Effectiveness of low dose Ethinylestradiol/Cyproterone Acetate, Ethinylestradiol/Desogestrel and metformin on hirsutism, hormonal and metabolic parameters of patients with polycystic ovary syndrome: A randomized, double-blind, placebo-controlled study

AbstractPolycystic ovary syndrome (PCOS) is one of the most common causes of infertility in women of reproductive age. Insulin resistance is a main pathophysiologic feature in these patients. According to some studies, the intake of probiotic bacteria may improve glucose homoeostasis. The aim of this study was to investigate the effect of synbiotics on metabolic parameters and apelin in PCOS patients. This randomised double-blind placebo-controlled trial was conducted on eighty-eight PCOS women aged 19–37 years old. The participants were randomly assigned to two groups receiving (1) synbiotic supplement (n44), and (2) placebo (n44) for 12 weeks. Fasting blood samples were taken at baseline and after 12 weeks. The two groups showed no difference in fasting blood sugar (adjusted mean difference: 0·60; 95 % CI −3·80, 5·00,P=0·727), plasma glucose fasting 2-h (adjusted mean difference 2·09; 95 % CI −9·96, 14·15,P=0·134), HbA1c (adjusted mean difference 0·06; 95 % CI −0·09, 0·22,P=0·959), homoeostatic model assessment-insulin resistance (HOMA-IR) (adjusted mean difference: 0·02; 95 % CI −0·99, 1·03,P=0·837), quantitative insulin sensitivity check index (QUICKI) (adjusted mean difference: −0·02; 95 % CI −0·33, 0·29,P=0·940) and C-reactive protein (CRP) (adjusted mean difference: 0·24; 95 % CI −1·61, 2·08,P=0·141) by the end of the intervention. A significant difference was observed in the mean apelin 36 before and after the intervention between synbiotic and placebo groups (adjusted mean difference: −4·05; 95 % CI −7·15, −0·96,P=0·004). A 12-week synbiotic supplementation has no significant beneficial effects on HOMA-IR and CRP in PCOS patients, whereas the level of apelin 36 significantly decreased.

Download Full-text

A randomized, double-blind, placebo-controlled study of liraglutide 3 mg [LIRA 3mg] on weight, body composition, hormonal and metabolic parameters in women with obesity and polycystic ovary syndrome (PCOS)

10.21203/rs.3.rs-799341/v1 ◽

2021 ◽

Author(s):

Karen Elkind-Hirsch ◽

Neil Chappell ◽

Donna Shaler ◽

John Storment ◽

Drake Bellanger

Keyword(s):

Body Composition ◽

Body Weight ◽

Polycystic Ovary Syndrome ◽

Polycystic Ovary ◽

Controlled Study ◽

Ovary Syndrome ◽

Double Blind ◽

Once Daily ◽

Double Blind Placebo ◽

Change In Mean

Abstract BackgroundThe efficacy of lifestyle modifications for established obesity is limited in women with polycystic ovary syndrome (PCOS) and more aggressive interventions are needed. We assessed the efficacy and safety of the GLP-1 analogue liraglutide 3mg (LIRA 3mg) versus placebo (PL) for reduction of body weight and hyperandrogenism in women with obesity and PCOSMethodsThis randomized, double-blind, placebo-controlled study enrolled women from a single-outpatient center diagnosed with PCOS (NIH criteria) with a body-mass index of at least 30 kg/m.2 Participants were randomly allocated (2:1) to treatment with a subcutaneous injection LIRA 3mg or visually matching placebo, once daily for 32 weeks, plus lifestyle intervention. Study visits at baseline, and 32 weeks included weight, blood pressure (BP), waist (WC) measures and body composition evaluated by dual-energy X-ray absorptiometry (DXA). Oral glucose tolerance tests (OGTT) were done to assess glycemia, mean blood glucose (MBG), and compute insulin sensitivity (SI) and secretion (IS) measures. Sex steroids, free androgen index (FAI), complete metabolic profile and lipid profiles were measured in the fasting sample. Co-primary endpoints were change in body weight (BW) and FAI. Safety was assessed in all patients who received at least one dose of study drug. This study was registered with ClinicalTrials.gov NCT03480022FindingsFrom October 2018 to June 2020, 88 patients were screened, of whom 82 were randomly assigned to LIRA 3mg (n = 55) or PL (n = 27). Change in mean BW from baseline to week 32 was − 5.7% (SE 0·.75) with LIRA 3mg vs. -1.4% (1.09) with PL (P < 0.002). At week 32, more patients on LIRA 3 mg than on placebo achieved weight reductions of at least 5% (25[57%] of 44 vs. 5 [22%] of 23; (p < 0·007). LIRA 3mg resulted in significant reduction of FAI, improvements in SI and IS as well as OGTT MBG, and improved body fat by DXA. Gastrointestinal adverse events, which were mostly mild to moderate, were reported in 32 (58.2%) of 55 patients with LIRA 3mg, and 5 (18.5%) of 27 with PL.InterpretationIn obese women with PCOS, LIRA 3mg once daily achieved a superior and clinically meaningful decrease in BW and androgenicity and improved cardiometabolic parameters compared with placebo.

Download Full-text