Endocrinology Unit, Medical Department, Azienda USL Bologna, Maggiore-Bellaria Hospital, Bologna, Italy.
J Sex Med. 2014 Jun;11(6):1577-92. doi: 10.1111/jsm.12536. Epub 2014 Apr 4.
The role of testosterone supplementation (TS) as a treatment for male sexual dysfunction remains questionable.
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).
An extensive Medline, Embase, and Cochrane search was performed.
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).
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.
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.
睾酮补充治疗（TS）作为男性性功能障碍治疗方法的作用仍然存在疑问。
本研究旨在对 TS 对男性性功能的影响及其与磷酸二酯酶 5 抑制剂（PDE5i）联合使用的协同作用进行荟萃分析。
我们进行了广泛的 Medline、Embase 和 Cochrane 检索。
所有比较 TS 与安慰剂相比的效果或 TS 作为 PDE5i 附加治疗对性功能影响的随机对照试验（RCT）均包括在内。数据提取由两位作者（A. M. Isidori 和 G. Corona）独立进行，如有冲突则由第三位调查员（M. Maggi）解决。
在检索到的 1702 篇文章中，有 41 篇被纳入研究。其中，29 篇比较了 TS 与安慰剂，12 项试验评估了 TS 作为 PDE5i 附加治疗的效果。TS 能够显著改善性腺功能减退患者的勃起功能，并改善男性性反应的其他方面。然而，检测到可能存在发表偏倚。应用“修剪和填充”方法后，TS 对勃起功能和性欲成分的积极影响仅在部分或完全由制药公司支持的 RCT 中保留意义（置信区间 [0.04-0.53] 和 [0.12；0.52]）。此外，我们还报告 TS 可能与 PDE5i 结局的改善相关。这些结果在安慰剂对照研究中并未得到证实。然而，大多数研究纳入了混合性腺功能减退/性腺功能减退患者，因此给统计分析带来了不确定性。
TS 对性腺功能减退患者的男性性功能有积极影响。在性腺功能正常的男性中，TS 的作用尚不确定。在有制药公司支持的研究和独立研究之间的明显差异可能更多地取决于试验设计，而不是发表偏倚。新的 RCT 探索 TS 在 PDE5i 治疗失败后持续保留低睾酮水平的情况下的效果是明智的。
