Objectives: The objective of this study is to evaluate weight change and analyze adverse events in overweight and obese women with polycystic ovary syndrome (PCOS) who were prescribed with Gamitaeeumjowee-tang. Methods: A retrospective chart review was conducted for medical records of patients with PCOS, who were administered with Gamitaeeumjowee-tang for a period of 12 weeks between January 2019 and December 2021. Outcomes were total weight loss/weight loss rate, the percentage of patients who lost more than 5% and 10% of their baseline weight. Adverse events (AEs) reported by patients were evaluated by severity, causality and system-organ classes. Results: A total of sixty-seven patients were included (mean±standard deviation, Age 28.78±5.25 years, weight 76.78±12.84 kg, body mass index 29.2±4.26 kg/m 2 ). The average total weight loss in PCOS patients was 6.57±3.07 kg and the average weight loss rate was 8.55±3.65%. The percentage of patients with more than 5% and 10% weight loss compared to their baseline weight was 86.56% and 25.37% respectively. The analysis of adverse events are as follows: Causality assessment with World Health Organization-Uppsala Monitoring Centre of AEs showed 'Unlikely' was the most common (71.7%) and severity evaluations with Common Terminology Criteria for Adverse Events showed almost all symptoms were mild (98.9%).Conclusions: Gamitaeeumjowee-tang helps to lose weight of PCOS patients, which is overweight or obese, and no serious adverse events have occurred. Additional well-designed clinical studies are recommended.

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