A RANDOMIZED TRIAL OF TESTOSTERONE THERAPY IN MALES WITH RHEUMATOID-ARTHRITIS

Thirty-five male patients, aged 34-79 yr, with definite rheumatoid art hritis (RA) were recruited from out-patient clinics and randomized to receive monthly injections of testosterone enanthate 250 mg or placebo as an adjunct therapy for 9 months. Endpoints included disease activi ty parameters and bone mineral density (BMD). At baseline, there were negative correlations between the ESR and serum testosterone (r = -0.4 2, P < 0.01) and BMD (hip, r= -0.65, P < 0.01). A total of 29.6% of al l patients had at least one vertebral fracture, most having multiple f ractures. Back pain, however, was not more prevalent in fracture patie nts (55% vs 50%). Disease activity was Significantly higher in the fra cture group (joint score P < 0.05, rheumatoid factor P < 0.01). Thirty patients completed the trial, 15 receiving testosterone and 15 receiv ing placebo. There were significant rises in serum testosterone, dihyd rotestosterone and oestradiol in the treatment group. There was no sig nificant effect of treatment on disease activity overall, five patient s receiving testosterone underwent a 'flare'. Differences in mean BMD following testosterone or placebo were non-significant (spine: +1.2% v s -1.1%; femur: -0.3% vs +0.3%). There was no suggestion of a positive effect of testosterone on disease activity in men with RA.