***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 To evaluate the efficacy , safety , and quality of life of 5 mg mifepristone per day compared with a placebo in treating uterine fibroids . Design R and omized , double-blind clinical study . Location Eusebio Hernández Gynecology and Obstetrics Teaching Hospital , Havana , Cuba . Subjects One hundred twenty-four subjects with symptomatic uterine fibroids . Treatment One daily capsule of 5 mg mifepristone or a mifepristone placebo over 3 months . Variables in evaluating safety Changes in fibroid and uterine volumes , changes in symptom prevalence and intensity , and changes in quality of life . Results Three months into treatment , fibroid volume was reduced by 28.5 % in the mifepristone group with an increase of 1.8 % in the placebo group ( P = 0.031 ) . There were significant differences between the groups with respect to pelvic pain prevalence ( P = 0.006 ) , pelvic pressure ( P = 0.027 ) , rectal pain ( P = 0.013 ) , hypermenorrhea ( P < 0.001 ) , and metrorrhagia ( P = 0.002 ) at the end of treatment . Amenorrhea was 93.1 % and 4.3 % in the mifepristone and placebo groups , respectively ( P < 0.001 ) . Treatment side effects were significantly greater in the mifepristone group . Estradiol levels did not differ significantly between the placebo and mifepristone groups at the end of treatment . Improvement in quality of life was significantly greater in the categories of “ symptoms ” ( P = 0.004 ) and “ activity ” ( P = 0.045 ) in the mifepristone group . Conclusion The 5 mg dosage of mifepristone presented significantly superior efficacy compared to the placebo BACKGROUND The efficacy and side-effect profile of ulipristal acetate as compared with those of leuprolide acetate for the treatment of symptomatic uterine fibroids before surgery are unclear . METHODS In this double-blind noninferiority trial , we r and omly assigned 307 patients with symptomatic fibroids and excessive uterine bleeding to receive 3 months of daily therapy with  oral ulipristal acetate  ( at a dose of either 5 mg or 10 mg ) or once-monthly intramuscular injections of leuprolide acetate ( at a dose of 3.75 mg ) . The primary outcome was the proportion of patients with controlled bleeding at week 13 , with a prespecified noninferiority margin of -20 % . RESULTS Uterine bleeding was controlled in 90 % of patients receiving 5 mg of ulipristal acetate , in 98 % of those receiving 10 mg of ulipristal acetate , and in 89 % of those receiving leuprolide acetate , for differences ( as compared with leuprolide acetate ) of 1.2 percentage points ( 95 % confidence interval [ CI ] , -9.3 to 11.8 ) for 5 mg of ulipristal acetate and 8.8 percentage points ( 95 % CI , 0.4 to 18.3 ) for 10 mg of ulipristal acetate .  Median times to amenorrhea were 7 days for patients receiving 5 mg of ulipristal acetate , 5 days for those receiving 10 mg of ulipristal acetate , and 21 days for those receiving leuprolide acetate .  Moderate-to-severe hot flashes were reported for 11 % of patients receiving 5 mg of ulipristal acetate , for 10 % of those receiving 10 mg of ulipristal acetate , and for 40 % of those receiving leuprolide acetate ( P<0.001 for each dose of ulipristal acetate vs. leuprolide acetate ) . CONCLUSIONS Both the 5-mg and 10-mg daily doses of ulipristal acetate were noninferior to once-monthly leuprolide acetate in controlling uterine bleeding and were significantly less likely to cause hot flashes . ( Funded by PregLem ; Clinical Trials.gov number , NCT00740831 . ) Clinical trials , systematic review s , and guidelines compare beneficial and non-beneficial outcomes following interventions . Often , however , various studies on a particular topic do not address the same outcomes , making it difficult to draw clinical ly useful conclusions when a group of studies is looked at as a whole.1 This problem was recently thrown into sharp focus by a systematic review of interventions for preterm birth prevention , which found that among 103 r and omized trials , no fewer than 72 different outcomes were reported.2 There is a growing recognition among clinical research ers that this variability undermines consistent synthesis of the evidence , and that what is needed is an agreed st and ardized collection of outcomes —a “ core outcomes set”—for