Monday 10 June 2019

Testosterone Implants, Benefits and Myths


Introduction [1][2]
-Testosterone is a hormone found in humans, as well as in other animals.
-The testicles primarily make testosterone in men and most often associated with sex drive, it also plays a vital role in sperm production, Women’s ovaries also make testosterone, though in much smaller amounts.
-Testosterone production starts to increase significantly during puberty, and begins to dip after age 30.
-It can boost libido, increase muscle mass, sharpen memory, and bump up energy. Yet, most men lose testosterone with age.
“A reported 20 to 40 percent of older men have a medical condition called hypogonadism and need testosterone replacement therapy (TRT).”
-Successful hormone therapy involves getting just the right dose by the right delivery method for your individual needs, there are patches, creams, injections, and testosterone pellets.
-For delivering a consistent dose on the long term, pellets may be a good option.

Low Testosterone levels
Low levels of testosterone can produce a variety of symptoms in men, including:
  • Decreased sex drive
  • Less energy
  • Weight gain
  • Feelings of depression
  • Moodiness
  • Low self-esteem
  • Less body hair
  • Thinner bones
Testosterone pellets and procedure
-Testosterone pellets, such as Testopel, are small and measure 3 millimeters (mm) by 9 mm and contain crystalline testosterone.
-It is slowly release testosterone over the course of three to six months.
-Implantation is a simple procedure that typically takes only 10 minutes.
-The skin of the upper hip or buttocks is thoroughly cleaned then injected with a local anesthetic to reduce discomfort.
-A small incision is made. Tiny testosterone pellets are placed under the skin with an instrument called a trocar.
-Typically, 10 to 12 pellets are implanted during the procedure.
-These pellets are a long-acting form of testosterone therapy.
-They should deliver a stable, steady dose of testosterone, typically providing the needed level of hormone for four months.

Benefits of testosterone implants [3][4][5][6]
  • For delivering a consistent dose over the long term, pellets are the best option. Pellets deliver consistent, physiologic levels of hormones and avoid the fluctuations of hormone levels seen with other methods of delivery.
  • Extrusion and implantation infection rates at high-volume centers with Testopel® (approved by the FDA) are less than 1 %, and patient acceptance of the procedure is very high.
  • None of the patients who complied with post-implant procedure instructions experienced infection or pellet extrusion.
  • Patient satisfaction was high and serum hormone values were improved.
  • Absence of foreign material within the pellet packaging.
  • Implanted testosterone pellets can normalize testosterone and LH levels and improve symptoms for at least 3 months and up to 6 months in men with hypogonadism, and should be considered as a therapeutic option for hypogonadal men.
  • Increase muscle mass, bump up energy, relieve depression, increase sense of well-being, relieve anxiety, improve memory
  • Increase lean body mass (muscle strength, bone density) and decrease fat mass.
  • Hormone replacement therapy with testosterone implants is superior to oral and topical (both the patch and gel) hormone replacement therapy for bone density.
Relationship between Testosterone therapy and prostate cancer?
There is no relationship.

Study (1)
“The relationship between testosterone and prostate cancer remains complex. While most studies suggest no relationship between testosterone supplementation and prostate cancer incidence and progression, most published studies are reassuring, with most of the discrepancy likely due to methodologic and patient heterogeneity. Current professional society guidelines for testosterone supplementation provide appropriate recommendations for proper patient treatment and monitoring” [7]

Study (2)
“Among men with low testosterone levels and normal PSA, testosterone treatment was not associated with an increased risk of aggressive or any prostate cancer (CaP). The clinical risks and benefits of testosterone treatment can only be fully addressed by large, longer-term randomized controlled trials.” [8]

Study (3)
“Despite the historical reluctance towards use of testosterone therapy in men with a history of prostate cancer, modern evidence suggests that testosterone replacement is a safe and effective treatment option for hypogonadal men with non-high-risk prostate cancer.” [9]

Study (4)
“The authors concluded that men with prostatic intraepithelial neoplasia (PIN) do not have an increased risk of cancer development when treated with testosterone replacement than men without PIN” [10]

Relationship between testosterone therapy and mortality risk?
There is no relationship.

Study (1)
“There appears to be no change in mortality risk overall for men utilizing long-term testosterone therapy.” [11]
The relationship between testosterone therapy and CV Risk
There is no relationship.

Study (1)
“There is no consistent evidence of increased cardiovascular risk with testosterone products” [12]

Study (2)
“Similar conclusions were reached as a joint consensus between the American Association of Clinical Endocrinologists and the American College of Endocrinology in an official position paper that essentially reports that no compelling evidence indicates that T therapy increases CV risk” [13]

Reference: –
  • Medically reviewed by University of Illinois-Chicago, College of Medicine on August 26, 2016 — Written by James Roland https://www.healthline.com/health/what-is-testosterone
  • Medically reviewed by Daniel Murrell, MD on August 24, 2018 — Written by Christine Case-Lo https://www.healthline.com/health/testosterone-pellets#talk-to-your-doctor
  • A Review of Testosterone Pellets in the Treatment of Hypogonadism Andrew McCullough 2014 Oct 3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4431706/
  • Cavender RK, Fairall M. Subcutaneous testosterone pellet implant (Testopel) therapy for men with testosterone deficiency syndrome: a single-site retrospective safety analysis. J Sex Med. 2009;6(11):3177-92. https://www.ncbi.nlm.nih.gov/pubmed/19796052
  • Kaminetsky JC, Moclair B, Hemani M, Sand M. A phase IV prospective evaluation of the safety and efficacy of extended release testosterone pellets for the treatment of male hypogonadism. J Sex Med. 2011;8(4):1186-96. https://www.ncbi.nlm.nih.gov/pubmed/21269402
  • Testosterone Pellet Therapy for Men by Paul Savage, MD, FAARM, ABAARM August 29, 2016 https://www.power2practice.com/article/male-testosterone-pellet-therapy/
  • Testosterone Replacement Therapy and Prostate Cancer Incidence Michael Louis Eisenberg World J Mens Health. 2015 Dec; 33 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4709428/
  • Testosterone treatment and the risk of aggressive prostate cancer in men with low testosterone levels PLoS One. 2018; 13 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6014638/
  • Testosterone Therapy Among Prostate Cancer Survivors Sex Med Rev. Author manuscript; 2017 Oct 1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5026903/
  • Testosterone replacement therapy and the risk of prostate cancer Asian J Androl 2015 Apr 10 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4814970/
  • Testosterone Therapy and Mortality Risk Int J Impot Res 2014 Jul 31 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4312542/
  • Hackett GI. Testosterone Replacement Therapy and Mortality in Older Men. Drug Saf. 2016;39(2):117-30. https://www.ncbi.nlm.nih.gov/pubmed/26482385
  • Testosterone Replacement Therapy and Cardiovascular Risk: A Review World J Mens Health 2015 Dec 23 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4709429/