Published on February 13th, 2019 | by Sumit Bhowal0
‘Low T’ Therapy Steroids Has Yet To Be Proven: FDA
Even though there are prescriptions from the doctor to take testosterone supplements to help increase the declining testosterone levels of an aging men, according to the U.S. Food and Drug Administration, there is still no guarantee if they are effective or safe.
From the New England Journal Medicine Aug. 20 edition, FDA officials said, the only controlled clinical trials can show whether men can really benefit from the treatment to reverse the age-related decline of testosterone. And the agency is requiring product manufacturer to conduct those trials.
In the present condition, these supplements are approved only for men with certain medical conditions that may cause abnormally low level of hormones such as damage to brain areas that is responsible to produce testosterone. But doctors are free to prescribe these supplements as they see fit since the FDA already approved it. Though this supplements are for men with abnormally low level of hormones, most American men that don’t have medical conditions are still undergoing the therapy to prevent aging process, researchers said.
The numbers of U.S. men on testosterone increased from 1.3 million to 2.3 million between 2009 and 2013, FDA said. The agency also said that the most common reason is the unclear diagnosis of “testicular hypofunction, not elsewhere classified”.
Even though there is still no evidence as to how effective the testosterone is, there are still many who are using it due to the aggressive marketing campaign of the manufacturers alerting men of the following potential effects of “low T”:
- Sexual dysfunction
- Declining muscle mass
- Gains in body fat
Dr. Christine Nguyen, lead author of the FDA report and the agency’s deputy director of safety said “The benefits and risks of testosterone therapy have not been established for the treatment of men who have low testosterone levels due to aging, even if there are symptoms that seem related to the low testosterone”.
It is just normal for the testosterone levels to decline as the age increases. And according to Dr. Bradley Anawait, an endocrinologist and professor of medicine at the University of Washington, in Seattle, there is a “rough correlation” between that decline and symptoms such as sexual dysfunction.
Until now, no one can still differentiate if your symptoms are low T or other factors such as chronic heath conditions, medications or aging itself. And Dr. Anawait said, that men with modestly low testosterone levels would get any benefit from supplement.
FDA is requiring prescriptions for testosterone products to have a warning about the potential hazards because there is a concern that testosterone increases man’s risk of heart attack or stroke. There are many evidences of testosterone but with different results. There is a study that men given a testosterone gel is more likely to develop hardening of heart’s arteries over three years compared to men who are given placebo gel that has no medicine. Though the study did not look at rates of heart attacks or stroke, FDA said that only further clinical trials can show whether those risks are real.
There are still some issues to consider. An older man’s testosterone is considered “low” if it falls below the normal range for healthy young man, Anawait said. She also said “It’s just been assumed that the normal range for young men applies to older men too”.
Another issue is that FDA research shows that many of the men taking testosterone did not undergo testing before getting the prescription to the supplements. There is a study that shows there is no ill effects on man’s heart arteries but there’s also no improvement in sexual function. And according to Nguyen, while it is not clear if testosterone is dangerous for man’s heart, there’s also little evidence that it benefits their well-being.
Men with medical conditions that limit testosterone production, it’s “pretty clear” that supplements can be helpful. The question remains what do you do with the much larger group of men who have “low T” related to aging? Anawait said. He also said that supplements are “unlikely to do much” for most men whose testosterone dips solely due to age.