***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: The effect of oral testosterone treatment ( 200 mg tid ) on liver morphology was examined in a double-blind , placebo controlled study including men with alcoholic cirrhosis ( n = 126 ) . Liver biopsies obtained before r and omization showed micronodular cirrhosis in 119 patients ( 94 % ) , alcoholic hepatitis in 64 ( 51 % ) , and fatty liver in 104 ( 83 % ) . These and other morphological findings did not differ significantly in the patients r and omized to testosterone ( n = 76 ) and to placebo ( n = 50 ) ( skewed r and omization 3:2 ) . Follow-up liver specimens ( biopsies or autopsies ) obtained after a median treatment duration of 30 months demonstrated a significant ( p less than 0.01 ) increase in the prevalence of macronodular cirrhosis ( from 6 to 51 % ) and a significant ( p less than 0.01 ) decrease in the prevalence of alcoholic hepatitis ( to 21 % ) and of fatty liver ( to 52 % ) . Testosterone treatment did not significantly influence the prevalence of these changes . Further , testosterone treatment had no significant effect on the prevalence of other morphological changes , including vascular and malignant changes . However , in the testosterone-treated group one patient developed diffuse sinusoidal dilation and one patient showed Budd-Chiari 's syndrome . The degree of fatty liver and of alcoholic hepatitis in follow-up liver specimens were significantly ( p less than 0.002 ) higher among patients who consumed ethanol during follow-up than in patients who abstained ( 76 versus 22 % and 30 versus 6 % ) . In conclusion , this study does not establish any indication or any contraindication in terms of hepatic histopathology with the possible exception of hepatic venous thrombosis for the use of oral testosterone treatment in men with alcoholic cirrhosis Liver haemodynamics and liver function were measured in 34 alcoholic cirrhotic men before entry and after 12 months ( median ) in a double-blind , placebo-controlled study on the effect of oral testosterone treatment ( 200 mg t.i.d . ) . Comparing data at entry with those at follow-up in the total patient group , a significant change in median values of portal pressure ( -23 % , n = 34 , P less than 0.005 ) , hepatic blood flow ( -22 % , n = 28 , P less than 0.001 ) , indocyanine green clearance ( + 16 % , n = 29 , P less than 0.01 ) , and galactose elimination capacity ( + 8 % , n = 31 , P less than 0.05 ) was observed . However , testosterone-treated patients did not differ significantly from placebo-treated patients regarding any of the measured variables . No significant relationships could be demonstrated between ethanol consumption and liver haemodynamics and liver function , but the number of patients consuming more than 100 g ethanol per day decreased significantly ( P less than 0.001 ) from 22 ( 65 % ) before entry to one ( 3 % ) during follow-up . In conclusion , oral testosterone treatment of men with alcoholic cirrhosis does not explain the significant improvement of liver haemodynamics and function observed in this study . However , the improvement may be due to reduced ethanol consumption BACKGROUND Baseline data collected on each patient at r and omisation in controlled clinical trials can be used to describe the population of patients , to assess comparability of treatment groups , to achieve balanced r and omisation , to adjust treatment comparisons for prognostic factors , and to undertake subgroup analyses . We assessed the extent and quality of such practice s in major clinical trial reports . METHODS A sample of 50 consecutive clinical -trial reports was obtained from four major medical journals during July to September , 1997 . We tabulated the detailed information on uses of baseline data by use of a st and ard form . FINDINGS Most trials presented baseline comparability in a table . These tables were often unduly large , and about half the trials inappropriately used significance tests for baseline comparison . Methods of r and omisation , including possible stratification , were often poorly described . There was little consistency over whether to use covariate adjustment and the criteria for selecting baseline factors for which to adjust were often unclear . Most trials emphasised the simple unadjusted results and covariate adjustment usually made negligible difference . Two-thirds of the reports presented subgroup findings , but mostly without appropriate statistical tests for interaction . Many reports put too much emphasis on subgroup analyses that commonly lacked statistical power . INTERPRETATION Clinical trials need a predefined statistical analysis plan for uses of baseline data , especially covariate-adjusted analyses and subgroup analyses . Investigators and journals need to adopt improved st and ards of statistical reporting , and exercise caution when drawing conclusions from subgroup findings BACKGROUND / AIM The efficacy of S-adenosylmethionine ( AdoMet ) in the treatment of liver cell injury has been demonstrated in several experimental models . The aim of this study was to investigate the effects of AdoMet treatment in human alcoholic liver cirrhosis . METHODS A r and omized , double-blind trial was performed in 123 patients treated with AdoMet ( 1200 mg/day , orally ) or placebo for 2 years . All patients had alcoholic cirrhosis , and histologic confirmation of the diagnosis was available in 84 % of the cases . Seventy-five patients were in Child class A , 40 in class B , and 8 in class C. Sixty-two patients received  AdoMet and 61 received placebo . RESULTS At inclusion into the trial no significant differences were observed between the two groups with respect to sex , age , previous episodes of major complications of cirrhosis , Child classification and liver function tests . The overall mortality/liver transplantation at the end of the trial decreased from 30 % in the placebo group to 16 % in the AdoMet group , although the difference was not statistically significant ( p = 0.077 ) . When patients in Child C class were excluded from the analysis , the overall mortality/liver transplantation was significantly greater in the placebo group than in the AdoMet group ( 29 % vs. 12 % , p = 0.025 ) , and differences between the two groups in the 2-year survival curves ( defined as the time to death or liver transplantation ) were also statistically significant ( p = 0.046 ) . CONCLUSIONS The present results indicate that long-term treatment with AdoMet may improve survival or delay liver transplantation in patients with alcoholic liver cirrhosis , especially in those with less advanced liver disease Seventy-three euthyroid male patients with alcoholic cirrhosis of the liver were r and omly allocated to oral testosterone ( 200 mg t.i.d . ) or placebo and followed for up to 36 months . Triiodothyronine ( T3 ) , tetraiodothyronine ( T4 ) , thyroxine binding globulin ( TBG ) and T4/TBG ratio were determined before entry and during follow-up . No significant differences were observed before entry or during follow-up between the two treatment groups . T3 , T4 and T4/TBG ratio did not change significantly during follow-up , while TBG concentrations decreased ( P less than 0.05 ) . Using a multivariate test , it is demonstrated that testosterone treatment significantly reduced TBG concentrations in cirrhotic men with preserved liver function , like normal men , but not in patients with moderate liver dysfunction . The lack of effect of testosterone in patients with more advanced cirrhosis may be due to a decreased function of sex hormone receptors in their liver The present studies were design ed to provide careful measures of effects of ox and rolone , an anabolic steroid , intravenous nutritional supplementation , and the combination of these two treatments on liver functions , metabolic balances , nitrogen metabolism , and nutritional status in patients with moderate to severe alcoholic hepatitis . Of 43 patients originally recruited , 39 ( 19 men , 20 women ) with typical clinical and laboratory features of alcoholic hepatitis ( 11 Child's-Pugh class B ; 28 class C ) were admitted to a metabolic unit and completed a 35-day three-phase protocol . Phase I was a 10-day baseline period of observation , during which routine and special quantitative tests of liver function ( galactose and antipyrine metabolism ) , a 7-day elemental balance study , and a 15N , 13C-leucine metabolism study were done . Phase II was a 21-day treatment period during which patients were r and omly assigned to receive one of four regimens : 1 ) st and ard therapy , consisting of abstinence , a balanced , nutritionally adequate diet , and multivitamins ; 2 ) ox and rolone ( 20 mg orally four times a day ) plus st and ard therapy ; 3 ) nutritional supplementation , consisting of 2 L daily of 3.5 % crystalline amino acids ( in 5 % dextrose ) , given by peripheral vein ; or 4 ) a combination of ox and rolone and nutritional supplementation , along with st and ard therapy . Metabolic balances were repeated during phase II . Phase III was 2 or 3 days posttreatment , during which special studies of liver functions and volumes and leucine metabolism