive Medicine at University of Alabama at Birmingham School of Medicine, and Melissa F. Wellons, MD, MHS, from the Division of Diabetes, Endocrinology and Metabolism at Vanderbilt University Medical Center in Nashville, Tennessee,  note that no other trials have been sufficiently powered to fully gauge safety profiles of regimens other than the ones WHI used.

"While data from observational studies deserve attention when they show potential harms, menopausal hormone therapy represents a 'poster child' for potentially misleading benefit signals from observational studies," they write.

A draft version of the current recommendation was published in May 2017, as reported by Medscape Medical News, and was opened to public comment.

In response to those comments, the USPSTF clarified that the patient population was postmenopausal women.

"It does not apply to women who are considering hormone therapy for the management of menopausal symptoms, such as hot flashes or vaginal dryness. It also does not apply to women who have had premature menopause (primary ovarian insufficiency) or surgical menopause," the authors wrote.

The task force also clarified that it reviewed evidence on oral or transdermal HRT but not formulations such as creams and rings because those are not generally used for primary prevention of chronic conditions.

The panel also added the word "primary" to "prevention" to emphasize that "this recommendation statement focuses on the use of hormone therapy for the primary prevention of chronic conditions in postmenopausal women, not on its use for the treatment of vasomotor, vulvovaginal, or other symptoms." It also did not review the potential of the drugs to treat or prevent symptoms of menopause.

The editorialists note that many physicians now consider HRT only for climacteric symptoms, and that's where the potential may lie, they say.

"[I]t does seem appropriate for relatively healthy, younger menopausal women with sufficiently severe vasomotor or other climacteric symptoms to draw some comfort from long-term WHI data," they write. "These women can consider hormone therapy for symptom relief. Physicians also have more evidence to impart to their patients during discussions about therapies for menopausal symptoms."

All members of the USPSTF receive travel reimbursement and an honorarium for participating in USPSTF meetings. The USPSTF is an independent, voluntary body. The US Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF. Dr Lewis was the principal investigator for the WHI Clinical Center at the University of Alabama at Birmingham. Dr Wellons reported serving as a junior faculty consultant for the WHI Southeast Regional Center and serving for Pfizer on a roundtable for conjugated equine estrogens/bazedoxifene.

JAMA. 2017;318:2224-2233, 2187-2189. Recommendiations full text, Editorial full text

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