Background:While combined oral contraceptives (COCs) are commonly used to treat polycystic ovary syndrome (PCOS),comparative data regarding metabolic effects of different progestogens on this patient population a...Background:While combined oral contraceptives (COCs) are commonly used to treat polycystic ovary syndrome (PCOS),comparative data regarding metabolic effects of different progestogens on this patient population are missing.This study aimed to compare the different effects of drospirenone (DRP)-containing COCs with cyproterone acetate (CPA)-containing COCs,combined with metformin and lifestyle modifications in women with PCOS and metabolic disorders.Methods:Ninety-nine women with PCOS and a metabolic disorder between January 2011 and January 2013 were enrolled into this prospective randomized clinical trial.Participants were randomized into two groups such as DRP-containing COCs,and CPA-containing COCs.Participants took COCs cyclically for 6 months,combined with metformin administration (1.5 g/d) and lifestyle modifications (diet and exercise).Clinical measures and biochemical and hormone profiles were compared.Comparisons for continuous variables were evaluated with paired and unpaired Student's t-tests.The Wilcoxon signed rank test was used when the data were not normally distributed.Analysis of covariance was used to control for age,body mass index (BMI),and baseline data of each analyzed parameter when compared between the two groups.Results:A total of 68 patients have completed the study.The combination regimen of COCs,metformin,and lifestyle modifications in these patients resulted in a significant decrease in BMI,acne,and hirsutism scores when compared to baseline levels in both groups (P 〈 0.05).Blood pressure (BP) was significantly different in the CPA group when compared to baseline (75.14 ± 6.77 mmHg vs.80.70 ± 5.60 mmHg,P 〈 0.01),and after 6 months of treatment,only the change in systolic BP was significantly different between the two groups (4.00 [-6.00,13.00] mmHg vs.-3.50 [-13.00,9.00] mmHg,P =0.009).Fasting glucose,fasting insulin,and homeostasis model assessment-insulin resistance decreased significantly in the DRP group (5.40 ± 0.41展开更多
Background: The effects of combined oral contraceptive pills and metformin on glucose and lipid metabolism and androgenic hormone profile of hirsute women with polycystic ovary syndrome (PCOS) are not clearly known. A...Background: The effects of combined oral contraceptive pills and metformin on glucose and lipid metabolism and androgenic hormone profile of hirsute women with polycystic ovary syndrome (PCOS) are not clearly known. Aims: To determine the effect of ethinylestradiol (35 microg)/cyproterone acetate (2 mg) (EE/CPA) and ethinylestradiol (20 microg)/desogestrel 0.15 mg (EE/DES) alone and in combination with metformin on glucose and lipid metabolism and androgenic hormone profile in hirsute women with PCOS. Settings and Design: This randomised, double-blind, triple dummy study was conducted at the Department of Pharmacology, Faulty of Science, University of Peradeniya, Sri Lanka. Methods and Material: A total of 107 patients with PCOS (Rotterdam Consensus Conference Criteria 2003) having hirsutism of 8 or more in the modified Ferriman-Gallwey Score (mFGS), were randomised to receive four drug therapies (arm A: EE/CPA, arm B: EE/DES, arm C: EE/CPA plus metformin, arm D: EE/DES plus metformin). Body mass index, fasting plasma glucose, area under the curve of the oral glucose tolerance test, fasting serum insulin, serum leptin, fasting lipids, serum total testosterone, serum sex hormone-binding globulin were determined at initiation and 12 months. Homeostasis model assessment of beta cell function (HOMA-β), homeostasis model assessment-estimated insulin resistance (HOMA-IR) and free androgen index were calculated. Statistical analysis was done with two ways ANOVA. Results: There was no significant difference in outcome measures at 12 months between the treatment arms. Within the treatment arms, there was reduction of HOMA-β in arm B, serum leptin in arm C, CHO/HDL ratio in arm D and an increase in total cholesterol and LDL-cholesterol in arms B and C. Conclusions: EE/DES and EE/CPA with and without low-dose metformin did not have a significant overall effect on glucose and lipid metabolism and androgenic hormonal profile in hirsute women with PCOS. However, desogestrel has reduced the beta-cell function and both desoges展开更多
