By Nurse Mark

 

A recently published study in JAMA (the Journal of the American Medical Association) has caused no end of worry among men. It seems that the study is quite clear in it’s conclusions that testosterone therapy does indeed cause an increased risk of death from all causes, including heart attacks and strokes.

Yikes!

Hey fellas, we better run, not walk to our doctors and get off that stuff that we’ve been prescribed, right?

Not so fast guys… let’s take another look at this.

First, what do the final numbers boil down to?

In the group of men that were studied, some 8700 veterans, 20% had “bad outcomes” over the course of the study – meaning they died from a heart attack, stroke, or some other reason. And that was the group that was NOT taking testosterone. In the group that WAS taking testosterone, 26% of the men had “bad outcomes.”

So, a whopping six percent difference between the two groups. That’s the difference between a fifth and a quarter.

And who were these men?

These men were veterans who had undergone coronary angiography – a heart imaging test. Many, probably most, had risk factors for heart problems, including blocked heart arteries. Of course they did – nobody does coronary angiography just for fun!

According to the researchers:

In the cohort [group] of 8709 veterans with a total testosterone level less than 300 ng/dL who underwent coronary angiography, there was a high burden of comorbidities. Approximately 20% had a prior history of MI, 50% had diabetes, and more than 80% had CAD.

 

Wow! “Co-morbidities” ?!?

One fifth of this bunch had already survived at least one heart attack.

Half of the group had diabetes.

Four out of every five of these guys had known coronary artery disease.

Most had additional health problems including high blood pressure and high cholesterol.

Talk about your “ticking time bombs”!

Could the researchers have possibly found a group of men at higher risk? Maybe, but they would have had to work hard to find them – these guys were in rough shape!

So let’s see… We’ll take a bunch of men with cardiovascular problems who are also experiencing the symptoms of low testosterone – low bone and muscle mass; increased fat mass; low energy; and impaired physical, sexual, and cognitive function – and we’ll give some of them testosterone.

The guys that get the testosterone suddenly start feeling better, and some of them might even feel better enough to “over-do” things a bit. Since the body might take a little longer to be stronger than it does to feel better, can you see a potential problem developing here?

“Well, Frank always loved tennis – but he hadn’t played much for the past few years, especially after that heart attack and the stents they put in. But then he saw his doc and started getting those testosterone shots and he was suddenly full of energy. His granddaughter came to visit and he just had to challenge her to ‘best two-out-of-three’ on the tennis court… He passed away that evening, after the big Thanksgiving family dinner – it must have been the testosterone that killed him, right?”

Yeah, sort of…

Or maybe this was a failure on his doctor’s part – perhaps a caution to “start slow, take it a little easy, and don’t over-do it just because you feel like you can” would have been in order… You see, Frank’s idea of excitement and activity for the past few years was sitting in his easy chair watching re-runs of “Dancing With The Stars” – he really hadn’t shown much interest or energy for anything else since the heart attack.

But the numbers don’t lie – it’s a six percent increase in risk of death, right?

Yes, the way the numbers were crunched in this study do show a six percent increase in risk of death.

And the authors of the study acknowledge a number of “limitations” to the accuracy of their work:

1. The study was “observational” meaning that they didn’t actually interact with the participants, they just looked at their records and drew their conclusions from that.
2. They couldn’t know whether the reported testosterone levels were accurate since they had no way of knowing what time of day the tests were done. Testosterone levels vary widely throughout the day.
3. This was a retrospective study – meaning that they got their cause of death information by looking at diagnosis codes in old patient charts – and ICD codes are not always entirely accurate. They didn’t go through the charts to see if the ICD code really matched what was in the patient’s records.
4. This ended up being a small group of patients, followed over a long period of time – this tends be less accurate than looking at a large group of patients over a shorter time period.
5. Finally, they acknowledge that this was a very specialized group of patients – and that this limits any ability to make the study apply to, for example, otherwise healthy men with low testosterone.

 

Well, haven’t there been other studies that show testosterone is dangerous?

Not really. There have been a few that have raised questions, but none that presented any “smoking guns.” One previous study, Adverse Events Associated with Testosterone Administration, also looked at a very small group of very debilitated (sick and sedentary) older men with low testosterone and found that improving their testosterone resulted in marked improvements in health and well-being, but also resulted in an increased risk of “cardiac adverse events”:

RESULTS
A total of 209 men (mean age, 74 years) were enrolled [...] there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity [...]
As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load.

