On Dec. 12, the U.S. Preventive Services Task Force (USPSTF) published a final recommendation statement(www.uspreventiveservicestaskforce.org) and final evidence summary(www.uspreventiveservicestaskforce.org) on hormone therapy for the primary prevention of chronic conditions in postmenopausal women.
Based on its review of the evidence, the USPSTF recommended against the use of combined estrogen and progestin -- also known as hormone replacement therapy, or HRT -- to prevent chronic conditions in postmenopausal women -- a "D" recommendation.
Furthermore, the task force recommended against the use of estrogen to prevent chronic conditions in postmenopausal women who have had a hysterectomy -- also a "D" recommendation.
This final recommendation is consistent with the USPSTF's 2017 draft recommendation and its 2012 final recommendation. The AAFP's recommendation mirrored that 2012 statement. Now, the Academy will review the task force's new final recommendation statement and supporting evidence and release its own recommendation on the topic.
- The U.S. Preventive Services Task Force posted a final recommendation statement against the use of combined estrogen and progestin to prevent chronic conditions in postmenopausal women -- a "D" recommendation.
- Furthermore, the task force recommended against the use of estrogen to prevent chronic conditions in postmenopausal women who have had a hysterectomy -- also a "D" recommendation.
- After the Women's Health Initiative published findings in 2002 that said hormone therapy use for chronic conditions was associated with serious adverse health effects, the percentage of U.S. women who said they used hormone therapy for this purpose declined sharply.
"In women who have already been through menopause, the use of hormone therapy to prevent chronic conditions has significant harms," said USPSTF Chair David Grossman, M.D., M.P.H., in a news release.(www.uspreventiveservicestaskforce.org) "But the task force has several other recommendations on effective ways women can reduce their risk of chronic conditions."
The harms of hormone therapy with combined estrogen and progestin use include an increased risk for invasive breast cancer and heart disease; harms of estrogen use alone include risk of stroke, blood clots and gallbladder disease.
Task force members were careful to note who is not covered by the new recommendation statement.
"Our recommendation only applies to women who have gone through menopause and are considering hormone therapy to prevent chronic health problems," said USPSTF member Maureen Phipps, M.D., M.P.H., in the news release. "Women who are considering hormone therapy to manage menopausal symptoms, such as hot flashes or night sweats, are not included in this recommendation and should talk to their doctors."
The task force said this final recommendation also doesn't apply to women who have experienced premature menopause or those who had their ovaries surgically removed before menopause, commonly known as surgical menopause.
Scope of Review
In updating its 2012 final recommendation, the USPSTF reviewed evidence about the benefits and harms of systemic hormone therapy for the prevention of chronic conditions, also assessing whether outcomes varied among women in different subgroups or by the timing of intervention after menopause. Hormone therapy to treat menopausal symptoms or for other indications was outside the scope of this review.
The task force found 18 fair- or good-quality trials that compared the effects of combined estrogen and progestin or estrogen alone versus placebo on the prevention of chronic conditions in postmenopausal women.
The Women's Health Initiative (WHI) Postmenopausal Hormone Therapy Trial(www.nhlbi.nih.gov) was the largest trial reviewed and the only one designed to evaluate the effectiveness of hormone therapy for primary prevention of the conditions on which the task force focused.
Additionally, the WHI trial provided most of the estimates of benefits and harms of menopausal hormone therapy used in developing the final recommendation -- largely because the trial involved up to 13 years of followup (including post-trial phases) to assess how risks for chronic conditions changed after women stopped hormone therapy.
Response to Public Comment
A draft version of the final recommendation statement was posted for public comment on the USPSTF website from May 16 to June 12.
In response to public comment, the task force modified the title of the recommendation statement to clarify that the patient population concerned was postmenopausal women.
The USPSTF also clarified that it reviewed the evidence on the benefits and harms of systemic menopausal hormone therapy (i.e., that administered orally or transdermally), not local hormone therapy (e.g., creams or rings).
In addition, the task force provided further details on the WHI trial, specifying the formulation of hormone therapy used and the average age of women enrolled in the trial.
The USPSTF also added two tables showing increases and decreases in absolute risk for various health outcomes among women who received combined estrogen and progestin(www.uspreventiveservicestaskforce.org) versus placebo or estrogen alone(www.uspreventiveservicestaskforce.org) versus placebo.
Some commenters observed that some subgroups of women (e.g., women ages 50-59 taking estrogen alone) typically experience a more beneficial balance of benefits and harms than the overall group of women included in the WHI trial. In response, the task force expanded its discussion on the interaction between age and health outcomes in the trial in the statement's "Discussion" section.(www.uspreventiveservicestaskforce.org)
The USPSTF also clarified that the WHI analyses that assessed whether time between menopause and initiation of hormone therapy affects benefits and harms were conducted post hoc.
The task force added the word "primary" to the recommendation summary to further clarify that the 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.
Finally, the USPSTF clarified the definition of menopause in the "Rationale" section(www.uspreventiveservicestaskforce.org) of the statement and added a reference to the Endocrine Society's guidelines on hormone therapy(academic.oup.com) in the "Recommendations of Others" section.(www.uspreventiveservicestaskforce.org)
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