To use or not to use hormone replacement therapy (HRT)? To prescribe
or not to prescribe? The answer lies somewhere between always and not at
all. In 2002 the WHI study made us ask these questions. Further study of
the WHI reports that women excluded from the study may have affected the
results. Dr. Zeidman nicely reviews the findings of this landmark study.
— Beverly Vaughn, MD, Medical
Coordinator, Menopause and You Program
WHI Study Background
“I’m so confused! Every day I hear different and conflicting
information about the safety of my hormone replacement therapy. I want
to stay healthy, and I want to stay up to date on the newest
information. I can’t stand my hot flashes and night sweats. And I don’t
want osteoporosis. But I don’t want breast cancer, heart disease, or a
stroke either. What should I do?”
Since the publication of the initial findings of the Women’s Health
Initiative (WHI) in 2002, this is the most common scenario heard in
every gynecologist’s office. Well-read, educated women who had been
following their doctors’ advice and taking HRT were suddenly told
by the media, friends, family, and frequently many of their doctors that
HRT was dangerous, that it didn’t help at all with the concerns it was
meant to help, and that it should be stopped immediately. Medical
opinion regarding estrogen replacement and postmenopausal women’s health
was turned on its ear in the moment it took for a sound bite to be heard
on the evening news or a headline to be read in the daily newspaper.
It’s now time for a reexamination of what the WHI set out to study and
what its initial findings may mean for the individual woman trying to
make the best decision for herself, her long-term health needs, and her
quality of life.
The WHI was the first randomized controlled study of HRT ever conducted
to evaluate the long-term benefits and risks of estrogen/progestin
therapy in postmenopausal women. Its primary goal was to evaluate HRT’s
effects in preventing coronary heart disease in healthy women, a
long-held belief based on many years of observational data. Subjects in
the study were separated into three groups: estrogen/progestin combined
therapy (utilizing the same formula as PremPro 0.625/2.5); estrogen
only, in women who had previously undergone hysterectomy (utilizing
Premarin 0.625); and a placebo group. After 5.2 years, the combined
therapy portion of the study was stopped because the early findings
suggested that there were more risks than benefits to taking combined
HRT, i.e., PremPro 0.625/2.5. Specifically, it was estimated that out of
10,000 women there would be 7 more heart attacks, 8 more strokes, 8 more
blood clots in the lung, and 8 more cases of breast cancer than in women
taking placebo. It was also found that there would be 6 fewer colon
cancer cases and 5 fewer hip fractures in this group as well.
Conversely, after 7 years of the study, women taking estrogen only,
i.e., Premarin 0.625, showed 12 more strokes, but 7 fewer breast
cancers, 6 fewer hip fractures, and no effect at all on the number of
cases of heart attacks or colon cancer per 10,000 women.
The overall conclusion drawn from these studies was that if the only
reason HRT is being utilized, particularly the combined
estrogen/progestin method necessary for women with a uterus, is to
prevent heart disease and osteoporosis, then there are better,
nonhormonal methods to accomplish these goals that don’t confer the
associated risks found in this study. No conclusions were drawn
regarding HRT’s safety when used for the prevention of menopausal
So what does all this mean to the individual woman who may be suffering
from hot flashes, night sweats, and vaginal dryness, and is trying to
make the best decision for herself? Well, there’s a lot more to any
study than just numbers when we’re looking at the individual rather than
at the public as a whole. There are a few points that must be emphasized
when choosing the best course of action.
WHI Study Update
First of all, it must be noted that women who were experiencing symptoms
such as hot flashes and night sweats were excluded from participating in
the study. Therefore, the average age of the participants was older than
the average woman still battling the symptoms of menopause. Older women,
in general, are at higher risk for breast cancer, heart disease, and
stroke. We don’t know what the findings may have been in a younger
population of women, although the newest data released from the WHI
suggest that women aged 50–59 taking HRT may not be at an increased
cardiovascular risk; in fact, there may even be some protection in that
Secondly, the risk for the individual woman still remains quite small.
If the numbers are translated to the individual, the risk is on the
order of less than 0.1% per year of experiencing one of these bad
Thirdly, and for many women most importantly, there is nothing better
than HRT to control the symptoms of menopause; and there is no other
So, does that help the confusion? As with every medical decision we
make, we must evaluate the risks against the benefits for the
individual by taking into consideration her unique needs. The American
College of Obstetricians and Gynecologists has supported the use of HRT
for the relief of menopausal symptoms at the lowest effective dose for
the shortest period that is in keeping with the goals of therapy. Only
the individual can determine, with the assistance of her doctor on an
annual basis, what is a reasonable risk for her in order to maintain her
quality of life.
This article is part of the Menopause and You library,
a Web-based program sponsored by Women’s Health Source.
It is intended as an information resource providing guidelines for
women. As always, check with your own healthcare practitioner with your
specific concerns and questions.
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