Testosterone: new proof of its safety


There is abundant literature and scientific information that shows that low levels of testosterone are associated with heart disease and increase in the fat mass in the hypogonadic patients studied.

After an exhaustive review of the enormous volume of medical literature published about this subject, the prescription by a doctor trained personally in the needs of each patient make hormone therapy with bioidentical hormone a safe medium for achieving improvements in the quality of life of patients that may result in healthier aging.

Dr. Francisco Martínez Peñalver – Neolife Medical Team


Testosterone hormone replacement, at the appropriate dosages and in patients who need it, it’s safe and it’s not related to the appearance of dreaded prostate cancer.

In 1942 Charles Huggins began to publish a series of articles that documented the improvement of patients with prostate cancer and which had been subjected to a chemical castration (1). Said research earned him the Nobel Prize for Physiology or Medicine in 1966. The fact of removing sources of testosterone from patients that that should improvement the development of the illness was quickly related to the Testosterone-Prostate cancer axiom and said hormone ceased to be used for cases of age-related hypogonadism for more than 30 years.

In 2004, Dr Abraham Morgentaler published in the medical journal with the highest impact factor, New England Journal of Medicine, his famous article “Risks of testosterone replacement therapy and recommendations for monitoring”, where it is shown that testosterone hormone replacement, at the appropriate dosages and in patients who need it, it’s safe and it’s not related to the appearance of dreaded prostate cancer (2).

testosterone

After a few in which the belief that testosterone hormone replacement was a safe treatment was consolidated, the FDA, the American body that regulates medications, decided to make a change to the label, in the directions for use, about testosterone, adding that it can increase the vascular risk of those patients who undergo the treatment (3).

Prior to the new alert released by the FDA, Androgel, the form of testosterone in a gel that it most widely marketed in the United States, already had 15 alerts in its directions for use about side effects such as gynecomastia, hepatic toxicity, edema and polycythemia, for which there is no evidence in the medical literature or any type of medical support. What’s more, the very alert about a greater vascular risk is full of inaccuracies and vague terms. But what scientific evidence really exists about the relationship between testosterone and cardiovascular events?

There is a group of scientific studies that claim to show that testosterone hormone replacement causes a greater number of vascular events. But when we analyze them, when we take them apart, they contain serious errors in their design, or they have counted as vascular events circumstances such as episodic inflammations of a toe, or others that completely destroy, discredit the results they provide. In fact, on correct design errors in those studies, testosterone really appeared to be a factor that protected against the appearance of cardiovascular events.

By contrast, there is abundant literature and scientific information that shows that low levels of testosterone are associated with heart disease and increase in the fat mass in the hypogonadic patients studied.

February 2016 saw the publication of all the results of the Testosterone Trial, the largest controlled multi-center clinical trial carried out to date. The results confirmed something that doctors already referred to in their daily consultations, that patients improved in all areas of the sexual sphere and in their levels of physical activity, with a greater number of hospitalizations and deaths for any reason in the placebo group compared to the group of patients undergoing testosterone replacement therapy. A sub-study of this Testosterone trial was more specific and studied the incidence of cardiovascular events, without finding any difference between the group that was being treated and the placebo group (4).

Since the FDA alert about a great vascular risk in those patients being treated with testosterone, two metanalyses have been carried out that that did not find a greater risk, but rather the tendency was the opposite, that is, a tendency for vascular events in patients treated with testosterone to be fewer than in the placebo group.

In conclusion, after an exhaustive review of the enormous volume of medical literature published about this subject, the prescription by a doctor trained personally in the needs of each patient make hormone therapy with bioidentical hormone a safe medium for achieving improvements in the quality of life of patients that may result in healthier aging.

At Neolife all the doctors are trained for that purpose and we can state we are really changing how our patients age.


BIBLIOGRAPHY

(1) Huggins et al. Prostatic cancer treated by orchiectomy; the five year results. J Am Med Assoc. 1946 Jun 15;131:576-581

(2) Rhoden EL, Morgentaler A. Risks of testosterone-replacement therapy and recommendations for monitoring. N Engl J Med. 2004 Jan 29;350(5):482-92.

(3) FDA Drug Safety Communications: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use 2015. Available from: http//www.fda.gov/Drugs/Drugsafety/ucm436259.htm

(4) Snyder et al. Testosterone Trials. Effects of Testosterone Treatment in Older Men. N Engl J Med. 2016;374(7):611-624.