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 / AIMS Uncontrolled studies suggest that cyclosporine administered as an enema may be of benefit for left-sided ulcerative colitis and safer than intravenous or oral administration . The efficacy and safety of cyclosporine enemas for left-sided ulcerative colitis in a placebo-controlled trial was assessed . METHODS Steroid and mesalamine enemas were withdrawn before the study . Forty patients were assigned to 1 of 4 strata : no concomitant therapy , oral steroids , oral salicylates , or oral steroids and salicylates . After stratification , patients were r and omized to nightly treatment with 350 mg cyclosporine ( n = 20 ) or placebo ( n = 20 ) enemas . Clinical response was determined at baseline and 4 weeks by endoscopy , physician assessment , and a patient diary of daily symptoms . Trough blood cyclosporine levels were measured by high-performance liquid chromatography . RESULTS At 4 weeks , 8 of 20 patients ( 40 % ) who received cyclosporine showed clinical improvement compared with 9 of 20 patients ( 45 % ) who received placebo . One patient receiving cyclosporine had reversible neutropenia attributable to sulfasalazine , and another patient receiving cyclosporine was unable to tolerate the enema vehicle . No other toxicity was noted during the trial . Blood cyclosporine levels were detectable in only two patients . CONCLUSIONS Cyclosporine enemas administered in a dosage of 350 mg/day for 4 weeks are not efficacious in mildly to moderately active left-sided ulcerative colitis 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 Thirty patients with distal ulcerative colitis in remission ( 17 proctitis , 13 proctosigmoiditis ) were r and omly given either 5-aminosalicylic acid ( 5-ASA ) or placebo suppositories , 400 mg bid . During the 1-yr follow-up , patients were assessed clinical ly every month , and flexible sigmoidoscopy with a rectal pinch biopsy specimen and laboratory data were carried out every 3 months . Two patients in the 5-ASA group chose to withdraw from the study , one relapsed , and 12 remained in remission . In the placebo group , one patient chose to withdraw , 11 relapsed , and three remained in remission . The cumulative remission rate at the 12th month was 92 % in the 5-ASA group and 21 % in the placebo group . Log rank test showed a significant difference in the relapse rate between the two groups ( chi 2 = 14.26 , p less than 0.001 ) . No side effects were observed . We conclude that 5-ASA in suppository form ( 800 mg/day ) , administered for 1 yr , is safe and effective in maintaining remission of distal ulcerative colitis The efficacy and safety of 4 g 5-aminosalicylic acid ( 5-ASA ) enemas were assessed in 59 patients with ulcerative colitis involving up to 50 cm of their distal colon . Twenty-nine patients received  5-ASA  and 30 received a placebo . There were 12 dropouts ( five in the active and seven in the placebo group ) during the study because of insufficient efficacy . After six weeks of therapy , 63 % of the patients receiving the 5-ASA were considered to be “ much improved ” by the study physician compared to 20 % patients on placebo ( P<0.0001 ) . A disease activity index ( DAI ) , based upon patient symptoms and sigmoidoscopic appearance , was used to assess efficacy . Mean DAI declined 75 % for patients on 5-ASA enemas and 32 % for patients on placebo ( P<0.05 ) . The 5-ASA enemas are well tolerated and are of benefit in the treatment of ulcerative colitis confined to the distal colon Background : 5‐Aminosalicylic acid ( 5‐ASA ) is known to be effective in the treatment of active ulcerative colitis ( UC ) . The aim of the current study was to investigate the effect of 5‐ASA enemas , as a maintenance therapy for UC , when administered twice weekly as a weekend treatment regimen , compared to daily oral 5‐ASA alone . We hypothesized that the weekend enema therapy would be better tolerated by patients who worked or attended school . Methods : Between January 2004 and August 2005 , patients with UC , in whom remission of the condition had just been induced , were r and omly assigned to either : the weekend 5‐ASA enema