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USPSTF releases draft recommendation on menopausal hormone therapy
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The U.S. Preventive Services Task Force has issued a draft recommendation against the use of combined estrogen and progestin for the prevention of chronic conditions in postmenopausal women, as well as the use of estrogen for the prevention of chronic conditions in postmenopausal women who had a hysterectomy.
The task force gave both draft recommendations a D grade, and the recommendations are consistent with the task force's final recommendation back in 2012.
“It’s important to note that this draft recommendation applies only to women who have gone through menopause and are considering hormone therapy to prevent chronic conditions,” Ann E. Kurth, PhD, CNM, MSN, MPH, task force member and dean, Yale School of Nursing, said in the release. “It does not apply to women who are considering hormone therapy to manage menopausal symptoms, such as hot flashes or night sweats.”
The release also stated that the draft recommendation does not apply to women younger than age 50 who have experienced premature menopause or who have had their ovaries surgically removed prior to menopause.
The task force “found convincing evidence” that combining estrogen and progestin is associated with moderate harms such as venous thromboembolism and invasive breast cancer; a small-to-moderate harm of increased risk for coronary heart disease; and “adequate evidence” of moderate harms, such as increased risk for urinary incontinence, gallbladder disease, dementia and stroke, according to the draft recommendation statement.
In addition, the task force “found adequate evidence” that estrogen use alone is associated with moderate harms, including an increase in the risk for venous thromboembolism, urinary incontinence, gallbladder disease, dementia and stroke.
According to the task force, guidelines from both the American Congress of Obstetricians (ACOG) and Gynecologists and the American Association of Clinical Endocrinologists note that hormone therapy is approved for women at increased risk for osteoporosis and fracture. In addition, the task force stated that the ACOG guidelines also mention the uncertainty about whether potential cardiovascular benefits for women may differ based on early vs. late initiation of hormone therapy. The task force stated that no current guidelines recommend the routine use of hormone therapy for primary or secondary prevention of heart disease, and most recommend against the use of hormone therapy for prevention of any chronic conditions.
The new draft statement and evidence review has been posted for public comment on the USPSTF website, at www.uspreventiveservicestaskforce.org. Such input will be accepted through June 12 at www.uspreventiveservicestaskforce.org/tfcomment.htm. – by Janel Miller
Disclosure: Healio Family Medicine was unable to determine Kurth’s relevant financial disclosures prior to publication.
Perspective
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Cynthia Stuenkel, MD
It has been 5 years since the U.S. Preventive Services Task Force (USPSTF) issued a Recommendation Statement against the use of menopausal hormone therapy (MHT) (combined estrogen and progestin or estrogen alone after hysterectomy) for the Primary Prevention of Chronic Conditions). In this new draft recommendation statement, the USPSTF — virtually verbatim — reiterates their recommendation against combined estrogen and progestin or estrogen alone (after hysterectomy) for the prevention of chronic conditions in postmenopausal women
How does this affirmation of the 2012 USPSTF recommendation affect your current practice of prescribing MHT for relief of symptoms? To my read, it probably will not have any effect. Most relevant organizations currently recommend initiating systemic MHT for relief of menopausal symptoms in women less than age 60 and less than 10 years since menopause in the absence of contraindications or elevated CVD or breast cancer risks. None of these statements currently include recommendations of MHT for prevention of CHD, breast cancer, dementia, or diabetes. Preservation of bone health might be a consideration, although in younger women close to the time of menopause, who you’re likely treating for symptoms, the fracture benefits in the Women’s Health Initiative were inconsistent (more compelling for combined therapy than estrogen alone). The FDA, in its treatment indications, states that “When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.”
What are the gaps or limitations in these recommendations? In the absence of new randomized clinical trials with relevant clinical outcomes, most of the discussion and analysis centers on the results of the Women’s Health Initiative clinical trials, limited to MHT with daily oral conjugated equine estrogens (CEE) 0.625 mg combined with medroxyprogesterone acetate 2.5 mg or oral CEE 0.625 mg alone in women after hysterectomy. In the wake of the Women’s Health Initiative, many practitioners, in an effort to prescribe ‘safer’ MHT have turned to transdermal estrogen therapies and micronized progesterone, often prescribing lower doses than those studied in the Women’s Health Initiative. The USPSTF statement reminds us that current evidence to determine whether different types, doses, or modes of delivery of MHT affect its benefit-to-harm profile for the prevention of chronic conditions remains limited.
Does the USPSTF consider the ‘timing hypothesis’ that preventive benefits might accrue if MHT is started early in the menopause transition? The USPSTF acknowledges that age and time since menopause may be important considerations in assessing risks and benefits, but again points out limitations, inconsistencies, and conflicting findings in published studies. They remind us that to date, no good-quality [randomized clinical trials] have prospectively evaluated the effects of timing of hormone therapy relative to the onset of menopause on associated benefits and harms (clinical events).
My bottom line: No change to your practice of treating with MHT for symptom relief. In the meanwhile, consider the recurrent theme of inadequate data to make clinical recommendations. Encourage more funding for MHT research to help us all do a more informed job of recommending therapies for this universal women’s health experience.
References:
ACOG Practice Bulletin, Obstet Gynecol, 2014.
Moyer AV, Ann Intern Med. 2013;158:47-54.
NAMS, Menopause, 2012.
Stuenkel CA, JCEM, 2015.
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