Effects of Probiotic Supplementation on Pancreatic β-cell Function and C-reactive Protein in Women with Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Clinical Trial The effects of synbiotic supplementation on hormonal status, biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial Effects of Probiotic Supplementation on Hormonal Profiles, Biomarkers of Inflammation and Oxidative Stress in Women With Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial. Probiotic supplementation and the effects on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome. Is Reducing Ovarian Volume in Polycystic Ovarian Syndrome Patients after Administration of Metformin Associated with Improving Cardiovascular Risk Factors? Internet-based randomised controlled trials for the evaluation of complementary and alternative medicines: probiotics in spondyloarthropathy A randomized, 48-week, placebo-controlled trial of intensive lifestyle modification and/or metformin therapy in overweight women with polycystic ovary syndrome: a pilot study. Effects of an antiandrogenic oral contraceptive pill compared with metformin on blood coagulation tests and endothelial function in women with the polycystic ovary syndrome: influence of obesity and smoking. The effects of metformin with lifestyle therapy in polycystic ovary syndrome: a randomized double-blind study. The impact of metformin, oral contraceptives, and lifestyle modification on polycystic ovary syndrome in obese adolescent women in two randomized, placebo-controlled clinical trials. Clinical and biochemical characterization of women with polycystic ovary syndrome in North Rhine-Westphalia. Effects of exercise and nutritional counseling in women with polycystic ovary syndrome. Serum uric acid concentration as non-classic cardiovascular risk factor in women with polycystic ovary syndrome: effect of treatment with ethinyl-estradiol plus cyproterone acetate versus metformin. Local recruitment experience in a study comparing the effectiveness of a low glycaemic index diet with a low calorie healthy eating approach at achieving weight loss and reducing the risk of endometrial cancer in women with polycystic ovary syndrome (PCOS). The effects of probiotic and selenium co-supplementation on parameters of mental health, hormonal profiles, and biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome Comparison of two oral contraceptive forms containing cyproterone acetate and drospirenone in the treatment of patients with polycystic ovary syndrome: a randomized clinical trial
Background : Polycystic ovary syndrome ( PCOS ) is a polygenic endocrine disorder in women of reproductive age that lead to infertility . The aim of this study was to investigate the effects of probiotic on pancreatic β-cell function and C-reactive protein ( CRP ) in PCOS patients . Methods : This r and omized double-blind placebo-controlled clinical trial was conducted among 72 women aged 15–40 years old diagnosed with PCOS . Participants were r and omly assigned to two groups receiving : ( 1 ) Probiotic supplements ( n = 36 ) , ( 2 ) placebo ( n = 36 ) for 8-week . Fasting blood sample s were taken at baseline and after 8-week of intervention . Results : Probiotic supplementation , compare with placebo , reduced fasting blood sugar ( −4.15 ± 2.87 vs. 2.57 ± 5.66 mg/dL , respectively P = 0.7 ) , serum insulin levels in crude model ( −0.49 ± 0.67 vs. 0.34 ± 0.82 μIU/mL , respectively , P = 0.09 ) , homeostasis model of assessment -insulin resistance score ( −0.25 ± 0.18 vs. −0.05 ± 0.18 , respectively , P = 0.14 ) nonsignificantly . Serum insulin levels after adjustment with covariates reduced significantly in probiotic group ( P = 0.02 ) . We did not found any significant differences in mean changes of CRP between groups ( −0.25 ± 0.18 vs. −0.05 ± 0.18 , respectively , P = 0.14 ) . Conclusions : A 8-week multispecies probiotics supplementation had nonsignificantly beneficial effect on pancreatic β-cell function and CRP in PCOS patients . After adjustment for some covariates , serum insulin changes were significantly different between groups Background To our knowledge , no reports are available indicating