1. In this non-randomized, double-blind, placebo-controlled study, men 65 years or older who had unexplained anemia with low serum testosterone had an increase in their measured serum hemoglobin with testosterone replacement.
2. Hemoglobin levels increased with testosterone therapy in patients with explained and unexplained anemia, as well as in non-anemic men.
Evidence Rating Level: 2 (Good)
Study Rundown: Decrease in serum testosterone commonly occurs in elderly men. Testosterone supplementation has not been demonstrated to have clear benefit but may increase risk of prostate cancer. Anemia is another common condition of older men and is often unexplained. Low serum testosterone has been associated with lower hemoglobin levels and small studies have demonstrated improvement with testosterone replacement. This double-blind, placebo-controlled study was conducted to evaluate the effect of testosterone replacement in older men with either explained or unexplained anemia.
The results of the study showed that, compared with placebo, replacement of testosterone was associated with an increase in serum hemoglobin. Hemoglobin rise was observed in treatment arms for both unexplained anemia and anemia of known cause. Hemoglobin increased amongst men without anemia as well. Testosterone supplementation was associated with a small but significant improvement in 6-minute walking distance, and subjective global impression of health. The strengths of the study included the double-blind, placebo control design, >90% follow up, and biochemical confirmation of compliance. The study opted for a minimization strategy for allocation rather than true randomization which may introduce bias. Additionally, the study sample was small and had limited ethnic diversity. Men with more profound anemia at baseline (<10 g/dL) were also not included in the study.
In-Depth [double-blind, placebo-controlled]: The Anemia Trial was one of 7 coordinated Testosterone Trials which enrolled men from 12 sites to participate. Men were included if they were 65 years and older, had two serum testosterone tests averaging less than 275 ng/dL, and had a hemoglobin level less than 12.7 g/dL. Participants were excluded if they had a hemoglobin less than 10.0 g/dL. Patients were evaluated to have either unexplained anemia or anemia of known cause if they had any of the following: renal insufficiency, B12/folate/iron deficiency, myelodysplasia, hemolysis, chronic inflammation, or plasma cell dyscrasia. 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).
Of the 788 men recruited from 2010 to 2013, 126 were anemic at baseline with 64 (50.8%) having anemia of known cause. Testosterone treatment was associated with greater likelihood of hemoglobin improvement of at least 1.0 g/dL compared to placebo among patients with unexplained anemia (aOR, 31.5; 95% CI, 3.7-277.8, p = 0.002), anemia of known cause (AOR, 8.2; 95% CI, 2.1-31.9; p = 0.003), and non-anemic men (OR, 20.7; 95% CI, 12.9-33.3; p < 0.001). In the non-anemic group, testosterone therapy was associated with erythrocytosis in 2% of participants. Improvement in hemoglobin was also associated with improvement in 6-minute walk distance by 8.3m, and global perceived health status.
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