Regression analysis indicated that increased total BMSFI score was significantly associated with increased total testosterone levels at 6 months. The authors concluded: "In hypogonadal patients, 12-month administration of topical testosterone gel resulted in increased total testosterone and free testosterone levels and significantly improved sexual function."
A Cochrane systematic study reviewed the benefits of testosterone for peri- and postmenopausal women. The authors concluded that “there is evidence that adding testosterone to hormone therapy has a beneficial effect on sexual function in postmenopausal women. There was a reduction in HDL cholesterol associated with the addition of testosterone to the hormone therapy regimens. Due to lack of targeted research, it is difficult to estimate the effect of testosterone on sexual function in association with any individual hormone treatment regimen.”72
Rhoden22 et al.73 point out that benign prostatic hyperplasia (BPH) symptoms are not exacerbated with testosterone supplementation. Cooper et al.74 studied the effect of exogenous testosterone on prostate volume, serum and semen prostate specific antigen (PSA) levels in healthy young men. Participants were given testosterone intramuscularly at doses of 100, 250, or 500 mg a week. Serum testosterone increased, and there was no change in prostate volume or serum and semen PSA. Morales75 and Prehn76 both concluded that there is no evidence to suggest that exogenous androgens promote the development of prostate cancer. Morley77 states that “There is no clinical evidence that the risk of either prostate cancer or BPH increases with testosterone replacement therapy.” A collaborative analysis published in the Journal of the National Cancer Institute in 2008 found that there was no association between the risk of prostate cancer and any hormone measured, including testosterone, DHT, estradiol and others. Gould et al.78 review of 15 studies of testosterone replacement, up to 15 years in duration, showed no increase of prostate cancer risk. Agarwal79 and Sarosdy80 found that testosterone treatment studies of patients with prostate cancer after radical prostatectomy and brachytherapy have shown no recurrences or significant increases of PSA. Morgantaler’s81 study reported dramatic evidence on the safety profile of TRT: 13 testosterone deficient men with biopsy proven prostate cancer were treated with TRT. After 2.5 years repeat biopsies were done and no cancer was found in 54%, there was also no local progression or metastasis found.
Attacks on Compounding Pharmacies
Compounding by pharmacists has been a foundational aspect of the practice of pharmacy. While today the majority of prescription medication is mass-produced by pharmaceutical companies, many patients require custom-made preparations that are prescribed by their physician and compounded by a trained pharmacist.
Compounding pharmacies are strictly regulated the respective state boards of pharmacy. Presently, U.S. Senate Bill S.959 would transfer control of compounding pharmacies to the Food and Drug Administration (FDA). This legislation would give sole authority of the FDA to determine what medications could be used in the practice of compounding pharmacy. Knowing its long time antipathy to bio-identical hormones, you can rest assured that the FDA would inevitably ban compounded bio-identical hormones. This has been its plan since the late 1980s. A series of federal court cases has prevented this. Despite this pending legislation, courts have repeatedly upheld pharmacists’ rights to compound despite repeated attempts by the FDA to challenge the activity. In May 2006, a U.S. District court judge ruled that the compounding of ingredients to create a customized medication in accordance with a valid prescription does not create a new drug subject to the FDA’s approval process (see Medical Center Pharmacy et al. v. Gonzales et al.). Additionally, the U.S. Supreme Court has held as unconstitutional FDA’s repeated attempts to regulate pharmacist compounding.
Attacks on Credentialed Physicians
The American Board of Anti-Aging & Regenerative Medicine (ABAARM) issues Board Certification to individuals with M.D. (Doctor of Medicine), D.O. (Doctor of Osteopathic Medicine), Doctors of Podiatric Medicine (DPM), and M.B.B.S. (Bachelor of Medicine/Bachelor of Science) degrees. The American Board of Anti-Aging Health Practitioners (ABAAHP) issues Diplomate Certification to Doctors of Chiropractic (DC), Doctors of Dentistry (DDS), Naturopathic Doctors (ND), Registered Pharmacists (RPh), scientists (PhD and similar), Registered Nurses, Nurse Practitioners, and Physician Assistants, and Licensed Acupuncturists (L.Ac.).
Through ABAARM and ABAAHP, the A4M is one of approximately 270 specialist medical societies and medical boards, only 24 of which in total have been approved by the American Board of Medical Specialties (the “ABMS”). A self-appointed organization, ABMS most recently approved a medical specialty – nuclear medicine – in 1985, 28 years ago as of this writing. In a field of over 270 specialist medical societies, ABMS approval is an arduous, time intensive, and resource depleting process. The A4M is one of nearly 250 societies that have yet to receive ABMS approval,. Statements that anti-aging medicine is not yet an ABMS-recognized medical specialty mischaracterize the reality of gaining such approval and to infer – improperly – a lack of credibility on the part of A4M.
Currently, A4M’s educational programming awards category 1 AMA/Physician’s Recognition Award (PRA) physician credits, the highest level available for physicians and surgeons. The content of A4M’s academic congresses are closely monitored and supervised by AMA-approved CME accreditation bodies. A4M’s educational programming has consistently received the highest ratings and excellent reviews for the quality of medical educational content by peer-reviewed organizations. A4M’s educational programming has received recognition and support of national governments and universities worldwide.
HORMONE REPLACEMENT THERAPY
History
Hormone replacement therapies with controlled substances such as testosterone and growth hormone have been used since many years. The first testosterone treatment of testosterone deficiency in adult men started around 1940 and since then, for more than 40 years growth hormone has been administered to treat short stature children and since 1985 with the safer, not contaminated recombinant growth hormone, product of biotechnology. In the latter 1980’s, the first clinical trial of adults with growth hormone deficiency were published, and since the beginning of the 1990s, growth hormone treatment of adult patients started in private medical practice.
The concept of Interventional Endocrinology acknowledges the fact that not everyone experiences symptoms of deficiency – relative or absolute - at the same levels. Therefore, taking a comprehensive medical history and physical can act to substantiate the application of replacement/supplementation protocols, in accordance with accepted standards of care. Clear documentation in this regard helps support the physician’s approach in treating the patient.
Safety & Efficacy
To-date, no adverse effects of hormone replacement therapies administered to adults with diagnosed deficiency(ies) have been reported to the US FDA’s Adverse Event Reporting System (FAERS), the national database providing post-marketing safety surveillance for drug and therapeutic biologic products. Likewise, as of this writing, the US CDC’s Medication Safety Program contains no reports of adverse effects relating to HRT.
HGH therapy has been in use for over 40 years on adults and children82, with one of the best safety records in modern pharmacia and whose dose in adults is typically only 1/5 to 1/7 of the pediatric dose and under the strict supervision of an endocrinologist or anti-aging specialist. As of this writing, the US National Library of Medicine’s PubMed database lists over 100,000 peer-reviewed citations on HGH therapy; not a single death or permanent life threatening morbidity has been reported in its use of AGHD in otherwise healthy but AGHD patients.
The side effects of GH replacement therapy, if any, are usually minor
