Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical Trial

Polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolicdisorders affecting women of reproductive age and is frequently associated with obesity,insulin resistance, dyslipidemia, and hormonal imbalance. Lifestyle modification remainsthe cornerstone of management; however, additional therapeutic options are needed toimprove metabolic and reproductive outcomes. Orlistat, a gastrointestinal lipaseinhibitor, promotes weight reduction by decreasing dietary fat absorption and hasdemonstrated potential benefits in improving insulin resistance and lipid metabolism.This study is a single‐center, randomized controlled clinical trial to be conducted atAyub Teaching Hospital, Abbottabad. A total of 120 women aged 18‐45 years with PCOSdiagnosed according to the Rotterdam criteria will be enrolled and randomly allocated ina 1:1 ratio to either the intervention group or the control group. Participants in theintervention group will receive orlistat capsules twice daily in addition to standardlifestyle advice, while participants in the control group will receive placebo togetherwith the same lifestyle recommendations, including a healthy diet and regular physicalactivity. The intervention period will last three months.Participants will undergo baseline assessment, telephone follow‐up visits at one and twomonths to monitor treatment adherence, and a final in‐person assessment after threemonths. The primary outcome is improvement in at least one abnormality defined by theRotterdam diagnostic criteria. Secondary outcomes include changes in sex hormone profile(LH, FSH, LH/FSH ratio, AMH, and free testosterone), fasting glucose and insulinparameters, HbA1c, lipid profile, liver function tests, lipid accumulation product,hepatic steatosis index, ultrasound grading of non‐alcoholic fatty liver disease,anthropometric measures, and PCOS‐related quality of life. The findings of this studywill provide evidence regarding the effectiveness of orlistat as an adjunct to lifestylemodification for improving the metabolic and hormonal manifestations of PCOS in women.