Background: Paroxetine 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.
Objective: To confirm the effect and safety of paroxetine for vasomotor symptoms (VMS).
Search strategy: MEDLINE, 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 criteria: We 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 analysis: Two 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 results: Five 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.
Conclusions: There was moderate quality of evidence supporting the effectiveness of paroxetine for vasomotor symptoms; however, it causes nausea and dizziness.
Tweetable abstract: Review finds paroxetine effective for menopausal symptoms with some side effects: evidence strength moderate.
Keywords: GRADE; low dose paroxetine salt; meta-analysis; paroxetine; vasomotor symptoms.
© 2016 Royal College of Obstetricians and Gynaecologists.