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: OBJECTIVE We aim ed to compare a combined oral contraceptive ( COC ) plus the anti and rogen spironolactone with the insulin sensitizer metformin in women with polycystic ovary syndrome ( PCOS ) . DESIGN We conducted a r and omized , parallel , open-label , clinical trial comparing COC ( 30 μg of ethinylestradiol and 150 μg of desogestrel ) plus spironolactone ( 100 mg/day ) with metformin ( 850 mg b.i.d . ) for one year in women with PCOS ( EudraCT2008 - 004531 - 38 ) . METHODS The composite primary outcome included efficacy ( amelioration of hirsutism , and rogen excess and menstrual dysfunction ) and cardiometabolic safety ( changes in the frequencies of disorders of glucose tolerance , dyslipidemia and hypertension ) . A complete anthropometric , biochemical , hormonal and metabolic evaluation was conducted every three months and data were su bmi tted to intention-to-treat analyses . RESULTS Twenty-four patients were assigned to COC plus spironolactone and 22 patients to metformin . Compared with metformin , COC plus spironolactone caused larger decreases in hirsutism score ( mean difference 4.6 points , 95 % CI : 2.6 - 6.7 ) , total testosterone ( 1.1 nmol/L , 0.4 - 1.7 ) , free testosterone ( 25 pmol/L , 12 - 39 ) , and rostenedione ( 5.5 nmol/L , 1.8 - 9.2 ) and dehydroepi and rosterone sulfate ( 2.7 μmol/L , 1.4 - 4.0 ) . Menstrual dysfunction was less frequent with COC plus spironolactone ( OR : 0.06 , 95 % CI : 0.02 - 0.23 ) . No differences were found in frequencies of abnormal glucose tolerance ( OR : 1.7 , 95 % CI : 0.7 - 4.4 ) , dyslipidemia ( OR : 0.6 , 95 % CI : 0.2 - 1.8 ) or hypertension ( OR : 0.3 , 95 % CI : 0.5 - 2.0 ) . No major adverse events occurred and biochemical markers were similarly safe with both treatments . CONCLUSIONS COC plus spironolactone was more effective than metformin for symptoms of PCOS showing similar safety and overall neutral effects on cardiometabolic risk factors Background We are hereby investigating for the first time the effect of the association ethinylestradiol30μg-drospirenone 3 mg ( DRP/EE30μg ) plus metformin and weight loss on endothelial status and C-reactive protein ( hsCRP ) levels in polycystic ovary syndrome ( PCOS ) . Methods 25 young women with PCOS ( mean age 22.76 ± 0.83 years , body mass index ( BMI ): 28.44 ± 6.23 ) who completed the study were prospect ively evaluated . The oral contraceptive- DRP/EE30μg ( 21 days/month ) and metformin ( 1700 mg daily ) were administered for 6 months to the PCOS group . Additionally , the 15 overweight and obese patients ( BMI > 25 kg/m2 ) were instructed in a diet of no more than 1500 cal daily . Primary outcome measures were surrogate markers of cardiovascular disease and included endothelial function , i.e. flow-mediated dilatation ( FMD ) on the brachial artery and endothelin-1 levels , as well as hsCRP concentrations , body composition ( measured by whole-body dual-energy X-ray-absorptiometry ) and insulin resistance . Variables were assessed at baseline , as well as after our medical intervention . Results The combination between DRP/EE30μg plus metformin combined with weight loss triggered a significant improvement in the FMD values ( FMD-PCOSbasal 3.48 ± 1.00 vs FMD-PCOS6 months7.43 ± 1.04 , p = 0.033 ) , as well as body composition and insulin insensitivity ( p < 0.05 ) . Regarding hsCRP levels , there was no significant intragroup ( PCOS6months – PCOSbasal ) difference . Conclusion A 6-month course of metformin- DRP/EE30μg ( associated with weight loss ) improves the endothelial dysfunction in PCOS and shows neutral effects on hsCRP concentrations as an inflammation marker . These data dem and for reevaluation of the medical therapy in PCOS , particularly in women with additional metabolic and cardiovascular risk factors ( Clinical Trials.gov Identifier : NCT01459445 ) Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials Background : Polycystic ovary syndrome ( PCOS ) is the most common cause of hyper and rogenism in women . Non-classic congenital adrenal hyperplasia ( NCAH ) is very close to PCOS . The diagnosis of hyper and rogenism is not based on the finding of decreased or increased levels of a single hormone . Objective : In our paper , we are going to test correlation between clinical signs and biochemical markers of hyper and rogenism . Material s and Methods : In this prospect i ve study , we calculated  free testosterone ( cFT ) , bioavailable testosterone ( cBT ) , free and rogen index ( FAI ) , free estrogen index ( FEI ) , total testosterone ( TT ) , sex-hormone binding globulin ( SHBG ) , estradiol ( E2 ) , dehydroepi and rosterone-sulfat ( DHEA-S ) , 17α -hydroxyprogesterone ( 17α -OHP ) , prolactin ( P ) , C-peptid