group ( n = 11 ) , who received 1 g 5‐ASA enemas twice a week on Saturday and Sunday plus oral 5‐ASA 3 g/day for 7 days , or to the daily oral 5‐ASA use only group ( n = 13 ) , who received only oral 5‐ASA 3 g/day for 7 days . The primary endpoint of the study was defined as the incidence of relapse . The study was stopped after 24 patients had been enrolled because an interim analysis showed a significant benefit of the weekend 5‐ASA enema group . Results : In the weekend enema group , 2 patients ( 18.2 % ) had relapses compared with 10 ( 76.9 % ) in the oral 5‐ASA only group . The multivariate hazard ratio of relapse associated with weekend 5‐ASA enema , relative to the oral alone group , was 0.19 ( 95 % confidence interval , 0.04–0.94 ) . Conclusions : This study demonstrated the beneficial effects of adding weekend 1 g 5‐ASA enema to daily 3 g oral 5‐ASA as maintenance therapy for UC Background : Current treatment of ulcerative colitis is imperfect . Trefoil peptides are known to stimulate repair in many models of injury , including animal models of colitis Background and aims : Oral aminosalicylates are well established in the treatment of active mild/moderate ulcerative colitis ( UC ) when the disease is extensive ( that is , beyond the splenic flexure ) . The majority of clinical symptoms relate to disease activity in the distal part of the colon and therefore this study was design ed to investigate if adding a mesalazine enema to oral mesalazine has additional benefit for patients with extensive mild/moderate active UC . Methods : A r and omised double blind study was performed in 127 ambulatory patients . All received 4 g/day ( twice daily dosing ) oral mesalazine for eight weeks . During the initial four weeks , they additionally received an enema at bedtime containing 1 g of mesalazine or placebo .  Disease activity was assessed using the ulcerative colitis disease activity index , with clinical and endoscopic signs at four and eight weeks . Results : Remission was obtained in 44 % ( 95 % confidence interval ( CI ) 31 % , 58 % ) of the mesalazine enema group ( Me ) and in 34 % ( 95 % CI 21 % , 49 % ) of the placebo enema group ( Pl ) at four weeks ( p = 0.31 ) and in 64 % ( 95 % CI 50 % , 76 % ) of the Me group versus 43 % ( 95 % CI 28 % , 58 % ) of the Pl group at eight weeks ( p = 0.03 ) . Improvement was obtained in 89 % ( 95 % CI 78 % , 96 % ) of the Me group versus 62 % ( 95 % CI 46 % , 75 % ) of the Pl group at four weeks ( p = 0.0008 ) and in 86 % ( 95 % CI 75 % , 94 % ) of the Me group versus 68 % ( 95 % CI 53 % , 81 % ) of the Pl group at eight weeks ( p = 0.026 ) . Conclusion : In patients with extensive mild/moderate active UC , the combination therapy is superior to oral therapy . It is safe , well accepted , and may be regarded as firstline treatment Background / Aim : To investigate patient-reported  health-related quality of life ( HRQoL ) in data collected from a multinational r and omized double-blind controlled trial comparing oral mesalazine ( 4 g ) + topical mesalazine enema ( 1 g ) to oral mesalazine alone ( 4 g ) . Methods : HRQoL was collected using the EQ-5D at baseline and weeks 2 , 4 and 8 . The EQ-5D assesses mobility , self-care , usual activities , pain/discomfort and anxiety/depression . Scores from each dimension were reported individually , and converted into a weighted health state which reflects an individual ’s perception of their health condition . Results : At week 4 , a significant HRQoL improvement was observed for patients on mesalazine enemas compared to placebo enemas , with EQ-5D scores of 0.906 and 0.838 , respectively ( p < 0.05 ) . Mesalazine enema was found to reduce the probability of impairment at week 4 for mobility ( p = 0.049 ) and anxiety/depression ( p = 0.048 ) , and was of borderline significance for pain/discomfort ( p = 0.053 ) ; there was also an increased probability of influencing HRQoL changes for mobility ( p < 0.005 ) , usual activities ( p < 0.005 ) , pain/discomfort ( p < 0.005 ) and anxiety/depression ( p < 0.005 ) , based on reported HRQoL problems at baseline . Conclusions : Including 1 g mesalazine enemas with 4 g oral mesalazine