Optimizing Your Hormone Replacement Therapy With BioTE Pellets

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