Human Identical Hormones for Hormone Replacement Therapy
by Phillip Warner, MD and Paul Hueseman, RPh, PharmD
October 2002
brought to you by Bellevue Pharmacy, a ProjectAWARE
sponsor
The abrupt cessation of a branch of the Women's Health Initiative
Randomized Controlled Trial (WHI), a study funded by the National
Institute of Health (NIH), caused a media frenzy and raised concerns
regarding Hormone Replacement Therapy (HRT) by both the professional
and lay community. Interestingly, this WHI study was actually one
of two studies which had results published at approximately the
same time. The other study was the Heart and Estrogen / Progestin
Replacement Study Follow-up (HERS II) study.
The WHI trial consisted of 16,608 post-menopausal women age 50-79
years with an intact uterus at baseline who were recruited by 40
US clinical centers from 1993-1998. The women took Premarin 0.625
milligrams plus Provera 2.5 milligrams (a combination called PremPro)
each day, or they took a placebo (a similar pill with no medication)
each day, and were unaware of which pill they were taking. The Women's
Health Initiative was asking the question "Does hormone replacement
with PremPro decrease the risk of chronic disease in healthy women
who have their uterus and ovaries?"
This study was ended early on May 31, 2002 after 5 years due to
an increase in the risk of breast cancer of 26% in the group receiving
PremPro. Because this study was ended early, it is difficult to
interpret the results for heart disease. However, preliminary results
(those that were seen with the amount of time that elapsed during
the study) demonstrated that there was an increased risk for non-fatal
heart attacks, stroke, and blood clots (deep vein thrombosis (DVT)
and pulmonary embolism (PE)). Again, it is important to note that
because this study was ended early, it is difficult to determine
whether these "heart effects" would have been reduced
with continued treatment once the "initial high risk period"
of treatment is complete. Benefits from treatment in this study
included a reduction in fractures, conferring protection from osteoporosis
or "bone disease". The authors of this study commented
that "the results of this study do not necessarily apply to
other formulations of oral estrogens and progestins (natural progesterone)."
In addition, they stated that "it remains possible that estradiol
with progesterone, which more closely mimics the normal physiology
and metabolism of endogenous sex hormones, may provide a different
risk-benefit profile".
The recently published HERS II study consisted of 2,321 post-menopausal
women in which treatment with hormones (most patients received Premarin
0.625 mg) was compared to no hormone treatment to evaluate the benefit
on coronary heart disease, as well as non-cardiovascular effects
such as cancer. This study demonstrated no differences with regard
to cardiovascular (heart) effects for patients who were treated
with hormones versus patients who received no treatment with hormones.
Additionally, this study showed that after an initial treatment
period of 2 years with hormones, the risk of blood clots declined
to a non-significant difference. Therefore, long-term there is no
increased risk of blood clots. The HERS II study also demonstrated
that there were no differences between the hormone group and the
placebo (sugar pill) group in the incidence or occurrence of any
types of cancer.
Both of these studies strengthen the idea that Hormone Replacement
Therapy (HRT) should be in the form of Human Identical Hormones
(HIH), and not products like PremPro and Premarin that are totally
foreign to the human female. The concept that estrogens and progesterone
coming from horse placentas or created in the laboratory will have
positive long-term benefits in the human female simply makes no
sense. The Human Identical Hormones (HIH) match exactly the estrogens
and progesterone made by the ovary, and therefore fit exactly on
the cell receptors as nature intended. These hormones are extracted
from various plants and have been available by prescription for
many years.
There have been some studies with positive benefits of HIH in reducing
the risk of heart disease, osteoporosis, stroke, cancer and Alzheimer's
disease. Generally, these studies showed no increased risk of breast
or endometrial cancer. Clearly, there have been contrasting results
with PremPro, and the authors of the WHI trial have even alluded
that the results may have been different with HIH. The bottom line
conclusion is that continued clinical research is needed to further
prove the benefits of HIH in preventing heart disease, stroke, cancer,
and Alzheimers disease in absence of an increased risk of
breast cancer. In the interim, however, hormone replacement therapy
with HIH continues to help women in many ways, including improvement
in quality of life, by treating various symptoms associated with
menopause.
For questions and further information, contact Bellevue
Pharmacy.

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