• Hormone Therapy
• Diabetes & Endocrinology Clinical Trials

• Hormone Therapy
• Diabetes & Endocrinology Clinical Trials
• Endocrinology
• Diabetes & Metabolic Syndrome

Men with opioid-induced androgen deficiency and chronic noncancer pain did not experience an improvement in most measurements of pain perception following testosterone therapy. Shehzad Basaria, MD, Brigham and Women's Hospital, Boston, Massachusetts, USA, presented data from a randomized, controlled trial that evaluated the effect of testosterone replacement on pain perception, pain tolerance, and quality of life (QoL) in men with opioid-induced androgen deficiency.

Patients that take opioid analgesics may experience a decrease of testosterone due to the suppression of the hypothalamic-pituitary-gonadal axis. Testosterone replacement therapy is effective in animal models in improving pain perception; however, the effect of testosterone replacement therapy on pain perception and QoL in men with opioid-induced androgen deficiency is not well understood. The hypothesis motivating this trial was that testosterone replacement therapy would improve pain perception and tolerance, as well as QoL, in men with opioid-induced androgen deficiency.

In the double-blind, placebo-controlled, parallel-group design study, 84 patients aged 18 to 64 years with chronic noncancer pain and opioid-induced androgen deficiency, (defined as serum testosterone levels <350 ng/dL) were randomized to receive transdermal testosterone gel 5 g (n=43) or placebo (n=41) daily for 14 weeks. Dose titration of testosterone was performed 2 weeks following randomization to achieve serum testosterone levels of 500 to 1000 ng/dL.

The final analysis included the 65 participants that completed the study (36 in the testosterone arm, 29 in the placebo arm). The primary endpoint was the reported clinical pain based on the Brief Pain Inventory (BPI) questionnaire. Secondary endpoints included quantitative sensory testing (QST) performed in the laboratory including pressure, mechanical and cold presser pain, QoL as measured by the Short Form-36 (SF-36) questionnaire, and change in dose requirements of the concomitant opioid analgesics.

Patients that received testosterone therapy experienced a nonsignificant decrease in BPI score compared with those that received placebo (p=0.38). As measured by BPI, there was no difference between the testosterone and placebo groups in pain severity, and a nonsignificant decrease in pain interference in the testosterone group. In addition, no significant difference was observed in the opioid analgesic dose requirements, QST measurements for the first stimulus of the mechanical probe and cold tolerance, and the SF-36 score for general health. A nonsignificant trend of improvement in role limitations due to emotional problems was observed in the SF-36 questionnaire (p=0.08). Pain sensitivity, as measured by the tenth stimulus of the mechanical probe during the QST was significantly decreased in patients that received testosterone compared with those that received placebo (p=0.05).

Although data from the trial suggest some improvement in QST and QoL following testosterone therapy in men with opioid-induced androgen deficiency, other measurements were not significantly improved. Dr. Basaria indicated that improvement in clinical pain is often seen in individual patients after laboratory-based measurements of pain perception. Therefore, a larger trial to allow definitive conclusions to be made is required. The effect of testosterone therapy on sexual function, body composition, and metabolic parameters will be evaluated in this patient population in future studies.

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