Objective: This systematic review was performed to evaluate the efficacy and safety of tramadol in patients with premature ejaculation (PE). Methods: A systematic search of PubMed®, Embase® and the Cochrane Library was performed to identify all randomized controlled trials (RCTs) that compared the effects of tramadol with placebo or no drug for patients with PE. The outcomes included post-therapeutic intravaginal ejaculation latency time (IELT), increases in IELT, satisfaction with sexual intercourse, control over ejaculation and side effects (SEs). The Cochrane Collaboration Review Manager software (RevMan 5.1.4) was used for statistical analysis. Results: A total of 5 trials, involving 715 patients, met the inclusion criteria. The synthesized data from these RCTs indicated that compared with the control, tramadol significantly increased IELT values post-therapeutically (SMD 3.51, 95% CI 2.14-4.88, p < 0.00001) and changes in IELT values were more pronounced in the tramadol group (SMD 2.87, 95% CI 2.63-3.10, p < 0.00001). Satisfaction with sexual intercourse and the ability to control ejaculation were both improved in patients in the tramadol group (p < 0.05). The incidence of SEs in the tramadol group were significantly higher than in the control group (RR 3.55, 95% CI 1.34-9.40, p = 0.01), however most SEs were mild or moderate and transient. Conclusions: Tramadol may be effective in PE treatment, especially when patients have failed therapies, like selective serotonin reuptake inhibitors. However, the possibility of drug addiction and SEs should still be considered before initial use or after chronic use of this agent. More high-quality (clear randomization sequences, allocation concealment and blinding introduction), long-term, RCTs with a large number of PE patients are expected.

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