Testosterone therapy in men with Parkinson disease : results of the TEST-PD study

Background: Testosterone deficiency has been reported in patients with Parkinson disease (PD), Alzheimer disease, and Huntington disease. It is not known whether testosterone therapy (TT) in men with borderline hypogonadism and neurodegenerative diseases will be of substantial benefit. Previously, we reported that testosterone deficiency is more common in patients with PD compared with age-matched control subjects, and we also reported in 2 small open-label studies that some nonmotor symptoms responded favorably to TT. Objective To define the effects of TT on nonmotor and motor symptoms in men with PD and probable testosterone deficiency. Design: Double-masked, placebo-controlled, parallel-group, single-center trial. Patients: Two experimental groups: patients with PD who were receiving either TT or placebo. Interventions: Participants received either the study drug by intramuscular injection (200 mg/mL of testosterone enanthate every 2 weeks for 8 weeks) or placebo (isotonic sodium chloride solution injections). In patients in each group, the testosterone serum concentration was obtained at each study visit. During 2 study visits, testosterone levels were blindly evaluated and the intramuscular testosterone dose was increased by 200 mg/mL if the free testosterone value failed to double from the baseline value. Main Outcome Measures: The primary outcome variable was the St Louis Testosterone Deficiency Questionnaire, and secondary outcome measures included measures of mood, cognition, fatigue, motor function, and frequency of adverse events. At the end of the double-blind phase, all patients were offered open-label TT and were followed up after 3 and 6 months. Results: Fifteen patients in the placebo group (mean age, 69.9 years), receiving a mean total levodopa equivalent dose of 924 mg/d, had a baseline free testosterone level of 47.91 pg/mL, compared with 15 patients in the TT group (mean age, 66.7 years), receiving an average total levodopa equivalent dose of 734 mg/d, who had a baseline free testosterone level of 63.49 pg/mL. Testosterone was generally well tolerated. More subjects in the TT group experienced lower extremity edema (40% vs 20%). In 2 patients, 1 in each group, prostate-specific antigen levels were elevated from baseline. The improvement in the TT group compared with the placebo group (1.7 vs 1.1) on the St Louis Testosterone Deficiency Scale was not statistically significant. In addition, there were no significant differences in motor and nonmotor features of PD between the 2 groups, although a few subscales showed improvements (Hopkins Verbal Learning Test, P<.04; and Backward Visual Span subtrial, P<.03). However, long-term open-label TT resulted in delayed but sustained improvement in subjects in the TT group who continued to receive treatment (n = 6) compared with subjects in the placebo group who elected not to receive TT (n = 3). Conclusions: Testosterone therapy was generally well tolerated in elderly men with PD and probable testosterone deficiency. While there was no significant difference in the motor and nonmotor scales between the TT and placebo groups at the end of 8 weeks compared with baseline, this may be due to several study limitations, including small sample size, a strong placebo effect with intramuscular therapy, and short follow-up that did not allow measurement of delayed effects of TT in some subjects. Until more definitive studies are reported, practitioners should be particularly cautious in treatment of low testosterone concentrations in men with PD and borderline testosterone deficiency, and careful consideration should be given to the risks vs the benefits of TT

Variations in treatment of C1 fractures by time, age, and geographic region in the United States: An analysis of 985 patients

The purpose of this investigation was to evaluate the variations in the treatment of C1 fractures over time, by age group, and by geographic region using a nationwide database. The Nationwide Emergency Department Sample (NEDS) database was queried to identify patients ≥18 years who sustained C1 fracture from 2006-2012. Patients were filtered based on the intervention they received: collar, halo, or surgery. Regions of hospital used in analysis were defined as Northeast, Midwest, South, and West. Surgical intervention for C1 fracture increased from 27.1% of cases in 2006 to 55.4% of cases in 2012 (P<0.001). The rate of collar treatment increased with increasing age. In contrast, rate of halo use decreased with increasing age. A greater proportion of patients in the Northeast were treated by collar compared to all other regions (P<0.001). We can conclude that there is considerable variation in the treatment of C1 fractures with regards to age and geographic region. Surgical treatment of these fractures is increasing over time. Future considerations should be given to developing treatment guidelines to decrease variation and potentially create cost-savings