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On July 9, 2002, the Women’s Health Initiative (WHI) released
information about the study involving 16,000 healthy women comparing
one group of women taking hormone replacement therapy to another
group taking a placebo pill. The two groups of women and their
doctors did not know which women were taking hormone replacement
therapy and which were not, and the goal was to record the number
of side effects during the eight year study. Five years after
the start of the WHI study, researchers abruptly halted the continuation
after realizing the risks of hormone replacement therapy was unethical
to allow the women to endure. A Mayo Clinic cardiologist and director
of the Women’s Heart Clinic answered questions about what
the WHI study means for hormone replacement therapy.
1. What did this WHI study examine
about hormone replacement therapy and what was the outcome?
2. Does this study apply to me?
3. Should I stop taking hormone replacement
therapy immediately, in light of this study?
4. Should I set up an appointment right away if I’m
taking this type of hormone replacement therapy?
5. What’s the long-term risk of
this type of hormone replacement therapy?
6. What if I want to stop taking hormone
replacement therapy?
7. Is taking this type of hormone replacement
therapy worth the risk?
8. What factors should my doctor and
I discuss at my next visit regarding hormone replacement therapy?
1.
What did this WHI study examine about hormone replacement therapy
and what was the outcome?
This WHI clinical trial studied the effect of hormone replacement
therapy taken as combination therapy — .625 milligrams (mg)
of estrogen (conjugated equine estrogen) and 2.5 mg of progestin
(medroxyprogesterone acetate). This combination is most commonly
prescribed as a single pill (Prempro). But it is also prescribed
as two separate pills — an estrogen (Premarin) and a progestin
(Provera, others).
The study didn't evaluate hormone replacement therapy taken in
other doses or in the form of a patch, vaginal ring or cream —
each of which has its own set of risks and benefits. Another part
of the WHI trial, evaluating the effect of just oral estrogen,
is ongoing.
Researchers ended the combination therapy portion of the trial
early because they said they found that the overall risks of this
therapy, particularly the risk of breast cancer, exceeded the
benefits. Among a group of 10,000 women taking estrogen plus progestin
versus an inactive substance (placebo) over the course of 1 year,
the researchers found these risks:
- Seven more coronary heart disease events
- Eight more strokes
- Eight more blood clots
- Eight more invasive breast cancers
- hey also found these benefits:
- Six fewer colorectal cancers
- Five fewer hip fractures
The study also concluded that women should not start or continue
taking this type of hormone replacement therapy for prevention
of heart disease. TOP
2. Does this study apply to me?
The results of this part of the WHI study apply directly to you
only if you are taking a specific type of hormone replacement
therapy — .625 mg of estrogen (conjugated equine estrogen)
with 2.5 mg of progestin (medroxyprogesterone acetate). This combination
is most commonly prescribed as a single pill (Prempro). But it's
also prescribed as two separate pills — an estrogen (Premarin)
and a progestin (Provera, others). TOP
3. Should I stop taking hormone
replacement therapy immediately, in light of this study?
No. First of all, this news applies only to women who are taking
this specific type of hormone replacement therapy. If you're not
taking this type, this study doesn't apply directly to you. If
you are taking this type of hormone replacement therapy, the risks
for you as an individual aren't so extreme that you need to make
a quick decision. Talk to your doctor at your next health care
visit, and if you don't have one scheduled, consider making an
appointment. TOP
If
you would like to receive more information on hormone replacement
therapy contact us.
4. Should I set up an appointment
right away if I’m taking this type of hormone replacement
therapy?
It isn't urgent, but it's important you talk about it with your
doctor at your next visit. Though this study is significant, the
risk of taking this type of hormone replacement therapy for a
short term — less than 5 years — is low.TOP
5. What’s the long-term risk
of this type of hormone replacement therapy?
The long-term risk of taking this type of hormone replacement
therapy may be an increased risk of breast cancer, heart disease,
stroke and blood clots in the legs or lungs. The long-term benefits
of taking it may be a decreased risk of colorectal cancer and
bone fractures due to osteoporosis.
If you're taking hormone replacement therapy for a medical condition,
such as osteoporosis, or to help relieve menopausal symptoms,
such as hot flashes and vaginal dryness, know that other medications
used to treat those conditions also carry risks. TOP
6. What if I want to stop taking
hormone replacement therapy?
Stopping immediately isn't proved to cause serious side effects.
But by stopping abruptly, you may experience a recurrence or worsening
of menopausal symptoms, particularly if you're taking hormone
replacement therapy for symptom relief. Working with your doctor
to gradually come off the medication over a period of several
weeks may help reduce the effects of quitting the drug. TOP
7. Is taking this type of hormone
replacement therapy worth the risk?
If you're taking this type of hormone replacement therapy to
prevent or manage osteoporosis or to reduce the symptoms of menopause,
the risk of serious side effects is low. Other medications used
to treat these conditions also carry risks. But you may wish to
discuss other treatment options with your doctor — especially
in light of this updated information — to see if there is
a better or more comfortable choice for you. If you're taking
hormone replacement therapy for general health promotion or to
prevent or treat heart disease, the long-term risks may not outweigh
the benefits for you. Discuss your options with your doctor and
possibly consider stopping. TOP
8. What factors should my doctor
and I discuss at my next visit regarding hormone replacement therapy?
Whether you're taking this type of hormone replacement therapy
or another, the first factor to consider is the reason you started
hormone replacement therapy. Then consider if the reason remains
relevant. For example, if you started taking hormone replacement
therapy for hot flashes several years ago, you may no longer have
hot flashes and could stop taking the drug. But if you started
taking hormone replacement therapy for prevention or treatment
of osteoporosis, you may still need to manage your risk.
Next, discuss your hormone replacement therapy alternatives.
Some alternatives may include antidepressants — such as venlafaxine
(Effexor) — bisphosphonates — such as alendronate (Fosamax)
and risedronate (Actonel) — and selective estrogen receptor
modulators — such as raloxifene (Evista). Know that every
treatment has benefits and risks. Discuss what they are for each
of your options and then work with your doctor to decide what's
best for you.TOP
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