Testosterone therapy in men with Crohn's disease improves the clinical course of the disease: data from long-term observational registry study.

BACKGROUND: Crohn's disease is an inflammatory chronic bowel disease characterized by an imbalanced production of pro-inflammatory mediators (tumor necrosis factor-α) and an increased recruitment of leukocytes to the site of inflammation. Low serum testosterone is associated with an increase in inflammatory factors, while testosterone administration reduces them. There is evidence for an immunomodulatory effect of testosterone on differentiation of regulatory T cells. MATERIALS AND METHODS: The research was carried out in clinics in Germany and Syria. The study was a cumulative, prospective, registry study with an increasing number of men over time receiving testosterone. While men diagnosed with Crohn's disease received appropriate treatment for Crohn's disease, they were tested for testosterone deficiency (cut-off point ≤12.1 nmol/L). In total, 92 men received parenteral testosterone undecanoate 1000 mg/12 weeks for up to 7 years. Fourteen men opted not to receive testosterone and served as a comparison group. RESULTS: In men receiving testosterone, the Crohn's Disease Activity Index declined from 239.36±36.96 to 71.67±3.26 at 84 months (p<0.0001 vs. baseline). C-reactive protein levels decreased from 12.89±8.64 to 1.78±1.37 mg/L at 84 months (p<0.0001 vs. baseline). Leukocyte count decreased from 11.93±2.85 to 6.21±1.01×109/L (p<0.0001 at 84 months vs. baseline). No changes were observed in the comparison group. There were no significant side effects of testosterone. CONCLUSIONS: Normalizing serum testosterone in hypogonadal men with Crohn's disease had a positive effect on the clinical course, also evidenced by biochemical parameters. Testosterone administration appeared safe.

Administration of testosterone to elderly hypogonadal men with Crohn's disease improves their Crohn's Disease Activity Index: a pilot study.

BACKGROUND: Both elevated and depressed testosterone (T) levels have been reported in Crohn's disease (CD). In this pilot study, effects of T administration on CD were assessed. MATERIALS AND METHODS: A total of 13 men with CD, aged 45-67 years, had subnormal plasma T (mean±SD=9.0±1.4 nmol/L) (reference >12.0); they were compared to a group of 110 men of similar age with sexual and urological problems whose plasma T was also subnormal: 10.4±1.4 nmol/L (p=0.02). All received treatment with parenteral T undecanoate for 24 months. The Crohn's Disease Activity Index (CDAI) was assessed as an indicator of the severity of the disease every 3 months. Levels of T and C-reactive protein (CRP) were compared between the 13 men with CD and the other men in this study. Values of CDAI and CRP were followed-up. RESULTS: CRP levels were 22.7 mg/dL (95% confidence interval of the mean: 14.9-34.3) in the 13 men with CD vs. 3.5 (2.9-4.1) in 107 control men (p=0.001). Upon normalization of serum T, there was a significant decline of CDAI (from 243±19 to 89±9), CRP levels from 22.7±8.1 to 6.9±2.9 mg/dL, and white blood cell count. Hemoglobin/hematocrit increased significantly. CONCLUSIONS: Upon normalization of plasma T the CDAI and CRP levels decreased in hypogonadal patients with CD. The mechanism of this improvement could be through immunosuppressive effects of T, reducing chronic inflammation of the intestinal wall in CD.