***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: 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 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 4-week double-blind controlled clinical trial was carried out in which fluspirilene , an injectable diphenylbutylpiperidine neuroleptic given weekly , was compared to chlorpromazine in the treatment of 40 newly admitted schizophrenic patients with acute exacerbation . Similar therapeutic improvement was obtained with both drugs , but men needed a significantly higher mean dose of fluspirilene ( 23 mg/week ) than women ( 13 mg/week ) . Fluspirilene induced more parkinsonism than chlorpromazine , but less drowsiness , dizziness , and dry mouth . The difference between the sexes in the potency of fluspirilene and its greater potential to induce parkinsonism may be related to its lesser presynaptic and D1-dopamine receptor blocking properties . The low incidence of autonomic side effects confirms the relative specificity of fluspirilene for dopamine receptors Five depot neuroleptics ( fluphenazinedeconoate , fluspirilene , pipothiazinepalmitate , penfluridol and perphenazine-enanthate ) were compared based on clinical trials in subacute and chronic schizophrenic patients . The psychopathological symptoms were documented by means of the AMP-system . Statistical analyses showed several differences between the effects of the five substances . The AMP-system proved a useful instrument to differentiate similar drugs BACKGROUND An increasing number of case reports indicate a superior therapeutic response of catatonialike symptoms , such as severe psychomotor disturbance and mutism , associated with psychiatric disorder to the benzodiazepine lorazepam ( LO ) . Equivocal results , however , are also reported with regard to other benzodiazepines for the treatment of this syndrome . The purpose of this study was to compare the effects of LO and oxazepam ( OX ) , benzodiazepines with comparable pharmacokinetics , on psychomotor retardation and mutism associated with psychiatric disorder . METHODS Twenty-one hospitalized patients with severe psychomotor retardation and mutism were treated with 2 mg LO and 60 mg OX in a double-blind crossover study design . RESULTS Both benzodiazepines significantly reduced psychomotor symptoms . When administered for the first time , 4 of 7 patients with LO and 6 of 10 patients with OX improved at least 50 % on visual analog scale ( VAS ) rating . Reduction in symptoms was significant with LO and OX treatment on either day of treatment . The second time , however , LO was significantly better compared with OX in alleviating the target symptoms . CONCLUSIONS Both OX and LO are effective for the treatment of psychomotor retardation . Thus , the beneficial effect of LO on psychomotor retardation and mutism is not a unique pharmacodynamic property but more likely due to its pharmacokinetic profile . The differential effect of the two benzodiazepines on the second day of treatment warrants further clarification . Several hypotheses are evaluated Little is known about patient compliance with topical aural antibiotic regimens . The compliance of 50 patients with unilateral otitis externa attending an otolaryngology clinic was studied by comparing the weight of dispensed topical ear preparations before and after completion of a 7-day-course of treatment . A st and ard was obtained from controlled administration of the preparation under laboratory conditions and the performance of different delivery systems evaluated . Thirty-seven patients re-attended for review with their medication . A total of 34 of 50 patients entering the study ( 70 % ) satisfied conventional criteria for compliance . However , over-use of preparations was common and stricter criteria are proposed and applied . Compliance was significantly increased when someone other than the patient administered the preparation A follow-up study of all patients entering the MRC double-blind trial of fluphenazine decanoate in chronic schizophrenic out- patients achieved a trace rate of 94 % . In general , these patients were severely disabled , continued under the care of the maintenance clinic , and their diagnoses remained remarkably consistent ; more than one-fifth were found to be in acute schizophrenic relapse and in over a half of these cases , the relapse was not known to the treatment agency . The maintenance clinic attenders were little different from those who no longer used such a facility A double-blind placebo trial of fluphenazine decanoate , a long-acting phenothiazine , was carried out to determine its value in maintenance therapy of chronic schizophrenic out patients already established on the drug for a minimum period of eight weeks . In low doses it was significantly more effective than placebo in preventing relapse and admission to hospital . Relapse was accompanied by a resurgence of specifically schizophrenic symptoms and by an increase in abnormalities described by the relatives . There was no difference between the experimental and control groups in the treatment required for depression . The group on active medication required more treatment for Parkinsonism , but this difference did not reach statistical significance . In the context of a well-run special clinic for outpatient follow-up of chronic schizophrenic patients these results confirm the usefulness of long-acting fluphenazine . By inference , the benefit of this treatment highlights the need for adequate community services to deal with the residual chronic disabilities which are characteristic of these patients 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 