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 pubication 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.
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.