and homeostasis model assessment for insulin resistance ( Homa-IR ) were measured in two groups of young untreated women with PCOS and NCAH . Results : In our research , we did not find any significant differences between PCOS and NCAH groups by age , hormonal and calculated parameters of and rogens . Waist to hip ratio ( WHP ) and body mass index ( BMI ) values were higher in the group of patients with PCOS than NCAH group . But in all patients we found positive correlation between hirsutism score and FAI , cFT , cBT , as well as we found negative correlation between hirsutism score and SHBG . We also tested hormonal and calculated parameters of and rogens between PCOS patients by upper body and lower body obesity , but we did not find any significant differences . There was not any difference by the hirsutism score in these groups either . Conclusion : In our research we found that the calculated values of cFT , cBT and FAI are helpful for determinate hirsutism score in all hirsute patients , despite of ovarian or adrenal hyper and rogenemia BACKGROUND A prospect i ve r and omized trial was conducted to compare efficacy of a drospirenone-containing combined oral contraceptives ( COC ) with desogestrel-containing COC in women with polycystic ovary-syndrome ( PCOS ) not desirous of child-bearing . STUDY DESIGN Sixty women were r and omized into study group [ ethinylestradiol ( EE ) 30 mcg+drospirenone 3 mg ] and control group ( EE 30 mcg+desogestrel 150 mcg ) , treated for 6 months and followed up at 1 month , 3 months , 6 months , during treatment and 3 and 6 months post-treatment . Acne and hirsutism scoring , bodyweight , body mass index ( BMI ) , blood pressure ( BP ) , ultrasound parameters , lipid profile , glycemic profile and hormonal profile were compared . RESULTS Cycles were regular in both groups during treatment . Effect of regular cycles persisted in 44.83 % ( 13/30 ) vs. 17.24 % ( 5/30 ) in study vs. control group at 6 months post-treatment with 33.3 % decreased hirsutism score in the study group ( versus no change in control group ) even at 6 months after stopping treatment . With treatment , BMI fell by 0.52 kg/m(2 ) in the study group ; systolic and diastolic BP fell in the study group while it rose in the control group . Low-density lipoprotein significantly decreased and high-density lipoprotein was elevated in the study group ( p<.05 ) . The study group showed a significant fall in fasting/postpr and ial blood sugar and insulin and total testosterone against a rise in the control group . CONCLUSION In women with PCOS , a drospirenone containing COC has better outcome in terms of persistent regular cycles , anti and rogenic effect , fall in BMI and BP , better lipid profile , favorable glycemic and hormonal profile than desogestrel-containing COC Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation  to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies The role of testosterone on the development of hypertension is controversial , especially in women with polycystic ovary syndrome ( PCOS ) who have higher prevalence of obesity and insulin resistance than women without PCOS . Little is known about the association between serum testosterone level and blood pressure in young women with PCOS . In the 151 young Taiwanese women with PCOS enrolled in this cross-sectional study , we measured the body mass index , waist circumference , blood pressure , fasting glucose , fasting insulin , lipid profile , and hormone profiles .  The  free and rogen index , total testosterone , and sex hormone-binding globulin  , but not the level of dehydroepi and rosterone sulfate  , significantly correlated with both systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) . In multiple linear regression models adjusted for age , body mass index , and other anthropometric , metabolic , and hormonal variables , the level of serum free and rogen index  or total testosterone , but not the sex hormone-binding globulin , were independently related to SBP and DBP . The age- and body mass index – adjusted least-square mean of serum-free and rogen index levels were significantly different between the highest quartile and other quartiles of the SBP and DBP levels . The high bioavailable testosterone levels ( free and rogen index : ≥19 % ) in women with PCOS increased the risk of elevated blood pressure ( SBP ≥130 mm Hg and /or DBP ≥85 mm Hg ) with an odds ratio of 3.817 ( P=0.029 ; 95 % CI : 1.14 to 12.74 ) after adjustment for age , anthropometric measures , and metabolic profiles . Our results suggest that the characteristic hyper and rogenemia in young women with PCOS was associated with an elevated SBP and DBP independent of age , insulin resistance , obesity , or dyslipidemia 
