Do the benefits of hormone therapy outweigh the risks?

At a July 2025 FDA panel, one menopause expert after another pleaded with the agency to remove the “black box” safety warning that currently appears on certain packages containing hormone therapy for women. “History got it wrong,” said Heather Hirsch, M.D., who founded the Menopause Clinic at Brigham and Women’s Hospital. “We are doing harm in the name of ‘do no harm.’”

The medical equivalent of yellow caution tape, the warning was added in 2003 after the landmark Women’s Health Initiative (WHI) study of more than 160,000 women linked hormone replacement therapy (HRT) with an increased risk of breast cancer.

Since then, those results have been called into question, or at least the interpretation of those results. Nonetheless, data shows that only about 5% of postmenopausal women were on HRT as of 2020, versus 35% before the WHI findings came out.

“Fear is preventing a lot of women from using hormones,” says Barbara Levy, M.D., a professor of obstetrics and gynecology at the George Washington University School of Medicine and Health Sciences. She says there’s also a lack of training among healthcare professionals. As of 2022, only 31% of OB/GYN residency programs were teaching menopause management.

Here is what you should know about HRT for menopause today, so — with the help fo your provider — you can make informed decisions for your body.

What is HRT?

Hormone replacement therapy (sometimes referred to as menopausal hormone therapy or MHT) supplements the ovarian hormones estrogen and progesterone, which your body stops producing at the end of the menopause transition. Used to treat hot flashes, night sweats, and other common symptoms of menopause, it can be administered by mouth (pills) or skin (patches, cream, gel, or spray).

Lower-dose HRT can also be applied vaginally for more localized symptoms, such as vaginal dryness and pain with intercourse.

You may have heard people refer to something called bioidentical hormones (not to be confused with compounded hormones). This is a type of HRT with the same chemical and molecular structure as your body’s natural hormones, and they’re sometimes marketed as being more natural — and therefore better — than synthetic hormones. “But you can’t say one is evil and one is great,” clarifies Dr. Stephanie Faubion, M.D., the director of the Mayo Clinic Center for Women's Health, medical director for The Menopause Society, and member of the WeightWatchers Scientific Advisory Board.

So, what are the safety concerns?

In 2002, the scientists conducting the WHI study linked oral combined estrogen-progesterone therapy, the most common form of hormone replacement therapy, to an increased risk of breast cancer, as well as blood clots and stroke. The study compared women on estrogen and progesterone, estrogen-only, and a placebo.

Decades later, the study findings are being reinterpreted for a few reasons:

• The type of hormone makes a difference. The WHI only studied one kind of estrogen and one kind of progesterone. Now, experts know that different forms — like estrogen patches and micronized progesterone, which is identical to natural progesterone — can carry different risks and may be safer for some women.

• Age and timing matter. Most of the women in the WHI study were in their 60s, well beyond menopause and already at a higher baseline risk for heart disease, stroke, and cancer. We now understand that HRT is much safer for women who are under 60 and within 10 years of menopause. For these women, the benefits often outweigh the risks.

• The study didn’t reflect most women seeking help. Again, most women in the study were in their 60s — but most women considering HRT are in their late 40s or 50s. This means the results didn’t match the group who usually needs treatment the most.

• Breast cancer risk was overstated. The increased risk was mainly linked to the combination of estrogen plus one specific type of progesterone. Estrogen alone (used in women without a uterus) actually lowered breast cancer risk in the WHI. Even with the estrogen and progesterone therapy, the increase in risk was small for short-term use: less than one additional case per 1,000 women. This risk is slightly greater than the risk associated with drinking a daily glass of wine, says Faubion.

“This updated interpretation of the WHI doesn’t suggest that hormone therapy carries no risks,” says Patricia Bhoola M.D., OB/GYN, a physician at WeightWatchers Clinic. But it does underscore the need for "clinicians to carefully weigh the risks against the potential to significantly improve someone's life.”

Who is (and isn’t) a candidate for hormone replacement therapy?

The best candidates for HRT are women within 10 years of menopause — the day they’ve gone without a menstrual period for over a year — or below the age of 60 with moderate to severe symptoms of menopause.

