Bioidentical Hormones - U.S. Senate Special Committee on Aging

EFFECTS OF POSTMENOPAUSAL ESTIROGEN
supported by [he Heart and Estrogen?
progestin Replacement Study (HERS).
which also tested CEE plus MPA in
women with known coronary artery disease
at baseline.'
Despite tihe early termination of the
WHI estrogen plus progectin trial, the
WHI esirogen-alone trial was continued
with ongoing careful scrutinybyan
independent data and safety monitoring
hoard (DSMB) because the health
risks and benefits had not been adequately
determined. In February 2004,
the National Institutes of Health (NIH)
decided to terminate the interventiot
phase of the estrogen-alone study, prior
to the scheduled close-out interval ofOctober
2004 to March 2005. This report
presents the results of the estrogenalone
trial uisitig available data through
February 29, 2004, prior to notifying
participants ofthedecision on March 1,
2004. Subsequent detailed reports will
include additional outcomes occurring
between the participants last routine follow-up
and the date of trial termination.
An ancillary study ofcdementia and
cognitive function will be reported separately.
Two remaining components of
the WHll clinical trial, testing the effects
of a low-fat eating pattern and, independently.
the effects of calcium plus
vitamin D supplementation, are continuing.
METHODS
Study Population and
Randomization
Detailed eligibility criteria and recruitment
methods have been published.'°
Briefly, most participants were recruited
by populauon-bascd direct mnailtig
campaigns to age-eligible women. in
conjunction with local and national
media awareness programs. Women
weie eligible if they were 50to 79 years
old at initial screening, had undergone
hysterectomy (thereby considered postmenopausal
for enrollment purposes).
and were likely to reside in the area for
3 years. Major exclusions were related
to competing risks (any medical condition
likely to be associated with a predicted
survival of 11.3 mmo/L); or who
tion to assess symptoms and reinforce were treated by their personal health care
adherence. Follov-up contacts by iele- practitioners with prescription estrophone
or clinic visit occurred every 6 gen, testosterone, or selecuve estrogen
months, with clinic visits required an- receptor modulators.
itually. At each contact, adherence to
study medication was assessed, and in- Outcome Ascertainment
formation on symptoms, safety con- Designated outcome events were evalucerns,
and outcomes was collected. ated by review of medical records by
Electrocardiograms were recorded at centrally trained physician adjutdica-
baseline atid at visit years 3, 6, and 9. tors at each clinical center who were
Annual mammograms and clinical blinded to treatment assignment and
breast examinations were required, symptoms related to study medica-
study medication was withheld if these tion. Final adjudication of key cardio-
safety procedures were not performed vascular and cancer outcomes, as well
or the results could not be verified. Par- as hip fractures and deaths, was perticipants
were followed up from the date formed centrally by comparably blinded
of entry until death, loss to follow-up, WHI physician adjudicators, neurolo-
or the tine of a request for no further gists, or cancer coders. Centrally adju-
contact, regardless of their adherence dicated results are reported when avail-
to study medication. Baseline and year able, with locally adjudicated events
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