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Randomized Controlled Trial About The Effect Among Dieting Adjustment, Oral Contraceptives And Metiformin In PCOS

Posted on:2011-12-20Degree:MasterType:Thesis
Country:ChinaCandidate:J J XuFull Text:PDF
GTID:2154360305497845Subject:Obstetrics and gynecology
Abstract/Summary:PDF Full Text Request
Section 1 Clinical features, endocrine and metabolic markers of patients with polycystic ovary syndrome(PCOS).Objective:To analyze clinical features, endocrine and metabolic characteristics of PCOS.Methods:PCOS group is made of 216 cases with PCOS from March 2008 to March 2010 in Obstetrics and Gynecology Hospital affiliated to Fudan University while the control group (CON group) is made of 104 out-patient cases of women whose infertile problem comes from fallopian tube or average people from medical screening, all the above objects were divided into obese (OB-PCOS) group, non-obese (NOB-PCOS) and obese control (OB-CON) group, non-obese control (NOB-CON) group according to patients' BMI(whether BMI≥25kg/m2). All the objects were asked menstrual/reproductive history, and measured body height and weight, reproductive endocrine and metabolic parameters.Results:①Obesity incidence in PCOS group was significantly higher than the CON group (51.85%vs 24.04%, p<0.05);②erum TT level in PCOS group was significantly higher than the CON group (0.72±0.23 vs 0.54±0.19 ng/ml, p< 0.01), OB-PCOS group and NOB-PCOS group have no significant difference (0.78±0.24 vs 0.70±0.22 ng/ml, p> 0.05), while OB-CON group and NOB-CON group present no significant difference (0.57±0.21 vs 0.51±0.27ng/ml, p>0.05), but NOB-PCOS is higher than the NOB-CON group (0.70±0.22 vs 0.51±0.27ng/ml, p<0.01); FAI in PCOS group was significantly higher than the CON group (4.92±2.27 vs 1.55±0.57, p<0.01), while that in OB-PCOS is significantly higher than NOB-PCOS (5.58±3.33 vs 4.76±2.65, p<0.05), and that in OB-CON was significantly higher than the NOB-CON(1.70±0.90 vs 1.16±0.85, p<0.05), but NOB-PCOS is higher than NOB-CON (4.76±2.65 vs 1.16±0.85, p<0.01);③serum FINS level in PCOS was significantly higher than the CON group (13.14±7.74 vs 8.83±5.18mIU/L, p <0.01), in which OB-PCOS were significantly higher than the NOB-PCOS group (20.41±6.40 vs 11.39±7.02mIU/L, p<0.05), and OB-CON group has significantly higher FAI than the NOB-CON (13.09±9.50 vs 5.30±2.52 mIU/L, p<0.05), while NOB-PCOS is higher than NOB-CON (11.39±7.02 vs 5.30±2.52, p<0.01); IR incidence rate in PCOS group is significantly higher than CON group (58.79% vs 6.73%, p<0.05), in OB-PCOS it is significantly higher than the NOB-PCOS group (80.36% vs 35.58%, p<0.05), and that in OB-CON is significantly higher than the NOB-CON group (28.00% vs 0%), in NOB-PCOS it is higher than NOB-CON (35.58% vs 0%, p<0.01);④lipid levels:Tc: PCOS were significantly higher than the CON group (4.57±0.14 vs 4.41±0.11mmol/L, p<0.01), OB-PCOS vs NOB-PCOS (4.60±0.18 vs 4.46±0.15 mmol/L, p<0.05), OB-CON vs NOB-CON (4.56±0.11 vs 4.39±0.09 mmol/L, p<0.01), NOB-PCOS vs NOB-CON (4.46±0.15 vs 4.39±0.09 mmol/L, p>0.05); TG:PCOS patients were significantly higher than the CON group (1.44±0.47 vs 1.12±0.31 mmol/L, p<0.05), OB-PCOS vs NOB-PCOS (1.61±0.27 vs 1.21±0.09 mmol/L, p<0.05), OB-CON vs NOB-CON (1.58±0.08 vs 0.94±0.06 mmol/L, p<0.01), there is no significant difference between NOB-PCOS and NOB-CON(1.21±0.09 vs 0.94±0.06 mmol/L, p> 0.05); LDL:PCOS is higher than CON(2.29±0.22 vs 2.06±0.11mmol/L, p<0.05), OB-PCOS was significantly higher than the NOB-PCOS (2.34±0.12 vs 2.26±0.19, p<0.05), OB-CON group and NOB-CON group was no significant difference, there was