Ensuring The Safety of Testosterone Replacement Therapy for Men

Written by Dr. White, Published on September 13th, 2014

Late last year, an article was published by the Journal of the American Medical Association that suggested that Testosterone Restoration was associated with an increased risk of stroke, heart attack, and general mortality in males suffering from Low-T.

Largely as a result of this study, the FDA now requires that all Testosterone Therapy Manufacturers clearly note these potential risks associated with therapy on every dose of Testosterone Treatment. There’s no reason to have issues with the FDA in this case, because that’s a reasonable step to take, but the study which precipitated this change in Testosterone Labeling was highly flawed, and an example of media entities taking studies in a vacuum and treating them as the definitive word on a particular treatment.

JAMA Testosterone Study Flawed

In reality, this Testosterone Study is highly flawed, at least when considered as a potential indictment against Low-T Treatment for men suffering from Testosterone Deficiency and Andropause. There’s even the risk that this study could lead patients that could seriously benefit from this form of Hormone Therapy Treatment to avoid life-changing treatment because of the unwarranted fears suggested by this study. In fact, there are many medical professionals that say the the effective validity of this study with regard to Testosterone Therapy prescribed and administered with care and caution is effectively nil.

Over the past decade, there have been a number of studies that provide strong evidence that Low-T Treatment with Bio-Identical Testosterone has the ability to both mitigate mortality risk while also safeguarding the heart from cardiovascular disease. For example, research released by the Journal of Clinical Endocrinology and Metabolism in June of 2012 provided the opposite evidence of the JAMA study—and found that Testosterone Replacement significantly reduced mortality risk among veterans with Low-T by almost 40%.

Testosterone Deficiency Leads to Increased Mortality Rates

It’s also incredibly clear in the scientific literature than males with Clinical Testosterone Deficiency have significantly higher mortality rates than their peers. Another study from JCEM, published in 2007 involving nearly 800 men from 50-91 years of age presented evidence that men with very low Testosterone Levels are at a much higher general mortality risk. These patients were followed for a total of eleven years, and it was found that the bottom 25% of patients ranked by Serum Testosterone Concentrations had a 40 percent increased risk of death than those with normal Testosterone Levels. Low-T was also strongly correlated with cardiovascular disease.

How Can Testosterone Therapy Also Contribute to Heart Risk?

Now the JAMA study, when compared to the results of this 2007 JCEM study, begs the question—How can both Low Testosterone and Testosterone Therapy both be linked to increased mortality and heart disease risk? There are a number of reasons for this. For example, in the JAMA study, the researchers explain that only six in ten patients ever had their Testosterone Levels monitored after they were initially prescribed the therapy. This is a major issue, because follow-up therapy is absolutely necessary both to assess the success of the therapy and to monitor for any potential side-effects. It was also found that on average, the patients that received Testosterone Therapy did not receive enough of the treatment to provide optimal benefits associated with Low-T Treatment.

Another major issue with this study is that two side-effects of Bio-Identical Testosterone Therapy were not adequately evaluated or mentioned—Red Blood Cell Count and Estradiol Levels. This is also a major problem because many physicians that prescribe Testosterone to their patients don’t pay enough attention to these two factors, which actually play the biggest role in the more dangerous cardiovascular side-effects associated with Low-T Therapy. If these two factors are appropriately accounted for, the safety profile of Bio-Identical Testosterone increases dramatically.

Testosterone and Erythrocytosis

In many patients, Low-T Therapy leads to a condition known as Erythrocytosis, in which the bone marrow produces more Red Blood Cells than normal, potentially leading to issues such as hypertension and blood clotting which increase the risk of a number of severe cardiovascular maladies. This condition literally causes the blood to become too thick. There are two simple ways to treat this condition and mitigate the risks associated with it—dropping the dosage or draining blood (which can be as simple as visiting the local Red Cross). Unfortunately, the patients analyzed in the JAMA research did not receive this care.

Testosterone and Estradiol

Furthermore, patients in the JAMA study were not effectively monitored for estradiol levels. As a part of the natural hormone cycle of the human body, some Testosterone is naturally turned into estradiol. This is called aromatization. Elevated Estradiol Levels are the mechanism by which the body tells the brain that Testosterone Production is too high, which suppresses Testosterone Levels and brings Estrogen back into balance. Of course, when you take Testosterone Therapy, the signals sent to the brain by Estrogen have no impact on Testosterone Concentrations, which elevates Estrogen Levels.

Elevated Estrogen Levels have long been associated with negative cardiovascular issues in men. In the JAMA Testosterone Study, patients were not evaluated for Estrogen Levels at any point, so there is no way to separate cardiovascular risk resulting from Estrogen or Testosterone. Resolving the issues associated with elevated Estrogen Levels is as easy as providing the patient with a single daily pill. Arimadex (anastrozole) is an Estrogen blocker which suppresses the activity of Estrogen, including the negative effects associated with male cardiovascular profile. The male body requires a specific level of Estrogen—not to high, and not too low. With use of Estrogen Inhibitors and blood monitoring, it is possible to keep Estrogen Levels balanced, and it is possible to vastly improve the safety profile of Testosterone, which is not acknowledged in the JAMA literature.

Testosterone and DHT

Another issue with Testosterone, is when levels are too high, too much of the hormone gets converted into DHT, also known as Dihydrotestosterone. The levels of DHT in the bloodstream are directly correlated with the levels of Testosterone, so if a patient receives too much Testosterone and does not get properly evaluated, he puts himself at risks associated with elevated DHT Levels, including male pattern baldness, prostate enlargement, and cardiovascular disease.

Testosterone Therapy Safe if You Follow The Guidelines

As you can see, there are risks associated with Testosterone Therapy, but most of these risks are associated with byproducts of Testosterone that are the result of overdose or can be easily prevented or mitigated with regular monitoring. By choosing a knowledgeable Hormone Therapy Provider, you can get the most out of treatment while also minimizing the risks associated with such therapy.

Don’t let the risks outlined in this study prevent you from getting the care you need and deserve. There is no reason to resign yourself with the slow physiological decline associated with Low-T. Talk to a licensed and board certified clinical specialist to find out more.

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