***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 Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate Background The aim of this paper is to evaluate the effect of antipsychotics for the treatment of schizophrenia in a community based study on sexual function and prolactin levels comparing the use of aripiprazole and st and ard of care ( SOC ) , which was a limited choice of three widely used and available antipsychotics ( olanzapine , quetiapine or risperidone ) ( The Schizophrenia Trial of Aripiprazole [ STAR ] study [ NCT00237913 ] ) . Method This open-label , 26-week , multi-centre , r and omised study compared aripiprazole to SOC ( olanzapine , quetiapine or risperidone ) in patients with schizophrenia ( DSM-IV-TR criteria ) . The primary effectiveness variable was the mean total score of the Investigator Assessment Question naire ( IAQ ) at Week 26 . The outcome research variables included the Arizona Sexual Experience scale ( ASEX ) . This along with the data collected on serum prolactin levels at week 4 , 8 , 12 , 18 and 26 will be the focus of this paper . Results A total of 555 patients were r and omised to receive aripiprazole ( n = 284 ) or SOC ( n = 271 ) . Both treatment groups experienced improvements in sexual function from baseline ASEX assessment s. However at 8 weeks the aripiprazole treatment group reported significantly greater improvement compared with the SOC group ( p = 0.007 ; OC ) . Although baseline mean serum prolactin levels were similar in the two treatment groups ( 43.4 mg/dL in the aripiprazole group and 42.3 mg/dL in the SOC group , p = NS ) at Week 26 OC , mean decreases in serum prolactin were 34.2 mg/dL in the aripiprazole group , compared with 13.3 mg/dL in the SOC group ( p < 0.001 ) . Conclusion The study findings suggest that aripiprazole has the potential to reduce sexual dysfunction , which in turn might improve patient compliance While r and omized clinical trials remain the " gold st and ard " for comparisons of treatment efficacy , conventional r and omized trials may not reflect the relative effectiveness of treatments under " real world " conditions . Observational data more closely reflect the conditions of actual practice , but are often limited in clinical detail and subject to bias in selection of treatments . The authors use available data on the cost-effectiveness of new antidepressant drugs  to illustrate the limitations of these methods . Modifications to the traditional r and omized trial may allow more accurate assessment of effectiveness in everyday practice . The authors describe the design of such a " real world " r and omized trial comparing newer antidepressants with older alternatives The present report deals with a double-blind study comparing the new butyrophenone derivative , bromperidol , with haloperidol as the reference substance . Both substances were found to be highly effective in the treatment of  psychotic syndromes belonging predominantly to the schizophrenia group . Certain clues , including the onset of action , seem to be indicative of the superiority of bromperidol . No differences between the two substances were observed with respect to side effects and general tolerability The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more .  ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas A total of sixty patients were trated with bromperidol first in open conditions ( 20 patients ) , then on a double blind basis ( 40 patients ) with haloperidol as the reference substance . The open study lasted for four weeks ; the drug was administrated in the form of 1 mg tablets . The daily dose ( initial dose : 1 mg ; mean dose at the end of the trial : 4.47 mg ) was always administered in one single dose . Nineteen patients finished the trial , and in 18 cases the therapeutic result was considered very good to good . These results were confirmed by statistical analysis . Nine patients exhibited mild to moderate extrapyramidal concomitant symptoms ; no other side effects were observed . The results of detailed laboratory tests and evaluations of various quantitative and qualitative tolerability parameters were not indicative of toxic effects . In the double blind study with haloperidol , both substances were found to be highly effective in the treatment of psychotic syndromes belonging predominantly to the schizophrenia group . Certain clues , including the onset of action , seem to be indicative of the superiority of bromperidol . No differences were observed with respect to side effects and general tolerability Within the scope of a clinical double-blind study , effects and side effects of Bromperidol and Perphenazine were compared . Forty newly-hospitalized schizophrenic patients were included in the trial . Assessment s were made on days 0 , 2 , 5 , 10 , 20 , and 30 . Data were documented by means of the AMP system , the EPRS scale of Simpson and Angus , and a Brief Ward Behaviour Rating Scale . Laboratory tests and ECGs were performed before and after treatment . Treatment was scheduled for 30 days and dosages were established depending on effects and side effects . We found a therapeutic effective mean daily dose of 6 mg for Bromperidol and 20 mg for Perphenazine . Both substances caused autonomic and extrapyramidal side effects and , in a few patients , temproary fatigue . The employed dosage caused no strong sedation . To sum up , Bromperidol and Perphenazine can be described as highly potent and well tolerated antipsychotic drugs . We observed stronger efficacy and earlier onset of action with Bromperidol . The superior effect of