title: Effects of testosterone replacement in men with opioid-induced androgen deficiency: a randomized controlled trial.
abstract: Symptomatic androgen deficiency is common in patients taking opioid analgesics, as these drugs potently suppress the hypothalamic-pituitary-gonadal axis. However, the efficacy of testosterone replacement in this setting remains unclear. The objective of this trial was to evaluate the efficacy of testosterone replacement on pain perception and other androgen-dependent outcomes in men with opioid-induced androgen deficiency. We conducted a randomized, double-blind, parallel placebo-controlled trial at an outpatient academic research center. Participants were men aged 18 to 64 years on opioid analgesics for chronic noncancer pain, and total testosterone levels were <350 ng/dL. Participants were randomly assigned to 14 weeks of daily transdermal gel that contained 5 g of testosterone or placebo. Primary outcomes were changes in self-reported clinical pain and objectively assessed pain sensitivity. Sexual function, quality of life, and body composition were also assessed. The mean age was 49 years. The median total and free testosterone levels at baseline were 243 ng/dL and 47 pg/mL and 251 ng/dL and 43 pg/mL in the testosterone and placebo arm, respectively. Of the 84 randomized participants, 65 had follow-up data on efficacy outcomes. Compared with men assigned to the placebo arm, those assigned to testosterone replacement experienced greater improvements in pressure and mechanical hyperalgesia, sexual desire, and role limitation due to emotional problems. Testosterone administration was also associated with an improvement in body composition. There were no between-group differences in changes in self-reported pain. In conclusion, in men with opioid-induced androgen deficiency, testosterone administration improved pain sensitivity, sexual desire, body composition, and aspects of quality of life.
authors.affiliation: The Research Program in Men's Health: Aging and Metabolism, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA Department of Medicine, Boston University School of Medicine, Boston, MA, USA Department of Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA Departments of Anesthesiology and Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
authors.forename: Shehzad
authors.initials: S
authors.lastname: Basaria
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Travison
authors.forename: Daniel
authors.initials: D
authors.lastname: Alford
authors.forename: Philip E
authors.initials: PE
authors.lastname: Knapp
authors.forename: Kjersten
authors.initials: K
authors.lastname: Teeter
authors.forename: Christine
authors.initials: C
authors.lastname: Cahalan
authors.forename: Richard
authors.initials: R
authors.lastname: Eder
authors.forename: Kishore
authors.initials: K
authors.lastname: Lakshman
authors.forename: Eric
authors.initials: E
authors.lastname: Bachman
authors.forename: George
authors.initials: G
authors.lastname: Mensing
authors.forename: Marc O
authors.initials: MO
authors.lastname: Martel
authors.forename: Dillon
authors.initials: D
authors.lastname: Le
authors.forename: Helene
authors.initials: H
authors.lastname: Stroh
authors.forename: Shalender
authors.initials: S
authors.lastname: Bhasin
authors.forename: Ajay D
authors.initials: AD
authors.lastname: Wasan
authors.forename: Robert R
authors.initials: RR
authors.lastname: Edwards
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000701:Analgesics, Opioid / Q000009:adverse effects*; D000728:Androgens / Q000097:blood / Q000172:deficiency*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000097:blood / Q000188:drug therapy; D013739:Testosterone / Q000008:administration & dosage* / Q000097:blood; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D000728:Androgens; D013739:Testosterone