CONCLUSIONS
In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy.

 

So that proves it’s dangerous, right?

No, it proves that if you take a sedentary old guy with low testosterone and make him feel young and spry again with testosterone therapy you might be asking for trouble.

But dangerous? Here’s what the paper Testosterone for the aging male; current evidence and recommended practice has to say:

Contrary to fears of the potential adverse effects of testosterone on cardiovascular disease, there are over forty epidemiological studies which have examined the relationship of testosterone levels to the presence or development of coronary heart disease, and none have shown a positive correlation. Many of these studies have found the presence of coronary heart disease to be associated with low testosterone levels.

 

But is it really safe? Why is the FDA so freaky about testosterone shots?

Guys, there is a big, big difference between anabolic steroid abuse by athletes, bodybuilders and wannabe tough guys and the legitimate medical treatment of low testosterone levels.

The feds are rightly concerned about the sleazy and dangerous side of this issue, and especially concerned with protecting impressionable young people from the dangers of inappropriate testosterone use. Contaminated and counterfeit testosterone products exist. “‘Roid-Rage” and other ill effects from abuse of steroids is a real thing. We really don’t need to have famous sports figures telling kids by example that they can only succeed / be popular / win by taking steroids.

But in their usual fashion, the feds have gone overboard in their efforts to “protect” us, making it very difficult for anyone to receive needed treatment. Testosterone, a hormone that occurs naturally in the human body (both make and female) is now as tightly regulated and controlled as morphine or even heroin!

So, if I’m just a regular guy with low testosterone it might be safe?

According to Testosterone for the aging male; current evidence and recommended practice:

…the effects of testosterone treatment are well recognised and it seems clear that testosterone treatment for aging hypogonadal men can be expected to increase lean body mass, decrease visceral fat mass, increase bone mineral density and decrease total cholesterol. Beneficial effects have been seen in many trials on other parameters such as glycemic control in diabetes, erectile dysfunction, cardiovascular risk factors, angina, mood and cognition.

 

Alright, so what is your opinion on all this, Nurse Mark?

Well fellas, since you ask… I am 58 years young now, and my testosterone levels are still within the “normal range” – so there is no possibility for me to use testosterone replacement therapy legally. But I can assure you that the day my T level falls below the reference range for normal I will be looking to start treatment. In my opinion the medical benefits of appropriately applied testosterone replacement therapy are far too important to be ignored, and the quality of life improvements far outweigh any minute risks that there may be.

However – for me and for all the rest of you men considering testosterone replacement therapy, Dr. Michael Ho, a cardiologist with the VA’s Eastern Colorado Health System in Denver and the lead author of the study that reports the 6% increase in overall risk acknowledged that this “should prompt doctors and patients to discuss potential risks and benefits of using the products.”

It can’t be said more clearly – in testosterone replacement or any other medical therapy – be aware of the benefits and of the risks, and discuss them fully with your doctor. If your doctor doesn’t have the time or doesn’t want to discuss the risks and benefits fully, get another doctor who will.

And don’t allow “studies” like this one to spook you!

 

References:

Testosterone Treatments May Increase Heart Risks: http://www.biosciencetechnology.com/news/2013/11/testosterone-treatments-may-increase-heart-risks?location=top#.UnwXSnBHTD4

Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels: http://jama.jamanetwork.com/article.aspx?articleid=1764051

Adverse Events Associated with Testosterone Administration: http://www.nejm.org/doi/full/10.1056/NEJMoa1000485

Low Serum Testosterone and Mortality in Older Men: Conclusions: Testosterone insufficiency in older men is associated with increased risk of death over the following 20 yr, independent of multiple risk factors and several preexisting health conditions. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2190742/

Testosterone for the aging male; current evidence and recommended practice: Contrary to fears of the potential adverse effects of testosterone on cardiovascular disease, there are over forty epidemiological studies which have examined the relationship of testosterone levels to the presence or development of coronary heart disease, and none have shown a positive correlation. Many of these studies have found the presence of coronary heart disease to be associated with low testosterone levels. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2544367/