In the phase I/II pilot study described here, we tested a novel hypothesis, that muscle pain and chronic fatigue, primary symptoms in women with fibromyalgia, are caused by testosterone deficiency, and that testosterone therapy can be safely delivered and it can significantly dampen chronic pain without the well known side effects of opioids, anti-depressants, NSAIDS or benzodiazepines, all of which have been prescribed for fibromyalgia.
The American College of Rheumatology diagnostic criteria for fibromyalgia were used as a set of parameters for tracking the efficacy of testosterone replacement therapy in dampening pain in these patients. Fibromyalgia patients treated transdermally with a testosterone gel formulation once a day (8:00 AM) for 28 days responded well with respect to raising both free testosterone and total testosterone serum levels significantly and safely above baseline. In addition, clinical symptoms of muscle pain, stiffness and fatigue were significantly decreased, libido was significantly increased, and symptoms not tightly associated with fibromyalgia failed to show a response.
Discussion and conclusions
Overview of findings
In the prospective study here, the hypothesis that testosterone therapy can decrease pain responses is supported by the clinical data: 28 days of once-a-day therapy with 0.75 g 1% (w/w) testosterone gel 1) raised serum concentrations of total and, most importantly, free testosterone in fibromyalgia patients from baseline to high-normal concentrations for premenopausal women, and 2) significantly reduced the pain and fatigue symptoms of fibromyalgia patients without any evidence of short term risk as determined by blood tests for cardiovascular, hepatic, kidney or hematologic function, by patient logs and by physical exam. Our findings of increased levels of testosterone taken together with improvements observed for clinical symptoms, including muscle pain, stiffness, fatigue and libido, support our hypothesis that testosterone therapy given to chronic pain patients can reduce pain, down-modulate an inflamed nociceptive nervous system (as discussed in the related Commentary in this issue) and help restore feelings of well-being.
Please contact me if you have been diagnosed with fibromyalgia and have NOT received some kind of hormonal birth control previously. I am interested in the negative effects of birth control on long-term hormones.