Effects of Testosterone Replacement on Pain Catastrophizing and Sleep Quality in Men with Opioid-Induced Androgen Deficiency
Abstract
OBJECTIVE: The objective of this investigation was to determine the effects of testosterone administration on pain catastrophizing and sleep quality in adult men with opioid-induced androgen deficiency.
DESIGN: Sixty-two men aged 18-64 years using opioid analgesics for chronic non-cancer pain with total testosterone levels < 350 ng/dl were randomized to 14 weeks of transdermal testosterone gel or placebo gel daily. Total testosterone levels were measured by liquid chromatography mass spectrometry and free testosterone was calculated using the law of mass action equation. Outcomes were assessed by administering validated instruments such as Pain Catastrophizing Scale (PCS) and Insomnia Severity Index (ISI) at baseline and 14 weeks.
RESULTS: Baseline characteristics were similar between the two groups. Mean (SD) total testosterone concentrations increased from 223 ± 86 to 775 ± 555 ng/dl in the testosterone group, but did not meaningfully change in placebo group. Mean changes in PCS and ISI scores during intervention did not differ significantly between groups and were not related to changes in on-treatment serum testosterone concentrations.
CONCLUSION: In this 14-week trial, testosterone administration in men with opioid-induced androgen deficiency was not associated with improvements in pain catastrophizing or sleep quality.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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