INTRODUCTION: The role of testosterone supplementation (TS) as a treatment for male sexual dysfunction remains questionable. AIM: The aim of this study was to attempt a meta-analysis on the effect of TS on male sexual function and its synergism with the use of phosphodiesterase type 5 inhibitor (PDE5i). METHODS: An extensive Medline, Embase, and Cochrane search was performed. MAIN OUTCOME MEASURES: All randomized controlled trials (RCTs) comparing the effect of TS vs. placebo or the effect of TS as add on to PDE5is on sexual function were included. Data extraction was performed independently by two of the authors (A. M. Isidori and G. Corona), and conflicts resolved by the third investigator (M. Maggi). RESULTS: Out of 1,702 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 PDE5is. TS is able to significantly ameliorate erectile function and to improve other aspects of male sexual response in hypogonadal patients. However, the presence of possible publication bias was detected. After applying "trim and fill" method, the positive effect of TS on erectile function and libido components retained significance only in RCTs partially or completely supported by pharmaceutical companies (confidence interval [0.04-0.53] 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 in placebo-controlled studies. The majority of studies, however, included mixed eugonadal/hypogonadal subjects, thus imparting uncertainty to the statistical analyses. CONCLUSIONS: TS plays positive effects on male sexual function in hypogonadal subjects. The role of TS is uncertain in men who are not clearly hypogonadal. 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 that persistently retain low testosterone levels are advisable.
INTRODUCTION: The role of testosterone supplementation (TS) as a treatment for male sexual dysfunction remains questionable. AIM: The aim of this study was to attempt a meta-analysis on the effect of TS on male sexual function and its synergism with the use of phosphodiesterase type 5 inhibitor (PDE5i). METHODS: An extensive Medline, Embase, and Cochrane search was performed. MAIN OUTCOME MEASURES: All randomized controlled trials (RCTs) comparing the effect of TS vs. placebo or the effect of TS as add on to PDE5is on sexual function were included. Data extraction was performed independently by two of the authors (A. M. Isidori and G. Corona), and conflicts resolved by the third investigator (M. Maggi). RESULTS: Out of 1,702 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 PDE5is. TS is able to significantly ameliorate erectile function and to improve other aspects of male sexual response in hypogonadal patients. However, the presence of possible publication bias was detected. After applying "trim and fill" method, the positive effect of TS on erectile function and libido components retained significance only in RCTs partially or completely supported by pharmaceutical companies (confidence interval [0.04-0.53] 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 in placebo-controlled studies. The majority of studies, however, included mixed eugonadal/hypogonadal subjects, thus imparting uncertainty to the statistical analyses. CONCLUSIONS: TS plays positive effects on male sexual function in hypogonadal subjects. The role of TS is uncertain in men who are not clearly hypogonadal. 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 that persistently retain low testosterone levels are advisable.
Authors: Glenn R Cunningham; Alisa J Stephens-Shields; Raymond C Rosen; Christina Wang; Shalender Bhasin; Alvin M Matsumoto; J Kellogg Parsons; Thomas M Gill; Mark E Molitch; John T Farrar; David Cella; Elizabeth Barrett-Connor; Jane A Cauley; Denise Cifelli; Jill P Crandall; Kristine E Ensrud; Laura Gallagher; Bret Zeldow; Cora E Lewis; Marco Pahor; Ronald S Swerdloff; Xiaoling Hou; Stephen Anton; Shehzad Basaria; Susan J Diem; Vafa Tabatabaie; Susan S Ellenberg; Peter J Snyder Journal: J Clin Endocrinol Metab Date: 2016-06-29 Impact factor: 5.958
Authors: Carol A Podlasek; John Mulhall; Kelvin Davies; Christopher J Wingard; Johanna L Hannan; Trinity J Bivalacqua; Biljana Musicki; Mohit Khera; Nestor F González-Cadavid; Arthur L Burnett Journal: J Sex Med Date: 2016-08 Impact factor: 3.802
Authors: Andrea Salonia; Giulia Rastrelli; Geoffrey Hackett; Stephanie B Seminara; Ilpo T Huhtaniemi; Rodolfo A Rey; Wayne J G Hellstrom; Mark R Palmert; Giovanni Corona; Gert R Dohle; Mohit Khera; Yee-Ming Chan; Mario Maggi Journal: Nat Rev Dis Primers Date: 2019-05-30 Impact factor: 52.329
Authors: John P Mulhall; Gerald B Brock; Sidney Glina; Simin Baygani; Craig F Donatucci; Mario Maggi Journal: J Sex Med Date: 2016-03-24 Impact factor: 3.802
Authors: Faysal A Yafi; Lawrence Jenkins; Maarten Albersen; Giovanni Corona; Andrea M Isidori; Shari Goldfarb; Mario Maggi; Christian J Nelson; Sharon Parish; Andrea Salonia; Ronny Tan; John P Mulhall; Wayne J G Hellstrom Journal: Nat Rev Dis Primers Date: 2016-02-04 Impact factor: 52.329