By Beverly Vaughn, MD
Medical Coordinator, Menopause and You Program
Have you heard about the KEEPS study? Everyone knows about the WHI study
but, the KEEPS study has flown under the radar. The Kronos Early
Estrogen Prevention Study has findings equally as important to the
health of menopausal women as the WHI. This study, funded by the Kronos
Longevity Research Institute, focused on hormone therapy in women who
were recently menopausal. The investigators, as in WHI, were nationally
renowned medical researchers from academic medical centers across the
The researchers involved in KEEPS looked at the effect of hormone
therapy in the following areas; common menopause symptoms, bone density,
sexual function, coronary artery calcium deposition (a marker for heart
disease), blood pressure and lipid values. A portion of the study also
looked at cognitive function.
There are important differences between KEEPS and WHI. The most
significant difference is the age of the women studied. In WHI, the
participants had an average age of 62 years and were many years beyond
their final menstrual period. KEEPS recruited women with an average age
of 52 and who were within 3 years of menopause. This difference is very
significant because women seeking relief from menopausal symptoms are
more likely to resemble the women in KEEPS than in WHI. They are also
less likely to have changes in their coronary arteries that predispose
them to heart disease. The type of hormone treatment was different as
well. The WHI study used an oral preparation that combined estrogen and
a progestin (artificial progesterone). One group of women in KEEPS used
an oral estrogen in a lower dose than WHI and natural oral progesterone.
A second group in KEEPS used an estrogen patch and the oral natural
progesterone. Both WHI and KEEPS had women who were given placebos. Some
of the study findings are illustrated in the chart below.
Pain with intercourse
Coronary artery calcium (CAC)
It is no surprise that women using either of the hormone therapies had a
diminution of their hot flushes. But, as you can see other effects were
dependent on the form of estrogen. In regard to the changes in
parameters that were reflective of heart disease (CAC and cholesterol)
the difference among the groups was actually small, the clinical
importance is not clear and warrants continued investigation.
The KEEPS trial found NO increase in breast or uterine cancer, heart
attack, stroke or development of blood clots. This is important but must
be tempered by the small number of participants in the study and the
fact that all participants were healthy. So it is difficult to draw any
The importance of this study is that prescribing estrogen therapy to
women who are close to their menopause and are healthy does not have the
same implications as beginning this therapy in older women such as those
in the WHI study. The kind of estrogen and progestin (natural
progesterone used in KEEPS vs. a synthetic used in WHI) also matter.
Each woman has different needs and a different medical profile. Now we
can begin to take all of these factors into account when considering the
use of hormone therapy.
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