Is Testosterone Replacement Therapy Safe?

by TC T-Nation

Here's what you need to know...

•  A dubious study recently appeared that links testosterone replacement therapy to heart attacks, and now the class action lawyers are getting involved.

•  Digging deeper, we see that the researchers didn't consider testosterone levels before or after the study. Neither did they consider post-therapy red blood cell counts or estrogen levels. What's more, the control group appears to have been compromised.

•  T replacement may actually help with certain heart-related issues and has a plethora of other health benefits.

The ridiculous repercussions continue. Back in January, a gas-bloated study surfaced from the research bog. It reported an increased risk of heart attacks in testosterone users in the first 90 days of therapy. The media went nuts and I got a lot of worried emails from panicked testosterone users clutching their chests for fear of a no-doubt already failing heart.

I didn't speak out publicly against the report because horse**** studies that draw attention to themselves by seemingly refuting numerous other studies come out all the time and they only see the light of day because they're catnip to faux news agencies looking for ratings. Most of the time, the studies fade from notice or memory because these news agencies invariably turn their attention to the latest celebrity that killed a lover, made a racial slur, toilet papered a neighbor's house, or slipped a nip on stage.

But now the lawyers have gotten involved and I can't watch a ballgame without seeing ads fishing for poor bastards who might have suffered a stroke or even death from using testosterone replacement therapy and who might want to join in a class action suit. (Can dead people sue? How's that work?) Man, I've got three close friends who are lawyers, but if I found out any of them were involved in something like this, I'd lobby to have them banished to the island of Litigia, a remote island inhabited by litigious soles whose national pastime is suing each other for having slipped on the banana peels that cover the roads, sidewalks, and driveways and whose laws prohibit lawyers from doing anything other than pro bono, or in this case, pro banana, work. It'd serve them right.

A Closer Look at the Study
Let's drag this study onto the examination table and take a surgical saw to its chest and poke around its guts a little. What the researchers did was scour a large healthcare database for guys who'd been on testosterone therapy for 90 days. They found that younger guys with a history of heart disease who started T therapy had a two to three-fold increase in the risk of myocardial infarction. Further, they found that guys over 65 who started TRT had a two-fold increase in cardiovascular disease regardless of their cardiovascular history. As I'd expect, they didn't find any increased risk in younger men without a history of heart disease. Too bad most of the media reports ignored the particulars and left you with the impression that testosterone therapy was universally equivalent, heart-health wise, to taking the two-inch wide pieces of fat and gristle you cut off the $1.99 steak you bought at Chuck's Heart Attack Café and having them surgically packed into your left ventricle.

But let's momentarily forget about which age group had more problems and let's autopsy this study a little more. The first NCIS moments come when you see that the study didn't bother to look at or consider testosterone levels before or after the study. Neither did they consider post-therapy red blood cell counts or estrogen levels. Ack!

How do you assess proper dosages if you haven't measured before or after T levels? Test replacement therapy isn't a one-size-fits-all scenario. No doctor would prescribe chemotherapy drugs without assessing the effects and side effects so that necessary dosage adjustments could be made. Hell, a physician wouldn't even prescribe a fiber supplement without checking to see if the effects were too little, just right, or producing stools the size and consistency of bales of hay that you place in stacks outside your apartment but look wildly out of place because you don't have a barn.

If you prescribe too much testosterone, you run the chance of a higher-than-desirable red blood cell count, which in itself could lead to heart attack or stroke. If your RBC is too high, you need to, at the very least, donate some blood and get a cookie. Alternately, you can adjust the dosage of testosterone. Of course, they didn't measure red blood cell counts anyhow so it's a moot point, but their basic testosterone 101 negligence didn't stop there. As mentioned, they didn't account for estrogen levels, either. Since some patients have higher levels of aromatase, they convert a proportionately greater amount of testosterone to estrogen, which in itself has been associated with increased rates of heart attack and stroke. As with red blood cells, high levels of estrogen can be countered, either by administering anti-aromatase drugs or supplements or by reducing the dosage of testosterone.

Testosterone
The biggest flaw in the study, though, or at least the most ridiculous one, had to do with the control group chosen by the researchers. They figured that higher levels of T led to more sex, and more sex, at least in old farts, can lead to heart attacks. So the researchers looked for another group that might be having more sex and in a remarkable display of one-dimensional thinking, they chose men who take PDE5 inhibitors, a class of drugs that's used to treat erectile dysfunction. Viagra and the other commonly known boner pills fall into this group of drugs.

On the surface, it makes sense to compare two groups of sex-minded men, both of who are now presumably having more sex because of pharmaceutical intervention. Fair enough, and when they compared the two groups they found that the testosterone users were either twice as likely or three times as likely to have heart attacks or strokes as the PDE5 users. The trouble is, PDE5 drugs relax blood vessels and some have even been approved for the treatment of hypertension. You see what I'm getting at? The guys on the boner pills were in effect taking a heart med to reduce cardiac events! How can you possibly use them as a control group? Ack again!

So was the increased risk of heart attack a result of "deadly" testosterone, or was it because of a failure of basic diligence -- a failure to assess before and after levels of T, a failure of prescribing physicians to do routine blood tests so that potential problems could be addressed or, most fundamentally, a failure to determine if the patients were even suitable candidates for testosterone replacement? Or was it a case of choosing a control group that was actually taking a heart-attack thwarting cardiovascular drug that ended up skewing and screwing the results?

It was all those things. Even if this study didn't have all these horrible shortcomings and showed the same results, you'd still have to consider it an outlier. A month before this ridiculous study appeared in the journal Plos One, another study appeared in the Journal of the American Heart Association that looked at 100 testosterone studies and found that low testosterone, contrary to what the Plos One study said, was associated with higher rates of mortality in general, along with higher rates of cardiovascular mortality, obesity, and diabetes. Additionally, the severity of the disease correlated with the degree of testosterone deficiency.

The Real Effects of TRT
According to the meta-analysis study in the heart association journal, T therapy relaxes coronary arteries and improves the ability of heart failure patients to do exercise. It improves insulin resistance, reduces the A1c level in diabetics (an indicator of the severity of the disease), and even lowers BMI in obese patients. Oh yeah, it also improves muscle mass and increases the zest for life and makes it more fun to look at naked pictures. But let's say for the sake of argument that testosterone actually did cause heart problems in certain age groups. Let me quote famed testosterone researchers Eberhard Nieshlage and Hermann Behre:

If testosterone in physiological doses should cause "side" effects these would indeed be the normal biological effects. The risks inherent to testosterone, be it of endogenous or exogenous origin, would then appear to be the tribute men have to pay for being men.

Source: http://www.t-nation.com/training/tes...safe-or-deadly