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How One Study Shaped 20 Years of Menopause Care

By now, many women navigating perimenopause or menopause know the headline: In 2002, a study linked hormone replacement therapy (HRT) to an increased risk of breast cancer. Overnight, women abandoned treatment. Doctors stopped prescribing it. Years later, we learned the data had been misinterpreted, but the damage was already done. The study—one arm of the Women’s Health Initiative (WHI), a massive trial on disease prevention in aging women—was never meant to serve as the final word on hormone replacement therapy, or even examine whether it was safe and effective for menopause symptoms like hot flashes, night sweats, insomnia, or brain fog. Recent data shows that for most women in menopause,…

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 Federal Officials Promise to Restore Funding to Women’s Health Initiative

The decades-long research effort has contributed to thousands of research papers, altering medical care for women around the world.

 The menopause myth: how demonised HRT came back from the brink

In 2002 everything changed. This was when the enormous US-based Women’s Health Initiative Study (WHI) was abruptly stopped after only 5.6 years, with enormous media attention. The researchers had apparently found an increase in breast cancer (and heart disease) with combination HRT (oestrogen plus progestogen). The horrific way the study and these findings were reported changed everything. Essentially the study was trying to find out whether the known health benefits of HRT meant you’re “never too old” to start. So the WHI study intentionally didn’t include many recently menopausal women. Because doctors already knew about the health benefits to them, didn’t we? The average age of the women in the study starting on HRT in the WHI was 63. But 25% of them were over 70 when they started their HRT. The women randomised to get HRT (versus placebo) were older. In fact two-thirds of the HRT recipients were between 60 and 79 years.

 The Real Story Behind the Women’s Health Initiative Study

If you Google “hormone replacement therapy” or “HRT,” you are bound to find articles warning you about its dangers. And you may be wondering if this type of therapy will cause more harm than good. Let’s set the record straight and separate fact from fiction by reviewing the study together that caused a media frenzy and stoked fears about the safety of hormone replacement therapy.

 ‘Tis but a scratch: a critical review of the Women’s Health Initiative evidence associating menopausal hormone therapy with the risk of breast cancer

Use of menopausal hormone therapy (HT) fell precipitously after 2002, largely as a result of the Women’s Health Initiative’s report claiming that the combination of conjugated equine estrogen (CEE) and medroxyprogesterone acetate increased breast cancer risk and did not improve quality of life. More recently, Women’s Health Initiative (WHI) publications acknowledge HTas the most effective treatment for managing menopausal vasomotor symptoms and report that CEE alone reduces the risk of breast cancer by 23% while reducing breast cancer death by 40%.

Articles of Interest

After Decades of Misunderstanding, Menopause is Finally Having Its Moment

Despite these advancements, many women still hesitate to consider HRT, often because of persisting fears sparked by the 2002 study. Amidst this uncertainty, though, there are encouraging signs of progress. Minkin reflects on how she once had to persuade women to consider HRT. Today, the conversation is shifting—patients are often initiating discussions about HRT before she even has the chance to raise it as an option.

Disputing the Original Women's Health Initiative (WHI) Research Findings

As a result of the study, a large number of women missed out on HRT treatments that could have benefited them during their menopausal years. However, the study organization has since expanded on the original findings. Although they do not recommend the therapy for disease prevention, further investigation has led the WHI to recognize HRT as the most effective treatment method for hot flashes and night sweats during menopause.

The Women’s Health Initiative and the Body Politic

The Women’s Health Initiative, a $625 million study, would examine the risks and benefits of menopause hormones, calcium and vitamin D supplements and low-fat diets. All told, the landmark study recruited more than 160,000 women, including 26,000 for the hormone research. Scientists fully expected the results to be predictable, including that hormones could prevent chronic illness in women, including heart disease. But the findings have consistently surprised, debunking conventional wisdom time and again — about hormones and health, calcium to protect bones and the importance of a low-fat diet. The results, while invaluable, have also had a negative effect, leaving some women feeling frustrated, betrayed and whipsawed by what often seem to be contradictory headlines. And they have fueled cynicism about the medical establishment’s treatment of women.

The Women’s Health Initiative has shaped women’s health for over 30 years, but its future is uncertain

I am a public health researcher who has studied chronic disease prevention in women for nearly 40 years. I have been centrally involved with the Women’s Health Initiative since its inception and currently co-direct one of its four regional centers at the University at Buffalo. The project’s findings have shaped clinical practice, prevention strategies and public health policies across the U.S. and the world, particularly for older women. In my view, its loss would be a devastating blow to women’s health.

Was The Women's Health Initiative Good Or Bad For Women's Health?

In part, this $725 million study was intended to resolve the controversy over whether menopause should be embraced as a natural transition in life, a position taken by the feminist movement at the time, or, as proposed by such books as Feminine Forever (Pocket Books, NY, 1968), that menopause was a hormone deficiency totally preventable with hormone therapy.

What the Media Got Wrong about the WHI

In 2002, published data from the Women’s Health Initiative (WHI), one of the largest and most influential hormone therapy clinical trials to date, inspired media headlines claiming that estrogen and progestin hormone therapy significantly increased the risk of breast cancer, stroke, and blood clots in post-menopausal women. Consequently, a ripple effect of fear and confusion around menopausal hormone therapy (MHT) ensued and negatively impacted the understanding of hormone therapy for years to come.

Resources

Women’s Health Initiative

Changing the future of women’s health. A landmark study since 1992. WHI strives to improve health through research on risk factors, prevention, and early detection of serious health conditions, so postmenopausal women thrive.