AAFP: Dilemma Surrounding
Hormone Replacement Therapy Remains Unresolved
By Mike Fillon
NEW ORLEANS, LA -- October 15, 2003 -- Family physicians face a
dilemma about whether to prescribe hormone replacement therapy (HRT)
for menopausal and post-menopausal patients, despite negative
findings from the Women's Health Initiative Estrogen Plus Progestin
Barbara Apgar, MD, MS, clinical professor, family medicine,
University of Michigan, Ann Arbor, United States, offered her
thoughts during her lecture here on October 4th
at the 55th
Annual Scientific Assembly of the American Academy of Family
In the summer of 2002, the WHI study announced findings that began
to offer women some guidance about hormone use. The postmenopausal
hormone-therapy clinical trial has two parts. The first part
involved 16,608 postmenopausal women with a uterus who took either
oestrogen plus progestin therapy or a placebo. The second part of
the study involved 10,739 women who have had a hysterectomy and are
taking oestrogen alone or a placebo.
The study was to have continued until 2005, but it was stopped in
July 2002 because the study's Data and Safety Monitoring Board (DSMB)
found an increased risk of breast cancer associated with hormone
therapy, and concluded that, overall, risks from the use of the
hormones outweighed and outnumbered the benefits.
More recently, two large observational studies indicated that
long-term oestrogen use increases the risk of ovarian cancer.
- For heart attack, the risk began to increase in the first year of
oestrogen plus progestin use, and became more pronounced in the
- Oestrogen plus progestin was shown to cause more strokes in
healthy women. By the end of the study, the oestrogen plus progestin
group had 41% more strokes than the placebo group -- or 8 more
strokes each year for every 10,000 women.
- Oestrogen plus progestin reduced hip fractures by 34% -- or 5
fewer hip fractures for every 10,000 women.
- The therapy also lowered the risk of colorectal cancer by 37% --
or 6 fewer colorectal cancers each year for every 10,000 women. This
reduction appeared after 3 years of hormone use, and became more
significant thereafter. The number of colorectal cancer cases,
however, was relatively small.
Dr. Apgar framed her lecture around the findings of the WHI. "There
hasn't been anything that's been very promising about using HRT
except for initial studies showing there is a reduction in total
fractures and colorectal cancers as a result of hormone therapy,"
said Dr. Apgar. "So the goal for all clinicians should be to get all
women off hormone-replacement therapy."
Clinicians urging patients to stop HRT have little guidance for the
best protocols to use, Dr. Apgar said. Whether they immediately drop
HRT or attempt to taper the treatment, women face a resumption of
"The process is very tricky," she admitted. "Because the patients
may come off abruptly and have a return of the flashes and other
symptoms, and you may need to bring them back on HRT. "There are no
good data that say abruptly stopping is better than tapering it."
Compounding the problem, she said, is the fact that many women have
turned to unproven natural alternatives.
"None of the alternatives such as black cohosh and soy have been
shown in large clinical studies to be effective," said Dr. Apgar.
"But women are buying all these substitutes thinking they're safer.
We don't know how much you can [consume] and be safe. Is it possible
you may take too much and run into the same problems we've seen in
Options include prescribing lower-dose hormones -- a practice she
encourages -- or changing to transdermal patches, Dr. Apgar said.
Many family physicians are not sure about these solutions, however,
because the health risks are still unknown.
Despite the discouraging situation, she said family physicians can
interpret WHI for their patients' benefit. HRT has no preventive
value, for example, for cardiovascular disease or osteoporosis, and
caries a high risk for some postmenopausal women, especially those
with chronic diseases.
Also, an individual's risk of being harmed by HRT is actually quite
small. Still, each patient has a one-tenth of 1% risk for any single
major health risk, and the cumulative risks of HRT should prompt
cancer and cardiovascular screenings.
"Even though there are no good recommendations about how to wean
patients off of HRT [and no good] research on alternatives, we need
to recognize some women are going to be very symptomatic," advised
Dr. Apgar. "We need to help them through this."
[Study title: HRT Dilemma. Abstract