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: This paper reports a double‐blind placebo‐controlled trial of oral tobramycin in acute ulcerative colitis . Eighty‐four patients with an acute relapse of ulcerative colitis were r and omized to receive oral tobramycin or placebo for 1 week as an adjunct to steroid therapy . At endpoint , 31 of 42 ( 74 % ) in the tobramycin group achieved complete symptomatic remission compared with 18 of 42 ( 43 % ) in the placebo group ( P= 0.008 ) . The tobramycin group achieved better histological scores ( P < 0.05 ) at endpoint . These findings show that treatment with oral tobramycin improves the short‐term outcome of patients with ulcerative colitis in relapse A double blind study compared the efficacy of metronidazole in two doses ( 20 mg/kg , 10 mg/kg ) with placebo in patients with Crohn 's disease . One hundred and five patients participated but only 56 completed the 16 week study -21 were withdrawn for deterioration of symptoms , 17 for adverse experiences , and 11 for protocol violation . Significant improvement in disease activity as measured by the Crohn 's disease activity index  ( metronidazole 20 mg/kg , 97 units ; metronidazole 10 mg/kg , 67 units ; placebo -1 unit , p = 0.002 ) and serum orosomucoid  ( metronidazole 20 mg/kg/day , 49 ; 10 mg/kg/day , 38 ; placebo , -9 , p = 0.001 ) ) were detected . Changes in C reactive protein concentrations did not achieve significance when all three groups were considered but were significant when all metronidazole treated patients were grouped and compared with the placebo treated patients ( 0.8 v -0.9 , p less than 0.05 ) . Although patients receiving metronidazole 20 mg/kg/day had a greater improvement in disease activity than those receiving 10 mg/kg/day ( difference 30 units ( 95 % confidence intervals -27 - 87 ) , the small sample size may have precluded the detection of statistical significance . Preliminary analysis suggests that metronidazole was more effective in patients with disease confined to the large intestine or affecting both small and large bowel than in those with small bowel disease only . There were no differences in remission rates between metronidazole and placebo treated patients . We conclude that metronidazole warrants further assessment in the treatment of patients with active Crohn 's disease A mycobacterial infection may be the cause of Crohn ’s disease in some patients . Measurement of intestinal permeability may identify Crohn ’s disease patients with a high likelihood of relapse and may quantify the severity of intestinal injury BACKGROUND & AIMS Although antibiotics are frequently used to treat Crohn 's disease , this practice is not supported by strong evidence from r and omized trials . METHODS We conducted a double-blind multicenter study of patients with active Crohn 's disease of the ileum , right colon , or both . Patients were r and omized to receive oral ciprofloxacin and metronidazole , both 500 mg twice daily , or placebo for 8 weeks . All patients received oral budesonide 9 mg once daily . The primary efficacy measure was the proportion of patients in remission at week 8 . RESULTS Of the 134 patients who were r and omized , 130 were evaluated for efficacy ; 66 received placebo , and 64 received antibiotics . At week 8 , 21 patients ( 33 % ) assigned to antibiotics were in remission as compared with 25 patients ( 38 % ) in the placebo group ( P = 0.55 ; absolute difference , -5 % ; 95 % confidence interval , -21 % to 11 % ) . An interaction ( P = 0.025 ) between treatment allocation and disease location on treatment response was identified . Among patients with disease of the colon , 9 of 17 ( 53 % ) were in remission after treatment with antibiotics , compared with 4 of 16 ( 25 % ) of those who received placebo ( P = 0.10 ) . Discontinuation of therapy because of adverse events occurred in 13 of 66 ( 20 % ) patients treated with antibiotics , compared with 0 of 68 in the group who received placebo ( P < 0.001 ) . CONCLUSIONS In patients with active Crohn 's disease of the ileum , the addition of ciprofloxacin and metronidazole to budesonide is an ineffective intervention , but this antibiotic combination may improve outcome when there is involvement of the colon BACKGROUND & AIMS Mycobacterium avium subspecies paratuberculosis has been proposed as a cause of Crohn 's disease . We report a prospect i ve , parallel , placebo-controlled , double-blind , r and omized trial of 2 years of clarithromycin , rifabutin , and clofazimine in active Crohn 's disease , with a further year of follow-up . METHODS Two hundred thirteen patients were r and omized to clarithromycin 750 mg/day , rifabutin 450 mg/day , clofazimine 50 mg/day or placebo  , in addition to a 16-week tapering course of prednisolone . Those in remission ( Crohn 's Disease Activity Index < or=150 ) at week 16 continued their study medications in the maintenance phase of the trial . Primary end points were the proportion of patients experiencing at least 1 relapse at 12 , 24 , and 36 months . RESULTS At week 16 , there were significantly more subjects in remission in the antibiotic arm ( 66 % ) than the placebo arm ( 50 % ; P=.02 ) . Of 122 subjects entering the maintenance phase , 39 % taking antibiotics experienced at least 1 relapse between weeks 16 and 52 , compared with 56 % taking placebo ( P=.054 ) . At week 104 , the figures were 26 % and 43 % , respectively ( P=.14 ) . During the following year , 59 % of the antibiotic group and 50 % of the placebo group relapsed ( P=.54 ) . CONCLUSIONS Using combination antibiotic therapy with clarithromycin , rifabutin , and clofazimine for up to 2 years , we did not find evidence of a sustained benefit . This finding does not support a significant role for Mycobacterium avium subspecies paratuberculosis in the pathogenesis of Crohn 's disease