human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND Investigation of a possible effect of metformin on and rogen levels in pregnant women with polycystic ovary syndrome ( PCOS ) . METHODS A prospect i ve , r and omized , double-blind , placebo-controlled pilot study was conducted . Forty pregnant women with PCOS received diet and lifestyle counselling  and were r and omized to either metformin 850 mg twice daily or placebo . Primary outcome measures were changes in serum levels of dehydroepi and rosterone sulphate , and rostenedione , testosterone , sex hormone-binding globulin , and free testosterone index . Secondary outcome measures were pregnancy complications and outcome . Two-tailed t-tests and chi2-tests were used . RESULTS Maternal and rogen levels were unaffected by metformin treatment in pregnant women with PCOS . While none of the 18 women in the metformin group experienced a severe pregnancy or post-partum complication , seven of the 22 ( 32 % ) women experienced severe complications in the placebo group ( P = 0.01 ) . CONCLUSIONS Metformin treatment did not reduce maternal and rogen levels in pregnant women with PCOS . In the metformin-treated group we observed a reduction of severe , pregnancy and post-partum complications .  Metformin treatment of pregnant PCOS women may reduce complications during pregnancy and in the post-partum period Background . Women with polycystic ovary syndrome have elevated homocysteine levels . Elevated homocysteine levels associate with pregnancy complications . Women with polycystic ovary syndrome are often treated with metformin , a drug that may increase homocysteine levels . Hence , we investigated the effect of metformin treatment on homocysteine levels in nonpregnant and pregnant women with polycystic ovary syndrome . Methods . Two prospect i ve r and omized placebo‐controlled studies included women with polycystic ovary syndrome in a university hospital setting . Sixty‐three infertile women were treated with metformin 1,000 mg bid or placebo for 16 weeks and 38 pregnant women with metformin 850 mg bid or placebo from the first trimester and throughout pregnancy . All the women had polycystic ovary syndrome and all participants received diet and lifestyle advice , and oral folate and vitamin B12 substitution , and a daily oral multivitamin tablet . The main outcome measures were serum levels of homocysteine , folate , and vitamin B12 . Results . Serum homocysteine levels were unaffected by metformin treatment both in nonpregnant and pregnant women with polycystic ovary syndrome . However , in nonpregnant women both serum folate and vitamin B12 levels decreased with treatment . At inclusion in nonpregnant women , serum homocysteine levels associated negatively with serum levels of folate and methyl malonic acid and positively with free testosterone index . No such associations were seen in pregnant women . Conclusions . Metformin treatment in women with polycystic ovary does not increase serum homocysteine levels in the nonpregnant or the pregnant state BACKGROUND Sulfonylurea drugs have been the only oral therapy available for patients with non-insulin-dependent diabetes mellitus ( NIDDM ) in the United States . Recently , however , metformin has been approved for the treatment of NIDDM . METHODS We performed two large , r and omized , parallel-group , double-blind , controlled studies in which metformin or another treatment was given for 29 weeks to moderately obese patients with NIDDM whose diabetes was inadequately controlled by diet ( protocol 1 : metformin vs. placebo ; 289 patients ) , or diet plus glyburide ( protocol 2 :  metformin and glyburide vs. metformin vs. glyburide  ; 632 patients ) . To determine efficacy we measured plasma glucose ( while the patients were fasting and after the oral administration of glucose ) , lactate , lipids , insulin , and glycosylated hemoglobin before , during , and at the end of the study . RESULTS In protocol 1 , at the end of the study the 143 patients in the metformin group , as compared with the 146 patients in the placebo group , had lower mean ( + /- SE ) fasting plasma glucose concentrations ( 189 + /- 5 vs. 244 + /- 6 mg per deciliter [ 10.6 + /- 0.3 vs. 13.7 + /- 0.3 mmol per liter ] , P < 0.001 ) and glycosylated hemoglobin values ( 7.1 + /- 0.1 percent vs. 8.6 + /- 0.2 percent , P < 0.001 ) . In protocol 2 , the 213 patients given metformin and glyburide , as compared with the 210 patients treated with glyburide alone , had lower mean fasting plasma glucose concentrations ( 187 + /- 4 vs. 261 + /- 4 mg per deciliter [ 10.5 + /- 0.2 vs. 14.6 + /- 0.2 mmol per liter ] , P < 0.001 ) and glycosylated hemoglobin values ( 7.1 + /- 0.1 percent vs. 8.7 + /- 0.1 percent , P < 0.001 ) . The effect of metformin alone was similar to that of glyburide alone . Eighteen percent of the patients given metformin and glyburide had symptoms compatible with hypoglycemia , as compared with 3 percent in the glyburide group and 2 percent in the metformin group . In both protocol s the patients given metformin had statistically significant decreases in plasma total and low-density lipoprotein cholesterol and triglyceride concentrations , whereas the values in the respective control groups did not change . There were no significant changes in fasting plasma lactate concentrations in any of the groups . CONCLUSIONS Metformin monotherapy and combination therapy with metformin and sulfonylurea are well tolerated and improve glycemic control and lipid concentrations in patients with NIDDM whose diabetes is poorly controlled with diet or sulfonylurea therapy alone OBJECTIVE To compare glycemic control and neonatal outcomes in women with gestational diabetes mellitus ( GDM ) treated with metformin vs. insulin . STUDY DESIGN Women with GDM not controlled with diet and exercise were r and omized to metformin ( n = 32 ) or insulin ( n = 31 ) . The levels of glycemic control as well as maternal/neonatal complications were evaluated . RESULTS The mean ( + /- SD ) fasting and 2-hour postpr and ial blood glucose did not differ statistically between the 2 treatment groups . No patient failed metformin and required insulin . The majority ( 27/32 ) were easily controlled on the initial dosage ( 500 mg twice a day ) . Gestational age at entry and delivery ( p = 0.077 , 0.412 ) were similar . The difference in the rate of cesarean delivery was not statistically significant between the 2 groups ( p = 0.102 ) . Neonatal statistics were also not different between the metformin and insulin groups : birth weight , Apgar score at 5 minutes , respiratory distress syndrome , hyperbilirubinemia , neonatal hypoglycemia and neonatal intensive care unit admission ( p = 0.144 - 0.373 ) . CONCLUSION Based on these preliminary data , metformin appears to be an effective alternative to insulin in the treatment of GDM OBJECTIVE We sought to investigate the association between glyburide dose , degree of severity in  gestational diabetes mellitus ( GDM ) ,  level of glycemic control , and  pregnancy outcome in insulin- and glyburide-treated patients . STUDY DESIGN In a secondary analysis of our previous r and omized study , 404 women were analyzed . The association among glyburide dose , severity of GDM , and selected maternal and neonatal factors was evaluated . Severity levels of GDM were stratified by fasting plasma glucose ( FPG ) from the oral glucose tolerance test ( OGTT ) . Infants with birth weight at or above the 90th percentile were considered large-for-gestational age ( LGA ) . Macrosomia was defined as birth weight > or = 4000 g. Well-controlled was defined as mean blood glucose < or = 95 mg/dL. The association between glyburide- and insulin-treated patients by severity of GDM and neonatal outcome was evaluated . RESULTS The dose received for the glyburide-treated patients was 2.5 mg-32 % ; 5 mg-23 % ; 10 mg-17 % ; 15 mg-8 % ; and 20 mg-20 % . Patients were grouped into low ( < or = 10 mg ) and high ( > 10 mg ) daily dose of glyburide . A comparison between severity of the disease ( fasting plasma glucose categories ) and highest dose of glyburide revealed a significant difference between the low-95 FPG and the other severity categories ( P = .02 ) . Of patients in the well-controlled glycemic group , only 6 % required the high dose of glyburide ( > 10 mg ) . In patients with poor glycemic control ( mean blood glucose > 95 mg/dL ) , 38 % received the high dose of glyburide ( P = .0001 ) . Comparison between the high glyburide ( > 10 mg ) and the low glyburide dosages ( < or = 10 mg ) revealed that the rate of macrosomia was 16 % vs 5 % and LGA 22 % vs 8 % , ( P = .01 ) , respectively . No significant difference was found in composite outcome , metabolic complications , and Ponderal Index between the 2 dose groups . Stratification by disease severity revealed a significantly lower rate of LGA for both the glyburide- and insulin-treated subjects . No significant difference was found between metabolic , respiratory , and neonatal intensive care unit ( NICU ) for patients within each fasting plasma glucose severity category . CONCLUSION Glyburide and insulin are equally efficient for treatment of GDM in all levels of disease severity . Achieving the established level of glycemic control , not the mode of pharmacologic