the effects of synbiotic supplementation on hormonal status , biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome ( PCOS ) . This research was done to assess the effects of synbiotic supplementation on hormonal status , biomarkers of inflammation and oxidative stress in subjects with PCOS . Methods This r and omized double-blind , placebo-controlled trial was conducted on 60 subjects diagnosed with PCOS according to the Rotterdam criteria . Subjects were r and omly assigned into two groups to take either synbiotic ( n = 30 ) or placebo ( n = 30 ) for 12 weeks . Endocrine , inflammation and oxidative stress biomarkers were quantified at baseline and after the 12-week intervention . Results After the 12-week intervention , compared with the placebo , synbiotic supplementation significantly increased serum sex hormone-binding globulin ( SHBG ) ( changes from baseline in synbiotic group : + 19.8 ± 47.3 vs. in placebo group : + 0.5 ± 5.4 nmol/L , p = 0.01 ) , plasma nitric oxide ( NO ) ( changes from baseline in synbiotic group : + 5.5 ± 4.8 vs. in placebo group : + 0.3 ± 9.1 μmol/L , p = 0.006 ) , and decreased modified Ferriman Gallwey ( mF-G ) scores ( changes from baseline in synbiotic group : − 1.3 ± 2.5 vs. in placebo group : − 0.1 ± 0.5 , p = 0.01 ) and serum high-sensitivity C-reactive protein ( hs-CRP ) ( changes from baseline in synbiotic group : − 950.0 ± 2246.6 vs. in placebo group : + 335.3 ± 2466.9 ng/mL , p = 0.02 ) . We did not observe any significant effect of synbiotic supplementation on other hormonal status and biomarkers of oxidative stress . Conclusions Overall , synbiotic supplementation for 12 weeks in PCOS women had beneficial effects on SHBG , mFG scores , hs-CRP and NO levels , but did not affect other hormonal status and biomarkers of oxidative stress . Trial registration This study was retrospectively registered in the Iranian website ( www.i rct .ir ) for registration of clinical trials ( I RCT 201509115623N53 ) , on 2015–09 - 27 BACKGROUND To the best of our knowledge , data on effects of probiotic administration on hormonal profiles , biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome ( PCOS ) are scarce . This investigation was conducted to assess the effects of probiotic supplementation on hormonal profiles , biomarkers of inflammation and oxidative stress in women with PCOS . METHODS This r and omized , double-blind , placebo-controlled trial was conducted on 60 women with PCOS , aged 18 - 40 years old . Subjects were r and omly assigned into 2 groups to receive either probiotics or placebo ( n = 30 each group ) for 12 weeks . Metabolic profiles were quantified at baseline and after a 12-week intervention . RESULTS After the 12-week intervention , compared with placebo , probiotic supplementation significantly increased serum sex hormone-binding globulin ( SHBG ) ( + 25.9 ± 32.5 vs. + 0.5 ± 15.6 nmol/L , P < 0.001 ) and plasma total antioxidant capacity ( TAC ) ( + 8.8 ± 120.5 vs. -98.3 ± 246.4 mmol/L , P = 0.04 ) , and significantly decreased serum total testosterone ( -0.2 ± 0.7 vs. + 0.2 ± 0.6 ng/mL , P = 0.03 ) , modified Ferriman-Gallwey ( mF-G ) scores ( -1.7 ± 1.5 vs. -0.2 ± 1.0 , P < 0.001 ) , serum high-sensitivity C-reactive protein ( hs-CRP ) ( -1150.0 ± 1295.2 vs. + 202.5 ± 1426.3 ng/mL , P < 0.001 ) and plasma malondialdehyde ( MDA ) concentrations ( -0.2 ± 0.6 vs. + 0.9 ± 1.3 µmol/L , P < 0.001 ) . We did not observe any detrimental effect of probiotic supplementation on other metabolic profiles . CONCLUSION Overall , probiotic supplementation of PCOS women for 12 weeks had beneficial effects on total testosterone , SHBG , mFG scores , hs-CRP , TAC and MDA levels but did not affect other metabolic profiles Abstract The aim of the current study was to assess the effects of probiotic supplementation on weight loss , glycaemia and lipid profiles in women with polycystic ovary syndrome ( PCOS ) . In a r and omized , double-blind , placebo-controlled trial , 60 women with PCOS were r and omized to receive probiotic capsule ( n = 30 ) or placebo ( n = 30 ) for 12 weeks . Consumption of probiotic supplements result ed in a significant reduction in weight ( −0.5 ± 0.4 vs. + 0.1 ± 1.0 kg , p = 0.004 ) and BMI ( −0.2 ± 0.2 vs. + 0.03 ± 0.4 kg/m2 , p = 0.004 ) compared with the placebo . In addition , compared with the placebo , probiotic administration was associated with a significant decrease in fasting plasma glucose ( −2.4 ± 8.4 vs. + 2.1 ± 7.0 mg/dL , p = 0.02 ) , serum insulin concentrations ( −2.0 ± 5.8 vs. + 1.6 ± 5.0 μIU/mL , p = 0.01 ) , homoeostasis model of assessment -insulin resistance ( −0.5 ± 1.4 vs. + 0.3 ± 1.1 , p = 0.01 ) , homoeostatic model assessment -beta cell function ( −7.5 ± 22.3 vs. + 6.3 ± 21.7 , p = 0.01 ) , serum triglycerides ( −13.3 ± 51.3 vs. + 13.6 ± 37.1 mg/dL , p= 0.02 ) and a significant increase in quantitative insulin sensitivity check index ( QUICKI ) ( + 0.006 ± 0.01 vs. −0.005 ± 0.02 , p = 0.01 ) . When we adjusted the analysis for baseline values of biochemical parameters , age and baseline BMI , except for QUICKI ( p = 0.08 ) , other findings did not alter . We found that probiotic supplementation among PCOS women for 12 weeks had favourable effects on weight loss , markers of insulin resistance , triglycerides and VLDL-cholesterol concentrations CONTEXT Insulin resistance and obesity are common features of the polycystic ovary syndrome ( PCOS ) . Weight loss and use of insulin-lowering drugs have been shown to improve both reproductive and metabolic aspects of PCOS . OBJECTIVE We evaluated exenatide ( EX ) and metformin ( MET ) , alone and in combination ( COM ) , on menstrual cyclicity , hormonal parameters , metabolic profiles , and inflammatory markers in overweight , insulin-resistant women with PCOS . DESIGN , SETTING , AND PARTICIPANTS Sixty overweight oligoovulatory women with PCOS ( body mass index > 27 ; 18 - 40 yr ) were r and omized to one of three treatment groups : MET [ 1000 mg twice daily ( BID ) ] , EX ( 10 microg BID ) , or COM ( MET 1000 mg BID , EX 10 microg BID ) for 24 wk . The primary outcome was menstrual frequency ; secondary outcome measures included changes in ovulation rate , insulin action , anthropometric measures , and rogen levels , and inflammatory markers .  RESULTS Forty-two ( 70 % ) patients completed the study .  COM therapy was superior to EX or MET monotherapy in improving menstrual cyclicity , ovulation rate , free and rogen index , and insulin sensitivity measures and reducing weight and abdominal fat . Both EX arms were more effective in promoting weight loss than MET ( P = 0.003 ) . CONCLUSIONS COM appears better than either EX or MET alone on menstrual cycle frequency and hormonal and metabolic derangements . A marked decrease in central adiposity could partly explain the improvements in reproductive function , insulin-glucose parameters , and adiponectin observed in these overweight women with PCOS treated with COM therapy . Larger trials of longer duration are warranted to assess the long-term efficacy and safety of combined EX-MET therapy in overweight women with PCOS Background Women with polycystic ovary syndrome ( PCOS ) are at increased risk for cardiovascular ( CV ) and metabolic disorders . There is a close relationship between elevated and rogen plasma levels and the ultrasound findings of stromal hypertrophy . In r and omized trials , the administration of metformin has been shown to be followed by an improvement in insulin sensitivity and decrease in and rogen levels in most women . In the present study , we investigate the association between reduced ovarian volume in PCOS patients after administration of metformin with improvement in CV risk factors . Material s and Methods This was a r and omized clinical trial study . A total of 28 women diagnosed with PCOS who referred to the infertility clinic were selected .  