significantly improved HRQoL  in patients with active ulcerative colitis . The improvement in QoL of patients with UC preceded clinical remission , and this underlines the importance of including QoL instruments in clinical studies AIM : To determine in a noninferiority study whether mesalamine foam is as effective as mesalamine liquid enema for inducing clinical remission in patients with active left-sided ulcerative colitis ( UC ) . METHODS : In a multicenter investigator-blind trial , 375 patients with mild-to-moderate UC were r and omized to receive mesalamine foam 1 g/80 mL/day or mesalamine liquid enema 1 g/100 mL/day for 4 wk ( W ) . Inclusion criteria were : disease extension at least 5 cm from anorectal junction and not above splenic flexure and Clinical Activity Index ( CAI ) 1–4 ≥ 4 . Primary end point was clinical remission at W4 defined as a CAI 1–4 ≤ 2 . Noninferiority of the foam to liquid enema was declared if the lower limit of the 97.5 % unilateral confidence interval ( 97.5 % CI ) of the difference in remission rates between foam and liquid enema groups was greater than −15 % . RESULTS : Remission rates at W4 in foam versus liquid were 68.3 % versus 73.6 % in per protocol ( PP ) population ( lower limit of 97.5 % CI −15.1 % ) and 66.7 % versus 70.5 % in intention-to-treat ( ITT ) population ( 97.5 % CI −13.4 % ) . Remission rates at W2 were 48.1 % versus 50.6 % in ITT ( 97.5 % CI −12.8 % ) and 49.1 % versus 52.1 % in PP ( 97.5 % CI −13.8 % ) in foam versus liquid , respectively . Both treatments were well tolerated . CONCLUSIONS : A 4-wk treatment of 1 g mesalamine foam  induced a clinical remission in 68 % patients versus 73 % with 1 g mesalamine liquid enema . Although the noninferiority of mesalamine foam could not be strictly demonstrated at W4 in the PP analysis , it was achieved in the ITT population and at W2 in both population s. Mesalamine foam represents a therapeutic alternative to mesalamine liquid enema in patients with mild-to-moderate active proctitis and proctosigmoiditis Sixty-two patients with ulcerative colitis 
    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 / AIMS Uncontrolled studies suggest that cyclosporine administered as an enema may be of benefit for left-sided ulcerative colitis and safer than intravenous or oral administration . The efficacy and safety of cyclosporine enemas for left-sided ulcerative colitis in a placebo-controlled trial was assessed . METHODS Steroid and mesalamine enemas were withdrawn before the study . Forty patients were assigned to 1 of 4 strata : no concomitant therapy , oral steroids , oral salicylates , or oral steroids and salicylates . After stratification , patients were r and omized to nightly treatment with 350 mg cyclosporine ( n = 20 ) or placebo ( n = 20 ) enemas . Clinical response was determined at baseline and 4 weeks by endoscopy , physician assessment , and a patient diary of daily symptoms . Trough blood cyclosporine levels were measured by high-performance liquid chromatography . RESULTS At 4 weeks , 8 of 20 patients ( 40 % ) who received cyclosporine showed clinical improvement compared with 9 of 20 patients ( 45 % ) who received placebo . One patient receiving cyclosporine had reversible neutropenia attributable to sulfasalazine , and another patient receiving cyclosporine was unable to tolerate the enema vehicle . No other toxicity was noted during the trial . Blood cyclosporine levels were detectable in only two patients . CONCLUSIONS Cyclosporine enemas administered in a dosage of 350 mg/day for 4 weeks are not efficacious in mildly to moderately active left-sided ulcerative colitis 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 Thirty patients with distal ulcerative colitis in remission ( 17 proctitis , 13 proctosigmoiditis ) were r and omly given either 5-aminosalicylic acid ( 5-ASA ) or placebo suppositories , 400 mg bid . During the 1-yr follow-up , patients were assessed clinical ly every month , and flexible sigmoidoscopy with a rectal pinch biopsy specimen and laboratory data were carried out every 3 months . Two patients in the 5-ASA group chose to withdraw from the study , one relapsed , and 12 