Effect and safety of paroxetine for vasomotor symptoms: systematic review and meta-analysis

BackgroundParoxetine is the first non-hormone therapy for vasomotor symptoms (VMS) approved based on the results of two phase 3, randomised, placebo-controlled trials by the Food and Drug Administration (FDA) in 2013. ObjectiveTo confirm the effect and safety of paroxetine for vasomotor symptoms (VMS). Search strategyMEDLINE, EMBASE, PsycINFO, CENTRAL, WHO International Clinical Trials Registry Platform (ICTRP) and four Chinese databases was searched from the date of their inception to 7 June 2014. Selection criteriaWe included RCTs on the effect of paroxetine compared with placebo or no treatment for perimenopausal and postmenopausal women who experienced moderate-to-severe vasomotor symptoms. Data collection and analysisTwo reviewers screened records and extracted the information independently. The included studies were appraised by two independent reviewers using the Cochrane risk of bias tool. We synthesised the data in random-effects models and rated the quality of evidence using GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach. Main resultsFive articles with six RCTs (1571 participants) were included. Paroxetine significantly reduced the frequency of hot flushes by 8.86 per week (95% confidence interval (CI) 5.69-12.04, P<0.00001, I-2=83%) at week 4 and 7.36 per week (95% CI, 4.25-10.46, P<0.00001, I-2=62%) at week 12. The quality of the evidence on the effect of paroxetine for VMS was moderate. ConclusionsThere was moderate quality of evidence supporting the effectiveness of paroxetine for vasomotor symptoms; however, it causes nausea and dizziness. Tweetable abstractReview finds paroxetine effective for menopausal symptoms with some side effects: evidence strength moderate. Tweetable abstract Review finds paroxetine effective for menopausal symptoms with some side effects: evidence strength moderate.