of the adequacy of r and omization and baseline comparisons . RESULTS Only 32 % of the reports described an adequate method for generating a sequence of r and om numbers , and only 23 % contained information showing that steps had been taken to conceal assignment until the point of treatment allocation . A mere 9 % described both sequence generation and allocation concealment . In reports of trials that had apparently used unrestricted r and omization , the differences in sample sizes between treatment and control groups were much smaller than would be expected due to chance . In reports of trials in which hypothesis tests had been used to compare baseline characteristics , only 2 % of reported test results were statistically significant , lower than the expected rate of 5 % . CONCLUSIONS Proper r and omization is required to generate unbiased comparison groups in controlled trials , yet the reports in these journals usually provided inadequate or unacceptable information on treatment allocation . Additional analyses suggest that nonr and om manipulation of comparison groups and selective reporting of baseline comparisons may have occurred A modification of an earlier rating scale for extrapyramidal system disturbance is described , and evidence for the validity and reliability of the scale is presented . The usefulness of the scale in studies of neuroleptic drugs is discussed . By its application it is possible to quantify extrapyramidal side effects and to separate them into four principal factors Fifty chronic schizophrenics were r and omly assigned to a 16‐week treatment either with fluspirilene or with fluphenazine decanoate . The aim of the study was to compare the antipsychotic action and the side effects of the two neuroleptics . Fluphenazine decanoate caused more side effects and the difference between the two groups was statistically significant in the items tremor , severe extrapyramidal effects and parkinsonism . More patients in the  fluspirilene group ( nine patients ) compared with only three in the fluphenazine decanoate  group remained free of side effects during the whole trial . Judged from the BPRS  fluspirilene proved an equally potent neuroleptic with fluphenazine decanoate although statistically significant improvement has been obtained in more items of the scale in the fluspirilene group . The improvement in the NOSIE‐30 was much more clear in the fluspirilene group . Although Clinical Global Impressions of the investigators and the nursing personnel favored fluspirilene , the differences between the two groups were not statistically significant BACKGROUND A recent review suggested an association between using unpublished scales in clinical trials and finding significant results . AIMS To determine whether such an association existed in schizophrenia trials . METHOD Three hundred trials were r and omly selected from the Cochrane Schizophrenia Group 's Register . All comparisons between treatment groups and control groups using rating scales  were identified . The publication status of each scale was determined and cl aims of a significant treatment effect were recorded . RESULTS Trials were more likely to report that a treatment was superior to control when an unpublished scale was used to make the comparison ( relative risk 1.37 ( 95 % CI 1.12 - 1.68 ) ) . This effect increased when a ' gold-st and ard ' definition of treatment superiority was applied ( RR 1.94 ( 95 % CI 1.35 - 2.79 ) ) . In non-pharmacological trials , one-third of ' gold-st and ard ' cl aims of treatment superiority would not have been made if published scales had been used . CONCLUSIONS Unpublished scales are a source of bias in schizophrenia trials This study is a part of a multicentric study of some new long-acting psychotropic drugs and their possible application in the maintenance treatment of patients suffering from chronic schizophrenic syndromes ( Perris , ( Ed . ) 1974 ) . The present article deals with a controlled trial of fluspirilene and fluphenazine enanthate carried out simultaneously at Department I1 of the Lillhagen Psychiatric Hospital in Gothenburg ' " , at the Restad Psychiatric Hospital in Vanersborg ' > ) ) , and at the Umedal Psychiatric Hospital in Umeb'+ * ) . The social structure of the hospitals involved in the trial has been investigated in separate studies reported in detail elsewhere ( Malm , Perris , R a p p & Roma'n 1974 a , b ; Perris , Rapp G Romrin 1974 ) . Fluspirilene , 8-[~,~-bis(p-fluorophenyl)butyl]-l-phenyl-l,~,8-triazaspiro ( 4,5 ) decan-4-on is a new compound synthesized at the Janssen Pharmaceutica Research Laboratories and related to the butyrophenones . Fig. 1 shows its chemical structure . The substance is a yellowish-white amorphous or crystalline solid , almost insoluble in water . It is prepared as a micronized suspension in water for intramuscular administration . Pharmacological ( lanssen et al. 1970 , Heykants 1969 ) and preliminary clinical investigations ( Haase et al. 1968 , Sterkmans et al. 1968 , Zmmich et al. 1970 , Knaack 1969 ) have shown fluspirilene to be a highly potent neuroleptic drug with a duration of action ranging from 6 to 15 days ( Madalena 1968 ) . Few side effects , mainly of the extrapyramidal type have been described . No toxic reactions have been reported . Peak effects usually occur 
    Output:
    
There are no convincing data showing fluspirilene decanoate 's  advantage over oral chlorpromazine or other depot antipsychotics .
REVIEW ER 'S CONCLUSIONS The total numbers in each comparison were small and there were no clear differences demonstrated between fluspirilene and oral medication or other depots .