Anthropometric characteristics of the patients , mean ovarian volume and plasma levels of fasting blood sugar ( FBS ) , lipid profile , luteinizing hormone ( LH ) , follicle stimulating hormone ( FSH ) , estradiol , testosterone , 17-α-OH progesterone ( 17OHP ) , dehydroepi and rosterone sulfate ( DHEAS ) , C-reactive protein ( CRP ) and homocysteine ( Hcy ) were evaluated before and after treatment with 500 mg metformin , three times daily for three months . Statistics were calculated with the aid of SPSS 16.0 with student ’s paired t- and Pearson ’s correlation coefficient tests . Significance was set at p<0.05 . Results There were significant reductions in mean ovarian volume and body mass index ( BMI ) , in addition to CRP , Hcy , testosterone , FBS , HDL and LDL levels . There was a positive correlation between mean ovarian volume and waist-to-hip ratio (WHR).After treatment , there correlation noted with reduction in mean ovarian volume and decreased BMI , in addition to reductions in CRP , LDL , Hcy and testosterone levels . Conclusion A positive correlation may exist between reduced mean ovarian volume and improvement in CV risk factors  after administration of metformin ( Registeration Number : I RCT 138903244176N1 ) Background The clinical effectiveness of complementary and alternative medicines ( CAMs ) is widely debated because of a lack of clinical trials . The internet may provide an effective and economical approach for undertaking r and omised controlled trials ( RCTs ) of low-risk interventions . We investigated whether the internet could be used to perform an internet-based RCT of a CAM fulfilling the revised CONSORT ( Consoli date d St and ards of Reporting Trials ) statement quality checklist for reporting of RCTs . A secondary aim was to examine the effect of probiotics compared to placebo in terms of well-being over 12 weeks . Methods People aged ≥18 years with confirmed spondyloarthropathy living in the United Kingdom with internet access were invited to participate in an internet-based RCT of probiotic compared to placebo for improving well-being and bowel symptoms . The intervention was a probiotic containing 4 strains of live bacteria or identical placebo taken by mouth daily for 3 months . The primary outcome measure was the performance of the trial according to the revised CONSORT statement . Results 147 people were r and omised into the trial . The internet-based trial of the CAM fulfilled the revised CONSORT statement such as efficient blinding , allocation concealment , intention to treat analysis and flow of participants through the trial . Recruitment of the required number of participants was completed in 19 months . Sixty-five percent ( 96/147 ) completed the entire 3 months of the trial . The trial was low cost and demonstrated that in an intention to treat analysis , probiotics did not improve well-being or bowel symptoms . Conclusion The internet-based RCT proved to be a successful and economical method for examining this CAM intervention . Recruitment , adherence and completion rate were all similar to those reported with conventional RCTs but at a fraction of the cost . Internet-based RCTs can fulfil all the criteria of the revised CONSORT statement and are an appropriate method for study ing low-risk interventions .Trial registration IS RCT OBJECTIVE To obtain data from a pilot r and omized trial on the effect of metformin therapy and lifestyle modification on ovulation and and rogen concentrations in women with polycystic ovary syndrome ( PCOS ) . DESIGN Prospect i ve , r and omized , placebo-controlled pilot trial . SETTING Academic medical center . PATIENT(S ) Thirty-eight overweight or obese women with PCOS . INTERVENTION(S ) All subjects were r and omized to one of four 48-week interventions : metformin 850 mg two times per day , lifestyle modification plus metformin 850 mg two times per day , lifestyle modification plus placebo , or placebo alone . MAIN OUTCOME MEASURE(S ) Recruitment , dropout , and compliance with a long-term lifestyle intervention in PCOS ; preliminary estimates of treatment effect on ovulation , as measured by weekly urinary pregnanediol glucuronide , and on total T and free and rogen index . RESULT ( S ) It was necessary to screen seven women to have one subject r and omized . The dropout rate was 39 % , with the majority of dropouts occurring within the first 24 weeks . Mean body mass index was > 39 mg/kg(2 ) . Modest weight reduction was found in all treatment groups , with the most significant reduction occurring with the combination of metformin and lifestyle intervention .  