no significant difference between NOB-PCOS and NOB-CON; HDL in each group showed no significant difference.CONCLUSION:①PCOS patients with increased incidence of obesity;②obese PCOS patients and non-obese patients with significant levels of TT, but the obese PCOS has higher androgen activity; on the other hand, obesity in patients with androgen activity than normal weight control group, indicating Obesity itself can increase the biological activity of androgen;③PCOS patients commonly have insulin resistance, obesity incidence in patients with higher IR, its extent is more serious;④PCOS patients with increased blood lipids, mainly Tc, TG and LDL increases, including obese patients dyslipidemia even more serious.⑤Obese PCOS patients has more serious endocrine metabolic disordersSection 2 Randomized controlled study about the effect among diet adjustment, oral contraceptives and metformin in polycystic ovary syndrome.Objective:To compare the effct, compliance and safety among diet adjustment, oral contraceptives and metiformin in polycystic ovary syndrome.Subjects and Methods:153 cases, aged 25.71±4.26 years old, met the diagnosis of PCOS were included in th study,they were randomized allocated into the dietary treatment group(51 cases), oral contraceptives (OC) treatment (51 patients) and metformin treatment (51 patients). Each patient were assesed every 3 months for compliance, efficacy and safety assessment.Results:①diet control group consisted of 51 patients,30 patients'weight decreased (weight loss group) during the therapy period; 14 patients did not changes in body weight, while 7 patients were lost. OC group included 14 patients lost cases because of loss; metformin group included 7 patients lost cases;②BMI change:before the treatment group showed no significant difference in BMI. Diet (weight loss group) 3 months after the decline in the average estimated value of BMI 1.48 kg/m2, about 6.66% decrease compared with before the intervention were significantly different (p <0.01); 6 months, BMI decreased an average estimated value of-1.90 kg/m2, about 8.55% decrease compared with before the intervention were significantly different (p <0.01).3 months after cessation of intervention, BMI higher than the average estimated value before intervention difference -1.81 kg/m2, p<0.01. OC group and the metformin group after treatment, BMI than 3,6 months of treatment has not significantly decreased;③ovulation:Before treatment, diet control group, only two cases of menstrual cycle in patients with the rules of diet after 3 months diet (weight loss group) 2/30 patients had basal body temperature (BBT) menstrual phase; 6 months 4/30 cases of biphasic BBT after menstruation; intervention 3 months after cessation of 8/30 people showed biphasic BBT period; body weight did not drop group No patients in 14 cases of menstrual phase BBT. OC group all the patients before treatment,51 cases of thinning hair or amenorrhea, menstruation, medication occurred during the monthly menstrual regularity drug withdrawal, but within 3 months after stopping only 18/37 patients with spontaneous menstruation (but BBT single phase). Metformin group therapy 51 patients prior to irregular menstruation, treatment for 3 months 21/44 patients had spontaneous ovulation (BBT atypical bipolar or bipolar), treatment of 6 months,33/44 patients had BBT phase of menstruation, withdrawal After 3 months 30/44 patients were still able to spontaneously ovulate (BBT phase);④parameters of reproductive endocrine changes: Before treatment, the endocrine parameters between groups were not significantly different, diet control group before the