文摘Background:While combined oral contraceptives (COCs) are commonly used to treat polycystic ovary syndrome (PCOS),comparative data regarding metabolic effects of different progestogens on this patient population are missing.This study aimed to compare the different effects of drospirenone (DRP)-containing COCs with cyproterone acetate (CPA)-containing COCs,combined with metformin and lifestyle modifications in women with PCOS and metabolic disorders.Methods:Ninety-nine women with PCOS and a metabolic disorder between January 2011 and January 2013 were enrolled into this prospective randomized clinical trial.Participants were randomized into two groups such as DRP-containing COCs,and CPA-containing COCs.Participants took COCs cyclically for 6 months,combined with metformin administration (1.5 g/d) and lifestyle modifications (diet and exercise).Clinical measures and biochemical and hormone profiles were compared.Comparisons for continuous variables were evaluated with paired and unpaired Student's t-tests.The Wilcoxon signed rank test was used when the data were not normally distributed.Analysis of covariance was used to control for age,body mass index (BMI),and baseline data of each analyzed parameter when compared between the two groups.Results:A total of 68 patients have completed the study.The combination regimen of COCs,metformin,and lifestyle modifications in these patients resulted in a significant decrease in BMI,acne,and hirsutism scores when compared to baseline levels in both groups (P 〈 0.05).Blood pressure (BP) was significantly different in the CPA group when compared to baseline (75.14 ± 6.77 mmHg vs.80.70 ± 5.60 mmHg,P 〈 0.01),and after 6 months of treatment,only the change in systolic BP was significantly different between the two groups (4.00 [-6.00,13.00] mmHg vs.-3.50 [-13.00,9.00] mmHg,P =0.009).Fasting glucose,fasting insulin,and homeostasis model assessment-insulin resistance decreased significantly in the DRP group (5.40 ± 0.41
文摘Background: The effects of combined oral contraceptive pills and metformin on glucose and lipid metabolism and androgenic hormone profile of hirsute women with polycystic ovary syndrome (PCOS) are not clearly known. Aims: To determine the effect of ethinylestradiol (35 microg)/cyproterone acetate (2 mg) (EE/CPA) and ethinylestradiol (20 microg)/desogestrel 0.15 mg (EE/DES) alone and in combination with metformin on glucose and lipid metabolism and androgenic hormone profile in hirsute women with PCOS. Settings and Design: This randomised, double-blind, triple dummy study was conducted at the Department of Pharmacology, Faulty of Science, University of Peradeniya, Sri Lanka. Methods and Material: A total of 107 patients with PCOS (Rotterdam Consensus Conference Criteria 2003) having hirsutism of 8 or more in the modified Ferriman-Gallwey Score (mFGS), were randomised to receive four drug therapies (arm A: EE/CPA, arm B: EE/DES, arm C: EE/CPA plus metformin, arm D: EE/DES plus metformin). Body mass index, fasting plasma glucose, area under the curve of the oral glucose tolerance test, fasting serum insulin, serum leptin, fasting lipids, serum total testosterone, serum sex hormone-binding globulin were determined at initiation and 12 months. Homeostasis model assessment of beta cell function (HOMA-β), homeostasis model assessment-estimated insulin resistance (HOMA-IR) and free androgen index were calculated. Statistical analysis was done with two ways ANOVA. Results: There was no significant difference in outcome measures at 12 months between the treatment arms. Within the treatment arms, there was reduction of HOMA-β in arm B, serum leptin in arm C, CHO/HDL ratio in arm D and an increase in total cholesterol and LDL-cholesterol in arms B and C. Conclusions: EE/DES and EE/CPA with and without low-dose metformin did not have a significant overall effect on glucose and lipid metabolism and androgenic hormonal profile in hirsute women with PCOS. However, desogestrel has reduced the beta-cell function and both desoges