Leading OB-GYN group updates menopause guidance for first time in 12 years

New advice supports hormone therapy as a good option for many women

The American College of Obstetricians & Gynecologists has issued its first updated guidance in a dozen years for managing hot flashes, night sweats, sleep changes and other disruptive symptoms that often accompany menopause. The new advice, released this month, stresses the importance of hormone therapies, which many women are considering again after the removal of federal safety warnings. On Friday, federal officials said the Food and Drug Administration has been taking steps to ensure an adequate supply.

“We would love our patients to go to their OB-GYNs regarding questions about menopause and really advocate for getting the treatment that they need,” said Dr. Camille Clare, the group’s president.

Menopause occurs when a woman has gone 12 consecutive months without a menstrual period, and in the United States it usually happens around age 50, according to ACOG. The years leading up to it are called perimenopause, when the body’s production of the hormones estrogen and progesterone declines sharply. Problems commonly arise: more than half of women in menopause report “vasomotor” issues such as hot flashes and night sweats, as many as two-thirds report menopause-related sleep disruption, and more than a third of perimenopausal and postmenopausal women worldwide report depressive symptoms, the group said.

In the past, doctors said, many women quietly suffered. There is growing consensus that “these symptoms should be treated,” said Dr. JoAnn Manson, a professor of medicine at Harvard Medical School. “This should help to empower women to discuss their symptoms with their healthcare provider.”

Manson said ACOG’s new guidelines are similar to those put out by other medical organizations. “Moderate to severe or bothersome menopausal symptoms should be treated with hormone therapy as the first line of treatment,” she said. The approach is not appropriate for all women, she added, but it is a good option for many.

But some women have been wary. In 2002, a landmark study in women taking a pill-based combination of estrogen and progestin was stopped early because of links to breast cancer, blood clots and other serious issues. Concerns lingered even though later studies showed the benefits of today’s hormone therapies outweigh the risks for many women. For more than 22 years, all hormone-based menopause treatments carried a government warning, which Manson said discouraged patients and doctors from using them.

Last year, the FDA announced it would remove the boxed warning from more than 20 pills, patches and creams containing the hormones estrogen and progestin. On Friday, the agency approved updated labeling for three additional estrogen-based patches. Removing the boxed warning has helped revive interest in and demand for the treatments.

Since the labeling change, some women have reported difficulty obtaining estrogen patches in certain doses and formulations. FDA officials said Friday that despite such reports, they are unaware of “an imminent risk of a nationwide shortage.” The officials also noted that drug manufacturers have doubled their output of the products over the last year by adding extra manufacturing shifts and production capacity.

Dr. Stephanie Faubion, medical director at The Menopause Society, said she is glad ACOG’s guidelines stress the importance of the treatments. “It’s undisputed that hormone therapy is the first line and most effective therapy for hot flashes,” she said.

The guidance reviews the latest evidence on hormone therapy and includes detailed information about the various types. Whole-body therapies, which come in pills, patches, sprays, gels and a vaginal ring, deliver hormones into the bloodstream at levels high enough to have significant effects on symptoms such as hot flashes. Low-dose vaginal estrogen therapy is applied directly, with very little circulating in the blood, and is often prescribed for women whose biggest complaint is vaginal dryness.

ACOG recommends that decisions about hormone therapy be made jointly by doctors and patients, weighing the benefits and risks given a patient’s age and medical history. If appropriate, the group advises starting treatment before age 60 or within 10 years of menopause.

Hormones are not the only treatments. Some patients choose not to take full-body hormonal medications, or their doctors advise avoiding them because of their medical histories or conditions. For those patients, doctors pointed to fezolinetant, which works in the area of the brain that controls body temperature and blocks a source of hot flashes and night sweats, and elinzanetant, which works similarly. Certain antidepressants can also help manage hot flashes and depression in patients with either or both problems, doctors said.

ACOG also cited evidence supporting some non-drug approaches for hot flashes, night sweats and sleep or mood problems: cognitive behavioral therapy, mindfulness, exercise, clinical hypnosis and acupuncture. The group said such approaches can be used alone or alongside medications.

Clare said women may see misinformation and disinformation about menopause treatments online, and she urged patients to bring any questions to their doctors. ACOG offers advice on sorting out truth from false claims as well as overall information on menopause.

“Women have options. They have lots of options, hormonal and nonhormonal,” Faubion said. “They shouldn’t be told that nothing can be done about their symptoms. Because again, we have evidence for many different things that can help.”