Abstract
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.
Acknowledgments
Farid Saad, Louis Gooren and Gheorge Doros contributed to the conception and design of the study. Mahmoud Nasser, Ahmed Haider and Winfried Kurtz were pivotal in data acquisition. Gheorge Doros, Farid Saad, Louis Gooren, Monika Fijak and Linda Vignozzi have analyzed and interpreted the data. All authors have approved the final version for submission.
Funding: Dr. Haider received compensation for data entry from Bayer Pharma. Dr. Doros received an honorarium for statistical analyses from Bayer Pharma. Dr. Nasser received free study medication from Bayer Pharma.
Conflicts of interest: Farid Saad is an employee of Bayer Pharma AG, the manufacturer of testosterone undecanoate, the androgen used in this study. The other authors declare no conflict of interests.
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