all trials in a specific clinical area.1 Recognizing that the current inconsistency is a serious hindrance to progress in our specialty , the editors of over 50 journals related to women ’s health have come together to support The CROWN ( CoRe Outcomes in WomeN ’s health ) Initiative ( ► Table 1 ) . Development of consensus is required around a set of welldefined , relevant , and feasible outcomes for all trials concerning particular obstetric and gynaecologic health conditions , such as preterm birth , incontinence , infertility , and menstrual problems . With somany subspecialties involved , this is no easy task . Duplication of effort can be avoided by working with the Core Outcome Measures in Effectiveness  Trials ( COMET ) Initiative , which is working toward core data sets for all medical specialties.3 Production of trustworthy core outcome sets will require engagement with patients , healthcare professionals , research ers , industry , and regulators , and the employment of scientifically robust consensus methods .1 The data for these core outcome sets , once agreed upon , should be collected in trials and reported in publications as st and ard practice in the future . Journal editors now invite research ers to take the lead in beginning this work . What will we do as editors to support them and their colleagues ? First , we are drawing wide attention toThe CROWN Initiative by publishing this editorial in the journals listed below . We shall ensure that the global research community , which includes our many review ers , is aware of the need for core outcome sets . Su bmi ssions which describe development of core outcome sets , if deemed acceptable after peer review , will be effectively disseminated . Our collaboration is not for enforcing harmony at the expense of innovation . To quote from the COMET home page ( www.comet-initiative.org ) : “ The existence or use of a core outcome set does not imply that outcomes in a particular trial should be restricted to those in the relevant core outcome set . Rather , there is an expectation that the core outcomes will be collected and reported , making it easier for the results of trials to be compared , contrasted and combined as appropriate ; while research ers continue to explore other outcomes as well . ” We also expect that as new or superior ways of capturing outcomes emerge , core outcome sets will themselves need updating . Table 1 Aims of The CROWN Objectives The aim of this study was to evaluate the safety and improvement in quality of life using 10 mg and 5 mg daily doses of mifepristone for the treatment of uterine fibroids . Design The research was a r and omized double-blind clinical study undertaken at the Eusebio Hernández Hospital in Havana , Cuba . Subjects and methods Seventy subjects with symptomatic uterine fibroids took one daily capsule of 10 mg or 5 mg mifepristone orally for 9 months . One to three endometrial biopsies were performed . In evaluating safety , the variables studied were endometrial changes associated with mifepristone , elevation of hepatic transaminases , side effects of mifepristone , and instances and duration of irregular bleeding . Results There were 30/49 ( 61.2 % ) and 13/24 ( 54.2 % ) diagnoses of endometrial changes associated with mifepristone in the 10 mg and 5 mg groups , respectively ( P = 0.282 ) . At every evaluation visit the average endometrial thickness was significantly greater in the 10 mg group than in the 5 mg group ( P = 0.013 , P = 0.002 , and P = 0.013 , respectively ) . Only five subjects had slight elevations in their hepatic transaminases after 9 months ’ treatment . Sixteen of 35 ( 45.7 % ) and eight of 33 ( 24.2 % ) subjects had the occasional hot flush in the 10 mg and 5 mg groups , respectively ( P = 0.032 ) . In total , there were 12.9 ± 4.6 ( n = 21 ) and 9.1 ± 3.9 ( n = 18 ) days of irregular bleeding in the 10 mg and 5 mg groups , respectively ( P = 0.009 ) . Conclusion According to the study findings , a 5 mg daily dose over 9 months has a relatively better safety profile than the 10 mg dose OBJECTIVE : To estimate the efficacy of daily administration of 5 mg compared with 10 mg of mifepristone for the treatment of uterine myomas . METHODS : One hundred women were r and omly assigned to receive oral mifepristone 5 mg or 10 mg daily for 3 months ( 50 per group ) . Abdominal ultrasonography was performed before treatment , at 45 days , and at 3 months to evaluate leiomyoma and uterine volumes .  