two physicians’ effort to expose their colleagues to TPI therapy the general recognition of this safe and remarkably effective from of TRT has been limited. Furthermore, knowledge of its use and relevant clinical and scientific studies, as well as knowledge of training venues to allow interested practitioners to learn how to use TPI has been lacking. At the December, 2012 A4M national conference in Las Vegas where I spoke on TPI, many well trained anti-aging physicians came up to me after my presentation and told me they have never heard of it, or if they have they are in the dark as to its benefits and safety. This article is designed to familiarize health practitioners with TPI and encourage them to consider adding it to their therapeutic armamentarium.
TESTOSTERONE DEFICIENCY
Some of the many symptoms of low testosterone include:
•Reduction of muscle mass despite adequate protein intake;
•Decreased muscle tone;
•Weight gain;
•Fatigue, low energy;
•Low self-esteem;
•Decreased level of HDL (high density lipoprotein) the so-called “good” cholesterol;
•Decreased sex drive;
•Mild depression;
•Dry, thin skin;
•Loss of pubic hair;
•Thinning and dry hair;
•Anxiety;
•Hypersensitive, hyper-emotional states;
•Erectile dysfunction (men only).
TRT can alleviate these symptoms. Restoring testosterone to normal levels can help to:
•Improve libido;
•Boost self confidence and self-esteem;
•Increase skeletal and cardiac muscle strength and mass;
•Improve stamina;
•Shed excess body fat;
•Stimulate growth of pubic and underarm hair;
•Maintain bone strength.
Testosterone also has vasodilating properties, which is valuable for patients with atherosclerosis. It also elevates neurotransmitters (especially dopamine), which can help to improve low motivation, depression and memory (especially in men). Finally, it also provides central negative feedback in order to temper overproduction of ACTH (adrenocorticotropic hormone) and cortisol.
When talking about TRT it is very important to consider the symptoms of testosterone excess, which include aggressiveness, facial hair or unwanted hair growth, acne or oily skin (face and body), and edema.
Interestingly there is a very poor correlation between scalp hair loss in men and women with elevated testosterone. Patients with these problems, both men and women, may have elevated dermal dihydrotestosterone (DHT), but almost all of these patients have low serum or salivary testosterone and serum DHT.
TESTOSTERONE DELIVERY VIA PELLETS
Testosterone can be delivered in a number of ways: topically (compounded or commercial), by injection, via patches, sublingually, or by pellet implantation. Each method has advantages and disadvantages. Table 1 lists the advantages and disadvantages associated with the use of commercial gels, compounded creams and gels, and injectable testosterone.
| Table 1. Advantages and Disadvantages of Different Methods of Testosterone Administration | ||
| Commercial Gels (Testim or Androgel) Advantages: •Well-absorbed; •May be more easily covered by insurance; •Single-use tubes, packets, or pumps. Disadvantages: •Strong alcohol odor; •Fixed dosages – not customizable; •Very expensive if not covered by insurance; •Limited to only 1 type of vehicle delivery (a problem if allergic to the gel); •Requires daily compliance – drop-out rate is a factor. | Compounded Creams and Gels Advantages: •Well-absorbed; •Dosage is customizable; •Multiple delivery forms (pumps, Topi-Click® syringes, tubs (with 1/8+ or 1/4 tsp spoons); •May be covered by insurance, but if not, not too expensive; •Multiple hypoallergenic vehicles available if skin allergy is a problem. • Disadvantages: •Thicker than commercial gels – hairy patients may have problems; •Lack of large multicenter studies; •Available only from quality compounded pharmacies (often requiring mail order); •Not uncommon adverse reactions include acne in both sexes and facial hair growth in women; •Aromatization concerns in men often requiring aromatase inhibition. | Injectable Testosterone Advantages: •May be covered by insurance but if not, inexpensive; •Available from all pharmacies; •Well-absorbed when delivered subcutaneously or intramuscularly; •Dosage is customizable; •Administration is not daily—once or twice weekly injections. Disadvantages: •Common adverse reactions include acne in both sexes (face and body), facial hair growth in women, and aggressiveness; •Commonly occurring aromatization to estradiol in men, very often requiring aromatase inhibition. •Pain with injection (not accepted by most women and many men); •Scar tissue/lipomas common form over time in the gluteal muscles; sometimes this interferes with selection of sites for injection |
The first published reports on TPI were in the 1940’s making it one of the first, if not the first, forms of bioidentical hormone replacement therapy. Pellets have the highest consistency of delivery of any form of hormone administration. Clinical trials show that TPI results in therapeutic hormone levels within just 24-hours, and most people feel a difference within 24 to 48-hours, although in some it may take up to 14-days. Pellets usually last for 4-months in women and between 4 and 5-months in men. Pellets do not need to be removed, as they completely dissolve over time. In the event of problems the active metabolites estradiol (E2) and DHT can be impeded by 5-alpha-reductase and aromatase inhibitors.
Reported major advantages associated with TPI include:
•Physiological hormone release – healthy young males produce 6-9 mg/day testosterone, the release rate of a 100 mg testosterone implant is ≈ 0.6 mg/day, therefore 12 x 100 mg pellets will provide > 7 mg/day testosterone;
•Elevations of DHT or E2 are uncommon in those whose levels are normal before TRT is begun;
•Suppression of follicle stimulating hormone (FSH) and luteinizing hormone (LH) is dose-dependent and correlates with clinical effects. As with other forms of testosterone administration the suppression of LH may cause the testicles to decrease in size, although this is much less common than with injections or creams in the author’s experience. In theory, letrozole (Femara®) may prevent this, but human chorionic gonadotrophin (HCG) is the more common method of maintaining testicular size if desired;
•Lack
