human
***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: Background : Delayed release budesonide was approved by the FDA for the treatment of mildly to moderately active Crohn 's disease involving the ileum and ascending colon . Controlled trials have demonstrated that budesonide is effective in inducing remission and for maintenance of remission , with less frequent steroid side effects than conventional steroids . We sought to determine the benefit of this medication in clinical practice and to identify any non‐ FDA ‐approved uses that may warrant further study . Methods : Patients in whom oral budesonide was prescribed between November 1 , 2001 and October 31 , 2002 , were identified and medical records were review ed . Patients were categorized by indication for therapy : ileocolonic Crohn 's disease ( group 1 ) , Crohn 's disease elsewhere ( group 2 ) , and other conditions ( group 3 ) . Results : A total of 225 patients were identified ( 108 in group 1 , 62 in group 2 , and 55 in group 3 ) . Group 3 included patients with microscopic colitis ( n = 28 ) , pouchitis ( n = 13 ) , ulcerative colitis ( n = 12 ) , and celiac disease ( n = 2 ) . A favorable outcome occurred in 61 % of group 1 patients but only 24 % of patients in group 2 . In group 3 , only microscopic colitis patients and pouchitis patients experienced response rates > 50 % ( 77 % and 60 % , respectively ) . Conclusion : Budesonide is effective in a majority of patients with ileocolonic Crohn 's disease and microscopic colitis , which is consistent with results reported from clinical trials . A majority of patients with pouchitis also benefit from budesonide therapy , but prospect i ve controlled trials are necessary to clarify the benefit in this group OBJECTIVE --To assess the safety and efficacy of a preparation of mesalazine ( 5-aminosalicylic acid ) coated with a pH dependent resin ( Eudragit L ) as compared with sulphasalazine in patients with active mild to moderate ulcerative colitis . DESIGN --Eight week r and omised double blind parallel group study . SETTING --Forty six gastroenterology outpatient clinics in seven countries . PATIENTS --Two hundred and twenty patients aged 18 - 70 who met the following criteria : clinical activity index greater than or equal to 6 and endoscopic index greater than or equal to 4 ; no concomitant treatment for ulcerative colitis ; no hypersensitivity to salicylates or sulphonamides . Of the 164 patients eligible for efficacy analysis , 87 received the coated preparation of mesalazine and 77 sulphasalazine . Most of the remaining patients ( 28 in each group ) were ineligible for the efficacy analysis because of treatment with steroid enemas . All pretrial characteristics were comparable in the two treatment groups . INTERVENTIONS --Coated mesalazine ( Mesasal ) 1.5 g daily or sulphasalazine 3.0 g daily for eight weeks . Compliance monitored by pill counts . END POINT-- Clinical and endoscopic remission . MEASUREMENTS AND MAIN RESULTS -- Clinical activity measured by daily diary cards , assessment by investigators , and laboratory findings . Endoscopic evaluation at week 8 . After four weeks 50 of 70 patients ( 71 % ) taking coated mesalazine and 38 of 58 ( 66 % ) taking sulphasalazine had achieved remission of their disease by eight weeks remission rates were 74 % ( 37/50 patients ) and 81 % ( 35/43 ) in the two treatment groups respectively . Endoscopic remission at eight weeks was recorded in 20 of 41 patients ( 49 % ) taking coated mesalazine and 18 of 38 ( 47 % ) taking sulphasalazine . There was a higher incidence of adverse events among patients taking sulphasalazine ( 25/105 ; 24 % ) than among those taking coated mesalazine ( 16/115 ; 14 % ) . CONCLUSION --Mesalazine coated with Eudragit L is a safe , logical alternative to sulphasalazine The efficacy and safety of 4-g 5-aminosalicylic acid enemas were assessed in 153 patients with ulcerative colitis involving up to 50 cm of distal colon . Seventy-six patients received active medication and 77 received a placebo .  