Testosterone replacement in hypogonadal men during inpatient rehabilitation following traumatic brain injury: Results from a double-blind, placebo-controlled clinical pilot study.
Functional Independence Measure (FIM)
TBI
Traumatic brain injury
aggression
agitation
function
hypogonadism
outcomes
randomized drug trial
strength
testosterone
Journal
NeuroRehabilitation
ISSN: 1878-6448
Titre abrégé: NeuroRehabilitation
Pays: Netherlands
ID NLM: 9113791
Informations de publication
Date de publication:
2020
2020
Historique:
pubmed:
7
4
2020
medline:
10
10
2020
entrez:
7
4
2020
Statut:
ppublish
Résumé
Endocrinopathy, including hypogonadism, is common following traumatic brain injury (TBI). Prior evidence suggests hypogonadism is associated with poorer function. Determine the feasibility, safety, and efficacy of testosterone (T) therapy in hypogonadal men following TBI in acute rehabilitation. Randomized, double blind, placebo-controlled pilot trial. Inpatient rehabilitation brain injury unit. Men ages 18 -65, post moderate to severe TBI receiving inpatient rehabilitation. Transdermal T gel or placebo. Revised FIM™ score, strength, adverse events. Of 498 screened, 70 participants were enrolled, and 22 meeting all criteria were randomized into placebo (n = 10) or physiologic T therapy (n = 12). There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, or slopes t = 0.61, p = 0.5472). The Treatment group demonstrated the greatest absolute improvement in FIM™ scores and grip strength compared to Placebo or Normal T groups. There was no difference in adverse events between groups. Percentage of time with agitation or aggression was highest in the Placebo group. Although there were no significant differences in rates of recovery, treatment group subjects showed greater absolute functional and strength improvement compared to the Placebo or Normal T groups.
Sections du résumé
BACKGROUND
BACKGROUND
Endocrinopathy, including hypogonadism, is common following traumatic brain injury (TBI). Prior evidence suggests hypogonadism is associated with poorer function.
OBJECTIVE
OBJECTIVE
Determine the feasibility, safety, and efficacy of testosterone (T) therapy in hypogonadal men following TBI in acute rehabilitation.
DESIGN
METHODS
Randomized, double blind, placebo-controlled pilot trial.
SETTING
METHODS
Inpatient rehabilitation brain injury unit.
PARTICIPANTS
METHODS
Men ages 18 -65, post moderate to severe TBI receiving inpatient rehabilitation.
INTERVENTIONS
METHODS
Transdermal T gel or placebo.
MAIN OUTCOME MEASURES
METHODS
Revised FIM™ score, strength, adverse events.
RESULTS
RESULTS
Of 498 screened, 70 participants were enrolled, and 22 meeting all criteria were randomized into placebo (n = 10) or physiologic T therapy (n = 12). There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, or slopes t = 0.61, p = 0.5472). The Treatment group demonstrated the greatest absolute improvement in FIM™ scores and grip strength compared to Placebo or Normal T groups. There was no difference in adverse events between groups. Percentage of time with agitation or aggression was highest in the Placebo group.
CONCLUSIONS
CONCLUSIONS
Although there were no significant differences in rates of recovery, treatment group subjects showed greater absolute functional and strength improvement compared to the Placebo or Normal T groups.
Identifiants
pubmed: 32250330
pii: NRE192992
doi: 10.3233/NRE-192992
doi:
Substances chimiques
Androgens
0
Testosterone
3XMK78S47O
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM