The new menopause hormone therapy study: what does the NWHN think?

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In early October, many women heard the news that a new study had found that menopause hormone therapy improves mood, specifically relieving depression and anxiety.  The study, called KEEPS (Kronos Early Estrogen Prevention Study) enrolled 727 women who were randomly assigned to menopause hormone therapy (HT) or placebo and followed for four years.  According to the researchers, women who took either form of menopause HT were significantly less likely to report depression or anxiety.  The researchers also report that they did not find any serious risks associated with using these forms of HT for up to four years, including no decrease in memory or cognitive ability, which had been found in other studies of menopause HT.  
 
However, there’s one important fact that women might not have learned when they heard this apparent good news.  These results have not been through the peer-review process, and have not yet been published in a medical journal.  The study results were released at a medical conference, and reporters were encouraged to write about the results.  While some reporters had the time to interview researchers involved in the study, other newspapers ran unedited versions of the press release written by the sponsors of the trial.  NWHN believes that women and their clinicians should wait until the trial results have been vetted by independent experts and published in a medical journal before making any treatment decisions based on these claims.  
 
NWHN will monitor the situation closely and report more fully as soon as the trial results are published.  In the meantime here is what we know:
 
The KEEPS study was designed to test the hypothesis that healthy women can prevent the development of heart disease by using HT to keep their bodies from experiencing the natural drop in estrogen and progesterone that occurs after menopause.  727 women who were an average of 52 years old were randomized to either low-dose Premarin, an estradiol patch, or placebo.  In addition, women who had not had their uterus removed took Prometrium, a form of natural progesterone, for 12 days each month. To keep women and their physicians from knowing whether they were taking placebos, all women were given pills and patches that looked exactly the same.  
 
During the four years of the trial, women had regular screening tests including blood pressure, cholesterol, triglycerides, artery thickness and calcium deposits – to evaluate risk for heart disease; blood sugar levels – to evaluate risk for diabetes; breast density on mammograms – to evaluate risk for breast cancer; and bone density – to evaluate risk for fractures.  These risk factors measurements are not always reliable predictors for the later development of disease, but the researchers believed that effect of HT on risk factors would be a strong signal of the effect of HT on heart disease.  
 
The researchers reported that neither form of menopause HT had any effect on risk factors for heart disease.  Women on placebo did just as well as women on HT.  While this seems to provide strong evidence that women don’t need to artificially create high hormone levels after menopause in order to stay healthy, we’ll follow our own advice and wait until the study is published until we declare this question answered.  
 
Other findings of this study – still to be confirmed – are that neither form of hormone therapy prevented cognitive decline and that both forms of HT improved bone density, hot flashes and vaginal dryness.  The researchers reported finding some differences between the two forms of HT, but we’ll wait until those reports have been vetted by independent experts before repeating them.  The NWHN believes that women should assume that the risks associated with using ET or HT for a few years – a small risk of blood clots and stroke -- might still exist with the forms of estrogen and progesterone used in KEEPS. 
 
The NWHN is proud of its insistence that all beliefs about menopause and menopause HT be tested in high quality, randomized clinical trials.  The KEEPS trial will give us useful information about the effects of taking HT for a few years around the time of menopause, once the information has gone through the proper process for publication.  
 
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