Hormonal and metabolic effects of Glycyrrhiza Glabra, Glycyrrhizic Acid, Cinnamomum Zeylanicum, Lagerstromia Speciose and Corosolic Acid in lean patients affected by Polycystic Ovary Syndrome

Introduction. Polycystic Ovary Syndrome (PCOS) is defined by the presence of two out of following parameters: oligo-anovulation, hyperandrogenism (clinical or biochemical), presence of 12 or more follicles in each ovary measuring 2–9 mm in diameter, and/or an increased ovarian volume (10 ml). Current evidence suggests that insulin resistance and compensatory hyperinsulinemia play an important pathogenic role in the hyperandrogenism and anovulation of both obese and lean women with PCOS. Moreover, in PCOS patients insulin resistance is commonly associated with hyperandrogenemia, and the latter acts synergistically with LH to enhance androgen production of theca cells. Considering this evidence, the aim of our work was to test a complex of Glycyrrhiza Glabra, Glycyrrhizic Acid, Cinnamomum Zeylanicum, Lagerstromia Speciose and Corosolic Acid in lean (Body Mass Index < 30) PCOS patients, in order to check its effect on metabolic and endocrine status. Material and methods. We performed a prospective cohort study, enrolling 20 lean patients affected by PCOS according to the Rotterdam Criteria. All the designs, analysis, interpretation of data, drafting, and revisions conform the CONSORT (CONsolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items: Recommendation for Interventional Trials) statements, the Committee on Publication Ethics (COPE) guidelines and were approved by an independent Institutional Review Board (IRB). As standard protocol, each patient was informed and signed a consent allowing data collection for research purposes. We analyzed the following pre-treatment (T0) parameters: systolic and diastolic blood pressure, glycaemia (mg/dl), insulin (uU/dl), reactive c protein (RCP; mg/dl), low-density lipoproteins (LDL; mg/dl), high-density lipoproteins (HDL; mg/dl), triglycerides (mg/dl), fibrinogen (mg/dl), androstenedione (ng/dl), mean follicular dimeter (mm). Transvaginal ultrasound was performed in all cases by the same dedicated physician using VOLUSON ultrasound machine BT Exp 12 E8 (GE Healthcare), with volumetric intracavitary probe RIC5-9-D; calculation of ovarian volume was performed using the simplified formula for a prolate ellipsoid (0.5 9 length 9 width 9 thickness); follicle number was estimated in both longitudinal and anterior-posterior cross sections of the ovaries. The size of follicles/10 mm was expressed as the mean of the diameters measured on the two sections. Patients with any kind of endocrinological disorders except PCOS were excluded from the current analysis. Moreover, we excluded patients with diabetic relatives (first or second degree). The routine biochemical tests were performed on the 3–5 days from the bleeding. The patients came to the hospital after a 12-h overnight fast. After T0, all the patients underwent treatment with Glycyrrhiza Glabra (200 mg/die), Glycyrrhizic Acid (38 mg/die), Cinnamomum Zeylanicum (150 mg/die), Lagerstromia Speciose (48 mg/die) and Corosolic Acid (480 mcg/die) for 3 months, starting on day 1 of menstruation. We re-evalauted the same patients after the treatment (T1), using the same methods described in T0. Any patients taking less than 80% of the allocated dose of study drug was regarded as noncompliant and excluded from our intention-to-treat analysis. During the treatment we did not suggest any change in diet and/or lifestyle. An independent data safety and monitoring committee evaluated the results of the study. Statistical analysis was performed using T test between T0 and T1; level of significance was set at 0.05. Results. We enrolled 20 patients that met inclusion/exclusion criteria of the study: mean age was 24,2 ± 3,0; mean BMI was 25,1 ± 2,9. As showed in Table 1, we evidenced a significant decrease of systolic (p=0,022) and diastolic (p=0,006) blood pressure, triglycerides (p=0,002), androstenedione (p=0,041) and mean follicular diameter (p=0,020). Conversely, we did not evidence any significant variation for the other investigated parameters. Conclusion. Our preliminary data analysis showed that a complex of Glycyrrhiza Glabra, Glycyrrhizic Acid, Cinnamomum Zeylanicum, Lagerstromia Speciose and Corosolic Acid can reduce systolic and diastolic blood pressure, triglycerides, androstenedione and mean follicular diameter in lean patients affected by PCOS. Nevertheless, our analysis is based on a small cohort, so we strongly solicit further studies on larger cohorts and with greater statistical power which may accurately define the effects of this mixture on hormonal and metabolic parameters in PCOS patients.