***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: Distal ulcerative colitis can be treated with oral or rectal mesalazine , or both . A foam enema preparation has been developed and its efficacy investigated . The aim of this study was to evaluate the efficacy and safety of mesalazine foam enemas compared with prednisolone foam enemas in the treatment of patients with acute distal ulcerative colitis . Patients aged over 18 years presenting with a relapse of distal ulcerative colitis were r and omly allocated treatment with mesalazine foam enema  ( n = 149 evaluable patients ) and prednisolone foam enema  ( n = 146 evaluable patients ) for four weeks . A r and omised multicentre investigator blind parallel group trial was conducted . It was found that after four weeks of treatment , clinical remission was achieved by 52 % of mesalazine treated patients and 31 % of patients treated with prednisolone ( p < 0.001 ) . There was a trend in favour of more patients in the mesalazine group achieving sigmoidoscopic remission ( 40 % v 31 % , p = 0.10 ) . Histological remission was achieved by 27 % and 21 % of patients receiving mesalazine and prednisolone respectively . Symptoms improved in both treatment groups . Significantly more mesalazine patients had no blood in their stools after four weeks of treatment ( 67 % v 40 % , p < 0.001 ) . Prednisolone treated patients had significantly fewer days with liquid stools than mesalazine patients , with a median of 0 and 1 days respectively by week 4 ( p = 0.001 ) . In this study mesalazine foam enema was superior to prednisolone foam enema with regards to clinical remission , this was supported by favourable trends in sigmoidoscopic and histological remission rates . Both treatments were well tolerated OBJECTIVE : Balsalazide is a novel azo-bonded 5-aminosalicylic acid treatment for mild-to-moderate ulcerative colitis . The study objective was to compare symptomatic remission rates with balsalazide and mesalamine while controlling for extent of disease and time since diagnosis in patients with active , mild-to-moderate ulcerative colitis . METHODS : A total of 173 patients with sigmoidoscopically verified ulcerative colitis were r and omized to 8 wk of double-blind treatment with balsalazide 6.75 g/day or mesalamine 2.4 g/day . Both treatments provided 2.4 g/day of oral 5-aminosalicylic acid . Patients maintained symptom diaries throughout the treatment period . RESULTS : Overall , 46 % of balsalazide- and 44 % of mesalamine-treated patients achieved symptomatic remission . Higher response rates were noted in newly diagnosed patients with ≤40 cm of disease ( 68 % vs 61 % ) than in recently relapsed patients with > 40 cm of disease ( 36 % vs 25 % ) . The median time to symptomatic remission was 12 days shorter with balsalazide ( 25 days ) than with mesalamine ( 37 days ) . Significantly more balsalazide patients showed sigmoidoscopic ( p = 0.002 ) , stool frequency ( p = 0.006 ) , rectal bleeding ( p = 0.006 ) , and physician 's global assessment score ( p = 0.013 ) improvement by 14 days than did mesalamine patients . Similar proportions of patients reported adverse events ( 54 % vs 64 % ) , which were most commonly related to the gastrointestinal and central and peripheral nervous systems . CONCLUSIONS : Balsalazide is an effective and safe treatment for mild-to-moderate ulcerative colitis . Improvement of symptoms occurs considerably earlier with balsalazide than with mesalamine Objectives : To determine the therapeutic equivalence and safety of once daily ( OD ) versus three times daily ( TID ) dosing of a total daily dose of 3 g Salofalk ( mesalazine ) granules in patients with active ulcerative colitis . Design : A r and omised , double-blind , double-dummy , parallel group , multicentre , international , phase III non-inferiority study . Setting : 54 centres in 13 countries . Patients : 380 patients