April 30, 2014 — The Lancet Diabetes & Endocrinology has published an editorial by Dr. Stephanie T. Page, of the University of Washington in Seattle, calling for new studies to evaluate the safety and effectiveness of testosterone therapy.
She cited two recent observational studies linking testosterone therapy to an increased risk of blood clots, heart attack, stroke, and death. The problem is that this “cumulative observational data cannot replace well-designed and undertaken randomized controlled trials.” There have also been contradictory findings in published studies.
The longest randomized controlled trial of testosterone therapy lasted only 36 months and was not large enough to assess cardiovascular risks, but was reassuring from a safety standpoint. Another study was halted prematurely because older men in poor health on testosterone had five-times as many cardiovascular events as men not on testosterone.
Dr. Page was reminded of the rise and fall of estrogen replacement therapy, which was once recommended for post-menopausal women until it was shown to increase the risk of cardiovascular events and breast cancer:
“These concerns are not new and are reminiscent of the debate about hormone replacement therapy and heart disease in women that raged before the Women’s Health Initiative [WHI]. … As the WHI showed, the results [for testosterone therapy] might be surprising.”
One side effect of testosterone replacement therapy is an increase in circulating estradiol (estrogen) in men. This can lead to side effects like gynecomastia (enlarged male breasts). Before starting testosterone therapy, it is a good idea to have a blood test to check estrogen and testosterone levels.
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