Hormone Therapy and Menopause: Facts and Fiction

Diana Zuckerman, Ph.D. and Akashleena Mallick, MD MPH, National Center for Health Research

Do women need to “replace” hormones as they age? Millions of women struggle with the decision about hormones during and after menopause: should I go on, should I stay on, or should I go off?

There is considerable debate about the risks and benefits of hormone therapy, and that is partly because some studies are better than others, and very few health professionals have read all the research. However, the research evidence is now clear: on average, the risks of hormones outweigh the benefits for most women. It is important to read articles like this one to help you talk to your physician about whether the risks are greater than the benefits for you.

What the FDA Said in November 2025

At a press conference in November 2025, Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announced that women had been misled about the dangers of hormone therapy for menopause. Experts can disagree, but in this case, the evidence is complicated, the results are nuanced, but overall, the hormone pills that the FDA has approved for the symptoms of menopause are likely to cause harm that outweighs the benefits. However, low-dose vaginal creams seem to be safer than expected. We will explain what the best evidence shows.

What the Research Says

In December 2017, the experts at the U.S. Preventive Services Task Force issued a clear recommendation:  post-menopausal women should NOT take hormones to prevent chronic health conditions, such as increasing bone strength to avoid fractures. The reason is that the risks of these hormones outweigh the benefits.1

This recommendation was based on clear evidence that taking hormones to “replace” those that are reduced in menopause is often bad for your health. The best evidence is based on randomized clinical trials called the Women’s Health Initiative (WHI), sponsored by the National Institutes of Health (NIH). These included more than 27,000 women in three different trials to study the effect of hormones on women’s bodies.2,3,4 The 3 trials were: 1) the Estrogen Plus Progestin Trial, 2) the Women’s Health Initiative Memory Study, and 3) the Estrogen-alone Trial.

The researchers found that women taking a combination of estrogen and progesterone hormones were more likely to develop breast cancer, stroke, and blood clots, and at least as likely to develop heart disease, compared to women taking a placebo. Those on estrogen alone were more likely to have a stroke or a dangerous type of blood clot called deep vein thrombosis (DVT).

The Memory Study (WHIMS) was a randomized double blind study that found that women taking a combination of estrogen plus progesterone were twice as likely to develop Alzheimer’s Disease and other forms of dementia compared to women on a placebo. 3

All three trials were stopped early for ethical reasons when it became clear that women taking hormones were more likely to be harmed than helped. While there are some short-term benefits to taking hormones, the researchers concluded that for most women, the risks of hormone therapy outweigh the benefits.

Cancer

Following the release of these findings, use of hormone therapy in the U.S. dropped significantly.  Since then, several large studies have pointed out that breast cancer incidence also dropped a few years after the decline in hormone use for menopause.5,6 This unexpected and unprecedented drop in breast cancer incidence suggests that HRT has a more dramatic impact on breast cancer risk than previously thought.7   

For example, in 2021, a meta-analysis of more than 4,000 women in 4 different studies of women previously being treated for breast cancer found that those who subsequently took hormone therapy (combined estrogen plus progesterone) were much more likely to have a recurrence of cancer than breast cancer survivors who took a placebo.8 The women who had estrogen receptor-positive breast cancer prior to hormone therapy were 80% more likely to have a recurrence than women taking a placebo, which was a statistically significant difference that did not occur by chance. The women who had estrogen receptor-negative breast cancer were 19% more likely to have a recurrence than the women taking a placebo, which was a small difference that might have occurred by chance.

In 2009, a study found that hormone therapy increased the risk of dying of lung cancer among women who smoked or previously smoked, compared to smokers or former smokers who did not take hormone therapy. For more information, click here.

Hormone therapy for menopause as a possible cause of breast cancer is particularly controversial. Studies indicate that hormones can increase or decrease the chances of developing breast cancer depending on the age and other traits of the women, and the types of hormones involved.  However, the two most recent studies indicate that hormones can increase the chances of younger women and women with dense breasts developing breast cancer. 9

In 2009, a study found that hormone therapy increased the risk of dying of lung cancer among women who smoked or previously smoked, compared to smokers or former smokers who did not take hormone therapy. For more information, click here.

