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The American College of Physicians issued a clinical guideline recommending menopausal hormone therapy as the first-line drug treatment for hot flashes and night sweats. The guidance lists certain SNRIs as second-line options and several other medicines as third-line options, while noting that many trial participants did not represent patients with conditions that can rule out hormone therapy.
The American College of Physicians (ACP) recommends menopausal hormone therapy as the first-line medication treatment for hot flashes and night sweats, known as vasomotor symptoms, in a new clinical guideline. The guidance recommends estrogen with progestogen for patients with a uterus and estrogen alone for those without one, and sets out nonhormonal medicines as alternatives when hormone therapy is unsuitable or not tolerated.
The guideline, published in Annals of Internal Medicine, gives both first-line hormone therapy recommendations a strong rating based on high-certainty evidence, according to ACP guideline authors led by Amir Qaseem, MD, PhD, MHA. The recommendations concern medication treatment of vasomotor symptoms; they do not mean hormone therapy is appropriate for every patient.
For people unable to use or unable to tolerate first-line treatment, the guideline names the serotonin-norepinephrine reuptake inhibitors desvenlafaxine and venlafaxine as second-line options. It lists the selective serotonin reuptake inhibitors escitalopram and paroxetine, gabapentin, and the neurokinin receptor antagonists fezolinetant and elinzanetant as third-line choices. The evidence ratings differ: moderate certainty for the SNRIs and neurokinin receptor antagonists, and low certainty for the SSRIs and gabapentin.
The recommendations draw on a systematic review and meta-analysis by Susan Diem, MD, MPH, of the VA Health Care System in Minneapolis, and colleagues. The review included 90 trials reported in 102 publications. The trials lasted at least eight weeks, with a median duration of 12 weeks, and covered studies conducted from 1980 through 2024.
How the Treatment Order Changes
The guideline gives clinicians and patients a clearer order for considering medicines when menopause-related hot flashes and night sweats disrupt daily life. It puts hormone therapy at the front of the treatment sequence, while identifying specific nonhormonal options for people who cannot use it or do not tolerate it. That can help structure conversations about symptom relief, treatment preferences and individual medical circumstances.
The change in emphasis also comes amid continuing concerns about hormone therapy’s risks. The guideline’s strong recommendation reflects the authors’ assessment of evidence for treating vasomotor symptoms; it should not be read as a blanket finding that treatment is risk-free or suitable for every person. Clinicians still need to account for a patient’s health history and whether hormone therapy is contraindicated.
Hot flashes and night sweats affect many people during the menopause transition and can substantially interfere with quality of life, the report says. The review found the greatest reductions in symptom frequency with estrogens, with or without progestogens, oxybutynin, and neurokinin receptor antagonists. Improvements in menopause-related quality of life were described as modest for hormone therapy, neurokinin receptor antagonists, SNRIs and SSRIs.
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Why Hormone Therapy Is Being Reconsidered
Hormone therapy has long been recognized as effective for vasomotor symptoms, but its use fell after the Women’s Health Initiative findings raised concerns about cardiovascular disease and breast cancer. Those findings led to boxed warnings, according to the source report. The FDA has since removed warnings about those risks, and reanalyses of the WHI data have been completed; the report says they suggest more favorable outcomes for women closer to menopause.
In 2022, the Menopause Society said the benefit-risk balance was favorable for treating symptoms in women under 60 who were within 10 years of menopause onset and had no contraindications. The ACP guideline now places medication choices into a ranked sequence based on a new review of trials, rather than treating all drug options as interchangeable.
The evidence base has limits. Trial participants were generally healthy, postmenopausal white women ages 49 to 57, and only eight studies involved perimenopausal women. Many trials excluded people with breast cancer, endometrial disease, cardiovascular disease, stroke or venous thromboembolism. Compounded estrogens were not evaluated.
“Hormone therapy should be the first-line treatment for women with menopausal vasomotor symptoms.”
— Amir Qaseem, MD, PhD, MHA, and ACP guideline co-authors
Evidence Gaps in Higher-Risk Groups
The trial evidence may not apply directly to patients whose medical histories excluded them from many studies. The review authors and editorialists say more research is needed in populations with contraindications to hormone therapy, so clinicians are not forced to extrapolate from generally healthy trial participants. Evidence is also limited for newer nonhormonal medicines.
The review could not establish how treatment results vary by age, race, ethnicity or menopausal status. It included few studies of perimenopausal patients, and did not evaluate compounded estrogens. The supplied report does not provide detailed patient-specific eligibility criteria or describe how every possible contraindication should be handled. The recommendations therefore do not settle individual treatment decisions.
Oxybutynin reduced symptom frequency and severity and improved sleep quality in the review, but that finding came from a small trial and was supported by low- to moderate-certainty evidence. ACP said more research is needed to assess its benefits and harms. The guideline’s evidence ratings also vary across the listed medicines, so the treatment order should not be mistaken for equal certainty across all options.
More Research and Clinical Discussion
The next steps are likely to include clinicians using the guideline to discuss symptom treatment and patient-specific risks, alongside further studies of groups that were underrepresented or excluded from trials. The accompanying editorial calls for research that addresses people whose clinical circumstances require evidence beyond results from healthier populations.
The evidence review searched Embase, Cochrane and Medline through March 3, 2026. The supplied report does not give a timetable for additional ACP updates or new trial results. For now, the published guidance establishes a treatment sequence while leaving important questions about applicability, longer-term outcomes and individual risk assessment unresolved.
Key Questions
What does the new ACP guideline recommend first?
It recommends menopausal hormone therapy as first-line medication treatment for vasomotor symptoms. The guideline specifies estrogen with progestogen for people with a uterus and estrogen alone for those without one.
What medicines are listed if hormone therapy is unsuitable?
The guideline 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.
Does the recommendation mean hormone therapy is right for everyone?
No. The guidance ranks treatments for vasomotor symptoms, but hormone therapy may not be suitable for some patients. Treatment choices depend on individual circumstances and should be discussed with a qualified clinician.
What are the main limits of the evidence?
Many trial participants were healthy, postmenopausal white women ages 49 to 57, and only eight studies focused on perimenopausal women. People with several conditions, including prior breast cancer and cardiovascular disease, were commonly excluded, limiting what the evidence can say about those groups.
When was the evidence review conducted?
The review searched Embase, Cochrane and Medline through March 3, 2026. It included 90 trials reported in 102 publications, conducted from 1980 to 2024.
Source: rss