There were 20 dropouts ( 6 in the active group and 14 in the placebo group ) during the study because of insufficient efficacy . After 6 wk of therapy , 48 of the 76 patients ( 63 % ) receiving 5-aminosalicylic acid were considered to be " much improved " by the study physician compared to 22 of the 77 patients ( 29 % ) on placebo ( p = 0.001 ) . A disease activity index based on patient symptoms and sigmoidoscopic appearance was used to assess efficacy . Mean disease activity index declined 55 % for patients on 5-aminosalicylic acid and 24 % for patients on placebo ( p = 0.0001 ) . Analysis of subgroups indicated that patients most likely to respond were those with disease confined to the 20 - 40 cm from the anus . Response was not affected by concurrent sulfasalazine , but patients requiring concurrent oral steroids had a diminished response . Rapid onset of efficacy was shown by a significant reduction in rectal bleeding within 3 days of treatment initiation . 5-Aminosalicylic acid enemas are well tolerated and are of benefit in the treatment of ulcerative colitis confined to the distal colon Forty mg has been shown to be the optimal daily dosage of prednisone for out patients requiring oral steroids for active proctocolitis . Although daily doses of oral steroids are commonly divided , a single dose each morning causes less adrenal suppression and is more convenient to take . A r and omized controlled trial has been performed on patients with proctocolitis , in which 23 received 40 mg prednisolone each morning as one dose , and 22 received 10 mg four times a day  , over two weeks  . Physicians unaware of the dosage schedule scored the disease activity and assessed the steroid side-effects when the patient entered the trial , at day 7 and at day 14 . Of those taking the divided dose the disease improved in 17 and failed to improve in five . No side-effects were observed in ten patients . Of those receiving a once daily regimen , 17 improved and six did not . Nine patients had no side-effects . Further assessment showed no difference between the two groups either in response rate or side-effects produced . When oral steroids are indicated for active proctocolitis , 40 mg prednisolone , as a single dose each morning can be recommended BACKGROUND Crohn 's disease is often treated with glucocorticoids or mesalamine . We compared the efficacy and safety of controlled-ileal-release budesonide capsules and slow-release mesalamine tablets in patients with active Crohn 's disease affecting the ileum , the ascending colon , or both . METHODS In a double-blind , multicenter trial , we enrolled 182 patients with scores of 200 to 400 on the Crohn 's Disease Activity Index ( with higher scores indicating greater disease activity ) and r and omly assigned 93 to receive 9 mg of budesonide once daily and 89 to receive 2 g of mesalamine twice daily for 16 weeks . The primary efficacy variable was clinical remission , defined as a score of 150 or less on the Crohn 's Disease Activity Index . RESULTS In the analysis of all patients who received at least one dose of study drug , the rates of remission after 8 weeks of treatment were 69 percent in the budesonide group and 45 percent in the mesalamine group ( P=0.001 ) ; the respective rates after 16 weeks of treatment were 62 percent and 36 percent ( P<0.001 ) . Seventy-seven patients in the budesonide group completed the 16 weeks of treatment , as compared with 50 patients in the mesalamine group ( P<0.001 ) . The numbers of patients with adverse events were similar in the two groups , but those assigned to budesonide had fewer severe adverse events . Among patients who completed 16 weeks of treatment , the morning plasma cortisol value was normal in 67 percent of budesonide-treated patients and 83 percent of mesalamine-treated patients ( P=0.06 ) ; 90 percent and 100 percent , respectively , had normal increases in cortisol in response to cosyntropin ( P=0.02 ) . CONCLUSIONS In patients with active Crohn 's disease affecting the ileum , the ascending colon , or both , a controlled-ileal-release formulation of budesonide was more effective in inducing remission than a slow-release formulation of mesalamine Budesonide , a corticosteroid with high topical anti‐inflammatory activity and low systemic activity , has been shown to prolong time