New Guideline Recommends Hormone Therapy First For Menopausal Symptoms

TL;DR

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The American College of Physicians recommends menopausal hormone therapy as first-line treatment for vasomotor symptoms, including hot flashes and night sweats. The guideline ranks selected SNRIs second and selected SSRIs, gabapentin and neurokinin receptor antagonists third, while noting that evidence is limited for some patient groups.

The American College of Physicians (ACP) recommends menopausal hormone therapy as the first-line medicine for women experiencing hot flashes and night sweats, known as vasomotor symptoms. The guideline distinguishes treatment by whether a patient has a uterus and lists several nonhormonal medicines for people who cannot use or do not tolerate hormone therapy.

For women with a uterus, ACP recommends estrogen combined with a progestogen; for women without a uterus, it recommends estrogen alone. The guideline authors classify both as strong recommendations supported by high-certainty evidence. Amir Qaseem, MD, PhD, MHA, and colleagues published the guidance in the Annals of Internal Medicine.

For patients with contraindications to hormone therapy or who do not tolerate it, the guideline places the SNRIs desvenlafaxine and venlafaxine in the second-line group, based on moderate-certainty evidence. Third-line options include the SSRIs escitalopram and paroxetine and gabapentin, supported by low-certainty evidence, as well as the neurokinin receptor antagonists fezolinetant and elinzanetant, supported by moderate-certainty evidence.

The recommendations draw on a systematic review and meta-analysis by Susan Diem, MD, MPH, and colleagues. Their review included 90 trials across 102 publications, identified through searches of Embase, Cochrane and Medline through March 3, 2026. Trials lasted at least eight weeks, with a median duration of 12 weeks. The researchers reported the greatest reductions in symptom frequency with estrogen treatments, oxybutynin and neurokinin receptor antagonists.

How the Guideline Ranks Treatments

Vasomotor symptoms affect most women during menopause and can disrupt daily life. The ACP recommendations give clinicians a ranked approach to medication choices, while spelling out alternatives for people who cannot take or tolerate the first-line option. That distinction matters because the guideline does not treat every medicine as equally supported: evidence certainty ranges from low to high across the listed treatments.

The guidance also arrives after years of concern about hormone therapy. Findings from the Women’s Health Initiative (WHI) led to boxed warnings about cardiovascular disease and breast cancer and a decline in use. The source report says the Food and Drug Administration recently removed warnings concerning those risks and that WHI data have since been reanalyzed. Those developments form part of the wider discussion around treatment, but the ACP guideline’s recommendations concern pharmacologic treatment of vasomotor symptoms.

An accompanying editorial by Mayo Clinic physicians Stephanie Faubion, MD, MBA, and Regina Castaneda, MD, says reduced use reflects patient and clinician concerns and misconceptions, alongside access barriers and undertreatment. They highlight the guideline’s encouragement for clinicians to start conversations about menopause and provide education.

Evidence Behind the Recommendations

The evidence review covered trials conducted from 1980 to 2024, mostly in North America and Europe. Participants tended to be healthy, postmenopausal white women aged 49 to 57 who experienced several vasomotor episodes each day. Only eight studies involved perimenopausal women, limiting what the review can say about that group.

The researchers found that hormone therapy’s efficacy did not vary by route of administration in the reviewed evidence. Higher estrogen doses were associated with more pronounced effects. The review also found modest improvement in menopause-related quality of life with estrogen, neurokinin receptor antagonists, SNRIs and SSRIs. Oxybutynin showed potential benefits for symptom frequency, severity and sleep, but the evidence came from a small trial and ACP said more research is needed.

The Menopause Society’s 2022 position statement said the risk-benefit ratio of hormone therapy is favorable for women under 60, within 10 years of menopause onset and without contraindications who seek treatment for vasomotor symptoms. That statement is separate from the new ACP guideline.

““Our results are consistent with previous systematic reviews reporting that estrogens, with and without progestogens, are highly effective for VMS.””

— Susan Diem, MD, MPH, and colleagues

Where the Evidence Has Gaps

The trial populations leave important questions open. Many studies excluded people with a history of breast cancer, endometrial disease, cardiovascular disease, stroke or venous thromboembolism. The editorialists say these groups need evidence specific to their clinical circumstances rather than assumptions based on healthier participants.

The review also had insufficient evidence to determine how treatment results vary by age, race, ethnicity or menopausal status. Compounded estrogens were not evaluated, and the relatively small number of perimenopause studies limits conclusions for that population. The available source does not provide a full account of how the guideline weighs every treatment’s potential harms or how individual clinical factors should affect a treatment choice.

The recommendations are guidance for clinicians, not a diagnosis or individualized treatment plan. Decisions about hormone therapy and other medicines depend on a patient’s health history and circumstances and should be discussed with a qualified health professional.

Research Needed Across Patient Groups

The guideline authors call for more evidence on nonhormonal treatments and populations with contraindications to hormone therapy. Research that includes groups commonly excluded from trials could help clarify how the balance of benefits and harms applies to people whose circumstances are not represented by the existing evidence.

For now, the ACP guidance sets out a medication sequence and encourages clinicians to discuss menopause and provide education. The source material does not specify a date for a formal update or identify a next guideline milestone. Clinicians and patients will need to consider the recommendations alongside individual medical histories as further evidence develops.

Key Questions

What does the new ACP guideline recommend first?

It recommends menopausal hormone therapy as first-line pharmacologic treatment for vasomotor symptoms. Women with a uterus should receive estrogen with a progestogen; women without a uterus can receive estrogen alone.

Which medicines does the guideline list if hormone therapy is unsuitable?

It lists desvenlafaxine or venlafaxine as second-line options for people with contraindications to, or intolerance of, first-line treatment. Third-line options include escitalopram, paroxetine, gabapentin, fezolinetant and elinzanetant, with different levels of evidence supporting them.

How strong is the evidence for the recommendations?

The recommendations for estrogen alone or estrogen with progestogen are strong and based on high-certainty evidence. Evidence certainty for alternatives ranges from low to moderate, according to the guideline summary.

Does the review answer questions for every patient group?

No. Many trials enrolled healthy postmenopausal women and excluded people with several significant medical histories. The review found too little evidence to determine how outcomes vary by age, race, ethnicity or menopausal status.

Source: rss