Tuesday, May 20, 2014. A trio of physicians writing in the April 8, 2014 issue of the Journal of Men's Health have called into question the concerns of a February New York Times editorial that unnecessarily alarmed its readers regarding possible harm associated with testosterone replacement therapy, which the Times editorial board insinuates is being indiscriminately prescribed. The editorial in question is based on the conclusion of an article published on January 29, 2014 in the journal PLoS One which reported an increased risk of nonfatal myocardial infarction (MI) within 90 days following an initial prescription for testosterone in comparison with the rate occurring over the previous year among older men and younger men diagnosed with heart disease. The study's investigators also reported a greater risk of MI in association with testosterone when compared to PDE5I inhibitors (which include Viagra®, Cialis and Levitra).
In the Journal of Men's Health article, authors Martin Miner, Joel Heidelbaugh and Abraham Morgentaler object to the Times editorial's assertion that testosterone is oversold to men who are simply reluctant to accept that they are getting older and point out the flaws in the PLoS One investigation upon which their unwarranted criticism of testosterone replacement therapy is based. One of the study's most glaring defects is its utilization of heart attack rates that occurred during a short period of time (up to 90 days or the first testosterone refill, which would be at one month for many subjects) following the prescription of the hormone, which is likelier to implicate underlying insufficiency, rather than its treatment, as a causative agent. Furthermore, overall increase in nonfatal MI following testosterone therapy was small, at 1.27 per 1,000 person-years. This low figure, combined with the small number of events in subgroups, also renders the study's subgroup analysis findings "unconvincing," according to Dr Miner et al.
Additionally, in the comparison of men who were prescribed testosterone to those prescribed PDE51 drugs, a more appropriate control group would have been testosterone-deficient men who did not receive hormone therapy.
"Over-the-top comments are scaring patients and physicians alike, thereby impeding the goal of conscientious physicians to serve their patients with the best available care," the authors observe. "The FDA announcement that it is investigating the reports of increased cardiovascular risks has only added to the impression that a major study has determined serious problems with testosterone therapy."
"It is unfortunate that the study by Finkle et al. has provoked so much unnecessary trouble for men's health, given the obvious weaknesses of the study," they conclude. "For those in the field who have had firsthand experience confirming the importance of testosterone therapy for symptomatic men with testosterone deficiency, we believe the appropriate response is education, reassurance, and support of further research that is designed to examine benefits and risks."
An article published online on November 25, 2013 in the journal Menopause describes a study of hysterectomized women that compared the effects of varying doses of testosterone on sexual function, lean body mass and muscle performance.
"Recently, there has been a lot of interest in testosterone treatment in postmenopausal women for sexual dysfunction and other various health conditions," commented lead author Grace Huang, MD, who is a research physician in the department of endocrinology at Brigham and Women's Hospital in Boston. "However, no previous studies have evaluated the benefits and negative effects of testosterone replacement over a wide range of doses."
The study included 71 postmenopausal women who had undergone hysterectomy with or without ovarian removal. The women were divided to receive weekly injections of a placebo or 3, 6.25, 12.5 or 25 milligrams testosterone enanthate for 24 weeks. Blood samples were analyzed for testosterone levels, and sexual function, lean and fat body mass, muscle strength and power, and physical function were assessed before and after treatment.
Improvements in sexual function, desire, arousal and sexual frequency were associated with increases in free testosterone, as were increases in lean body mass and measures of muscle power, with those who received 25 milligrams experiencing a significant effect. Dr Huang noted that "A primary concern with testosterone therapy is that it can cause symptoms of masculinization among women. These symptoms include unwanted hair growth, acne and lower voice tone. It's important to note that very few of these side effects were seen in our study."
While testosterone was not associated with adverse effects in this trial, the U.S. Food and Drug Administration has not approved the hormone for women. The authors suggest the initiation of long-term clinical trials to further evaluate testosterone's risks versus benefits.
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