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Introduction Insulin resistance is a fundamental factor in the pathogenesis of polycystic ovarian syndrome (PCOS) and has been found to mediate a close association with obesity and dyslipidemia. While the anti-diabetic and anti-inflammatory properties of fenugreek seed extracts have been demonstrated, research on its anti-hyperlipidemic properties is still in its novice stage, with inconclusive evidence. The present study assessed the impact of fenugreek seed extracts rich in furostanolic saponins (Furocyst) on lipid profiles across different categories of body mass index (BMI) in women with PCOS. Methodology The study was a single-blinded, randomized clinical study conducted among 230 patients between 18 and 45 years of age, presenting to the Gynecology and Obstetrics OPD for treatment of PCOS. After screening for eligibility, patients were enrolled and randomized into the experimental group (receiving Furocyst BD for three months) and the placebo group. Blood samples collected before treatment and after the completion of treatment were investigated for insulin resistance and lipid profile. The final analysis was conducted on 188 patients (104 in the Furocyst group and 84 in the placebo group) and stratified for different categories of BMI (based on WHO classification). Results A significant reduction in the mean BMI in all patients overall and in patient subgroups according to BMI was noted after 12 weeks of treatment with Furocyst, which was statistically significant in the obese (p<0.001). The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) index was also reduced in the Furocyst group across all BMI categories, including sub-classes of obese (p<0.001). The lipid-lowering effects of Furocyst were observed on total cholesterol, triglyceride, and VLDL (very-low-density lipoprotein) in all patients, irrespective of the initial BMI category (p<0.05). The drug did not affect the mean serum HDL (high-density lipoprotein) levels. In obese patients, Furocyst also exhibited a statistically significant reduction in LDL-HDL ratio and cholesterol-HDL ratio. Conclusion The present study demonstrates the insulin-sensitizing, glucose-regulating, anti-obesity, and anti-hyperlipidemic properties of Furocyst in women with PCOS. The overweight and obese seem to benefit most from the drug. The use of Furocyst may be considered a pragmatic approach to treating PCOS-related symptoms and improving metabolic disturbances, specifically by optimizing the lipid profile in the affected women and lowering cardiovascular risk factors in the long term., Competing Interests: Human subjects: Consent for treatment and open access publication was obtained or waived by all participants in this study. King George's Medical University issued approval 208/Ethics/2019 dated 13-03-2019. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: The drug (Furocyst) and the placebo used in the trial were provided by Chemical Resources (CHERESO), Panchkula, Haryana, India. All laboratory tests were carried out in the Department of Biochemistry, KGMU, and ultrasonography was conducted by the Department of Radiology, KGMU. However, the study, which included patient enrollment, interviews, baseline data collection, drug dispensation, and patient follow-up, was conducted independently by the first author (Aparna Shukla). Financial relationships: Apurva Goel, Kiran Tiwari declare(s) employment from Chemical Resources (CHERESO). Apurva Goel (4th author) and Kiran Tiwari (5th author) are direct employees of the drug sponsoring company, Chemical Resources (CHERESO). Aparna Shukla declare(s) Drugs from Chemical Resources (CHERESO). The drug (Furocyst) and placebo were provided by the company for conducting the trial, which was also the PhD research of the first author. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Shukla et al.)

Introduction Characterized by a range of symptoms including irregular menstrual cycles, hirsutism, and infertility, polycystic ovarian syndrome (PCOS) also poses substantial metabolic challenges. Among these, dyslipidemia and obesity are particularly concerning due to their long-term implications for cardiovascular health. The present study explores the intricate relationship between lipid profile and body mass index (BMI) in patients with PCOS presenting to the Department of Obstetrics and Gynaecology, King George's Medical University, Lucknow, a tertiary care teaching hospital in Northern India. Methods The present work involves analysis of clinical characteristics of 230 premenopausal women between 18-45 years of age diagnosed with PCOS (according to Rotterdam Criteria). Patients with conditions such as congenital adrenal hyperplasia; Cushing's syndrome; uncontrolled hypertension, smoking, hypogonadism; using oral contraceptives; pregnant or lactating mothers; smoking or drug addiction; psychiatric illness; and those diagnosed with androgen-secreting tumors were excluded. For each participant, data was collected pertaining to demographics (age, marital status), clinical presentation, height, and weight (for BMI calculation), and total lipid profile comprising of total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and very low-density lipoprotein cholesterol (VLDL-C). The patients were stratified according to their BMI as per the WHO Asian classification, and Pearson's correlation coefficient was calculated to see the correlation between lipid profile and BMI. Results The final analysis was done on 228 patients, with a mean age of 25.22 (±4.82) years, and 45.6% were currently married. Among the participants, 28.1% of the participants were overweight, and 42.5% of them classified as obese, while the remaining 29.4% had a BMI in the normal range. The mean (SD) total cholesterol was 172.26 (49.55) mg/dl, and 65 patients (28.5%) had elevated serum cholesterol (≥200 mg/dl). Triglycerides were raised (≥ 150 mg/dl) in a majority of the study participants (n=160, 70.2%). While none of the patients had high VLDL-C, LDL-C was elevated in 52 patients (22.8%). HDL-C levels were lower than the threshold value of 50 mg/dl in 152 participants (66.7%). On performing correlation analysis, a significant negative correlation was noted between HDL-C and BMI in the entire study cohort (r=-0.342, p=0.003). Overweight patients exhibited a statistically significant positive correlation between triglycerides and BMI (r=2.628, p=0.002). Participants with BMI in the overweight range demonstrated statistically significant correlations with HDL-C (r=-0.497, p=0.017) and triglycerides (r=2.628, p=0.002); and BMI of obese patients significantly correlated with total cholesterol (r=0.301, p=0.037) and triglycerides (r=0.146, p=0.028). Conclusion The findings of the study underscore the multifaceted nature of PCOS, affecting reproductive health as well as metabolic components. The significant correlations between BMI and lipid parameters, specifically, HDL-C, triglycerides, and total cholesterol, highlight the importance of weight management in reducing cardiovascular risks in women with PCOS., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Institutional Ethics Committee, King George's Medical University, Lucknow issued approval No. 208/Ethics/2019 dated 13-3-2019. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Shukla et al.)