Testosterone replacement in hypogonadal men during inpatient rehabilitation following traumatic brain injury: Results from a double-blind,placebo-controlled clinical pilot study

Abstract

BACKGROUND:

Endocrinopathy, including hypogonadism, is common following traumatic brain injury (TBI). Prior evidence suggests hypogonadism is associated with poorer function.

OBJECTIVE:

Determine the feasibility, safety, and efficacy of testosterone (T) therapy in hypogonadal men following TBI in acute rehabilitation.

DESIGN:

Randomized, double blind, placebo-controlled pilot trial.

SETTING:

Inpatient rehabilitation brain injury unit.

PARTICIPANTS:

Men ages 18 –65, post moderate to severe TBI receiving inpatient rehabilitation.

INTERVENTIONS:

Transdermal T gel or placebo.

MAIN OUTCOME MEASURES:

Revised FIM™ score, strength, adverse events.

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:

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.