therapy , is the key to improving the outcome in GDM BACKGROUND We prospect ively assessed growth and motor-social development during the first 18 months of life in 126 live births ( 122 pregnancies ) to 109 women with polycystic ovary syndrome ( PCOS ) who conceived on and continued metformin ( 1.5 - 2.55 g/day ) through pregnancy . METHODS The lengths and weights of PCOS neonates were compared with gender-specific Centers for Disease Control and Prevention ( CDC ) infant data . Gestational diabetes ( GD ) and pre-eclampsia in women with PCOS were compared with 252 healthy women without PCOS who had > or=1 live birth ( 262 live births ) . RESULTS There were 101 out of 126 ( 80 % ) term ( > or=37 gestational weeks ) PCOS births , which was not significantly different ( P = 0.7 ) from controls , 206 out of 252 ( 81.7 % ) . There were two ( 1.6 % ) birth defects . GD occurred in nine out of 119 PCOS pregnancies ( 7.6 % ) versus 40 out of 251 ( 15.9 % ) controls , P = 0.027 . The prevalence of pre-eclampsia did not differ in PCOS versus control pregnancies ( 4.1 versus 3.6 % , P = 0.8 ) . The birth length and weight of the 52 male neonates did not differ ( P > 0.05 ) from those of CDC males ; the 74 female neonates were shorter than CDC females ( 48.9 + /- 5.4 versus 50.6 + /- 2.7 cm , P = 0.006 ) and weighed less ( 3.09 + /- 0.85 versus 3.29 + /- 0.52 kg , P = 0.04 ) . There were no systematic differences in growth between PCOS and CDC infants over 18 months . At 3 , 6 , 9 , 12 and 18 months , of a potential 100 % motor-social development score , scores ( + /-SD ) were 95 + /- 13 , 98 + /- 8 % , 95 + /- 10 , 97 + /- 8 and 94 + /- 16 % ; no infants had motor-social developmental delays . CONCLUSIONS Metformin reduced development of GD , was not teratogenic and did not adversely affect birth length and weight , growth or motor-social development in the first 18 months of life The Metformin in Gestational Diabetes ( MiG ) trial is a prospect i ve r and omized multicenter trial in women with gestational diabetes mellitus ( GDM ) that is testing the hypothesis that metformin treatment , compared with insulin , is associated with similar perinatal outcomes , improved markers of insulin sensitivity in the mother and baby , and improved treatment acceptability . Women with GDM who are at 20–33 weeks ’ 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND Investigation of a possible effect of metformin on and rogen levels in pregnant women with polycystic ovary syndrome ( PCOS ) . METHODS A prospect i ve , r and omized , double-blind , placebo-controlled pilot study was conducted . Forty pregnant women with PCOS received diet and lifestyle counselling  and were r and omized to either metformin 850 mg twice daily or placebo . Primary outcome measures were changes in serum levels of dehydroepi and rosterone sulphate , and rostenedione , testosterone , sex hormone-binding globulin , and free testosterone index . Secondary outcome measures were pregnancy complications and outcome . Two-tailed t-tests and chi2-tests were used . RESULTS Maternal and rogen levels were unaffected by metformin treatment in pregnant women with PCOS . While none of the 18 women in the metformin group experienced a severe pregnancy or post-partum complication , seven of the 22 ( 32 % ) women experienced severe complications in the placebo group ( P = 0.01 ) . CONCLUSIONS Metformin treatment did not reduce maternal and rogen levels in pregnant women with PCOS . In the metformin-treated group we observed a reduction of severe , pregnancy and post-partum complications .  Metformin treatment of pregnant PCOS women may reduce complications during pregnancy and in the post-partum period Background . Women with polycystic ovary syndrome have elevated homocysteine levels . Elevated homocysteine levels associate with pregnancy complications . Women with polycystic ovary syndrome are often treated with metformin , a drug that may increase homocysteine levels . Hence , we investigated the effect of metformin treatment on homocysteine levels in nonpregnant and pregnant women with polycystic ovary syndrome . Methods . Two prospect i ve r and omized placebo‐controlled studies included women with polycystic ovary syndrome in a university hospital setting . Sixty‐three infertile women were treated with metformin 1,000 mg bid or placebo for 16 weeks and 38 pregnant women with metformin 850 mg bid or placebo from the first trimester and throughout pregnancy . All the women had polycystic ovary syndrome and all participants received diet and lifestyle advice , and oral folate and vitamin B12 substitution , and a daily oral multivitamin tablet . The