Heart Disease

Experts who promote the use of hormones for menopause have criticized the WHI for enrolling women after menopause rather than just before or in the earliest stages.  So, it is important to note that in 2014, a study of 727 women in early menopause showed that hormone therapy did not prevent atherosclerosis (artery thickening), as had been claimed previously.  Following women on HRT for 4 years, the researchers from the Kronos Longevity Research Institute, a pro-HRT research institute, and other institutions, found no difference in artery thickening between the women who took HRT and those who didn’t.10 

Although the average age of the women in the WHI was 60, the study included over 27,000 women in their 50s.  When the younger women were evaluated separately, the researchers still found the harms were greater than the benefits. 12  

Memory Loss and Mood

In 2015, the same group published an article admitting that hormone therapy also had no impact on “cognitive decline,” despite claims that it would prevent Alzheimer’s and memory loss.11 Although the authors focused on a small improvement in mood related to using hormone pills for 4 years (but not found with hormone creams), they downplayed the more important finding: no impact on depression as measured by the valid and reliable Beck Depression Inventory.

Is Hormone Therapy a Good Idea for You?

For younger women with debilitating symptoms of menopause who are not otherwise likely to develop breast cancer or heart disease in the next few years due to family history, the increased health risks of hormone therapy may be worth it to them.  That is very different from urging all women to take hormone therapy for menopause.

To emphasize that lost hormones don’t necessarily need to be replaced, the term “hormone replacement therapy” was changed to “hormone therapy” or menopausal hormone therapy (MHT). Many experts have advised women to use hormone therapy only for severe symptoms of menopause that reduce the quality of life, such as severe hot flashes, night sweats, insomnia, and vaginal dryness. Women have been urged to take hormones at the lowest dose that is effective and for the shortest possible period of time. We think this is still the best advice.

However, research has shown that topical hormone creams for vaginal dryness are safe for short-term use. Better research is needed to know how safe these creams are for long-term use, but there is reason to believe that they are safer than hormone pills.

One of the misleading statements made by government officials in 2025 about hormone therapy was that it would prevent dementia, so that issue deserves particular attention.  In addition to the previously mentioned WHI Memory Study that showed an increase in dementia among women taking hormone pills for menopause 3, a 2015 Cochrane review confirmed that hormone therapy for menopause does not prevent dementia. 13

In contrast, there are no well-designed studies that support the FDA claim that hormone therapy prevents Alzheimer’s or any other types of dementia.  For example, a study by Simpkins and colleagues reviewed rodent studies and other research that could not accurately establish the impact of hormone therapy on women. 14 A 30-year-old study by Paganini-Hill and Henderson (1996) was not a randomized trial and used death certificates to ascertain Alzheimer’s disease. 15

Death certificates are not accurate enough to determine dementia and since this was not a randomized clinical trial it did not statistically control for other differences between the women who were reported as having dementia and those who did not.  A study by focused on APOE4 carriers, which is a group at extremely high genetic risk for dementia, only 29 of whom had used hormone therapy. 16 That study is not generalizable to most women because it focused on a small number of women, all of whom were more likely to develop dementia than the general population of women.

The Bottom Line

The risks and benefits of hormone therapy depend on the woman involved. It is important to take into account the research, but since the risks vary so much, a major issue is that the only proven benefits are reducing unpleasant symptoms of menopause and the temporary benefit of reducing the chance of developing osteoporosis. There are many safe ways to cope with hot flashes, and numerous studies show that women on a placebo often report their hot flashes have been cut almost in half, indicating the importance of mind over matter.  Low-dose estrogen cream is safer than hormone pills for vaginal symptoms. Osteoporosis can often be prevented with diet and exercise.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

The National Center for Health Research is a nonprofit, nonpartisan research, education, and advocacy organization that analyzes and explains the latest medical research and speaks out on policies and programs. We do not accept funding from pharmaceutical companies or medical device manufacturers. Find out how you can support us here.

References:

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