Misleading Testosterone Study Challenged
Steven F. Hotze, M.D., David Sheridan M.D.
November 24, 2013
“Beware of statisticians!”
On November 6, 2013, the Journal of the American Medical Association (JAMA) published a study on the effects of testosterone in veterans who had known heart disease. The study purported to demonstrate that testosterone therapy in veterans had increased their risk of heart attacks, strokes and overall mortality when in fact the raw data reveals just the opposite conclusion. News media from across the country picked up this story and began to warn about the supposed dangers of testosterone.
The Wall Street Journal (WSJ) wrote “Of the men, 1,223 had testosterone therapy—and nearly 26% of them suffered a heart attack, stroke or died for any reason within the next three years. That compared with 20% of those not taking testosterone.” This statement was derived from a sentence in the result abstract which reads, “The absolute rate of events were 19.9% in the no testosterone therapy group vs. 25.7% in the testosterone therapy group.”
The raw data presented in this study does not support these conclusions; in fact just the opposite conclusions should have been reached.
So let’s look strictly at the numbers that are given.
This was a retrospective study of 8,709 males who were being treated at the VA medical facilities, who had undergone a coronary angiography and whose total testosterone levels were <300ng.dL. They were divided into two groups; 7,846 patients who were not treated with testosterone and 1,223 who underwent testosterone therapy. The average follow up was 27.5 months. Let’s look at the data presented in the study and do our own analysis.
Group 1: 7,846 no testosterone therapy Group 2: 1,223 received testosterone
1) 681 died (9.1% mortality rate) 1) 67 died (5.5% mortality rate)
2) 420 had MI (heart attacks) (5.4%) 2) 23 had MI (heart attacks) (1.9%)
3) 486 had CVA (strokes) (6.2%) 3) 33 had CVA (strokes) (2.7%)
4) 1,587 total events from (1-3) (20%) 4) 123 total events from (1-3) (10%)
Analyzing the data reported, the group of veterans treated with testosterone had a lower mortality rate, as well as a lower incidence of both heart attacks and strokes, and a lower incidence of combined adverse events. It is just simple math that leads to these results.
The aging process involves the inevitable decline of naturally occurring hormones including testosterone. It has been demonstrated in numerous studies that men with the high levels of testosterone have less cardiovascular disease, and a decreased incidence of diabetes and hypertension as compared to men with low levels of testosterone. The decline in testosterone adversely affects men’s initiative, assertiveness, sense of well-being, self-confidence, moods, goal orientation, drive, decisiveness, and analytical ability. These are all brain functions. Supplementation with physiological doses of testosterone restores these behavior patterns.
Testosterone enhances the conversion of T4 to the active thyroid hormone, thus raising the metabolism. It also improves muscle tone, mass and strength, libido and sexual ability.
Even if the results of the study that were published were correct, there are several problems that would make the conclusion questionable.
1. There was no standardized dose of testosterone mentioned. Testosterone was prescribed in gels, injections and patches. It was not noted whether the testosterone was bioidentical or methyl testosterone. 2. The follow up blood levels of those treated with testosterone averaged 332 ng/ld. after an initial average of 175 ng/ld. This is still a very low level of testosterone. Studies have demonstrated that health benefits begin to occur when testosterone levels are above 550ng/dL. 3. There were no estradiol levels reported for the men taking testosterone therapy. It must be assumed that estradiol levels were not checked. This is a serious oversight which indicates that those administering the study are unaware of the adverse effects of elevated estradiol in men. Testosterone may be converted to estradiol by the enzyme aromatase. This is especially common in men who are overweight. There is no mention of the average body mass index of the treated patients. Elevated estradiol levels increase the risk of clots, leading to strokes and heart attacks.
It is unfortunate that this study was accepted for publication without doing a thorough analysis of it methodology and conclusions. Because of the media attention that it was given to this study, there may be millions of men who will be denied the benefits of bioidentical testosterone replacement therapy by their physicians.