Endometrial biopsy specimens were taken before and after treatment . Efficacy was estimated by the reduction percentages of the leiomyoma and uterine volumes . RESULTS : After 90 days treatment there was a 45 % ( 95 % confidence interval [ CI ] 37–54 , P<.001 ) and a 57 % ( 95 % CI 48–67 , P<.001 ) reduction in the leiomyoma volume in the 10-mg and 5-mg groups , respectively , and one of 40 % ( 95 % CI 34–46 , P=.002 ) , and 36 % ( 95 % CI 31–40 , P<.001 ) , respectively , in the uterine volume . Symptomatic improvement was noted , and the prevalence of symptoms diminished significantly . There were no significant differences in reduction of volume and symptoms in the treatment groups , P>.05 in all cases . After treatment , 44 of 49 ( 89.8 % ) women from the mifepristone 10 mg group and 45 of 50 ( 90.0 % ) from the 5-mg group , respectively , were amenorrheic ( P=.487 ) . Endometrial biopsy after treatment showed simple hyperplasia in 1 of 50 ( 2.0 % ) in the mifepristone 10 mg group . CONCLUSION : Five-milligram doses of mifepristone produce reductions in leiomyoma and uterine volumes and symptomatic improvement similar to 10-mg doses . LEVEL OF EVIDENCE : OBJECTIVE Our purpose was to examine the effects of RU 486 and leuprolide acetate on uterine artery blood flow and uterine volume . STUDY DESIGN Patients were r and omly assigned to group A ( eight patients ) receiving 25 mg of RU 486 daily for 3 months or group B ( six patients ) receiving 3.75 mg of leuprolide acetate monthly for 3 months .  Uterine artery blood flow change was determined by resistive index by means of vaginal color Doppler ultrasonography . Uterine volume was measured before and during the study with abdominal ultrasonography . RESULTS Both groups showed an increase in resistive index . Patients receiving RU 486 had uterine artery blood flow decreased by 40 % , and those receiving leuprolide acetate had a 21 % decrease . We noted a significant decrease in uterine volume compared with pretreatment in both groups at 3 months . There was no significant decrease between groups . CONCLUSION Both RU 486 ( 25 mg daily ) and leuprolide acetate ( 3.75 mg monthly ) are effective in decreasing blood flow to the uterus ( increasing resistive index ) and decreasing uterine volume at 3 months . A significant decrease in uterine artery blood flow may provide a mechanism for the decrease in uterine size and the decrease in uterine blood loss at the time of surgery Background & objectives : Uterine myoma is a common indication for hysterectomy in India . An effective medical treatment option may reduce hysterectomy associated morbidity . This study was undertaken to evaluate efficacy and safety of low dose mifepristone in medical management of myoma and to compare two doses - 10 vs. 25 mg/day . Methods : In this r and omized clinical trial , women with symptomatic myoma or myoma>5 cm were included . Uterine size > 20 wk , fibroids > 15 cm were excluded .  Pictorial blood loss assessment chart ( PBAC ) score was used to assess menstrual-blood-loss and visual analog scale ( VAS ) for other symptoms . Haemogram , liver function test , ultrasound with doppler and endometrial histology was performed . Patients were r and omized and were given oral mifepristone as 25 mg/day in group 1 and 10 mg/day in group 2 for 3 months . Patients were followed at 1 , 3 and 6 months 
    Output:
    
Short-term use of SPRMs result ed in improved quality of life , reduced menstrual bleeding and higher rates of amenorrhoea than were seen with placebo .
Thus , SPRMs may provide effective treatment for women with symptomatic fibroids .
Evidence derived from one RCT showed no difference between leuprolide acetate and SPRM with respect to improved quality of life and bleeding symptoms .
Evidence was insufficient to show whether effectiveness was different between SPRMs and leuprolide .
Investigators more frequently observed SPRM-associated endometrial changes in women treated with SPRMs than in those treated with placebo or leuprolide acetate .
As noted above , SPRM-associated endometrial changes are benign , are not related to cancer and are not precancerous .