to relapse in Crohn 's disease . In the present study , the efficacy of budesonide in an oral pH‐modified‐release formulation was evaluated for maintenance treatment in patients with steroid‐dependent ulcerative colitis Indium 111-leukocyte scanning has recently been introduced as a new method for imaging inflammatory bowel disease . The technique has recently been made more specific for acute inflammation by labeling a pure granulocyte fraction rather than the conventional mixed leukocyte preparation . We now report a prospect i ve study comparing 111In-granulocyte scanning with endoscopy , histology , and fecal 111In-granulocyte excretion for the assessment of disease extent and severity in colonic inflammatory bowel disease . In 52 patients with Crohn 's disease or ulcerative colitis , disease extent and severity were assessed macroscopically , histologically , or by scanning using a numerical grading system . Excellent correlations were found between both endoscopy and histology and 111In scans [ r = 0.90 ( endoscopy ) and r = 0.90 ( histology ) for extent ; r = 0.86 and r = 0.91 for disease activity ] . Severity grade d by scanning also showed a close correlation with fecal 111In-granulocyte excretion ( r = 0.90 ) . Indium 111-granulocyte scans are a rapid , accurate , noninvasive means of assessing both disease extent and severity of colonic involvement in inflammatory bowel disease Budesonide , a topical corticosteroid , has proven useful for the management of Crohn 's disease . Its efficacy is similar to prednisone but it has fewer side effects . A new pH-modified release capsule ( Budenofalk ) is probably efficacious in distal ulcerative colitis . The aim of the present study was to establish the pharmacokinetics , pharmacodynamics , and safety of two dosage regimens of budesonide capsules and to obtain efficacy information . Budenofalk 9 mg daily was administered as a single dose 9 mg in 8 patients and as three 3 mg doses in 7 patients with active distal ulcerative colitis for 8 weeks . Symptoms were assessed at three timepoints during the study : baseline , 4 and 8 weeks after start of treatment . Endoscopic evaluation and budesonide concentration in mucosal biopsy specimens was performed at 0 and 8 weeks . A pharmacokinetic profile and pharmacodynamic profile ( cortisol , lymphocytes and neutrophils ) was performed at day 5 . In the 9 mg o.d . group , higher peak concentrations and systemic availability was found compared to the 3 mg t.i.d . group . Cortisol suppression was more pronounced after 9 mg o.d . than after 3 mg t.i.d . Lag-time , AUC and pharmacodynamic effects were comparable ( 14 % mean decrease lymphocyte count and 26 % mean increase neutrophil count ) . Mucosal biopsy specimens in the distal colon revealed significant budesonide levels with both regimens . After 8 weeks , 71 % in the 9 mg o.d . group and 38 % in the 3 t.i.d . group responded . The endoscopic index improved from 10 + /- 2 to 2 + /- 3 ( p < 0.001 ) with 9 mg o.d . and from 9 + /- 2 to 4 + /- 4.7 ( p = 0.02 ) with 3 mg t.i.d . The pharmacokinetic and pharmacodynamic profiles found in this study indicate that Budenofalk reaches the distal part of colon and rectum , but further studies to vali date the budesonide assay in the mucosa and comparison with a control group are necessary . This limited study suggests that Budenofalk is effective in distal colitis and side effects are rare . Based on these observations a large clinical trial using 9 mg o.d . is indicated to confirm efficacy and assess further possible side effects Objective Budesonide MMX is a novel oral formulation of budesonide that uses Multi-Matrix System ( MMX ) technology to extend release to the colon . This study compared the efficacy of budesonide MMX with placebo in patients with active , mild-to-moderate ulcerative colitis ( UC ) . Design Patients were r and omised 1:1:1:1 to receive budesonide MMX 9 mg or 6 mg , or Entocort EC 9 mg ( budesonide controlled ileal-release capsules ; reference arm ) or placebo once daily for 8 weeks . The primary endpoint was combined clinical and endoscopic remission , defined as UC Disease Activity Index score ≤1 with a 
    Output:
    