    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: OBJECTIVE We aim ed to compare a combined oral contraceptive ( COC ) plus the anti and rogen spironolactone with the insulin sensitizer metformin in women with polycystic ovary syndrome ( PCOS ) . DESIGN We conducted a r and omized , parallel , open-label , clinical trial comparing COC ( 30 μg of ethinylestradiol and 150 μg of desogestrel ) plus spironolactone ( 100 mg/day ) with metformin ( 850 mg b.i.d . ) for one year in women with PCOS ( EudraCT2008 - 004531 - 38 ) . METHODS The composite primary outcome included efficacy ( amelioration of hirsutism , and rogen excess and menstrual dysfunction ) and cardiometabolic safety ( changes in the frequencies of disorders of glucose tolerance , dyslipidemia and hypertension ) . A complete anthropometric , biochemical , hormonal and metabolic evaluation was conducted every three months and data were su bmi tted to intention-to-treat analyses . RESULTS Twenty-four patients were assigned to COC plus spironolactone and 22 patients to metformin . Compared with metformin , COC plus spironolactone caused larger decreases in hirsutism score ( mean difference 4.6 points , 95 % CI : 2.6 - 6.7 ) , total testosterone ( 1.1 nmol/L , 0.4 - 1.7 ) , free testosterone ( 25 pmol/L , 12 - 39 ) , and rostenedione ( 5.5 nmol/L , 1.8 - 9.2 ) and dehydroepi and rosterone sulfate ( 2.7 μmol/L , 1.4 - 4.0 ) . Menstrual dysfunction was less frequent with COC plus spironolactone ( OR : 0.06 , 95 % CI : 0.02 - 0.23 ) . No differences were found in frequencies of abnormal glucose tolerance ( OR : 1.7 , 95 % CI : 0.7 - 4.4 ) , dyslipidemia ( OR : 0.6 , 95 % CI : 0.2 - 1.8 ) or hypertension ( OR : 0.3 , 95 % CI : 0.5 - 2.0 ) . No major adverse events occurred and biochemical markers were similarly safe with both treatments . CONCLUSIONS COC plus spironolactone was more effective than metformin for symptoms of PCOS showing similar safety and overall neutral effects on cardiometabolic risk factors Background We are hereby investigating for the first time the effect of the association ethinylestradiol30μg-drospirenone 3 mg ( DRP/EE30μg ) plus metformin and weight loss on endothelial status and C-reactive protein ( hsCRP ) levels in polycystic ovary syndrome ( PCOS ) . Methods 25 young women with PCOS ( mean age 22.76 ± 0.83 years , body mass index ( BMI ): 28.44 ± 6.23 ) who completed the study were prospect ively evaluated . The oral contraceptive- DRP/EE30μg ( 21 days/month ) and metformin ( 1700 mg daily ) were administered for 6 months to the PCOS group . Additionally , the 15 overweight and obese patients ( BMI > 25 kg/m2 ) were instructed in a diet of no more than 1500 cal daily . Primary outcome measures were surrogate markers of cardiovascular disease and included endothelial function , i.e. flow-mediated dilatation ( FMD ) on the brachial artery and endothelin-1 levels , as well as hsCRP concentrations , body composition ( measured by whole-body dual-energy X-ray-absorptiometry ) and insulin resistance . Variables were assessed at baseline , as well as after our medical intervention . Results The combination between DRP/EE30μg plus metformin combined with weight loss triggered a significant improvement in the FMD values ( FMD-PCOSbasal 3.48 ± 1.00 vs FMD-PCOS6 months7.43 ± 1.04 , p = 0.033 ) , as well as body composition and insulin insensitivity ( p < 0.05 ) . Regarding hsCRP levels , there was no significant intragroup ( PCOS6months – PCOSbasal ) difference . Conclusion A 6-month course of metformin- DRP/EE30μg ( associated with weight loss ) improves the endothelial dysfunction in PCOS and shows neutral effects on hsCRP concentrations as an inflammation marker . These data dem and for reevaluation of the medical therapy in PCOS , particularly in women with additional metabolic and cardiovascular risk factors ( Clinical Trials.gov Identifier : NCT01459445 ) Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials Background : Polycystic ovary syndrome ( PCOS ) is the most common cause of hyper and rogenism in women . Non-classic congenital adrenal hyperplasia ( NCAH ) is very close to PCOS . The diagnosis of hyper and rogenism is not based on the finding of decreased or increased levels of a single hormone . Objective : In our paper , we are going to test correlation between clinical signs and biochemical markers of hyper and rogenism . Material s and Methods : In this prospect i ve study , we calculated  free testosterone ( cFT ) , bioavailable testosterone ( cBT ) , free and rogen index ( FAI ) , free estrogen index ( FEI ) , total testosterone ( TT ) , sex-hormone binding globulin ( SHBG ) , estradiol ( E2 ) , dehydroepi and rosterone-sulfat ( DHEA-S ) , 17α -hydroxyprogesterone ( 17α -OHP ) , prolactin ( P ) , C-peptid