remained in remission . In the placebo group , one patient chose to withdraw , 11 relapsed , and three remained in remission . The cumulative remission rate at the 12th month was 92 % in the 5-ASA group and 21 % in the placebo group . Log rank test showed a significant difference in the relapse rate between the two groups ( chi 2 = 14.26 , p less than 0.001 ) . No side effects were observed . We conclude that 5-ASA in suppository form ( 800 mg/day ) , administered for 1 yr , is safe and effective in maintaining remission of distal ulcerative colitis The efficacy and safety of 4 g 5-aminosalicylic acid ( 5-ASA ) enemas were assessed in 59 patients with ulcerative colitis involving up to 50 cm of their distal colon . Twenty-nine patients received  5-ASA  and 30 received a placebo . There were 12 dropouts ( five in the active and seven in the placebo group ) during the study because of insufficient efficacy . After six weeks of therapy , 63 % of the patients receiving the 5-ASA were considered to be “ much improved ” by the study physician compared to 20 % patients on placebo ( P<0.0001 ) . A disease activity index ( DAI ) , based upon patient symptoms and sigmoidoscopic appearance , was used to assess efficacy . Mean DAI declined 75 % for patients on 5-ASA enemas and 32 % for patients on placebo ( P<0.05 ) . The 5-ASA enemas are well tolerated and are of benefit in the treatment of ulcerative colitis confined to the distal colon Background : 5‐Aminosalicylic acid ( 5‐ASA ) is known to be effective in the treatment of active ulcerative colitis ( UC ) . The aim of the current study was to investigate the effect of 5‐ASA enemas , as a maintenance therapy for UC , when administered twice weekly as a weekend treatment regimen , compared to daily oral 5‐ASA alone . We hypothesized that the weekend enema therapy would be better tolerated by patients who worked or attended school . Methods : Between January 2004 and August 2005 , patients with UC , in whom remission of the condition had just been induced , were r and omly assigned to either : the weekend 5‐ASA enema group ( n = 11 ) , who received 1 g 5‐ASA enemas twice a week on Saturday and Sunday plus oral 5‐ASA 3 g/day for 7 days , or to the daily oral 5‐ASA use only group ( n = 13 ) , who received only oral 5‐ASA 3 g/day for 7 days . The primary endpoint of the study was defined as the incidence of relapse . The study was stopped after 24 patients had been enrolled because an interim analysis showed a significant benefit of the weekend 5‐ASA enema group . Results : In the weekend enema group , 2 patients ( 18.2 % ) had relapses compared with 10 ( 76.9 % ) in the oral 5‐ASA only group . The multivariate hazard ratio of relapse associated with weekend 5‐ASA enema , relative to the oral alone group , was 0.19 ( 95 % confidence interval , 0.04–0.94 ) . Conclusions : This study demonstrated the beneficial effects of adding weekend 1 g 5‐ASA enema to daily 3 g oral 5‐ASA as maintenance therapy for UC Background : Current treatment of ulcerative colitis is imperfect . Trefoil peptides are known to stimulate repair in many models of injury , including animal models of colitis Background and aims : Oral aminosalicylates are well established in the treatment of active mild/moderate ulcerative colitis ( UC ) when the disease is extensive ( that is , beyond the splenic flexure ) . The majority of clinical symptoms relate to disease activity in the distal part of the colon and therefore this study was design ed to investigate if adding a mesalazine enema to oral mesalazine has additional benefit for patients with extensive mild/moderate active UC . Methods : A r and omised double blind study was performed in 127 ambulatory patients . All received 4 g/day ( twice daily dosing ) oral mesalazine for eight weeks . During the initial four weeks , they additionally received an enema at bedtime containing 1 g of mesalazine or placebo .  