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In addition, the following primary outcome was extracted: IELT, defined as the time from the start of vaginal insertion to the start of intravaginal ejaculation and measured using the stopwatch. The secondary outcomes were as follows: PGIC, also called the clinical global impression of change (CGIC or CGI) in some studies, defined as a validated tool used to measure overall perceived change in patients with better and much better results after treatment (i.e., “Compared to the start of the study, would you describe your PE problem as much worse, worse, slightly worse, no change, slightly better, better, or much better?27”) and AEs, defined as potential symptoms related to dapoxetine discontinuation syndrome such as nausea, diarrhea, insomnia, headache, dizziness, erectile dysfunction, fatigue. The methodological quality of the included studies was measured independently by two reviewers using the Cochrane Handbook for Systematic Reviews of Interventions28. The main evaluation items included: (1) random sequence generation (selection bias), (2) allocation concealment (selection bias), (3) blinding of participants (performance bias), (4) blinding of outcome assessment (detection bias), (5) incomplete outcome data (attrition bias), (6) selective reporting (reporting bias) and (7) other bias. These criteria for a judgment of low, high, or unclear risk of bias for each item were used to describe the bias. A “Yes,” “No,” or “Unclear” assessment expressed as low risk of bias, high risk of bias, or uncertain risk of bias, respectively. Disagreements were discussed and resolved by using a third person-evaluation. These assessments were reported for each individual study in the “risk of bias in included studies” in Figure 2.

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Included in the study were all published or unpublished RCTs evaluating dapoxetine interventions for PE. Studies comparing dapoxetine intervention versus placebo or another drug intervention were eligible for this review. All relevant studies were included in this study if they met the following criteria: (1) all patients were older than 18 years; (2) patients were diagnosed with PE; (3) patients were treated with oral dapoxetine on-demand (1–3 hours before sexual activity); (4) data were available for at least one of the predefined outcome measurements. Studies were excluded if (1) patients were diagnosed with mixed sexual dysfunction such as erectile dysfunction plus PE; (2) patients were treated with a fixed-dose orally daily; (3) the data referred to data from an animal study; or (4) studies reported data from non-RCTs or quasi-RCTs. The following variables from each study were recorded independently by two reviewers and cross-checked: first author name, publication year, research design type, total number of patients enrolled, patient age, intervention method, outcome measures. All statistical analyses were conducted using Review Manager, version 5.1.0 (Cochrane Collaboration, Oxford, UK). Statistical analysis of dichotomous variables (PGIC and AEs) were performed using the RR as the summary analysis, while continuous variable (IELT) was analyzed using the MD; accompanying 95% CIs and P-values were reported. For all statistical results, P < 0.05 was considered statistically significant.

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Additionally, nearly all trials included in this study lacked a clear description of the allocation concealment, but all trials included in this meta-analysis were RCTs, the methods were designed well. Thus, the data from the studies included in our meta-analysis were reliable. In summary, our meta-analysis has shown that either 30 mg or 60 mg dapoxetine on-demand orally was associated with a significantly greater increase in mean IELT and PGIC compared placebo. Additionally, 60 mg had a better efficacy than 30 mg dapoxetine on-demand orally. However, the meta-analysis also demonstrated that those treated with dapoxetine (especially 60 mg on-demand orally) reported more AEs than placebo or the dapoxetine 30 mg group. The Mantel-Haenszel χ2 test and I2 statistic for heterogeneity were conducted. I2 values of <50% were defined as acceptable; those >50% indicated high levels of heterogeneity. When there was a lack of heterogeneity, a fixed-effects models was used, otherwise random-effects model was applied for the meta-analysis. Sexual problems among women and men aged 40–80 y: prevalence and correlates identified in the global study of sexual attitudes and behaviors. The Premature Ejaculation Prevalence and Attitudes (PEPA) survey: prevalence, comorbidities and professional help-seeking. An update of the international society of sexual medicine's guidelines for the diagnosis and treatment of premature ejaculation (PE). An evidence-base definition of lifelong premature ejaculation: report of the internation society for sexual medicine ad hoc committee for the definition of premature ejaculation. Symonds, T., Roblin, D., Hart, K. & Althof, S. How does premature ejaculation impact a man's life? Bailey, G.