Significant and rogen reduction occurred in the combination group only . Ovulation rates did not differ significantly between groups . However , when data were analyzed by presence or absence of weight reduction in subjects , independent of treatment group , the estimated odds ratio for weight loss was 9.0 ( 95 % confidence interval 1.2 - 64.7 ) with respect to regular ovulation . If weight loss occurred during metformin therapy , the odds ratio for regular ovulation was 16.2 ( 95 % confidence interval 4.4 - 60.2 ) . CONCLUSION ( S ) Key method ologic issues for a large-scale , r and omized trial of lifestyle intervention in PCOS include minimizing early dropout from the lifestyle intervention and including a range of body mass index that is not skewed toward severe obesity . Weight reduction might play the most significant role in restoration of ovulation in obese women with PCOS OBJECTIVE To study the blood clotting tests and endothelial function of polycystic ovary syndrome ( PCOS ) patients and non-hyper and rogenic women , and their changes during PCOS treatment , as a function of the presence of obesity and smoking . DESIGN Case-control study followed by a r and omized clinical trial . METHODS Blood clotting and endothelial function were analyzed in 40 PCOS patients and 20 non-hyper and rogenic women . Thirty-four PCOS women were r and omized to an oral contraceptive containing 35 microg ethinyl-estradiol plus 2 mg cyproterone acetate ( Diane(35)Diario ) or metformin ( 850 mg twice daily ) , monitoring the changes on these parameters during 24 weeks of treatment . The influence of obesity and smoking was also analyzed . RESULTS Blood clotting and endothelial function tests were similar among PCOS patients and controls with the exception of a higher platelet count in the former . Obesity increased circulating fibrinogen levels , prothrombin activity and platelet counts , and reduced prothrombin and activated partial thromboplastin times . Smoking increased fibrinogen levels , platelet counts , and prothrombin activity , and reduced prothrombin time , in relation to the larger waist circumference of smokers . Irrespective of the treatment received , PCOS patients showed a decrease in prothrombin time and an increase in prothrombin activity , with a parallel increase in homocysteine levels in metformin users . The activated partial thromboplastin time decreased markedly in the patients treated with Diane(35)Diario . Finally , flow-mediated dilation improved in non-smokers irrespective of the drug received , but worsened in smokers . CONCLUSIONS Oral contraceptives and metformin may exert deleterious effects on blood clotting tests of PCOS women , yet the effects of metformin appear to be milder . Because smoking potentiates some of these effects and deteriorates endothelial function , smoking cessation should be promoted in PCOS patients OBJECTIVE To determine if the combination of lifestyle ( caloric restriction and exercise ) and metformin ( MET ) would be superior to lifestyle and placebo ( PBO ) in improving the polycystic ovary syndrome ( PCOS ) phenotype . DESIGN Double-blind r and omized 6-month trial of MET versus PBO . SETTING Two academic medical centers . PATIENT(S ) One hundred fourteen subjects with PCOS were r and omized to MET  ( N = 55 ) or PBO ( N = 59 ) . INTERVENTION(S ) Subjects collected urine daily for ovulation monitoring , had monthly monitoring of hormones and weight and determination of body composition by dual-energy x-ray absorptiometry , glucose tolerance , and were evaluated for quality of life at baseline and completion . MAIN OUTCOME MEASURE(S ) Ovulation rates and testosterone levels . RESULT ( S ) Dropout rates were high . There was no significant difference in ovulation rates . Testosterone levels were significantly lower compared with baseline in the MET group at 3 mos but not at 6 mos . There were no differences in weight loss between groups , but MET showed a significant decline at 6 months compared with baseline ( -3.4 kg , 95 % confidence interval -5.3 to -1.5 kg ) . We noted divergent effects of MET versus PBO on oral glucose tolerance test indices of insulin sensitivity ( increased ) and secretion ( worsened ) . Total bone mineral density increased significantly in MET . There were no differences in quality of life measures between the groups . The MET group had increased diarrhea and headache , but fewer bladder infections and musculoskeletal complaints . CONCLUSION ( S ) The addition of metformin to lifestyle therapy produced little reproductive or glycemic benefit in women with PCOS , although our study had limited power owing to a high dropout rate . It is not possible at baseline to identify women likely to drop out CONTEXT Polycystic ovary syndrome ( PCOS ) presents in adolescence , and obesity is a common finding . The benefits and risks of alternate approaches to the management of PCOS in obese adolescent women are not clear . OBJECTIVE We investigated the effects of metformin , oral contraceptives ( OCs ) , and /or lifestyle modification in obese adolescent women with PCOS . DESIGN Two small , r and omized , placebo-controlled clinical trials were performed . PATIENTS AND PARTICIPANTS A total of 79 obese adolescent women with PCOS participated . INTERVENTIONS In the single treatment trial , subjects were r and omized to metformin , placebo , a lifestyle modification program , or OC . In the combined treatment trial , all subjects received lifestyle modification and OC and were r and omized to metformin or placebo . MAIN OUTCOME MEASURES Serum concentrations of and rogens and lipids were measured . RESULTS Lifestyle modification alone result ed in a 59 % reduction in free and rogen index with a 122 % increase in SHBG . OC result ed in a significant decrease in total testosterone ( 44 % ) and free and rogen index ( 86 % ) but also result ed in an increase in C-reactive protein ( 39.7 % ) and cholesterol ( 14 % ) . The combination of lifestyle modification , OC , and metformin result ed in a 55 % decrease in total testosterone , as compared to 33 % with combined treatment and placebo , a 4 % reduction in waist circumference , and a significant increase in HDL ( 46 % ) . CONCLUSIONS In these preliminary trials , both lifestyle modification and OCs significantly reduce and rogens and increase SHBG in obese adolescents with PCOS . Metformin , in combination with lifestyle modification and OC , reduces central adiposity , reduces total testosterone , and increases HDL , but does not enhance overall weight reduction Polycystic ovary syndrome ( PCOS ) , defined as the combination of oligoanovulation and hyper and rogenism , affects more than 5 % of women of reproductive age . Insulin resistance and hyperinsulinemia appear to play an important role in its pathogenesis . Here , we will present a characterization of a PCOS cohort from North Rhine-Westphalia in Germany . Clinical features , family history as well as endocrine and metabolic parameters were prospect ively recorded from 200 successive patients . All patients were evaluated for insulin resistance and beta-cell-function by oral glucose tolerance test .  Patient data were compared with those of 98 age-matched control women . PCOS patients showed significantly higher BMI , body fat mass and and rogen levels as well as impaired glucose and insulin metabolism . A positive family history of PCOS and diabetes was more frequent in PCOS patients . Insulin resistance ( 71 % ) was the most common metabolic abnormality in PCOS patients followed by obesity ( 52 % ) and dyslipidemia ( 46.3 % ) , with an incidence of 31.5 % for the metabolic syndrome . C-reactive protein and other cardiovascular risk factors were frequently elevated even in young PCOS patients . While the clinical characteristics and endocrine parameters of this German PCOS cohort were heterogeneous , they were comparable to those from other Caucasian population This pilot study assessed the effects of exercise and nutritional counseling on hormonal , menstrual , and reproductive function in women with polycystic ovary syndrome ( PCOS ) . Twelve females with a clinical , biochemical , and ultrasonographic diagnosis of PCOS were r and omly assigned to endurance and resistance exercise plus nutritional counseling ( EN ) or nutritional counseling only ( N ) for a