Letter to the Editor on “Efficacy and safety of pharmacological treatments in patients with premature ejaculation: an umbrella review of meta-analyses of randomized controlled trials”: reexamining the clinical weight of intravaginal ejaculatory latency time after pharmacological therapy for premature ejaculation
Abstract
We applaud Raisi et al for their meticulous umbrella review of drug therapy for premature ejaculation.1 Yet, 2 points deserve closer scrutiny: (1) the sole reliance on intravaginal ejaculatory latency time (IELT) as the primary outcome and (2) the absence of a patient-defined minimal clinically important difference (MCID) that is anchored to real-life bother. First, IELT is only weakly correlated with patient- or partner-reported distress. In the only population-based cohort that collected stopwatch IELT and administered the Male Sexual Health Questionnaire–Ejaculatory Dysfunction Short Form, only 34% of men with an IELT 4 minutes still expressed high concern. Thus, pooling trials by mean IELT differences may overstate clinical relevance. Second, the 0.67-minute MCID used by Raisi et al was derived from a single expert Delphi panel.2 A recent individual-patient data reanalysis of 6 dapoxetine trials found that a 1.5-minute gain corresponded to a 50% probability of feeling better on the Clinical Global Impression of Change, whereas 0.67 minutes did not separate from placebo.3 Applying the higher threshold would downgrade several agents labeled “effective” in the umbrella review.
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