intervention the average estimated value of T and FAI were 0.68ng/ml,5.84,3 months after intervention diet (weight loss group) T and FAI were significantly lower 0.54,5.35 (p<0.05), intervention after 6 months T and FAI decreased further 0.52,5.32 (p<0.05), stopped 3 months after intervention T, FAI decreased significantly 0.50,5.22 (p<0.05); body weight did not drop group T and FAI were no significant changes. OC group before treatment T and FAI were 0.61 and 5.30, after 3 months treatment of T and FAI were significantly reduced to 0.30,4.29 (p<0.05),6 months down 0.19,4.37 (p<0.05), withdrawal 3 months after the group T and FAI level remains low before treatment,0.35 and 4.41 (p<0.05). Metformin group before treatment, T and FAI were 0.66 and 5.24, after 3 months of treatment T and FAI were significantly reduced to 0.37,4.56 (p<0.05),6 months down 0.28,4.44 (p<0.05), withdrawal 3 months after the group T and FAI level remains low before treatment,0.45 and 4.49 (p<0.05);⑤insulin sensitivity index changes:diet control group before intervention FINS and the estimated average value of HOMA-IR 16.78mIU/L,2.18, weight loss, diet control group 3 months (14.27,2.12),6 months (11.69,1.92) and 3 months after drug withdrawal (8.98,1.88) FINS and HOMA-IR was significantly lower (p<0.01); body weight did not drop group FINS and HOMA-IR was no significant change. OC group during treatment, FINS and HOMA-IR was no significant change. However,7 patients before treatment FPG normal, taking OC6 months after IGT. Metformin group before treatment, FINS and HOMA-IR was 16.30 mIU/L and 2.10, after 3 months treatment was significantly lower (FINS 14.21, HOMA-IR2.03, p<0.05), treatment and further decreased after 6 months (FINS 10.82, HOMA-IR1.95, p<0.05),3 months after treatment remained low (FINS7.11, HOMA-IR1.88) than before treatment were significantly different, p<0.05.⑥lipids:dietary control group before the intervention Tc4.64mmol/L, TG1.26mmol/L, HDL1.17 mmol/L, LDL2.58 mmol/L, weight loss, diet control group 3 months,6 months, stopping 3 months later when the Tc, TG was significantly lower, (Tc:4.00,4.00,3.54, p<0.01; TG:0.87,0.87,0.85, p<0.05; LDL:2.29,2.23,2.06, p<0.05), intervention process there was no significant change in HDL. OC group before the intervention Tc4.73mmol/L, TG1.44mmol/L, treatment for 3 months,6 months,3 months after drug withdrawal when the Tc, TG was significantly lower, (Tc:3.50,3.35,3.39, p< 0.01, TG:0.87,0.86,0.86, p<0.05), HDL and LDL in no significant change during the intervention. Metformin group before the intervention Tc4.62mmol/L, TG1.37mmol/L, LDL2.48 mmol/L, treatment for 3 months,6 months,3 months after drug withdrawal when the Tc, TG, LDL decreased significantly, (Tc:3.86,3.91,3.24, p<0.05; TG:0.99,0.85,0.84, p<0.01, LDL: 2.14,2.09,1.67, p<0.01), HDL in the intervention had no significant change during the period. CONCLUSION:①dieting can reduce body weight in PCOS patients, thereby promoting the recovery of ovarian function, while effective treatment of obese patients with PCOS, hyperandrogenism, hyperinsulinemia and other symptoms;②metformin to insulin by reducing the level of autonomy to patients ovulatory function, and can be hung down, down insulin, lipid-lowering side effects are significant, safe;③OC can reduce blood lipid Tc, TG, but this study has not yet found that insulin sensitivity significantly changed, but impaired glucose tolerance if the drug was used for more than 6 month.
Keywords/Search Tags:polycystic ovary syndrome, obesity, insulin resistance, hyperandrogenism, metformin, diet, oral contraceptives
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