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, WHI evaluated women well past the age of
menopause, with the average age of 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 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.
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.
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. If initiated, the
risks and benefits must be continually re-evaluated as long as
the patient continues to use them. 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, data provided by the
WHI should only be applied to women with the same
characteristics and given the same treatment as those who were
studied in the trial. 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 for a
thorough review. Over the past several years, more
large, European population-based studies have been published,
including EPIC trial, 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 evaluation.