Below is a white paper published by Dr. Gary Donovitz the founder of BioTE:
Sub-Cutaneous
Hormone Pellet Therapy- The
Comprehensive
Treatment to Optimize and Balance
Hormones
Using the BioTE
Method
GARY
S. DONOVITZ, M.D., F.A.C.O.G.
The
BioTE
method of hormone replacement is a time tested method of hormone
optimization
that was created from the hundreds of studies performed on hundreds
of
thousands
of patients worldwide to successfully optimize the hormone levels of
women
as
they meander through the “seasons” of peri-menopause and
menopause and men as
the
traverse the “season” of andropause.
After
monitoring outcomes for tens of thousands of men and women who have
benefited
from this therapy, we have found results have been better than
expected
with
more than 96% of patients satisfied and with side effects much less
than that
quoted
in literature.
Hormone
replacement therapy (HRT) is used to treat menopausal symptoms in
women
and
andropause symptoms in males. Most women who take HRT for menopausal
reasons
are given an estrogen/progesterone/testosterone combination, except
those
who
have had a hysterectomy, as they may not need progesterone. HRT has
shown to
reduce
fatigue, improve sleep, improve libido in women and sexual
performance in
men,
decrease muscle loss and reduce body fat (Staland 78, Thom 81,
Brincat 84, and
Davis
95). It also has been shown to reduce irritability, anxiety and
depression. The
symptoms
of osteoarthritis and rheumatoid arthritis are significantly reduced.
Long
term,
men and women will have reduced incidence of Alzheimer’s disease,
heart
disease,
and osteoporosis (Studd 90, Sands 97, Worboys 00). There are multiple
studies
showing
the long term reduction in breast cancer in women using pellet
therapy
(Notelovitz
04, Glaser 2013) 02) rather than the increase in the incidence of
breast
cancer
that has been associated with oral, synthetic methyl-testosterone
(Tamimi 06).
Even
after over 20 years of therapy with hormone implants, the risk of
breast cancer is
not
increased (Gambrell 06).
Hormone
replacement therapy by pellet implantation has been used with great
success
in
the United States, Europe and Australia since 1938, and has been
found to be
superior
to other methods of hormone delivery (Greenblatt49, Mishnell 41,
Stanczyk
88).
It
is not experimental.
Pellets deliver consistent physiologic levels of hormones and
avoid
the fluctuations of hormone levels seen with other methods of
delivery like pills,
creams,
gels and injections (Greenblatt 49, Thom 81, Stanczyk 88). Pellets
are superior
to
oral and topical hormone therapy with respect to relief of menopausal
symptoms
(Staland
78, Cardoza 84).
Hormones
delivered by the subcutaneous implants bypass the liver, do not
affect
clotting
factors and do not increase the risk of thrombosis (Notelovitz 87).
Testosterone
and estradiol delivered by pellet implantation, does not adversely
affect
blood
pressure, glucose or liver functions (Burger 84, Barlow 86,
Notelovitz 84, Stanczyk
88,
Davis 95, Sands 97, Seed 00, Cravioto 01). In fact, testosterone and
estradiol
improved
lipid profiles by reducing cholesterol, reducing triglycerides, and
increasing
HDL
cholesterol (Davis 05). This has positive benefits on the
cardiovascular system.
Hormone
replacement therapy with estradiol and testosterone implants is
superior to
oral
and topical (both the patch and gel) hormone replacement therapy for
bone density
(Savvas
88, 92, Davis 95, Anderson 97). The pellets not only prevent bone
loss but also
actually
increase bone density (Savvas 88, Studd 90, Garnett 91, Savvas 92,
Naessen 93,
Holland
94, Studd 94, Davis 95, and Anderson 97).
Testosterone
replacement therapy in men with subcutaneous implants (pellets) has
been
shown to be extremely effective, convenient and safe (Handelsman 90,
92, 97,
Kelleher
01, 04, Conway 88,Jockenhoval 96, Zacharin 03, Schubert 03, Dunning
04). The
continuation
rate continues to be 93% or above. This is excellent for long term
compliance
and exceeds the continuation seen with all other treatments for
andropause.
The
routine doses of testosterone delivered by pellet implantation in
recent studies are
between
1000 and 2400 mg in men. The pharmacokinetics and pharmacodynamics
are
well
established showing that these doses deliver reproducible physiologic
levels of
testosterone
for 4-6 months. A 6-9 mg daily production of testosterone is a
‘physiologic’
level
produced by the testicle. Peak serum testosterone levels with the
implants are
usually
seen at month one. Therapeutic testosterone levels at month one, are
expected
at
the upper limits of normal for healthy young males (900-1100 ng/dL).