Disease activity was assessed using the ulcerative colitis disease activity index , with clinical and endoscopic signs at four and eight weeks . Results : Remission was obtained in 44 % ( 95 % confidence interval ( CI ) 31 % , 58 % ) of the mesalazine enema group ( Me ) and in 34 % ( 95 % CI 21 % , 49 % ) of the placebo enema group ( Pl ) at four weeks ( p = 0.31 ) and in 64 % ( 95 % CI 50 % , 76 % ) of the Me group versus 43 % ( 95 % CI 28 % , 58 % ) of the Pl group at eight weeks ( p = 0.03 ) . Improvement was obtained in 89 % ( 95 % CI 78 % , 96 % ) of the Me group versus 62 % ( 95 % CI 46 % , 75 % ) of the Pl group at four weeks ( p = 0.0008 ) and in 86 % ( 95 % CI 75 % , 94 % ) of the Me group versus 68 % ( 95 % CI 53 % , 81 % ) of the Pl group at eight weeks ( p = 0.026 ) . Conclusion : In patients with extensive mild/moderate active UC , the combination therapy is superior to oral therapy . It is safe , well accepted , and may be regarded as firstline treatment Background / Aim : To investigate patient-reported  health-related quality of life ( HRQoL ) in data collected from a multinational r and omized double-blind controlled trial comparing oral mesalazine ( 4 g ) + topical mesalazine enema ( 1 g ) to oral mesalazine alone ( 4 g ) . Methods : HRQoL was collected using the EQ-5D at baseline and weeks 2 , 4 and 8 . The EQ-5D assesses mobility , self-care , usual activities , pain/discomfort and anxiety/depression . Scores from each dimension were reported individually , and converted into a weighted health state which reflects an individual ’s perception of their health condition . Results : At week 4 , a significant HRQoL improvement was observed for patients on mesalazine enemas compared to placebo enemas , with EQ-5D scores of 0.906 and 0.838 , respectively ( p < 0.05 ) . Mesalazine enema was found to reduce the probability of impairment at week 4 for mobility ( p = 0.049 ) and anxiety/depression ( p = 0.048 ) , and was of borderline significance for pain/discomfort ( p = 0.053 ) ; there was also an increased probability of influencing HRQoL changes for mobility ( p < 0.005 ) , usual activities ( p < 0.005 ) , pain/discomfort ( p < 0.005 ) and anxiety/depression ( p < 0.005 ) , based on reported HRQoL problems at baseline . Conclusions : Including 1 g mesalazine enemas with 4 g oral mesalazine significantly improved HRQoL  in patients with active ulcerative colitis . The improvement in QoL of patients with UC preceded clinical remission , and this underlines the importance of including QoL instruments in clinical studies AIM : To determine in a noninferiority study whether mesalamine foam is as effective as mesalamine liquid enema for inducing clinical remission in patients with active left-sided ulcerative colitis ( UC ) . METHODS : In a multicenter investigator-blind trial , 375 patients with mild-to-moderate UC were r and omized to receive mesalamine foam 1 g/80 mL/day or mesalamine liquid enema 1 g/100 mL/day for 4 wk ( W ) . Inclusion criteria were : disease extension at least 5 cm from anorectal junction and not above splenic flexure and Clinical Activity Index ( CAI ) 1–4 ≥ 4 . Primary end point was clinical remission at W4 defined as a CAI 1–4 ≤ 2 . Noninferiority of the foam to liquid enema was declared if the lower limit of the 97.5 % unilateral confidence interval ( 97.5 % CI ) of the difference in remission rates between foam and liquid enema groups was greater than −15 % . RESULTS : Remission rates at W4 in foam versus liquid were 68.3 % versus 73.6 % in per protocol ( PP ) population ( lower limit of 97.5 % CI −15.1 % ) and 66.7 % versus 70.5 % in intention-to-treat ( ITT ) population ( 97.5 % CI −13.4 % ) . Remission rates at W2 were 48.1 % versus 50.6 % in ITT ( 97.5 % CI −12.8 % ) and 49.1 % versus 52.1 % in PP ( 97.5 % CI −13.8 % ) in foam versus liquid , respectively . Both treatments were well tolerated . CONCLUSIONS : A 4-wk treatment of 1 g mesalamine foam  induced a clinical remission in 68 % patients versus 73 % with 1 g mesalamine liquid enema . Although the noninferiority of mesalamine foam could not be strictly demonstrated at W4 in the PP analysis , it was achieved in the ITT population and at W2 in both population s. Mesalamine foam represents a therapeutic alternative to mesalamine liquid enema in patients with mild-to-moderate active proctitis and proctosigmoiditis Sixty-two patients with ulcerative colitis 
    Output:
    