The AP story did a much better job than the Wall Street Journal in addressing the study’s limitations and significance within the greater context of hormonal replacement research.
A new trial called the Kronos Early Estrogen Prevention Study (KEEPS) contradicts findings from the well-known Women’s Health Initiative (WHI). Despite the new study’s limitations of being “too small and too short,” it still is fresh research that may shed some more light on the effects of hormone replacement therapy on menopausal women. But as the AP story effectively points out, “Women need to realize the new study is much less definitive than the big federal one.”
The take-away from this study should be that FOR WOMEN WHO HAVE BOTHERSOME MENOPAUSAL SYMPTOMS, there is some reassurance that HT is does not seem to promote cardiovascular disease. There’s also a little disappointment that, contrary to the researcher’s hypothesis (which has some decent evidence behind it) estrogen did not seem to protect the arteries from atherosclerotic changes that accompany aging. By the end of the article, these points are made pretty clear.
Hormone therapy was a popular way to combat menopausal symptoms for decades. But when the WHI suggested that estrogen and progesterone treatments may increase risks for heart attacks and strokes, prescriptions for these hormones fell. The WHI established the current medical wisdom regarding hormone replacement therapy, but this new clinical study questions the causal link between estrogen-progestin pills and higher rates of cardiovascular disease in women who recently stopped having periods [or recently went through menopause].
Although the article details the manufacturers of the low-dose estrogen pills and low-dose estrogen skin patches, it does not go into the pricing of these products.
The story lists the benefits out in bullet form, but does not quantify any of the claims. For example, the story states that both types of estrogen reduced hot flashes and improved bone density, mood and sexual health, but by how much? And how were these benefits measured by researchers?
A bigger problem is that we don’t know enough about how the comparison was done and the outcome terms are vague. “Mood?” “Sexual health?” (Who doesn’t want a better mood and “sexual health”)? But how was the comparison made? This was not a trial designed to test benefits of HT vs placebo for perimenopausal depression and sexual dysfunction, but the way it was reported implies it was.
It is not surprising that women felt better when using estrogen in terms of hot flashes. The study recruited menopausal women and assigned them to take some form of HT or to take placebo. Among their recruits, a fair number of women would be expected to have bothersome symptoms such as hot flashes and mood fluctuations, but not all would. When you lump them all together, of course those who got estrogen will have fewer hot flashes compared to the placebo group. We’ve known for years that placebos have only limited benefit for menopausal symptoms compared with estrogen.
The story explains what triglycerides are and how their levels may rise in the bloodstream. The article also does a good job in clarifying the beneficial and harmful effects of estrogen, depending on whether patients receive the oral or patch form. And the story points out the patients more likely to experience harmful effects, as with the example of smokers and oral estrogen.
The strength of this story is it provides better context by considering the issue of breast cancer as well as cardiovascular risk — both of which were most important adverse effects reported by WHI.
The story does a great job in keeping the study in perspective. For one, the article points out that “the research didn’t address the risk of breast cancer, as the study “was too small and too short for that.” It gives a much needed context on where this new study lies within the realm of hormone research and how KEEPS differs from WHI. Most importantly, the article quotes a researcher cautioning readers : “Women need to realize the new study is much less definitive than the big federal one that found more lung and breast cancer deaths among women on estrogen-progestin pills.”
The story does not commit disease mongering.
The story does list independent sources, such as Dr. Rowan Chlebowski of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, who was involved in a separate analysis. The article also has comments from two study participants and mentions that KEEPS was funded by the Kronos Longevity Research Institute, “a Phoenix-based group with no industry ties.” (But one question was unanswered: The Kronos Institute is supported by the nonprofit “Aurora Foundation”, which gave $34 million for this study according to Indiana University Philanthropy website. Who are they?)
Instead of just recommending hormone replacement therapy, the article outlines current medical wisdom : “Use hormones only for severe symptoms – not to prevent bone loss or aging-related problems – at the lowest dose for the shortest time possible.”
It can be inferred from the story that estrogen and progesterone hormone therapies are common and widely available. (Note: there is a factual error in the statement implying there are few forms of patches available. There are many different patches – more than 6 – which have been available for years. It should also be noted that some insurers do limit coverage for certain forms of estrogen patches, and also for Prometrium, the form of estrogen used in this study.)
The story makes it clear that hormone replacement therapy is not a new approach. It clarifies the role of KEEPS within the greater body of hormone replacement research. For example, the article mentions that the new study tested whether “some hormones might help certain women, and that the type and dose might matter.”
There is clear evidence of original reporting, with comments from study leaders, patients and independent researchers.