agent
***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: Background : Delayed release budesonide was approved by the FDA for the treatment of mildly to moderately active Crohn 's disease involving the ileum and ascending colon . Controlled trials have demonstrated that budesonide is effective in inducing remission and for maintenance of remission , with less frequent steroid side effects than conventional steroids . We sought to determine the benefit of this medication in clinical practice and to identify any non‐ FDA ‐approved uses that may warrant further study . Methods : Patients in whom oral budesonide was prescribed between November 1 , 2001 and October 31 , 2002 , were identified and medical records were review ed . Patients were categorized by indication for therapy : ileocolonic Crohn 's disease ( group 1 ) , Crohn 's disease elsewhere ( group 2 ) , and other conditions ( group 3 ) . Results : A total of 225 patients were identified ( 108 in group 1 , 62 in group 2 , and 55 in group 3 ) . Group 3 included patients with microscopic colitis ( n = 28 ) , pouchitis ( n = 13 ) , ulcerative colitis ( n = 12 ) , and celiac disease ( n = 2 ) . A favorable outcome occurred in 61 % of group 1 patients but only 24 % of patients in group 2 . In group 3 , only microscopic colitis patients and pouchitis patients experienced response rates > 50 % ( 77 % and 60 % , respectively ) . Conclusion : Budesonide is effective in a majority of patients with ileocolonic Crohn 's disease and microscopic colitis , which is consistent with results reported from clinical trials . A majority of patients with pouchitis also benefit from budesonide therapy , but prospect i ve controlled trials are necessary to clarify the benefit in this group OBJECTIVE --To assess the safety and efficacy of a preparation of mesalazine ( 5-aminosalicylic acid ) coated with a pH dependent resin ( Eudragit L ) as compared with sulphasalazine in patients with active mild to moderate ulcerative colitis . DESIGN --Eight week r and omised double blind parallel group study . SETTING --Forty six gastroenterology outpatient clinics in seven countries . PATIENTS --Two hundred and twenty patients aged 18 - 70 who met the following criteria : clinical activity index greater than or equal to 6 and endoscopic index greater than or equal to 4 ; no concomitant treatment for ulcerative colitis ; no hypersensitivity to salicylates or sulphonamides . Of the 164 patients eligible for efficacy analysis , 87 received the coated preparation of mesalazine and 77 sulphasalazine . Most of the remaining patients ( 28 in each group ) were ineligible for the efficacy analysis because of treatment with steroid enemas . All pretrial characteristics were comparable in the two treatment groups . INTERVENTIONS --Coated mesalazine ( Mesasal ) 1.5 g daily or sulphasalazine 3.0 g daily for eight weeks . Compliance monitored by pill counts . END POINT-- Clinical and endoscopic remission . MEASUREMENTS AND MAIN RESULTS -- Clinical activity measured by daily diary cards , assessment by investigators , and laboratory findings . Endoscopic evaluation at week 8 . After four weeks 50 of 70 patients ( 71 % ) taking coated mesalazine and 38 of 58 ( 66 % ) taking sulphasalazine had achieved remission of their disease by eight weeks remission rates were 74 % ( 37/50 patients ) and 81 % ( 35/43 ) in the two treatment groups respectively . Endoscopic remission at eight weeks was recorded in 20 of 41 patients ( 49 % ) taking coated mesalazine and 18 of 38 ( 47 % ) taking sulphasalazine . There was a higher incidence of adverse events among patients taking sulphasalazine ( 25/105 ; 24 % ) than among those taking coated mesalazine ( 16/115 ; 14 % ) . CONCLUSION --Mesalazine coated with Eudragit L is a safe , logical alternative to sulphasalazine The efficacy and safety of 4-g 5-aminosalicylic acid enemas were assessed in 153 patients with ulcerative colitis involving up to 50 cm of distal colon . Seventy-six patients received active medication and 77 received a placebo .  