with confirmed diagnosis of established or first attack of ulcerative colitis ( clinical activity index (CAI)>4 and endoscopic index ⩾4 at baseline ) were r and omised and treated . Interventions : 8-week treatment with either 3 g OD or 1 g TID mesalazine granules . Main outcome measures : Clinical remission ( CAI⩽4 ) at study end . Results : 380 patients were evaluable for efficacy and safety by intention-to-treat ( ITT ) ; 345 for per protocol ( PP ) analysis . In the ITT population , 79.1 % in the OD group ( n = 191 ) and 75.7 % in the TID group ( n = 189 ) achieved clinical remission ( p<0.0001 for non-inferiority ) . Significantly more patients with proctosigmoiditis achieved clinical remission in the OD group ( 86 % ; n = 97 ) versus the TID group ( 73 % ; n = 100 ; p = 0.0298 ) . About 70 % of patients in both treatment groups achieved endoscopic remission , and 35 % in the OD group and 41 % in the TID group achieved histological remission . About 80 % of all patients preferred OD dosing . Similar numbers of adverse events occurred in 55 patients ( 28.8 % ) in the OD group and in 61 patients ( 32.3 % ) in the TID group , indicating that the two dosing regimens were equally safe and well tolerated . Conclusions : OD 3 g mesalazine granules are as effective and safe as a TID 1 g schedule . With respect to the best possible adherence of patients to the treatment , OD dosing of mesalazine should be the preferred application mode in active ulcerative colitis . Clinical Trials.gov Identifier : OBJECTIVE : Balsalazide is a new innovative , mesalamine-containing prodrug that is activated by bacteria in the colon . Balsalazide has been shown previously to be well tolerated and effective in the treatment of acute ulcerative colitis . The aim of this study was to determine the dose-response of balsalazide for efficacy and safety in active , mild-to-moderate ulcerative colitis and to compare this profile with that of mesalamine , pH-dependent , delayed-release tablets . METHODS : A multicenter , r and omized , active control , double-blind , double-dummy , dose-response , parallel-group study was performed comparing balsalazide ( 6.75 g daily ) , balsalazide ( 2.25 g daily ) , and mesalamine ( 2.4 g daily ) , administered for 8 wk to 154 patients with active , mild-to-moderate ulcerative colitis as verified by sigmoidoscopy . RESULTS : Eight weeks of treatment with 6.75 g of balsalazide daily provided significantly greater improvement than did balsalazide ( 2.25 g daily ) in rectal bleeding ( 64.7 % [ 6.75-g balsalazide ] vs 32.4 % [ 2.25-g balsalazide ] , p < 0.006 ) , stool frequency ( 58.8 % vs 29.4 % , p < 0.006 ) , sigmoidoscopic score ( 78.9 % vs 52.5 % , p < 0.015 ) , and Physician 's Global Assessment ( 73.7 % vs 51.3 % , p < 0.03 ) . The efficacy of balsalazide showed a significantly more rapid onset of action than that of mesalamine ( 2.4 g daily ) ( 2-wk sigmoidocopic score improvement , 54.7 % [ 6.75-g balsalazide ] vs 29.4 % [ 2.4-g mesalamine ] , p = 0.006 ) with numerically greater improvement at 8 wk in five of seven measured signs and symptoms .  Balsalazide ( 6.75 g daily ) was well tolerated , and the safety profile did not differ significantly from that of balsalazide ( 2.25 g daily ) or mesalamine . CONCLUSIONS : Eight weeks of treatment with balsalazide ( 6.75 g daily ) is significantly more effective than balsalazide ( 2.25 g daily ) and more rapid in onset than mesalamine ( 2.4 g daily ) in improving signs and symptoms of acute ulcerative colitis .  Balsalazide ( 6.75 g daily ) is well tolerated , and the safety profile does not differ from that of balsalazide ( 2.25 g daily ) and mesalamine ( 2.4 g daily ) Background : We report a multicenter study of oral tacrolimus ( FK506 ) therapy in steroid‐refractory ulcerative colitis ( UC ) . Methods : In a placebo‐controlled , double‐blind study , 62 patients with steroid‐refractory , moderate‐to‐severe UC were r and omized into either a tacrolimus group or a placebo for 2 weeks . Patients were evaluated using the Disease Activity Index ( DAI ) . As an entry criterion , patients had to have a total DAI score of 6 or more as well as a mucosal appearance subscore of 2 or 3 .  