Testosterone therapy benefits elusive, JAMA studies find

The testosterone gel used in a series of trials assessing health effects. AbbVie

The studies were published Tuesday in the Journal of the American Medical Association and JAMA Internal Medicine.

But there are conflicting studies when it comes to testosterone improving older men's health. Among men using the testosterone gel, there were statistically significant improvements in lumbar spine and hip bone density and bone strength.

A separate study published Tuesday in JAMA Internal Medicine found that men using prescription testosterone gel, patches or injections had fewer heart attacks and strokes during about three years of follow-up than non-users. Their Testosterone Trials (TTrials) covered 788 males ages 65 and above who had low testosterone levels. Today's publications of the Bone, Anemia, Cognition and Cardiovascular Trials conclude the primary results of the study.

Hence, the group then screened men 51,085 men to find 790 who has low testosterone levels and those who qualify for their remaining criteria to participate in the study.

The effectiveness of synthetic testosterone are claimed to be controversial.

Further, testosterone treatment also increased haemoglobin concentrations, corrected the anaemia of men who had no other identifiable cause of anaemia and corrected the blood levels of men who had an identifiable cause, such as iron deficiency. We studied the effects of testosterone treatment for one year as compared to placebo for men 65 and older with low testosterone. One study, part of the Testosterone Trials, linked testosterone treatment with more plaque buildup in the vessels that carry oxygen-rich blood to the heart.

In the United Kingdom, men have to see a doctor to get a prescription, although some buy it on the internet.

The four 12-month, placebo-controlled studies won't resolve the long-standing medical debate over the usefulness of testosterone replacement therapy.

Overall plaque volume and coronary artery calcification scores by CT angiography were similar between groups in their study within the Testosterone Trials ("T Trials"), the first of which showed an increase in libido but not vitality. The TTrials were also supplemented by funds from the National Heart, Lung and Blood Institute, National Institute of Neurological Diseases and Stroke, and National Institute of Child Health and Human Development.

"Final decisions about testosterone treatment for older men will depend on balancing the results from these seven TTrials with the results from a much larger and longer-term trial created to assess cardiovascular and prostate risk in the future", he says.

"The results on diverse outcomes indicate the potential trade-offs between benefits and risks of testosterone treatment in older men", said Evan Hadley, M.D., director of NIA's Division of Geriatrics and Clinical Gerontology. Many associations that emerge from observational studies vanish once they are tested in clinical trials.

Until the first year of TTrials was over, neither the participants nor the researchers knew which men were getting the placebo or the testosterone gel. However, the Testosterone Trials were too short-term to assess this risk. Patients were allocated by minimization to either placebo or testosterone gel titrated to normal serum testosterone range (defined as the range in normal, young males).

PATTI NEIGHMOND, BYLINE: The studies, called the TTrials, were conducted at 12 medical centers across the country.

Susan S. Ellenberg, the study's lead biostatistician, clarified that TTrials are a single trial and randomization. And other drugs may be more effective at treating anemia and improving bone mass than testosterone.

SHALENDER BHASIN: The frail elderly or people who have preexisting heart disease or have had a recent heart attack or a stroke - I think one should be particularly careful in those individuals. The men in the study who were using the testosterone gel experienced a significantly greater buildup of plaque in their arteries compared to the men who were taking the placebo.

Dr. Snyder also suggests future testosterone treatments should balance the health benefits with the risks.

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