There was a lot of media coverage Wednesday about new findings regarding menopausal hormone therapy. “Menopause Therapy Found Less Risky,” declared one headline. "Hormone Study May Reassure Women,” stated another. “Study Counters WHI on Risk of Hormones in Menopause,” announced a third.
WHI is the acronym for the Women’s Health Initiative, a massive, randomized, double-blinded controlled trial that found, starting in 2002, an increased risk for blood clots, stroke, heart disease, breast cancer, colon cancer, incontinence and dementia among women who took menopausal hormone therapy.
The WHI findings have been so striking that menopausal hormone therapy (either estrogen or estrogen plus progesterone) is now recommended only for women with severe hot flashes or night sweats, and then at the lowest dose and for the shortest period of time, although the safety of taking the drugs under even these tight restrictions is not known.
Too soon to know
So do the new findings reported on Wednesday really counter those of the WHI?
No. To begin with the findings, which were from a new clinical trial called the Kronos Early Estrogen Prevention Study (KEEPS), were reported at a medical meeting. They haven’t been published, or even peer-reviewed.
It’s too soon to know what these findings really are, let alone what they mean.
In addition, even if the findings are found to be solid after they are published and analyzed by other experts, they pertain only to those women who are taking the drugs at low doses and for short periods of time.
Those headlines, in other words, are way ahead of the evidence.
“It’s being framed as countering the WHI study — which people have had a long time to digest, re-analyze and pick apart,” wrote Gary Schwitzer, publisher of the Minnesota-based HealthNewsReview website, which reviews and rates health-related news articles, in an e-mail response to my questions about Wednesday’s media reports. “Shouldn’t we at least hear the presentation at the meeting and hear discussion before jumping to conclusions, etching new stone tablets, and framing this as countering the WHI? How can one even give a cogent comparative reaction when you’re hearing a brief abstract or presentation at a meeting?”
“It’s often not a good batting average when you track what eventually results from work presented in talks at scientific meetings,” he added.
Many caveats
In their HealthNewsReview analysis of one of the articles announcing KEEPS' preliminary findings, medical journalist Euna Lhee and Dr. Karen Carlson, director of Women’s Health Associates at Massachusetts General Hospital in Boston, had this to say about the study itself:
The main purpose of this trial of hormone therapy was to see if, when given close to menopause, it might help protect arteries from changes that could lead to future heart attack and stroke. The researchers reported a negative trial result: the hypothesized benefit wasn’t present. The study was not an endorsement “supporting” estrogen.
The results showed that there was NO effect, beneficial or harmful, on “hardening of the arteries” in the blood vessels supplying the brain and the heart. … [The study’s] intermediate endpoints that look at risk factors for heart attack and stroke (such as cholesterol, and signs of thickening or calcium deposits in arteries) are not what we care about, which is whether heart attacks and strokes were any more or less common. Since it takes longer to detect such events, the researchers chose to look at markers for future disease rather than cardiovascular events. That’s a legitimate way to explore a hypothesis, but must be emphasized as preliminary. Don’t forget that we got into the widespread but misguided practice of prescribing estrogen for cardiovascular prevention back in the 80s based on just such assumptions, based on data that showed [hormone therapy] had favorable effects on cholesterol and other markers — yet in the end it caused more heart attacks and strokes.
Lhee and Carlson also wrote this:
The WHI ran for 15 years and enrolled more than 160,000 postmenopausal women, the majority of whom were older and well beyond menopause. KEEPS, on the other hand, enrolled younger postmenopausal women and used different formulations of hormone therapy. It followed 727 women for 4 years and only looked at markers of cardiovascular risk, not at actual heart attacks and strokes. The results are of value as a preliminary finding, but the limits of the study must be kept in mind.
Dr. Jennifer Wu, an obstetrician/gynecologist at Lenox Hill Hospital in New York City, also expressed caution, in an interview with HealthDay reporter Amanda Gardner:
"We've gone back and forth on how safe hormones are and this is just one study," she said. "It only looks at early menopause and it's only looking at hardening of the arteries. It didn't look at breast cancer, which is also a very big concern."
Before she could wholeheartedly encourage patients to take hormone replacement therapy in early menopause, Wu said she would like to see more studies on breast cancer. "We may not catch breast cancer in four years, though it may develop," she noted.
In other words, it's too early for women to be reassured by these reported (but not published) findings, despite the hyped headlines.