Bromperidol can not be explained by a higher dosage as compared with Perphenazine , since both substances showed a similar severity of extrapyramidal side effects , and the dosage of both substances was established individually for each patient , depending on effects and side effects A 1 year double-blind trial of bromperidol decanoate and fluphenazine decanoate was conducted in the maintenance treatment of 47 out patients with schizophrenia . Six patients relapsed on bromperidol decanoate and none on fluphenazine decanoate , a difference which is statistically significant . No significant differences in positive and negative symptoms , nor depression measures were found between treatment groups when comparisons were made for change in score from entry to last visit . However , patients on fluphenazine decanoate achieved significantly better changes on social disability ( Morningside scale ) compared to those on bromperidol decanoate . The incidence of extrapyramidal side-effects was similar in both groups , and no statistically significant differences emerged in body weight change between treatments R and omised controlled trials , when appropriately design ed , conducted , and reported , represent the gold st and ard in evaluating healthcare interventions . However , r and omised trials can yield biased results if they lack method ological rigour [ 1 ] . To assess a trial accurately , readers of a published report need complete , clear , and transparent information on its methodology and findings . Unfortunately , attempted assessment s frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information [ 2,3,4 ] . That lack of adequate reporting fuelled the development of the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement in 1996 [ 5 ] and its revision five years later [ 6,7,8 ] . While those statements improved the reporting quality for some r and omised controlled trials [ 9,10 ] , many trial reports still remain inadequate [ 2 ] . Furthermore , new method ological evidence and additional experience has accumulated since the last revision in 2001 . Consequently , we organised a CONSORT Group meeting to up date the 2001 statement [ 6,7,8 ] . We introduce here the result of that process , CONSORT 2010 . The relationship between Taq1 A polymorphism of dopamine D(2 ) receptor ( DRD(2 ) ) gene and extrapyramidal adverse effects of bromperidol and nemonapride , which are both antipsychotic drugs with selective and potent DRD(2 ) antagonistic property , was investigated in Japanese schizophrenic in patients . Twenty-seven patients were treated with bromperidol  at 6 or 12 or 18 mg/day , while 25 patients were treated with nemonapride  at 18 mg/day . The duration of treatment was 3 weeks . The A1 and A2 alleles were determined by PCR . The extrapyramidal adverse effects were assessed by the Udvalg for Kliniske Unders¿ogelser side effects rating scale . Six patients were homozygous for the A1 allele , 27 were heterozygous for the A1 and A2 alleles , and 19 were homozygous for the A2 allele . There were no significant differences in the incidences or severity of extrapyramidal adverse effects between the patients with one or two A1 alleles and those with no A1 allele . The present study suggests that Taq1 A polymorphism is not related to the development of extrapyramidal adverse effects during acute phase of bromperidol and nemonapride treatments Previous studies have shown that subjects without Del alleles of the--141C Ins/Del polymorphism in the promoter region of the dopamine D2 receptor ( DRD2 ) gene have lower DRD2 density that those with one or two Del alleles . The present study aims to investigate the relationship between the -141C Ins/Del polymorphism and extrapyramidal adverse effects of bromperidol and nemonapride , antipsychotic drugs with a selective and potent DRD2 antagonistic property , in schizophrenic in patients . Twenty-seven patients were treated with  bromperidol  at a fixed-dose of 6 , 12 or 18 mg/day , and 25 patients were treated with  nemonapride  at a fixed-dose of 18 mg/day . The duration of treatment with these drugs was 3 weeks . The Ins and Del alleles were determined by PCR . Extrapyramidal adverse effects were assessed by the Udvalg for Kliniske Undersøgelser side effects rating scale . The subjects consisted of 38 homozygotes of the Ins allele and 14 heterozygotes of the Ins and Del alleles . There were no significant differences in the incidence or severity of extrapyramidal adverse effects between patients with and without the Del allele . It is possible that this result was due to a lack of statistical power . However , the present study suggests that the--141C Ins/Del polymorphism is not related to the development of extrapyramidal adverse effects during acute-phase treatment with antidopaminergic agents OBJECTIVE To assess the method ologic quality of approaches used to allocate participants to comparison groups in r and omized controlled trials from one medical specialty . DESIGN Survey of published , parallel group r and omized controlled trials . DATA SOURCES All 206 reports with allocation described as r and omized from the 1990 and 1991 volumes of four journals of obstetrics and gynecology . MAIN OUTCOME MEASURES Direct and indirect measures 
    Output:
    
Minimal poorly reported trial data suggests that bromperidol decanoate may be better than placebo injection but less valuable than fluphenazine or haloperidol decanoate .
If bromperidol decanoate is available it may be a viable choice , especially when there are reasons not to use fluphenazine or haloperidol decanoate .