During the last century, medical practitioners and women
alike have become accustomed to talking about bio-identical
hormone replacement therapy (BHRT) in menopause medicine.
But there is a problem with this terminology. Hormones are
not really bio-identical. They can be mimicked, but they
are not identical. Furthermore, they cannot be replaced,
rather they can be restored.
The latest treatment for women in menopause is multi-phasic
rhythmic dosing of bio-mimetic hormone replacement therapy
(BHRT) using natural hormones in a bio-mimetic way. More
than two million women in the U.S. use customized hormones
for menopause symptoms.
"Natural hormones are not bio-mimedic unless the body can
recognize them as hormones, and they are not considered
restoration unless what has been lost is truly restored,"
said Author T.S. Wiley.
"I asked myself if hormone restoration was made of real
bio-mimedic hormones and dosed to mimic the ups and downs
of the hormone blood levels in a normal menstrual cycle in
a 20 year-old woman, would all of the symptoms and disease
states of aging decline?"
Currently an accepted standard for compounded bio-identical
hormone replacement protocol or therapy does not exist.
However, she has created a registered pharmacy system to
circumvent the current lack of legitimacy and availability
of bio-mimetic, currently known as bio-identical hormones,
for testing and study.
Further, a new study is underway at University of Texas and
its multi-phasic physiologic dosing will be called
Bioidentical Hormones On Trial, or B.H.O.T., a comparison
of patterns of administration and dosing of compounded
bio-identical hormone therapy (BHT). This study will be the
first of its kind to track and quantify outcomes based on
dosing and patterns of administration of BHT. The main
objective of the study will be to examine clinical outcomes
and quality of life indicators of patients receiving BHT at
10 to 12 primary care provider's practices.
The results of the study will be used to help establish
which dosage and pattern of BHT administration is most
effective. Results will be used to design a prospective,
randomized clinical trial with the goal of standardizing
BHT dosing and administration patterns.
The study is an observational, prospective study of women
ages 35 to 60 who are current users of compounded
bioidentical hormone therapy (BHT). Clinical care of study
participants will not be changed as a result of study
participation. The duration of the study is three years.
Outcomes to be monitored include quality of life, symptom
relief, and impact of BHT on physical health including
breast, endometrial, and cardiovascular measures.
These critically needed study results will be presented at
national and international meetings, and will be submitted
for publication in professional journals to share the
findings with women's health care professionals. Results
will be used to design a prospective, randomized clinical
trial with the goal of standardizing BHT dosing and
administration patterns.
The primary objectives of the study are to: examine
clinical outcomes and quality of life indicators of
patients receiving bioidentical hormone therapy at 10-12
primary care providers' practices; compare the
effectiveness and safety, and quality of life of
participants using one of three dosing patterns for
bio-identical hormones: multi-phasic physiologic, bi-phasic
or continuous dosing; monitor lab and imaging data of women
using these bio-identical hormones; evaluate the safety of
the hormone regimens by tracking adverse events experienced
by women using bioidentical hormone therapy prescribed by
their PCP's; and assess the performance of compounding
pharmacies in standardizing the products.
----------------------------------------------------
Kristin Gabriel is the marketing communications director
for T.S. Wiley, a medical writer and researcher in
chronobiology, environmental endocrinology and circadian
rhythmicity. Wiley is the author of "Sex, Lies &
Menopause," and the also the developer of The Wiley
Protocol.
(http://www.thewileyprotocol.com )
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