Demographic data for all 45 included subjects is displayed in . None of the subjects had been previously treated with testosterone replacement therapy. The majority (79.6%, N=35) of men meeting criteria for non-specific, diffuse musculoskeletal pain and hypogonadism were referred to endocrinology for possible hormone replacement therapy, with only one of these subjects choosing not to undergo evaluation by endocrinology; 33.3% (N=15) were lost to follow-up with no information available after the initial diagnostic visit. No subjects had baseline or increases in PSA >4.0 reported (0.22–3.68) after testosterone replacement therapy, though there were significant numbers of missing PSA values (Nmissing=20/45). Vitamin D status was measured in only eight subjects, with four of these demonstrating low serum concentrations and four with adequate vitamin D stores. The four subjects with missing baseline serum total testosterone values who were excluded from analysis had slightly fewer years of pain, were mostly white, were more frequently smokers, used more alcohol, used pain medications more frequently as compared to included subjects, and had no diagnosed hypothyroidism, malignancies, history of trauma, or fibromyalgia. There were no significant differences in age, baseline free testosterone concentrations, BMI, presence of weakness, fatigue, or comorbid rheumatologic diseases between groups.
Demographic information for male patients with diffuse musculoskeletal pain
Spearman correlation coefficients were determined to show the relationship between variables of interest and baseline serum total and free testosterone values (). Duration of pain was negatively correlated with baseline total (−0.32, p=0.05), but not free testosterone values (0.10, p=61). No other variables reached statistical significance.
Association between baseline total and free testosterone and demographic and health related characteristics
Psychiatric medication use divided into categorical type (SSRI, SNRI, benzodiazepine, TCA, and other) is reported with associated mean baseline free testosterone values (). Five of the 16 subjects (31.3%) using any psychiatric medication were in the lowest quartile of total testosterone with four (25%) of these subjects also in the lowest quartile for free testosterone. There were no significant differences between quartiles of free or total testosterone in subjects using psychiatric medications. Association with mean baseline testosterone values and use of benzodiazepines (p=0.07) and psychiatric medications in the “other” category (p= 0.06) approached, but did not reach, statistical significance. Only four subjects were taking more than one category of psychiatric medication consisting of the following combinations: SSRI, SNRI, and benzodiazepine; SSRI, benzodiazepine, and TCA; benzodiazepine and other; and SSRI, TCA and other. The “other” category included bupropion (N=1), St John’s Wort (N=2), zolpidem (N=1), nefazodone (N=1), gabapentin (N=1), and chlorpromazine (N=1). Two of the six subjects taking medications in the “other” category were on more than one psychiatric medication in the following combinations: SSRI, TCA, and other; and benzodiazipine and three medications in the “other” class.
Psychiatric medication use by type*
Only 10 of the 45 subjects with baseline serum free and total testosterone values had pain scores recorded both at initial clinic presentation and after testosterone replacement therapy. None of these 10 subjects met clinical criteria for fibromyalgia. No significant correlations between initial pain score for these 10 men at time of diagnosis and the variables tested were found. Of these 10 subjects, two did not continue on testosterone replacement therapy for at least 3 months. Of the remaining eight subjects, a paired t test was performed demonstrating no significant changes in self reported pain scores (mean=0, p=1.0).