period of 12 weeks . Anthropometry , resting metabolic rate ( RMR ) , selected hormones , and ovarian follicle population were measured pre and post-intervention . Following the 12 week intervention , greater decreases in sum of 2 skinfolds ( p = 0.002 ) and a greater increase in estimated VO2 max ( p = 0.017 ) occurred in the exercise group . Significant decreases in waist girth ( p = 0.001 ) and insulin levels ( p = 0.03 ) occurred in both groups . Hormonal changes were not statistically significant ; however , a trend towards an improved hormonal profile , specifically sex-hormone binding globulin ( EN , 39 % increase ; N , 8 % increase ) and lutenizing hormone : follicle-stimulating hormone ( LH : FSH ) ( EN , 9 % decrease ; N , 27 % decrease ) occurred in the absence of weight loss . These findings suggest exercise and nutritional counseling may benefit the metabolic and reproductive abnormalities associated with PCOS BACKGROUND Serum uric acid levels have emerged as a cardiovascular risk factor , and interventions aim ed to decrease its level have been related with an improvement in clinical and non- clinical cardiovascular outcomes . METHODS Serum uric acid levels were measured in 40 polycystic ovary syndrome ( PCOS ) patients and 40 non-hyper and rogenic women matched for BMI and grade of obesity , and were followed-up in 34 PCOS patients who were r and omized to an oral contraceptive containing 35 mg ethinyl-estradiol plus 2 mg cyproterone acetate ( Diane(35 ) Diario ) or metformin ( 850 mg twice daily ) for 24 weeks . RESULTS There were no statistically significant differences in uric acid levels between PCOS and non-hyper and rogenic control women . Considering all PCOS and non-hyper and rogenic control women as a whole , obese women showed higher uric acid concentrations than lean and overweight women , and the main determinant of serum uric acid level was the BMI . In PCOS women , Diane(35 ) Diario treatment was related with a decrease in uric acid levels ( P = 0.018 ) , whereas no changes were observed with metformin . CONCLUSIONS Obesity is the main determinant of serum uric acid concentrations in PCOS patients , yet amelioration of and rogen excess with an anti and rogenic contraceptive pill results in a significant decrease in these levels , an effect that is not observed with metformin . Clinical Trials.gov NLM Identifier : NCT00428311 OBJECTIVE Feasibility of a clinical -trial comparing a low-glycaemic diet with a low-calorie healthy eating approach at achieving weight loss and reducing the risk of endometrial cancer in women with PCOS . DESIGN A pilot R and omised-Controlled-Trial using different recruitment strategies . SETTING A University Hospital in the United Kingdom . PATIENTS Women seen at specialist gynaecology clinics over a 12 month period in one University Hospital , and women self identified through a website and posters . INTERVENTIONS Potential recruits were assessed for eligibility , gave informed consent , r and omised , treated and assessed as in the definitive trial . MAIN OUTCOME MEASURES Eligibility and recruitment rates , compliance with the allocated diet for 6 months and with clinical assessment s , blood tests , pelvic ultrasound scans and endometrial biopsies . RESULTS 1433 new and 2598 follow up patients were seen in 153 gynaecology clinics for over 12 months . 441 ( 11 % ) potentially eligible women were identified , 19 ( 0.4 % ) of whom met the trial entry criteria . Eleven consented to take part , of which 8 ( 73 % ) completed the study . CONCLUSIONS Planned future trials on over-weight women with PCOS should be multicentre and should incorporate primary care . This data will help other research ers plan and calculate the sample size and potential recruitment rates in future clinical trials in PCOS . The results will also be useful for inclusion in future meta-analyses Background The aim of this study was to evaluate the effect of the co-administration of probiotic and selenium on parameters of mental health , hormonal profiles , and biomarkers of inflammation and oxidative stress in women with PCOS . Data on the effects of selenium and probiotic co-supplementation