FAQ on the risks of HRT
Q. Do the results of the Women's Health Initiative (WHI) apply to
bio-identical hormones?
A. The Women's Health Initiative
specifically studied a population of women who were broken into 3
separate arms of the study: one arm received premarin, a second
received prempro, and a 3rd arm received placebo. Bio-identical
hormones were NOT studied in the WHI. Many physicians have
extrapolated the results of the WHI to bio-identical hormones,
implying varying side effects with all forms of HRT, which cannot be
proven at this time, as the WHI did not use bio-identical hormones.
Conversely, other practitioners have also claimed that bio-identical
hormones are superior and safer based on negative results of the WHI
using pharmaceutical agents. This is also extrapolation and cannot
be proven at this time. Whether positive or negative, the only
hormone regimens for the treatment of menopausal symptoms which have
had proven results in large-scale (high statistical power),
gold-standard trials of placebo-controlled, randomized, double-blind
studies to date include premarin and prempro, but NOT the typical
bio-identical skin preparations such as Bi-est, Tri-est, or
progesterone creams. Furthermore, most randomized, controlled trials
(WHI included) have tested women well past the age of menopause.
For example, the average age of women in the WHI were 63.5 years
old, and only slightly over 20% of the studied women had ever been
on HRT before entering the trial. Numerous critiques have
ensued in the years following the initial publication of the WHI
results, most of which have pointed to the proven protective effects
of HRT in women less than the age of 60, indicating a "window
of opportunity" to replace hormones quickly after women lose
them, rather than waiting 10-15 years AFTER menopause. In
fact, several large organization bodies have revised their
guidelines since 2002, indicating the importance of not missing this
"window of opportunity" for women less than the age of 60
years old. For an excellent unbiased critique of the WHI, I
recommend readers study the position statements by the Expert Panel
of the International Menopause Society (IMS), revised in 2004, and
again in 2007, with recent updates from 2008. This is available
on-line at www.imsociety.org.
Although
there are numerous studies in the scientific literature documenting
beneficial effects of estrogens, over 90% of all such studies were
done with premarin/prempro products, so once again, extrapolation is
rampant. Furthermore, many studies were done on animals and such
results cannot necessarily be directly applied to humans with
certainty. In recent years, there have been small human trials
(compared to the large scale of WHI) looking at low doses of
estrogen +/- progesterone or synthetic progestins and their
abilities to prevent bone loss and treat menopausal symptoms. Such
trials generally use bio-identical FDA-approved name brand estradiol
patches and not the bio-identical Bi-est or Tri-est creams, which
are commonly prescribed by physicians focusing on anti-aging
medicine, and have mostly yielded positive results based on
individual physician feedback.
Thankfully, large randomized,
placebo-controlled studies are underway now using bio-identical
hormones in order to give us vitally-needed information for
comparison. These include the KEEPS (Kronos Early Estrogen
Prevention Study, a 5 year study funded by the Kronos Longevity
Resesarch Institute, results due out in 2011), and BHOT
(Bio-identical Hormones On Trial, a study now in its data collection
phase, via the University of Texas).
Q. Will using hormone replacement therapy (HRT) increase my risk
of heart disease and breast cancer?
A. These types of claims
are largely based on the WHI results, and do not necessary apply to
everyone. The decision to start HRT or not is a very individualized
process, based on each woman's specific situation, risk factors,
quality of life, among other factors in weighing the pros and cons.
In interpreting the WHI results, I agree with the Expert Panel from
the IMS that "the WHI study was not designed, and therefore was
not powered, to investigate the consequences of hormone therapy (HT)
in women below 60 years of age. Therefore, any attempt to present
the results of the study as indicating the HT may inflict damage to
the heart in general--a message that was accepted by many medical
societies and regulatory authorities--is simply wrong and must be
amended". Furthermore, re-analysis of the WHI data actually
showed a 25% reduction in the risk of breast cancer in the women
given premain only. Once again, falling prey to such comments
represents extrapolation of the WHI data, when clearly such data
should only be applied to women with the same characteristics and
given the same treatment as those who were studied in the WHI. Once
again, I refer patients to the position statement by the Expert
Panel of the International Menopause Society for a thorough critique
of the WHI at www.imsociety.org.
Over the past 2 years, more large, European population-based
studies have been published looking specifically at cyclical vs.
continuous/combined HRT, with reference to the potential of
increased cardiovascular side-effects. Such results thus far favor
cyclical approach with specific reference to cardiovascular
protection. There is also continued varied opinion among more
recently published results with reference to breast and ovarian
cancers. Once again, risks vs. benefits profile needs to be
carefully assessed in each individual patient, based on her own risk
factors, and sweeping conclusions can not be given without a
thorough evlauation.