A Pilot Study of Testosterone Treatment for Men with Relapsing Remitting Multiple Sclerosis
Nancy L. Sicotte, Barbara S. Giesser, Vinita Tandon, Barbara Steiner, Ricki Klutch, Ann Drain, David W. Shattuck, Laura Hull, Ronald Swerdloff, Torrance, CA, Rhonda R. Voskuhl, Los Angeles, CA
OBJECTIVE: To determine the effect of testosterone treatment in men with relapsing remitting MS.
BACKGROUND: Men are less susceptible to many autoimmune diseases including multiple sclerosis but the reason is not known. Possibilities include sex hormone or sex chromosome effects. In men, the age at MS onset is later (30-40s) corresponding to the onset of decline in bioavailable testosterone. In addition, testosterone ameliorates disease severity in experimental autoimmune encephalomyelitis and other animal models of autoimmune disease. Testosterone may have direct neuroprotective effects and may be important in maintaining cognitive function. Whether testosterone treatment is beneficial for men with MS has not been studied previously.
DESIGN/METHODS: Eligible participants were men with relapsing remitting MS, off all immunomodulators. The study was a single crossover design with a six month observation period followed by twelve months of daily treatment with 100mg testosterone gel applied topically. The EDSS and MSFC were performed every 3 months during the 18 month study period. Other cognitive and quality of life measures were collected at 6 monthly intervals. Enhanced cerebral MRIs were performed monthly during the baseline and treatment periods.
RESULTS: At study onset, none of the ten subjects studied were hypogonadal. Testosterone treatment induced a 50% increase in testosterone levels on average and was well tolerated. Improvements were observed in PASAT performance and spatial memory tasks with treatment along with quality of life measures related to physical functioning. MRI inflammatory activity was relatively low in the group prior to treatment, with no increase in enhancing lesion numbers and volumes observed with treatment.
CONCLUSIONS/RELEVANCE: Testosterone treatment of men with RRMS is safe, well-tolerated and is associated with significant improvements in cognitive function. Further study of the use of testosterone treatment in RRMS in larger groups over longer time periods is warranted.
Supported by: National MS Society.Category - MS and Related DiseasesSubCategory - Clinical ScienceTuesday, April 4, 2006 7:30
So, testosterone's responsible for thicker myelin and in this initial trial anyway, significantly improved cognitive function. Not bad.
I hope everyone has some fun this week end.