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Testosterone too dangerous for older men trial stopped

The days of testosterone as an anti-aging drug are over. A halt was called to a US trial, in which older men used testosterone gels, when it became clear that the male hormone dramatically increased the chance of fatal cardiovascular disease. The results of the incomplete study were published recently in the New England Journal of Medicine.

Nearly all studies on the effects of testosterone have been paid for by the industry. And that's a problem. It's possible that these studies give a biased picture of the risks involved, doctors at the Mayo Clinic concluded three years ago. These doctors attempted to determine how good or bad testosterone supplements are for the heart.

Testosterone too dangerous for older men  trial stopped
The American government, the National Institute on Aging of the National Institutes of Health to be more precise, wanted to know whether you can maintain elderly men's condition by giving them testosterone, and therefore it financed the Testosterone in Older Men with Mobility Limitations trial.

In the study, researchers gave the testosterone gel Testim to unhealthy men over the aged of 65 for six months. Testim is produced by Auxilium Pharmaceuticals. The men rubbed 10 g of the gel onto their bodies every day. This amount contains 100 mg testosterone. If necessary, the researchers lowered or raised the dose.

A total of 252 men were supposed to take part in the experiment. Half would get a placebo and the other half would be given Testim. The researchers had only recruited 209 men when a committee decided to call a halt to the experiment. Too many men in the testosterone group had fallen ill.

Testosterone too dangerous for older men  trial stopped

There were a total of 23 'incidents' in the testosterone group. The men developed chest pains, their blood pressure rose, they fainted, had a heart attack, needed a by-pass, had a stroke and there was one death. In the placebo group there were only 5 incidents all of which were less serious than in the testosterone group.

The graph below shows the 'cardiovascular incidents' during the trial, and the one below it shows the 'incidents' for which the subjects had to go to a doctor.

Testosterone too dangerous for older men  trial stopped

Testosterone too dangerous for older men  trial stopped

After the 6 months were up, the researchers monitored the test subjects for another 3 months. During this period there were more 'incidents' in the testosterone group.

The testosterone supplementation did have a positive effect on the subjects' strength. The strength that the men developed on the chest press and the leg press increased, and their stair-climbing performance improved noticeably.

Testosterone too dangerous for older men  trial stopped

The men in the trial were in bad condition. Many had high blood pressure, diabetes or a cardiovascular problem. Their average age was 74. The researchers conclude that older men in this kind of condition should not use testosterone, but do not exclude its use for other groups. "Caution is warranted in extrapolating these findings to other populations, particularly young men who have hypogonadism without cardiovascular disease or limitations in mobility", they write.

The makers of this study are not your average scientists. They are the experts. If these people say that older men should not be using testosterone, then there's only conclusion to be drawn: testosterone is not an anti-aging drug.

N Engl J Med. 2010 Jun 30. [Epub ahead of print].

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