were repeated . All patients who completed phase I of study and were r and omly allocated to one of the four treatment groups completed the subsequent two phases . Overall , with time , patients showed highly significant improvements in most clinical and laboratory features . For most st and ard laboratory tests ( e.g. , serum albumin , transferrin , prothrombin time ) improvements were more marked in patients treated with nutritional supplementation and /or ox and rolone than in those given st and ard therapy alone . Liver volumes fell in all treatment groups , with greater improvement in those treated with nutritional supplementation . Improvements in galactose and antipyrine metabolism rates were significant only in those treated with nutritional supplementation or ox and rolone . Effects of treatments on metabolic balances , nitrogen metabolism , and measures of nutrition are described in this issue in a companion paper . We conclude that the addition of nutritional supplementation and ox and rolone to st and ard therapy of moderately severe or severe alcoholic hepatitis is well tolerated , and leads to more rapid improvement in the laboratory parameters measured The prevalence and course of sexual dysfunction was evaluated in 221 alcoholic cirrhotic men participating in a double-blind , placebo-controlled study on the effect of oral testosterone treatment on liver disease . At entry , 67 % ( 95 % confidence limits , 61%-74 % ) complained of sexual dysfunction .  Sexual dysfunction was significantly ( p less than 0.05 ) associated with lower serum concentrations of testosterone , non-protein-bound testosterone , and non-sex hormone-binding globulin-bound testosterone . The significant associations between sexual dysfunction and non-protein-bound and non-sex hormone-binding globulin-bound testosterone concentrations disappeared , however , when age , ethanol consumption , and severity of liver disease were included as covariates in the analysis . During follow-up ( median 30 mo , range 1 - 48 mo ) sexual dysfunction improved significantly ( p less than 0.05 ) at 6 , 12 , and 24 mo . Furthermore , the reported libido and erectile and ejaculatory function improved significantly at the end of the follow-up period ( p less than 0.01 ) . However , the testosterone-treated patients did not differ significantly from the placebo-treated patients regarding any of the changes in sexual function . In conclusion , oral testosterone treatment does not significantly influence the type or course of sexual dysfunction in alcoholic cirrhotic men . However , sexual function improved after reduction of ethanol consumption in these patients The relationship of protein calorie malnutrition ( PCM ) to alcoholic liver disease was studied in 666 patients enrolled in two Veterans Administration Cooperative Studies . Some findings of malnutrition could be detected early in 62 % of the comparison patients ( 43 subjects who were alcoholic , but had not yet developed clinical or laboratory evidence of liver injury ) . In those who had progressed to the stage of liver injury sufficient to manifest clinical jaundice ( 536 patients ) , some findings of malnutrition were present in every patient ( 100 % ) . The degree of malnutrition correlated closely with the development of all the serious complications of the liver disease ( ascites , encephalopathy , and hepatorenal syndrome ) , as well as the overall mortality . The degree of malnutrition was also important in predicting response to some forms of treatment . When prednisolone , a catabolic adrenal steroid , was used , efficacy was independent of the level of malnutrition . However , a relationship was observed with the severity of the liver injury [ quantified by the level of jaundice and coagulopathy , i.e. , Maddrey 's discriminant function ( DF(Maddrey ) ] . For prednisolone , the response was seen only when the DF was 81 - 100 reducing mortality 45 % When ox and rolone , an and rogenic anabolic steroid treatment was given , efficacy was observed only in those with moderate malnutrition ( PCM score 60 - 79 % of normal ) and maximized with adequate caloric intake reducing mortality 86 % . To simplify the method of calculating the PCM score for predicting response to anabolic therapy , a multiple logistic regression model was developed from the parameters used to assess nutritional status : DF(PCM ) = 0 
    Output:
    
: This systematic review could not demonstrate any significant beneficial effects of anabolic- and rogenic steroids on any clinical ly important outcomes of patients with alcoholic liver disease