There were 20 dropouts ( 6 in the active group and 14 in the placebo group ) during the study because of insufficient efficacy . After 6 wk of therapy , 48 of the 76 patients ( 63 % ) receiving 5-aminosalicylic acid were considered to be " much improved " by the study physician compared to 22 of the 77 patients ( 29 % ) on placebo ( p = 0.001 ) . A disease activity index based on patient symptoms and sigmoidoscopic appearance was used to assess efficacy . Mean disease activity index declined 55 % for patients on 5-aminosalicylic acid and 24 % for patients on placebo ( p = 0.0001 ) . Analysis of subgroups indicated that patients most likely to respond were those with disease confined to the 20 - 40 cm from the anus . Response was not affected by concurrent sulfasalazine , but patients requiring concurrent oral steroids had a diminished response . Rapid onset of efficacy was shown by a significant reduction in rectal bleeding within 3 days of treatment initiation . 5-Aminosalicylic acid enemas are well tolerated and are of benefit in the treatment of ulcerative colitis confined to the distal colon Forty mg has been shown to be the optimal daily dosage of prednisone for out patients requiring oral steroids for active proctocolitis . Although daily doses of oral steroids are commonly divided , a single dose each morning causes less adrenal suppression and is more convenient to take . A r and omized controlled trial has been performed on patients with proctocolitis , in which 23 received 40 mg prednisolone each morning as one dose , and 22 received 10 mg four times a day  , over two weeks  . Physicians unaware of the dosage schedule scored the disease activity and assessed the steroid side-effects when the patient entered the trial , at day 7 and at day 14 . Of those taking the divided dose the disease improved in 17 and failed to improve in five . No side-effects were observed in ten patients . Of those receiving a once daily regimen , 17 improved and six did not . Nine patients had no side-effects . Further assessment showed no difference between the two groups either in response rate or side-effects produced . When oral steroids are indicated for active proctocolitis , 40 mg prednisolone , as a single dose each morning can be recommended BACKGROUND Crohn 's disease is often treated with glucocorticoids or mesalamine . We compared the efficacy and safety of controlled-ileal-release budesonide capsules and slow-release mesalamine tablets in patients with active Crohn 's disease affecting the ileum , the ascending colon , or both . METHODS In a double-blind , multicenter trial , we enrolled 182 patients with scores of 200 to 400 on the Crohn 's Disease Activity Index ( with higher scores indicating greater disease activity ) and r and omly assigned 93 to receive 9 mg of budesonide once daily and 89 to receive 2 g of mesalamine twice daily for 16 weeks . The primary efficacy variable was clinical remission , defined as a score of 150 or less on the Crohn 's Disease Activity Index . RESULTS In the analysis of all patients who received at least one dose of study drug , the rates of remission after 8 weeks of treatment were 69 percent in the budesonide group and 45 percent in the mesalamine group ( P=0.001 ) ; the respective rates after 16 weeks of treatment were 62 percent and 36 percent ( P<0.001 ) . Seventy-seven patients in the budesonide group completed the 16 weeks of treatment , as compared with 50 patients in the mesalamine group ( P<0.001 ) . The numbers of patients with adverse events were similar in the two groups , but those assigned to budesonide had fewer severe adverse events . Among patients who completed 16 weeks of treatment , the morning plasma cortisol value was normal in 67 percent of budesonide-treated patients and 83 percent of mesalamine-treated patients ( P=0.06 ) ; 90 percent and 100 percent , respectively , had normal increases in cortisol in response to cosyntropin ( P=0.02 ) . CONCLUSIONS In patients with active Crohn 's disease affecting the ileum , the ascending colon , or both , a controlled-ileal-release formulation of budesonide was more effective in inducing remission than a slow-release formulation of mesalamine Budesonide , a corticosteroid with high topical anti‐inflammatory activity and low systemic activity , has been shown to prolong time