Is Testosterone Therapy Dangerous for Men with Low T?

Hundreds of studies have been done on the safety of testosterone (T) therapy in men. This includes the drug approval testing required by FDA for use of T creams and patches in men with symptoms of low T. And the numerous studies done in the US and around the world looking at giving reproductive aged men T for birth control.

It is likely that in the next decade there will be a testosterone-based male contraceptive.

Is Taking Testosterone Safe for Men?

Numerous studies support that taking T does not increase the chance of prostate cancer, and is especially safe in men who are routinely screened for cancer. The only types of men that should NOT take T, as suggested by the ISSAM, are men with hematocrits over 52%, untreated obstructive sleep apnea, or untreated congestive heart failure — until these issues are treated first.

Recent Research

Getting accurate information and advice regarding the risk of T therapy for men recently got a lot harder. Two recent “retrospective” (observational) studies have made quite a splash in the news.

Researchers in both studies looked back at people’s medical records to observe their health outcomes to see if they had been taking T — and if so whether that increased their chances of strokes, heart attack or death.

Observational studies like these provide low level evidence for medical outcomes.

A classic example from history: At one time people thought that matches themselves caused lung cancer because people who had lung cancer carried matches around to light their cigarettes. The cigarettes actually caused the cancer but “observationally” it looked like the matches were the culprit because smokers were often out of cigarettes at the moment of observation for the study.

All this said, no studies are perfect. One of my main concerns with these recent studies is that they did not adequately take into account that men taking T (with the reported higher incidence of cardiac events) were likely having more sex and higher levels of activity.

Men on T feel better and they are more active–but having sex and going for a run also increases death rates.

Man running
Image Credit: tpsdave

In the recent studies, was it the testosterone or was it certain activities that led to the heart attacks? If we could ask these men, would they still have chosen the T therapy or not? These are questions our current medical knowledge cannot answer. The statistics used in these studies are complex and should be topics of debate in the medical community. They are OBSERVATIONAL studies and should be taken as just that, observations deserving more follow up.

Concerns About Popular Study

In fact, in the April, 2014 Journal of Sexual Medicine, an Editorial Review of one of the studies that has generated a great deal of press (Vigen et al, JAMA 2013), highlighted serious concerns and flaws in the paper. Specifically, the average T level AFTER men were taking testosterone medication in this study was 332 ng/dL (still very low), post therapy T levels should be between 450-500 ng/dL.

We know that low T can lead to increased death rates, were “treated” men in this study dying because their T levels were still too low? The statistics were very complicated with a great many assumptions not based in proven medical science (the lead author is affiliated with a statistics program used in the study). These irregularities lead the editors to state “It is unfortunate that this study with so many flaws has received so much attention in the lay media…”

Another View: Taking Testosterone Lowered Death Rate

In contrast, an excellent study published around the same time (Muraleedharan et al., EJE 2013) found mortality rates in men with Type 2 diabetes and low T decreased from 19% without testosterone therapy to 8% for men taking T.

The summary of this study is consistent with Level 1 (the highest level evidence in medicine) that “Low testosterone levels are strongly associated with all-cause mortality during long-term follow-up, particularly in men with type 2 diabetes.”

This study found that taking testosterone lowered the death rate in men by half if they had low T and diabetes.

Don’t let the media scare you or the men in your life away from feeling better!

- Dr. E

Science can help us nurture and enjoy our sexual selves. 
sexscienceandnature.com

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