Twenty years of fear of hormone therapy.

Although the American FDA has already revised its position by the end of 2025, I still hear daily in the consultation room that hormone therapy is said to be dangerous. Fear of breast cancer, thrombosis and a heart attack prevents many women from starting a treatment that could significantly improve their quality of life. Is that fear still justified?

More than twenty years ago, the Women's Health Initiative (WHI) study changed the way hormone therapy was viewed. The message that stuck was simple: hormone therapy increases the risk of breast cancer and cardiovascular diseases and is therefore dangerous.

Millions of women stopped their treatment or dared not to start.

But science has not stood still.

An important course change

In October 2025, the American Food and Drug Administration (FDA) announced that the general warnings for menopausal hormone therapy needed to be revised. The existing warnings were based on studies that are not representative of the women who currently use hormone therapy.

The original WHI study primarily examined women with an average age of 63 years, often more than 10 years after menopause, who were treated with oral conjugated equine estrogens and synthetic progestogens.

That is a very different situation than a healthy woman of 48 or 52 years who starts with body-identical estradiol via a gel or patch, possibly combined with micronised progesterone.

What does current science say?

One of the key messages from the FDA review is that the timing of when hormone therapy is started is of great importance.

Randomised studies show that women who start hormone therapy within ten years after the onset of menopause (usually before the age of 60) can achieve clear health benefits.

According to the FDA and the underlying scientific literature, this includes:

• a reduction in total mortality (all-cause mortality);

• fewer bone fractures;

• up to 50% fewer cardiovascular conditions;

• approximately 35% less chance of Alzheimer's disease;

• 50–60% fewer bone fractures.

Based on these insights, the FDA advises that for systemic hormone therapy, if indicated, it should start within ten years after the onset of menopause or before the age of 60. This aligns with the so-called timing hypothesis: the earlier treatment is started during the transition, the more favourable the balance between benefits and risks.

Of course, hormone therapy remains personalised. The choice of treatment, dosage, route of administration, and duration of therapy are always determined individually, taking into account symptoms, medical history, and personal risk factors.

That is precisely why it is time to say goodbye to the general message that hormone therapy would be dangerous. Current scientific insights show that modern, body-identical hormone therapy, started at the right time and with the right woman, not only reduces menopausal symptoms but can also make an important contribution to healthy aging.

Not all hormones are the same

An important lesson from the past twenty years is that we can no longer speak of "hormone therapy" as a single treatment.

Modern, body-identical hormones differ fundamentally from the preparations used in the original studies.

In particular, transdermal estradiol (gel or patch) and vaginal estradiol avoid the first pass through the liver and therefore have little effect on blood clotting. Micronised progesterone also has a more favourable safety profile than the synthetic progestogens from the WHI study.

What does this mean for women?

Does this mean that hormone therapy is suitable for everyone? Of course not. Every treatment requires an individual assessment of symptoms, age, medical history, and personal risk factors.

But it does mean that the general fear that has existed for more than twenty years no longer aligns with current scientific insights.

Time for a new conversation

The menopause is a natural hormonal life phase that affects almost every organ system. Hot flashes, sleep problems, mood swings, fatigue, joint pain, and vaginal complaints can severely reduce quality of life.

Modern, body-identical hormone therapy is a safe and effective treatment for many peri- and postmenopausal women, where the benefits often outweigh the risks.

The question should therefore no longer be: "Is hormone therapy dangerous?"

but:

"Which woman benefits from which form of hormone therapy, based on current scientific insights?"

For not treating also has consequences for health, functioning, and quality of life.