Department of Urology, PGIMER, Chandigarh, India.
Int Braz J Urol. 2021 Sep-Oct;47(5):921-934. doi: 10.1590/S1677-5538.IBJU.2020.0561.
Tramadol has been used for the treatment of premature ejaculation, however, the studies published for the same are not well designed. The primary objective of this study was to explore the literature pertaining to the use of tramadol in patients with PE to determine its safety and efficacy in this population. Materials ande methods: Systematic literature search of various electronic databases was conducted to include all the randomized studies and quasi-randomized studies. Standard PRISMA (Preferred reporting Items for Systematic reviews and Meta-analysis) guidelines were pursued for this review and study protocol was registered with PROSPERO (CRD42019123381).
Out of 9 studies included in this review, 5 were randomized controlled trials, and rests of the 4 studies were quasi-randomized studies. Tramadol resulted in significantly higher improvement of IELT with the mean difference (MD) of 139.6 seconds and confidence interval (CI) 106.5-172.6 seconds with a p-value of p < 0.00001. All dosages except 25mg fared well as compared to placebo. Tramadol fared better than placebo at 1 month, 2 months, and 3 months after initiation of therapy as compared to the placebo. Tramadol group had reported a significantly higher number of adverse events with treatment as compared to placebo but none of them were serious.
Tramadol appears to be an effective drug for the management of PE with a low propensity for serious adverse events. However, evidence obtained from this study is of low to moderate quality. Furthermore, effective dose and duration of therapy remain elusive.
曲马多已被用于治疗早泄,但相关研究的设计并不完善。本研究的主要目的是探讨曲马多在早泄患者中的应用文献,以确定其在该人群中的安全性和疗效。
系统检索了各种电子数据库,纳入所有随机研究和准随机研究。本综述遵循标准的 PRISMA(系统评价和荟萃分析的首选报告项目)指南,并在 PROSPERO(CRD42019123381)上注册了研究方案。
在纳入的 9 项研究中,有 5 项为随机对照试验,其余 4 项为准随机试验。曲马多可显著提高 IELT,平均差异(MD)为 139.6 秒,置信区间(CI)为 106.5-172.6 秒,p 值<0.00001。与安慰剂相比,除 25mg 外,所有剂量均表现良好。与安慰剂相比,曲马多在治疗开始后 1 个月、2 个月和 3 个月时的疗效更好。与安慰剂相比,曲马多组报告的治疗相关不良事件明显更多,但均不严重。
曲马多似乎是治疗早泄的有效药物,不良反应发生率低,但本研究获得的证据质量为低到中等。此外,有效剂量和治疗持续时间仍不明确。