and homeostasis model assessment for insulin resistance ( Homa-IR ) were measured in two groups of young untreated women with PCOS and NCAH . Results : In our research , we did not find any significant differences between PCOS and NCAH groups by age , hormonal and calculated parameters of and rogens . Waist to hip ratio ( WHP ) and body mass index ( BMI ) values were higher in the group of patients with PCOS than NCAH group . But in all patients we found positive correlation between hirsutism score and FAI , cFT , cBT , as well as we found negative correlation between hirsutism score and SHBG . We also tested hormonal and calculated parameters of and rogens between PCOS patients by upper body and lower body obesity , but we did not find any significant differences . There was not any difference by the hirsutism score in these groups either . Conclusion : In our research we found that the calculated values of cFT , cBT and FAI are helpful for determinate hirsutism score in all hirsute patients , despite of ovarian or adrenal hyper and rogenemia BACKGROUND A prospect i ve r and omized trial was conducted to compare efficacy of a drospirenone-containing combined oral contraceptives ( COC ) with desogestrel-containing COC in women with polycystic ovary-syndrome ( PCOS ) not desirous of child-bearing . STUDY DESIGN Sixty women were r and omized into study group [ ethinylestradiol ( EE ) 30 mcg+drospirenone 3 mg ] and control group ( EE 30 mcg+desogestrel 150 mcg ) , treated for 6 months and followed up at 1 month , 3 months , 6 months , during treatment and 3 and 6 months post-treatment . Acne and hirsutism scoring , bodyweight , body mass index ( BMI ) , blood pressure ( BP ) , ultrasound parameters , lipid profile , glycemic profile and hormonal profile were compared . RESULTS Cycles were regular in both groups during treatment . Effect of regular cycles persisted in 44.83 % ( 13/30 ) vs. 17.24 % ( 5/30 ) in study vs. control group at 6 months post-treatment with 33.3 % decreased hirsutism score in the study group ( versus no change in control group ) even at 6 months after stopping treatment . With treatment , BMI fell by 0.52 kg/m(2 ) in the study group ; systolic and diastolic BP fell in the study group while it rose in the control group . Low-density lipoprotein significantly decreased and high-density lipoprotein was elevated in the study group ( p<.05 ) . The study group showed a significant fall in fasting/postpr and ial blood sugar and insulin and total testosterone against a rise in the control group . CONCLUSION In women with PCOS , a drospirenone containing COC has better outcome in terms of persistent regular cycles , anti and rogenic effect , fall in BMI and BP , better lipid profile , favorable glycemic and hormonal profile than desogestrel-containing COC Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation  to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies The role of testosterone on the development of hypertension is controversial , especially in women with polycystic ovary syndrome ( PCOS ) who have higher prevalence of obesity and insulin resistance than women without PCOS . Little is known about the association between serum testosterone level and blood pressure in young women with PCOS . In the 151 young Taiwanese women with PCOS enrolled in this cross-sectional study , we measured the body mass index , waist circumference , blood pressure , fasting glucose , fasting insulin , lipid profile , and hormone profiles .  The  free and rogen index , total testosterone , and sex hormone-binding globulin  , but not the level of dehydroepi and rosterone sulfate  , significantly correlated with both systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) . In multiple linear regression models adjusted for age , body mass index , and other anthropometric , metabolic , and hormonal variables , the level of serum free and rogen index  or total testosterone , but not the sex hormone-binding globulin , were independently related to SBP and DBP . The age- and body mass index – adjusted least-square mean of serum-free and rogen index levels were significantly different between the highest quartile and other quartiles of the SBP and DBP levels . The high bioavailable testosterone levels ( free and rogen index : ≥19 % ) in women with PCOS increased the risk of elevated blood pressure ( SBP ≥130 mm Hg and /or DBP ≥85 mm Hg ) with an odds ratio of 3.817 ( P=0.029 ; 95 % CI : 1.14 to 12.74 ) after adjustment for age , anthropometric measures , and metabolic profiles . Our results suggest that the characteristic hyper and rogenemia in young women with PCOS was associated with an elevated SBP and DBP independent of age , insulin resistance , obesity , or dyslipidemia 
    Output:
    