ECE2014 Poster Presentations Steroid metabolism and action (12 abstracts)
1Endocrinology Unit, Bologna, Italy; 2Sexual Medicine and Andrology Unit, Florence, Italy; 3Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy; 4Centre ETPARP, Lille, France; 5Good Hope Hospital, Sutton Coldfield, UK; 6Department of Biochemical, Metabolic and Neural Sciences, Chair of Endocrinology, University of Modena and Reggio Emilia and Azienda USL of Modena, Modena, Italy.
Introduction: The role of testosterone supplementation (TS) as a possible treatment for male sexual dysfunction remains questionable. The aim of the present study is to meta-analyse data evaluating the effects of TS on male sexual function and its therapeutic synergism with the use of phosphodiesterase type 5 (PDE5i).
Methods: An extensive Medline Embase and Cochrane search was performed including the following words: testosterone, erectile dysfunction. All randomized controlled trials (RCTs) comparing the effect of TS vs placebo on sexual function or the effect of TS as add on to PDE5ì s on sexual function were included. Data extraction was performed independently by two of the authors (A.M.I, G.C), and conflicts resolved by the third investigator (M.M).
Results.: Out of 1702 retrieved articles, 41 were included in the study. In particular, 29 compared TS vs placebo, whereas 12 trials evaluated the effect of TS as add on to PDE5ìs. TS is able to significantly ameliorate erections and to improve other aspects of male sexual response in hypogonadal patients. However, the presence of publication bias was detected. After applying Duval and Tweedie trim and fill method, the positive effect of TS on erectile function and libido components retained significance only in RCTs partially or completed supported from pharmaceutical companies (CI (0.040.53) and (0.12;0.52) respectively). In addition, we also report that TS could be associated with an improvement in PDE5i outcome. These results were not confirmed when placebo-controlled studies were selectively analysed. The majority of them, however, included mixed eugonadal/hypogonadal subjects.
Conclusions: TS plays positive effects on male sexual function in hypogonadal subjects. The apparent difference between industry-supported and independent studies could depend on trial design more than on publication bias. New RCTs exploring the effect of TS in selected cases of PDE5i failure who persistently retain low T levels are advisable.