Clinical response was defined as improvement in all DAI subscores . Mucosal healing was defined as mucosal appearance subscore of 0 or 1 . Clinical remission was defined as a total DAI score ≤2 with an individual subscore of 0 or 1 . Results : The mean total DAI score at study entry was 9.8 ± 1.61 in the tacrolimus group and 9.1 ± 1.05 in the placebo group . At week 2 the clinical response rate was 50.0 % ( 16/32 ) in the tacrolimus group and 13.3 % ( 4/30 ) in the placebo group ( P = 0.003 ) . The rate of mucosal healing observed was 43.8 % ( 14/32 ) in the tacrolimus group and 13.3 % ( 4/30 ) in the placebo group ( P = 0.012 ) and the rate of clinical remission observed was 9.4 % ( 3/32 ) in the tacrolimus group and 0.0 % ( 0/30 ) in the placebo group ( P = 0.238 ) . The therapies in this study were well tolerated , with only minor side effects . Conclusions : Oral tacrolimus therapy in patients with steroid‐refractory UC shortened the acute phase and induced rapid mucosal healing . These results suggest that tacrolimus therapy is useful as an alternative therapy for steroid‐refractory UC . ( Inflamm Bowel Dis 2011 ; BACKGROUND Corticosteroid therapy for ulcerative colitis ( UC ) frequently results in Steroid-dependency . The objective of this study was to evaluate the long term clinical and endoscopic efficacy of infliximab ( IFX ) in steroid-dependent UC . METHODS An open-label , prospect i ve , single center study was design ed . Patients older than 18 years with steroid-dependent UC , either intolerant or did not respond to azathioprine , were consecutively enrolled . Steroid-dependency was defined as the ECCO criteria . Patients received IFX ( 5 mg/kg ) at 0 , 2 and 6 weeks and every 8 weeks thereafter for 2 years . All patients were clinical ly evaluated at weeks 8 , 52 and 104 and a colonoscopy was performed at week 104 . Response to IFX was defined as clinical remission without steroids together with mucosal healing ( endoscopic Mayo score of 0 or 1 ) . RESULTS Seventeen consecutive patients were included ( 11 male , mean age 45 , range 25 - 70 ) . Thirteen ( 76 % ) had extensive colitis ( E3 ) . All patients completed IFX therapy . Clinical response was in 13/17 at weeks 8 and 52 . Twelve out of seventeen patients maintained clinical remission without steroids and endoscopic response at week 104 . Six out of seventeen patients needed dose intensification of IFX ( every 6 weeks ) ; 3/6 patients did not reach remission despite dose intensification . Including those patients who needed dose intensification as non-responders , 9/17 patients were in clinical and endoscopic remission at week 104 . A significant correlation was found between clinical and endoscopic findings ( p<0.01 ) . CONCLUSIONS Infliximab therapy is effective for maintenance of clinical remission and mucosal healing in patients with steroid-dependent UC Objective The aim of this study was to assess the efficacy and safety of adalimumab ( ADA ) , a recombinant human monoclonal antibody against tumour necrosis factor α ( TNF ) , for the induction of clinical remission in anti-TNF naïve patients with moderately to severely active ulcerative colitis . Methods This 8-week , multicentre , r and omised , double-blind , placebo-controlled study ( NCT00385736 ) , conducted at 94 centres in North America and 
    Output:
    
Results The literature review showed that many endoscopic indices have been proposed to evaluate disease activity in ulcerative colitis ; most are unvali date d and arbitrary definitions have been used in clinical trials for defining endoscopic response or remission .