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| Date: 12-31-2015 | HC# 121561-535 |
Swaroop A, Jaipuriar AS, Gupta SK, et al. Efficacy of a novel fenugreek seed extract (Trigonella foenum-graecum, Furocyst™) in polycystic ovary syndrome (PCOS). Int J Med Sci. October 3, 2015;12(10):825-831.
Polycystic ovary syndrome (PCOS) is characterized by the imbalance of normal female hormones, likely due to ovarian cysts, and may lead to diabetes, heart disease, and infertility. Hyperinsulinemia also is common to patients with PCOS, and therapeutics used to treat diabetes, such as metformin, are standards for PCOS treatment. Several botanicals have been reported to be efficacious in treating PCOS. Fenugreek (Trigonella foenum-graecum, Fabaceae) seed extract has shown bioactivity in diabetic animal models. This open-label, observational study investigated the effects of a fenugreek seed extract (Furocyst™; Cepham, Inc.; Piscataway, New Jersey) for the potential treatment of PCOS in premenopausal women.
The study took place at Garg Hospital in Gorakhpur and the Hormone and Maternity Clinic in Meerut, both in Uttar Pradesh, India. Patients with PCOS aged 18-45 years old, premenopausal, and with a body mass index of less than 42 kg/m2 were included. Patients were excluded if they were postmenopausal, pregnant, or lactating, or had a hysterectomy, adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, thyroid dysfunction, or hypogonadism or hypogonadotropic. Furocyst is a water-ethanol extract of fenugreek seed standardized to contain 40% furostanolic saponins. From 67 potential patients, 50 were included in the study and were given 2 capsules of Furocyst (500 mg each) daily for 3 months.
Primary outcomes were any decrease of ovarian volume and cysts. Ovarian volume, cysts, and menstrual regularity were assessed at baseline and endpoint. Glucose, triglyceride, and high-density lipoprotein (HDL) cholesterol concentrations, as well as concentrations of liver and kidney function markers and hemoglobin and leukocyte, were measured at baseline and after 90 days. Blood parameters for efficacy, such as luteinizing hormone (LH, an ovulation signaler) and follicle-stimulating hormone (FSH, a hormone central to menstruation) concentrations, were measured at baseline and after 1, 2, and 3 months of the study. In addition to laboratory measurements, patients were asked to note any adverse side effects.
Significant increases were seen in LH concentrations (10.33 ± 7.25 IU/L vs. 13.93 ± 10.14 IU/L, P=0.045) from baseline to endpoint and in FSH concentrations from baseline to both 2 and 3 months (5.36 ± 1.73 IU/L vs. 6.38 ± 2.37 IU/L and 8.36 ± 3.34 IU/L, P=0.010 and P=0.000, respectively). [Note: Statistical tests were not specified in this study, and the reporting of P values as 0.000 is questionable.] At the end of the study, a significant reduction in right ovary volume was observed (14.00 ± 6.27 cm3 vs. 10.00 ± 4.19 cm3, P=0.000). The left ovary volume was nonsignificantly reduced. Regular menstrual cycles increased starting at 2 months into the study, with greater increases after 3 months. It is stated that 71% of patients had regular menstrual cycles at the end of the study. Statistical relevance is not stated. The authors also report that 46% of patients showed a reduction in cyst size and 36% showed no cysts at the end of the study. Data and statistical relevance are again not stated. Hemoglobin concentrations were increased from baseline to endpoint (12.37 ± 1.047 vs. 13.00 ± 0.926, P=0.000 [units not specified]). No significant differences were noted in leukocyte, triglyceride, or HDL concentrations. Indicative of safety, markers of liver and kidney function remained unchanged.
It is stated that 94% of patients saw improvement in PCOS in some form, whether reduction or elimination of cysts, regular menstrual cycles, or pregnancy (12% of patients became pregnant during the study), showing that daily consumption of Furocyst resulted in improvement of PCOS symptoms and characteristics. No adverse side effects were observed either by patients or with blood parameters. Furocyst appears to effectively alleviate PCOS independent of normalizing disrupted metabolism as supplementation had no effect on patients' diabetes-related symptoms such as blood glucose. In summary, this product may be an effective and safe treatment for those suffering from PCOS.
Three of the authors (A. Swaroop, M. Bagchi, and D. Bagchi) are employed by Cepham, Inc..
—Amy C. Keller, PhD
