Menopause and the Big Lie: Part 2

This is the second installment of a 5 part series. If you missed Part 1, you can find it here.

The Rise of Hormone Replacement Therapy

Hormone replacement therapy (HRT) used to be the norm - as far back as the 1960’s. At that time, epidemiologic studies were showing a benefit in women’s health outcomes. And the finding of benefit seemed logically plausible - after all, women experience various negative health effects following natural hormone loss. Shouldn’t hormone replacement be an obvious antidote?

But epidemiologic studies are not definitive proof that a treatment is more helpful than harmful. Specifically, it’s hard to account for hidden biases in epidemiologic trials. For example, women who are more health conscious – or who have the means to interact with the health care system more regularly - may be more likely to take hormone supplements post menopause, thus accounting for the better health results.

Plus, seemingly beneficial treatments don’t always yield a net benefit.

Here’s a scary story from my world:

In the 1970s and 1980s, cardiologists were confident that suppressing certain heart arrhythmias after a heart attack would save lives. It made perfect sense, since those very arrhythmias were linked to an increased risk of sudden death. So we started to put patients on medications that reduced arrhythmia burden. But the CAST trial, halted early in 1989, proved us wrong. The drugs did reduce the arrhythmias they were designed to suppress—but they paradoxically increased the risk of dying compared to doing nothing. Turns out, the treatment was worse than the disease.

It was a sobering lesson that the medical community has never forgotten: What seems like it should be beneficial isn’t always the right thing to do.

That skepticism carried over into women’s health.

And the National Institutes of Health (NIH) decided to put HRT to the test - initiating the Women’s Health Initiative (WHI) trial. The WHI was a large, long-term health study focused on preventing major diseases in postmenopausal women, like heart disease, breast cancer, colorectal malignancy, and osteoporosis.

The WHI involved over 160,000 women aged 50 to 79 across the United States. It began in 1993 and followed participants for many years. The WHI was made up of several sub-studies including the Hormone Therapy Trial which evaluated whether hormone replacement therapy (equine-based estrogen with or without synthetic progestin) helped prevent heart disease and other conditions.

What the WHI Revealed

Women enrolled in WHI’s Hormone Therapy Trial were randomly assigned to either a treatment group (estrogen alone – or estrogen with progesterone, all in pill form) or a placebo group (taking an inactive pill), without knowing which intervention they got. This helped make the study fair and unbiased. The Hormone Therapy Trial was supposed to follow the women for at least 8 years.  

However, the estrogen with progesterone arm of the trial was halted early due to concerns around health outcomes: Higher risk of heart attack, stroke and breast cancer in hormone users. It was CAST all over again! This time the treatment that seemed so logical but turned out to have opposite effects was HRT.

Data for the estrogen with progesterone group was first presented in 2002 and threw the medical community for a loop.  

We have never recovered.

Even though there was so much more to this story… 

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