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Nonetheless, the most commonly reported AEs were mild and tolerated. We searched the following databases up to and including June 2014: MEDLINE by PubMed, EMBASE, Cochrane Central Register of Controlled Trials (Cochrane Library). We did not restrict our search to articles published in English and the following search terms were used in conjunction with: dapoxetine, SSRIs and premature ejaculation, sexual dysfunction. We also searched the relevant references of all studies included in the analysis. All retrieval literatures were independently performed by Cao D and HY. C. & Trost, L. W. Current diagnosis and management of premature ejaculation. Curr Sex Health Rep 6, 65–80 (2014). Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. Carson, C. & Gunn, K. Premature ejaculation: definition and prevalence. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomized controlled trials. Treatment benefit of dapoxetine for premature ejaculation: result from a placebo-controlled phase III trial. Perceived control over ejaculation is central to treatment benefit in men with premature ejaculation: results from phase III trials with dapoxetine. Dapoxetine for the Treatment of Premature Ejaculation: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 trial in 22 Countries. Treatment of premature ejaculation in the Asia-Pacific region: results from a phase III double-blind, parallel-group study of dapoxetine. A prospective randomized study to compare pelvic floor rehabilitation and dapoxetine for treatment of lifelong premature ejaculation. Comparison of paroxetine and dapoxetine, a novel selective serotonin reuptake inhibitor in the treatment of premature ejaculation. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. & Dinsmore, W. W. Dapoxetine: an evidence-based review of its effectiveness in treatment of premature ejaculation. Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study. Results from a prospective observational study of men with premature ejaculation treated with dapoxetine or alternative care: the pause study. Safarinejad, M. R. Comparison of dapoxetine versus paroxetine in patients with premature ejaculation: A double-blind, placebocontrolled, fixed-dose, randomized study. Safarinejad, M. R. Safety and efficacy of dapoxetine in the treatment of premature ejaculation: a double-blind, placebo-controlled, fixed-dose, randomized study. Porst, H. An overview of pharmacotherapy in premature ejaculation. Single- and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation. Comparison between on-demand dosing of dapoxetine alone and dapoxetine plus mirodenafil in patients with lifelong premature ejaculation: prospective, randomized, double-blind, placebo-controlled, multicenter study. & Yurdakul, T. On-demand tramadol hydrochloride use in premature ejaculation treatment. Validity of the patient-reported Clinical Global Impression of Change as a measure of treatment response in men with premature ejaculation. & Green, S.

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The heterogeneity was significantly decreased when comparing dapoxetine with placebo in the IELT by subgroup analysis. However, this heterogeneity of data still exists in the PGIC and AEs analyses, which we were unable to improve. We believe this heterogeneity might have resulted in the evaluation of the PGIC value using a 7-point scale (from −3 = much worse to 3 = much better) and AEs that were assessed using a subjective evaluation by individual patients. Additional factors might have been potentially amplified heterogeneity; these include differences in treatment duration, individual differences and mental or physical conditions. Secondly, some of the included studies did not report the outcome measures; hence, the statistical results might be influenced by the statistical parameters used for calculations. Cochrane Handbook For Systematic Review Of Intervention 5.1.0. This study was supported by the National Natural Science Foundation of China (Grant No.81200551 and 81270841). No funding bodies played any role in study design, data collection and analysis, decision to publish, or preparation this manuscript. The authors would like to thank their colleagues and staff in the Chinese Cochrane Centre for their help. contributed to the conception and design of the study, C.D. wrote the main manuscript text and H.Y. The authors declare no competing financial interests. This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article's Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder in order to reproduce the material.