main outcome measures were serum levels of homocysteine , folate , and vitamin B12 . Results . Serum homocysteine levels were unaffected by metformin treatment both in nonpregnant and pregnant women with polycystic ovary syndrome . However , in nonpregnant women both serum folate and vitamin B12 levels decreased with treatment . At inclusion in nonpregnant women , serum homocysteine levels associated negatively with serum levels of folate and methyl malonic acid and positively with free testosterone index . No such associations were seen in pregnant women . Conclusions . Metformin treatment in women with polycystic ovary does not increase serum homocysteine levels in the nonpregnant or the pregnant state BACKGROUND Sulfonylurea drugs have been the only oral therapy available for patients with non-insulin-dependent diabetes mellitus ( NIDDM ) in the United States . Recently , however , metformin has been approved for the treatment of NIDDM . METHODS We performed two large , r and omized , parallel-group , double-blind , controlled studies in which metformin or another treatment was given for 29 weeks to moderately obese patients with NIDDM whose diabetes was inadequately controlled by diet ( protocol 1 : metformin vs. placebo ; 289 patients ) , or diet plus glyburide ( protocol 2 :  metformin and glyburide vs. metformin vs. glyburide  ; 632 patients ) . To determine efficacy we measured plasma glucose ( while the patients were fasting and after the oral administration of glucose ) , lactate , lipids , insulin , and glycosylated hemoglobin before , during , and at the end of the study . RESULTS In protocol 1 , at the end of the study the 143 patients in the metformin group , as compared with the 146 patients in the placebo group , had lower mean ( + /- SE ) fasting plasma glucose concentrations ( 189 + /- 5 vs. 244 + /- 6 mg per deciliter [ 10.6 + /- 0.3 vs. 13.7 + /- 0.3 mmol per liter ] , P < 0.001 ) and glycosylated hemoglobin values ( 7.1 + /- 0.1 percent vs. 8.6 + /- 0.2 percent , P < 0.001 ) . In protocol 2 , the 213 patients given metformin and glyburide , as compared with the 210 patients treated with glyburide alone , had lower mean fasting plasma glucose concentrations ( 187 + /- 4 vs. 261 + /- 4 mg per deciliter [ 10.5 + /- 0.2 vs. 14.6 + /- 0.2 mmol per liter ] , P < 0.001 ) and glycosylated hemoglobin values ( 7.1 + /- 0.1 percent vs. 8.7 + /- 0.1 percent , P < 0.001 ) . The effect of metformin alone was similar to that of glyburide alone . Eighteen percent of the patients given metformin and glyburide had symptoms compatible with hypoglycemia , as compared with 3 percent in the glyburide group and 2 percent in the metformin group . In both protocol s the patients given metformin had statistically significant decreases in plasma total and low-density lipoprotein cholesterol and triglyceride concentrations , whereas the values in the respective control groups did not change . There were no significant changes in fasting plasma lactate concentrations in any of the groups . CONCLUSIONS Metformin monotherapy and combination therapy with metformin and sulfonylurea are well tolerated and improve glycemic control and lipid concentrations in patients with NIDDM whose diabetes is poorly controlled with diet or sulfonylurea therapy alone OBJECTIVE To compare glycemic control and neonatal outcomes in women with gestational diabetes mellitus ( GDM ) treated with metformin vs. insulin . STUDY DESIGN Women with GDM not controlled with diet and exercise were r and omized to metformin ( n = 32 ) or insulin ( n = 31 ) . The levels of glycemic control as well as maternal/neonatal complications were evaluated . RESULTS The mean ( + /- SD ) fasting and 2-hour postpr and ial blood glucose did not differ statistically between the 2 treatment groups . No patient failed metformin and required insulin . The majority ( 27/32 ) were easily controlled on the initial dosage ( 500 mg twice a day ) . Gestational age at entry and delivery ( p = 0.077 , 0.412 ) were similar . The difference in the rate of cesarean delivery was not statistically significant between the 2 groups ( p = 0.102 ) . Neonatal statistics were also not different between the metformin and insulin groups : birth weight , Apgar score at 5 minutes , respiratory distress syndrome , hyperbilirubinemia , neonatal hypoglycemia and neonatal intensive care unit admission ( p = 0.144 - 0.373 ) . CONCLUSION Based on these preliminary data , metformin appears to be an effective alternative to insulin in the treatment of GDM OBJECTIVE We sought to investigate the association between glyburide dose , degree of severity in  gestational diabetes mellitus ( GDM ) ,  level of glycemic control , and  pregnancy outcome in insulin- and glyburide-treated patients . STUDY DESIGN In a secondary analysis of our previous r and omized study , 404 women were analyzed . The association among glyburide dose , severity of GDM , and selected maternal and neonatal factors was evaluated . Severity levels of GDM were stratified by fasting plasma glucose ( FPG ) from the oral glucose tolerance test ( OGTT ) . Infants with birth weight at or above the 90th percentile were considered large-for-gestational age ( LGA ) . Macrosomia was defined as birth weight > or = 4000 g. Well-controlled was defined as mean blood glucose < or = 95 mg/dL. The association between glyburide- and insulin-treated patients by severity of GDM and neonatal outcome was evaluated . RESULTS The dose received for the glyburide-treated patients was 2.5 mg-32 % ; 5 mg-23 % ; 10 mg-17 % ; 15 mg-8 % ; and 20 mg-20 % . Patients were grouped into low ( < or = 10 mg ) and high ( > 10 mg ) daily dose of glyburide . A comparison between severity of the disease ( fasting plasma glucose categories ) and highest dose of glyburide revealed a significant difference between the low-95 FPG and the other severity categories ( P = .02 ) . Of patients in the well-controlled glycemic group , only 6 % required the high dose of glyburide ( > 10 mg ) . In patients with poor glycemic control ( mean blood glucose > 95 mg/dL ) , 38 % received the high dose of glyburide ( P = .0001 ) . Comparison between the high glyburide ( > 10 mg ) and the low glyburide dosages ( < or = 10 mg ) revealed that the rate of macrosomia was 16 % vs 5 % and LGA 22 % vs 8 % , ( P = .01 ) , respectively . No significant difference was found in composite outcome , metabolic complications , and Ponderal Index between the 2 dose groups . Stratification by disease severity revealed a significantly lower rate of LGA for both the glyburide- and insulin-treated subjects . No significant difference was found between metabolic , respiratory , and neonatal intensive care unit ( NICU ) for patients within each fasting plasma glucose severity category . CONCLUSION Glyburide and insulin are equally efficient for treatment of GDM in all levels of disease severity . Achieving the established level of glycemic control , not the mode of pharmacologic therapy , is the key to improving the outcome in GDM BACKGROUND We prospect ively assessed growth and motor-social development during the first 18 months of life in 126 live births ( 122 pregnancies ) to 109 women with polycystic ovary syndrome ( PCOS ) who conceived on and continued metformin ( 1.5 - 2.55 g/day ) through pregnancy . METHODS The lengths and weights of PCOS neonates were compared with gender-specific Centers for Disease Control and Prevention ( CDC ) infant data . Gestational diabetes ( GD ) and pre-eclampsia in women with PCOS were compared with 252 healthy women without PCOS who had > or=1 live birth ( 262 live births ) . RESULTS There were 101 out of 126 ( 80 % ) term ( > or=37 gestational weeks ) PCOS births , which was not significantly different ( P = 0.7 ) from controls , 206 out of 252 ( 81.7 % ) . There were two ( 1.6 % ) birth defects . GD occurred in nine out of 119 PCOS pregnancies ( 7.6 % ) versus 40 out of 251 ( 15.9 % ) controls , P = 0.027 . The prevalence of pre-eclampsia did not differ in PCOS versus control pregnancies ( 4.1 versus 3.6 % , P = 0.8 ) . The birth length and weight of the 52 male neonates did not differ ( P > 0.05 ) from those of CDC males ; the 74 female neonates were shorter than CDC females ( 48.9 + /- 5.4 versus 50.6 + /- 2.7 cm , P = 0.006 ) and weighed less ( 3.09 + /- 0.85 versus 3.29 + /- 0.52 kg , P = 0.04 ) . There were no systematic differences in growth between PCOS and CDC infants over 18 months . At 3 , 6 , 9 , 12 and 18 months , of a potential 100 % motor-social development score , scores ( + /-SD ) were 95 + /- 13 , 98 + /- 8 % , 95 + /- 10 , 97 + /- 8 and 94 + /- 16 % ; no infants had motor-social developmental delays . CONCLUSIONS Metformin reduced development of GD , was not teratogenic and did not adversely affect birth length and weight , growth or motor-social development in the first 18 months of life The Metformin in Gestational Diabetes ( MiG ) trial is a prospect i ve r and omized multicenter trial in women with gestational diabetes mellitus ( GDM ) that is testing the hypothesis that metformin treatment , compared with insulin , is associated with similar perinatal outcomes , improved markers of insulin sensitivity in the mother and baby , and improved treatment acceptability . Women with GDM who are at 20–33 weeks ’ 
    Output:
    