to relapse in Crohn 's disease . In the present study , the efficacy of budesonide in an oral pH‐modified‐release formulation was evaluated for maintenance treatment in patients with steroid‐dependent ulcerative colitis Indium 111-leukocyte scanning has recently been introduced as a new method for imaging inflammatory bowel disease . The technique has recently been made more specific for acute inflammation by labeling a pure granulocyte fraction rather than the conventional mixed leukocyte preparation . We now report a prospect i ve study comparing 111In-granulocyte scanning with endoscopy , histology , and fecal 111In-granulocyte excretion for the assessment of disease extent and severity in colonic inflammatory bowel disease . In 52 patients with Crohn 's disease or ulcerative colitis , disease extent and severity were assessed macroscopically , histologically , or by scanning using a numerical grading system . Excellent correlations were found between both endoscopy and histology and 111In scans [ r = 0.90 ( endoscopy ) and r = 0.90 ( histology ) for extent ; r = 0.86 and r = 0.91 for disease activity ] . Severity grade d by scanning also showed a close correlation with fecal 111In-granulocyte excretion ( r = 0.90 ) . Indium 111-granulocyte scans are a rapid , accurate , noninvasive means of assessing both disease extent and severity of colonic involvement in inflammatory bowel disease Budesonide , a topical corticosteroid , has proven useful for the management of Crohn 's disease . Its efficacy is similar to prednisone but it has fewer side effects . A new pH-modified release capsule ( Budenofalk ) is probably efficacious in distal ulcerative colitis . The aim of the present study was to establish the pharmacokinetics , pharmacodynamics , and safety of two dosage regimens of budesonide capsules and to obtain efficacy information . Budenofalk 9 mg daily was administered as a single dose 9 mg in 8 patients and as three 3 mg doses in 7 patients with active distal ulcerative colitis for 8 weeks . Symptoms were assessed at three timepoints during the study : baseline , 4 and 8 weeks after start of treatment . Endoscopic evaluation and budesonide concentration in mucosal biopsy specimens was performed at 0 and 8 weeks . A pharmacokinetic profile and pharmacodynamic profile ( cortisol , lymphocytes and neutrophils ) was performed at day 5 . In the 9 mg o.d . group , higher peak concentrations and systemic availability was found compared to the 3 mg t.i.d . group . Cortisol suppression was more pronounced after 9 mg o.d . than after 3 mg t.i.d . Lag-time , AUC and pharmacodynamic effects were comparable ( 14 % mean decrease lymphocyte count and 26 % mean increase neutrophil count ) . Mucosal biopsy specimens in the distal colon revealed significant budesonide levels with both regimens . After 8 weeks , 71 % in the 9 mg o.d . group and 38 % in the 3 t.i.d . group responded . The endoscopic index improved from 10 + /- 2 to 2 + /- 3 ( p < 0.001 ) with 9 mg o.d . and from 9 + /- 2 to 4 + /- 4.7 ( p = 0.02 ) with 3 mg t.i.d . The pharmacokinetic and pharmacodynamic profiles found in this study indicate that Budenofalk reaches the distal part of colon and rectum , but further studies to vali date the budesonide assay in the mucosa and comparison with a control group are necessary . This limited study suggests that Budenofalk is effective in distal colitis and side effects are rare . Based on these observations a large clinical trial using 9 mg o.d . is indicated to confirm efficacy and assess further possible side effects Objective Budesonide MMX is a novel oral formulation of budesonide that uses Multi-Matrix System ( MMX ) technology to extend release to the colon . This study compared the efficacy of budesonide MMX with placebo in patients with active , mild-to-moderate ulcerative colitis ( UC ) . Design Patients were r and omised 1:1:1:1 to receive budesonide MMX 9 mg or 6 mg , or Entocort EC 9 mg ( budesonide controlled ileal-release capsules ; reference arm ) or placebo once daily for 8 weeks . The primary endpoint was combined clinical and endoscopic remission , defined as UC Disease Activity Index score ≤1 with a 
    Output:
    