on mental health , hormonal and inflammatory parameters of patients with polycystic ovary syndrome ( PCOS ) are scarce . This investigation was carried out to evaluate the effects of selenium and probiotic co-supplementation on mental health , hormonal and inflammatory parameters in women with PCOS . Methods This r and omized , double-blinded , placebo-controlled clinical trial was conducted on 60 subjects , aged 18–40 years old . Participants were r and omly allocated into two groups to intake 8 × 109 CFU/day probiotic plus 200 μg/day selenium supplements ( n = 30 ) or placebo ( n = 30 ) for 12 weeks . Hormonal and inflammatory parameters were measured at baseline and after the 12-week intervention . Results Probiotic and selenium co-supplementation result ed in a significant improvement in beck depression inventory ( β − 0.76 ; 95 % CI , − 1.26 , − 0.26 ; P = 0.003 ) , general health question naire scores ( β − 1.15 ; 95 % CI , − 1.97 , − 0.32 ; P = 0.007 ) and depression anxiety and stress scale scores ( β − 1.49 ; 95 % CI , − 2.59 , − 0.39 ; P = 0.009 ) compared with the placebo . Furthermore , probiotic and selenium co-supplementation  significantly reduced total testosterone ( β − 0.26 ng/mL ; 95 % CI , − 0.51 , − 0.02 ; P = 0.03 ) , hirsutism ( β − 0.43 ; 95 % CI , − 0.74 , − 0.11 ; P = 0.008 ) , high-sensitivity C-reactive protein ( hs-CRP ) ( β − 0.58 mg/L ; 95 % CI , − 0.97 , − 0.19 ; P = 0.004 ) and malondialdehyde ( MDA ) levels ( β − 0.29 μmol/L ; 95 % CI , − 0.56 , − 0.02 ; P = 0.03 ) , and significantly increased total antioxidant capacity ( TAC ) ( β + 84.76 mmol/L ; 95 % CI , + 48.08 , + 121.44 ; P < 0.001 ) and total glutathione ( GSH ) levels ( β + 26.78 μmol/L ; 95 % CI , + 4.33 , + 49.23 ; P = 0.02 ) compared with the placebo . Conclusions Overall , the co-administration of probiotic and selenium for 12 weeks to women with PCOS had beneficial effects on mental health parameters , serum total testosterone , hirsutism , hs-CRP , TAC , GSH and MDA levels . This study was prospect ively registered in the Iranian website ( www.i rct .ir ) for registration of clinical trials ( http://www.i rct .ir : I RCT 20170513033941N22).Trial registration I RCT 20170513033941N22 Purpose To compare the effects of combined oral contraceptives ( OCs ) containing cyproterone acetate and drospirenone in the treatment of polycystic ovary syndrome ( PCOS ) . Methods Fifty-two patients with PCOS were r and omized in two groups : group A ( n = 26 ) received 0.035 mg ethinyl estradiol + 2 mg cyproterone acetate and group B ( n = 26 ) received 0.03 mg ethinyl estradiol + 3 mg drospirenone-containing OCs for 12 months . Baseline clinical features including body mass index , waist to hip ratio ( WHR ) , and modified Ferriman-Gallwey ( mFG ) score were noted . Baseline biochemical parameters included and rogen profile , carbohydrate metabolism , lipid profile , and oxidative stress . The percentages of changes for all parameters were compared . Results The groups were comparable regarding the baseline characteristics . WHR decreased significantly from baseline ( −4 % [ −31 to 35 ] ) in group B when compared to group A ( 0 % [ −11 to 14 ] ) ( P = 0.033 ) . The total mFG score decreased significantly from baseline ( −35 % [ −71 to 10 ] ) in group A when compared to group B ( −18 % [ −72 to 30 ] ) ( P = 0.035 ) . Changes in and rogen hormone profile were comparable except DHEA-SO4 ( −32 % [ −53 to 15 ] in group B vs. −10 % [ −49 to 63 ] in group A ; P = 0.046 ) . The effects of the drugs were similar regarding carbohydrate metabolism , lipid profile , and oxidative stress parameters . Conclusions Cyproterone acetate containing OCs seem to be more effective to treat clinical hirsutism in patients with PCOS after 12 months of treatment
The findings suggest that pro-/synbiotic supplementation may improve glucose homeostasis parameters , hormonal , and inflammatory indices in women with PCOS
This study aim ed to systematic ally review r and omized clinical trials ( RCTs ) to clarify the effects of pro-/synbiotic supplementation on anthropometric and biochemical measurements in women with polycystic ovary syndrome ( PCOS ) .