These levels are
necessary
to protect the brain from Alzheimer’s disease, diabetes, heart
disease,
prostate
cancer, osteoporosis and all-cause mortality (Zitzman M. J Clin
Endocrinology
2006).
By month 4 to 5 testosterone levels drop to below 500-600 ng/dL at
which time
symptoms
return and the pellets are reinserted. Each individual has their own
reproducible
levels where symptoms return.
Testosterone
implants have been used in women in 5 continents for decades. Doses
used
in studies are as low as 50 mg and up to 225 mg Glaser and
Dimitrakakis Maturitas:
2004).
Normal testosterone levels are not established in females (Fertility
and Sterility
2002).
Symptoms return when testosterone levels reach the lower end of
endogenous
ranges
(Burger 85). End organ response to testosterone remains optimal
(i.e., relief of
depression,
increase in bone density, relief from insomnia, relief from aches and
pains,
lessened
anxiety, improved memory and concentration, increased energy, etc.)
when
testosterone
levels at 4-6 weeks after pellet insertion are 150-250 ng/dL. Steady
state is
subsequently
is achieved at approximately half of these levels equaling 80-120
ng/dL,
which
is in the physiologic to slightly supra-physiologic range. It
is of primary
importance
to titrate the dose to achieve symptom relief and minimize side
effects,
not
to achieve some phantom blood level.
As women age, testosterone receptors
become
less responsive and more often than not, higher levels of
testosterone are
required
to achieve the clinical outcome desired of symptom relief and
long-term
protection
to the brain, breast, heart and bones. Some
women require upwards of 300
ng/dl
to achieve these results. Side
effects from testosterone therapy in women are
more
of a nuisance and are reversible; there are no known long-term
adverse effects in
women,
even at supra-physiologic levels.
Patient
compliance becomes a non-issue using the pellet modality.
The
method of sub-cutaneous hormone replacement therapy has been
consistent
throughout
the literature. What was needed was a refinement of the pellets
themselves.
BioTE Medical
has established the “gold standard” in pellet preparation.
We
standardized the process and then used independent labs to assure
proper density,
purity,
potency, sterility, dissolution rate, solubility and temperature
tolerance; all of
which
significantly affect how well a patient responds to the therapy. This
extensive
safeguard
allows us to supply pellets with only 3% tolerance for potency (i.e.
our pellets
when
prescribed will nearly match that requested). This is in contrast to
prescribed pills
and
creams which may have 10-30% tolerance. We use no fillers in our
compounded
pellets
and as such purity testing is superior. No pellets are dispensed
until sterility is
certified
and assured.
The
literature is substantial supporting sub-cutaneous hormone pellet
therapy as the
superior
method of hormone replacement in men and women. By using the BioTE
dosing
site (which is based on 30 years of clinical experience), by using
the highest
quality
pellets made in the United States, and by continuing to educate,
supervise and
monitor
all BioTE
practitioners, we at BioTE
have made pellet therapy the superior
method
now available to practitioners and patients across the country. This
has
established
the new standard of care for HRT.
BioTE
has created innovative and industry leading protocols and processes
in properly
balancing
hormones using not only Estradiol, Testosterone, and Progesterone,
but also
natural
support supplements like Vitamins A, D, K, Iodine and DIM. The
BioTE
Method
also
aggressively treats thyroid conditions, as those contribute greatly
to overall
hormone
balance and the well-being of the patient. All serum levels are
tracked pre and
post
insertion as well as annually.
BioTE
tracks and monitors nearly 100,000 procedures performed annually by
our
network
of Certified Practitioners throughout the United States and Puerto
Rico. Any
and
all complications that may arise are also tracked and include
conditions such as
breast
cancer, stroke, heart attacks, DVTs, endometrial cancer and prostate
cancer.
Finally,
BioTE recognizes
there are many medical practitioners that are “experimenting
with
pellet therapy,” and they have had varied (sometimes even
disastrous) results.
After
all, the only thing between medicine and poison is the dose (Aspirin
can be bad if
taken
improperly). However, BioTE
provides all of our practitioners extensive clinical
and
didactic training, as well as 24/7 dosing support thus ensuring the
highest safety
and
efficacy and results for our patients.
For
more info on BioTE Medical please contact info@biotemedical.com
or visit
www.biotemedical.com
