New studies fail to change 'unfavorable balance' of risks/benefits of testosterone supplements

Cognition Trial - No improvements found in memory and other measures of cognition for men using testosterone gel.

Bone trial - The goal of this trial was to determine whether testosterone treatment would increase volumetric bone mineral density (vBMD) - the amount of mineral in bone - and estimated bone strength in older men with low testosterone. vBMD, a marker of increased risk for fractures, was measured in hip and spine at baseline and 12 months later. For example, a larger and longer followup trial to the bone density study will be needed to determine if the therapy decrease the risk of fractures.

The use of testosterone-replacement therapy has almost doubled in recent years, from 1.3 million patients in 2009 to 2.3 million in 2013, according to the U.S. Food and Drug Administration.

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"I don't think anybody would interpret these results as saying, 'Wow, this is a fountain of youth, this is a magical anti-aging potion, '" said study co-author Susan Ellenberg, a University of Pennsylvania researcher.

It is commonly known that testosterone levels decrease as men age, but until previous year, little was known about the effects of testosterone treatment in older men with low testosterone.

Another study published in JAMA Internal Medicine that tracked heart health over a period of about three years suggests possibly not, but experts say it is too soon to be sure. Sales of testosterone supplements for "Low T" skyrocketed, increasing tenfold in the United States between 2000 and 2011. 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. Yet amid conclusions, the researchers mentioned that overall health benefit of the testosterone and a fake gel is yet to be determined. But the same can't be said of the fourth study - the one on cardiovascular health. This would lead him to carefully weigh whether to prescribe the hormone to a man with low-but-normal testosterone levels and no outward symptoms related to low T. The treatment also increased hemoglobin concentrations, corrected the anemia of men who had no other identifiable cause of anemia and corrected the anemia of men who had an identifiable cause, such as iron deficiency. Many associations that emerge from observational studies vanish once they are tested in clinical trials. The agency requires testosterone labels to include possible risks for heart attacks and strokes, based on some previous studies.

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"Our study finds benefits of testosterone treatment in improving bone density and anaemia". Those changes could signal increased chances for heart attacks although none occurred in the study. Testosterone therapy now carries a boxed warning of potential heart risks, mandated by the FDA.

Romashkan noted that the FDA is working with the pharmaceutical industry to conduct additional large-scale clinical trials looking at the heart health effects of testosterone. Those looked at sexual function, physical activity and mood and found that sexual function and desire did improve significantly among men using the testosterone gel. The studies received support from the National Institutes of Health and from AbbVie (formerly Solvay and Abbott Laboratories), which makes a testosterone product. 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). However, other studies have found mixed results on this. The recently published JAMA studies conclude the research. And other drugs may be more effective at treating anemia and improving bone mass than testosterone. A larger, longer study would be needed to confirm the findings.

The study was small, however, and followed the men for only a year.

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Among 126 men with anemia, a fatigue-linked condition involving inadequate red blood cells, those on testosterone showed substantial improvement. It remedied anemia and was linked to a lower risk of heart attack and stroke.