A preview of the PDF is not available
Dapoxetine for Premature Ejaculation: a Harmful Placebo?
Abstract and Figures
Background: Recently, dapoxetine was approved by the European Medicines Agency (EMA) as an effective and safe pharmacological agent for the treatment of premature ejaculation (PE). The objective of this study was to systematically review the efficacy and harm of dapoxetine. Methods: We included randomized controlled trials that investigated the efficacy of dapoxetine for PE by comparing to placebo. We searched for both published and unpublished relevant trials using PUBMED, EMBASE, the Cochrane Central Register of Controlled Trials, a clinical trials register (clinicaltrials.gov), the EMA and the Food and Drug Administration clinical reviews through december 2013. We evaluated the blinding status of trials with the Cochrane Risk of Bias (ROB) Tool, using the domains of allocation sequence concealment, blinding of participants, healthcare providers and outcome assessors. For the latter 3 ROB domains, we applied additional criteria. Across these domains, studies that scored low risk of bias were judged to be adequately blinded and the remaining studies were judged to be inadequately blinded. Reporting followed PRISMA guidelines. Results: We included 8 studies that involved 6,954 randomized participants; Seven studies had a short duration (6 to 12 weeks). Information on study blinding was mostly absent, many participants dropped out of studies (short (21%) vs long (47%) term studies) and many conflicts of interests were found. One adequately blinded study reported ejaculation delayed on dapoxetine with 42 [-8, 76] seconds. Inadequately blinded studies reported ejaculation time was 2.29 [1.37, 3.21] and 1.70 [0.50, 2.90] minutes on dapoxetine and placebo respectively. Risk ratios for the most common adverse events (AEs) were: nausea RR 5.93 [4.31, 8.18], headache RR 1.21 [0.94, 1.55], dizziness RR 3.17 [2.25, 4.47], diarrhoea RR 3.18 [2.06, 4.92]. One study reported substantially more headache RR 5.16, more dizziness RR 7.22 and more diarrhoea RR 11.35. Conclusions: We found no evidence that dapoxetine is effective. Any small ejaculation-time delaying effects seem to result from a placebo effect. The data suggest that dapoxetine may add around 30 seconds to postpone an man's ejaculation, but this could not be statistically confirmed. Unfortunately, dapoxetine comes with its risks. It has several adverse effects and a significant proportion of patients quit dapoxetine early. Dapoxetine's overall risk/benefit profile is unfavourable.
Figures - uploaded by Frederik Feys
All figure content in this area was uploaded by Frederik Feys
Content may be subject to copyright.