Levy explains that introducing estrogen in early menopause, when your blood vessels are still relatively flexible, can help keep those vessels healthy. That’s because estrogen binds to receptors in your blood vessels, and “if you wait too long to take it, those receptors can go dormant,” she says. This makes the estrogen less effective and potentially destabilizes the plaque that’s had a chance to build up along the walls of your arteries, raising your risk of stroke or heart attack.

In general, women with breast, ovarian, or uterine cancer; a history of blood clots; or cardiovascular disease should not use hormone therapy. The exception here is lower-dose HRT that’s applied vaginally.

“Vaginal estrogen doesn't absorb and spread through your whole body like the other forms do,” says Bhoola. Because it’s localized, it’s clinically appropriate to use even if you’re past that 10-year mark or have health conditions that preclude you from using systemic therapy. Because it doesn't spread through the whole body, though, that also means it’s not much help for symptoms that go beyond the vaginal area.

Ultimately, whether you’re a candidate for any form of HRT comes down to a conversation with your provider.

The benefits of HRT

According to the 2022 Menopause Society position statement, hormone replacement therapy remains the most effective treatment for hot flashes, night sweats, and other symptoms of menopause related to changes in the blood vessels, called “vasomotor” symptoms (VSM).

Treating these symptoms doesn’t just make you more comfortable, it can also improve your long-term health. Researchers have found that women with frequent or persistent hot flashes who were not taking hormone therapy had a higher risk of cardiovascular disease. Severe menopause symptoms have also been linked to cognitive impairment.

Relief can have a ripple effect. “Let's say you're getting night sweats. So, now your sleep is off — which affects your concentration during the day. Chronic poor sleep can also increase risk of developing depression or other mood disorders. So, a lot of it is closely tied,” says Bhoola. “Now that you’re sleeping better, a lot of other things can get better as well.”

There are also significant benefits beyond VSM, says Bhoola. Research shows that HRT increases bone mineral density and reduces the risk of fractures; it may even prevent osteoporosis. And at the October 2025 Menopause Society meeting, new research showed that women who used HRT for at least 10 years before hitting menopause had 60% lower odds of developing breast cancer, heart attack, and stroke compared to those who started HRT after menopause and those who never took hormones.

There is also some evidence that estrogen, while not prescribed for weight loss, can combat the accumulation of the harmful visceral fat surrounding the organs that tends to occur in the years leading up to and following menopause.

“By replacing the estrogen, you can help counteract that,” says Bhoola. And this effect may be enhanced when combined with a GLP-1 agonist — like Wegovy (semaglutide) or Zepbound (tirzepatide). They’re more powerful together together than separate: One study found that adding HRT to a GLP-1 was 30% more effective for weight loss than a GLP-1 alone.

Alternatives to hormone therapy

The best alternative depends on what you’re looking to treat. In terms of the most common menopause symptom, hot flashes, hormone therapy is the most research-backed treatment — but it’s not the only one.

Two classes of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) have also been shown to reduce the frequency and severity of hot flashes, and they may also help with the mood symptoms that tend to peak during the menopause transition. Additionally, nonhormonal medications like gabapentin, oxybutynin, and clonidine are also effective for menopausal vasomotor symptoms.

And in 2023, the FDA approved fezolinetant (brand name: Veozah), the first nonhormone drug specifically for the treatment of moderate to severe VSM associated with menopause. It works by binding to and blocking the activities of something called the NK3 receptor, which helps your brain regulate your body temperature.

Focusing on lifestyle factors can also minimize symptoms — eating a balanced diet, exercising regularly, finding ways to relax, and managing your weight can improve how you feel across the board. “Weight loss is actually one of the lifestyle modifications that is proven to reduce the number of hot flashes you have,” says Bhoola.

While calcium and vitamin D supplements may strengthen your bones (the loss of which menopause speeds up), there’s no evidence that black cohosh, evening primrose oil, red clover, and other supplements marketed for menopause work. Some may even be harmful.

Is hormone therapy right for you?

If you are 60 or younger and are experiencing hot flashes, night sweats, vaginal dryness, or trouble sleeping — and your last period was less than 10 years ago — reach out to your healthcare provider or meet virtually with a clinician at WeightWatchers Clinic for Menopause. After reviewing your symptoms, your health history, and your treatment goals, they will be able to provide a personalized recommendation that takes both the risks and benefits into account.