Aims: The aim of this study was to assess the effects of orlistat on weight lossrelated clinical variables in overweight/obese women with polycystic ovary syndrome (PCOS) and to compare treatment with orlistat vs. metformin in this group. Methods: We conducted a systematic review and meta-analysis of the evidence about the use of orlistat in women with PCOS. We searched the literature published until May 2015 in MEDLINE, Cochrane Central Register of Controlled Trials and LILACS. Results: Of 3951 studies identified, nine were included in the systematic review (three prospective, non-randomised studies and six randomised control trials). Eight studies used the Rotterdam criteria and 1 used NIH criteria to diagnose PCOS. Data suggest that orlistat promotes a significant reduction in BMI/ weight in overweight/obese PCOS women. Eight studies evaluated orlistat impact on testosterone. Seven reported an improvement in testosterone levels. Eight studies evaluated impact on insulin resistance, and five reported improvement. Finally, five studies evaluated impact on lipid profile, and four reported improvement. Three randomised control trials were included in the fixed effects model meta-analysis for a total of 121 women with PCOS. Orlistat and metformin had similar positive effects on BMI (À0.65%, 95% CI: À2.03 to 0.73), HOMA (À3.60%, 95% CI: À16.99 to 9.78), testosterone (À2.08%, 95% CI: À13.08 to 8.93) and insulin (À5.51%, 95% CI: À22.27 to 11.26). Conclusion(s): The present results suggest that orlistat leads to significant reduction in BMI/body weight in PCOS. In addition, the available evidence indicates that orlistat and metformin have similar effects in reducing BMI, HOMA, testosterone and insulin in overweight/obese PCOS women.This study was registered in PROSPERO under number CRD42014012877.
Review criteria• We conducted a systematic review and metaanalysis of the evidence about the effect of orlistat on weight, BMI, androgens and insulin resistance in women with polycystic ovary syndrome.• We systematically searched literature published until May 2015 in electronic databases MEDLINE, Cochrane Central Register of Controlled Trials and LILACS.• We conducted a descriptive systematic review and a fixed effects model meta-analysis and evaluated heterogeneity using the I 2 statistics and Cochran's Q test.
Message for the clinic• Orlistat leads to significant reduction in BMI/body weight in overweight/obese PCOS.• Orlistat and metformin have similar effects in reducing BMI, testosterone and insulin/HOMA in overweight/obese PCOS women.