in the majority of patients . Short-term improvement was seen when this combination was added to corticosteroids , most likely because of nonspecific antibacterial effects OBJECTIVES The aim of this prospect i ve , r and omized , controlled trial was to evaluate the role of ciprofloxacin as an adjunct to corticosteroids in acute ulcerative colitis . METHODS Seventy consecutive patients with mild ( n = 37 ) or moderately active ( n = 33 ) ulcerative colitis were r and omized to receive oral ciprofloxacin ( 250 mg b.i.d . , n = 34 ) or placebo ( n = 36 ) for 14 days . In addition , they were given oral prednisolone ( initial dose 20 or 40 mg for mild and moderately active ulcerative colitis , respectively ) and rectal betamethasone enemas ( 2 g at night ) for 7 - 9 weeks . All patients were receiving olsalazine ( 0.5 g twice daily ) . At study entry , the groups were similar with respect to age , sex , extent , duration , and severity of disease , and previous treatments . Patients were assessed clinical ly , endoscopically , and histologically before , at the end of the trial ( day 14 ) , and on completion of steroid treatment , or at any time worsening of symptoms or a complication of ulcerative colitis occurred . RESULTS At the end of the study , 24 patients ( 70.5 % ) in the ciprofloxacin group and 26 patients ( 72 % ) in the placebo group achieved remission ( p > 0.1 , Yates chi 2 ) . Ten patients in each group necessitated higher doses of oral ( n = 12 ) or intravenous ( n = 8) steroids . Of the latter patients , two underwent emergency colectomy without perioperative deaths . Clostridium difficile toxin A was not detected in nonresponders to ciprofloxacin treatment . CONCLUSIONS A short course of oral ciprofloxacin treatment does not seem to increase the proportion of patients with active ulcerative colitis going into remission We have undertaken a prospect i ve r and omized trial of one month 's antimicrobial therapy for patients with symptomatic relapse of Crohn 's disease . Criteria for entry included two major symptoms : fever , abdominal pain , diarrhea , weight loss , abdominal mass or complications ( excluding perianal disease ) ; and two hematologic abnormalities : hemoglobin , ESR , albumin , C reactive protein , iron , or total iron binding capacity . Patients were monitored for the aforementioned clinical and hematologic ( hemoglobin , albumin , CRP ) parameters over six weeks and for changes in fecal flora . R and omization was to four groups : metronidazole alone ( M ) , cotrimoxazole alone ( C ) , metronidazole and cotrimoxazole ( C plus M ) , or double placebo ( P ) . Seventy-two patients entered the study ( 18=M , 16=C 21=C plus M , 17=P ) . After two weeks , improvement was reported as follows : M=67 percent , C=17 percent , C plus M=71 percent , P=35 percent . In the metronidazole group , two patients required surgery and one had trouble-some side effects . In the cotrimoxazole group , two had side effects . In the combined group ( C plus M ) , four had troublesome side effects and two of the placebo group ( P ) required operation . By four weeks , there was no difference in response among the groups : ( M=44 percent , C=62 percent , C plus M=57 percent , P=41 percent ) . Antimicrobials had no effect on fecal flora or hematologic parameters . These results indicate that antimicrobials have little therapeutic potential for relapse of intestinal Crohn 's disease OBJECTIVES The aim of this study was to evaluate the role of metronidazole and tobramycin as an adjunct to corticosteroids in acute , severe ulcerative colitis . METHODS Thirty-nine consecutive patients with severe ulcerative colitis were r and omized on admission to the hospital to receive intravenously either metronidazole ( 0.5 g tid ) and tobramycin ( 4 mg/kg tid ) ( n = 19 ) , or placebo ( n = 20 ) . In addition , they were given parenteral nutrition , intravenous hydrocortisone ( 100 mg qid ) and hydrocortisone enemas ( 100 mg bid ) . All patients were assessed after 10 days of continuous treatment , or at any time a severe complication occurred . RESULTS Twelve of 19 patients ( 63.15 % ) treated with antibiotics and 13/20 patients ( 65 % ) with placebo showed substantial improvement . Seven patients in each group did not improve ( n = 9 ) , or developed complications ( n = 5 ) and underwent emergency colectomy without perioperative deaths or late deaths . CONCLUSIONS These results do not support the routine use of intravenous tobramycin and metronidazole in the treatment of severe ulcerative colitis Twenty-two patients with active Crohn 's disease treated with salazosulfapyridin or prednisone  , were in addition given metronidazole 1.000 mg daily or placebo for two months each in a double-blind cross-over study . No statistically significant effect was observed on the overall clinical condition in the 20 patients who completed the trial , although haemoglobin rose and ESR fell significantly in the metronidazole periods . In the 6 patients with colonic involvement only an improvement was registered both in symptoms and laboratory values Based on limited reports of the successful use of antibiotics in the treatment of Crohn 's disease ( CD ) and on the possibility that intestinal bacteria may be one of the etiologic factors playing a role in the pathogenesis of this condition , we undertook a study to evaluate the use of a broad-spectrum antibiotic in CD . Our team studied the efficacy of adding the antibiotic ciprofloxacin to the treatment of moderately active , but resistant cases of CD . Forty-seven adults with moderately active CD were r and omly assigned treatment with ciprofloxacin 500 mg twice daily versus placebo twice daily for 6 months . The primary endpoint was the change in scores on the Crohn 's Disease Activity Index ( CDAI ) from baseline to month 6 . Although 47 patients were r and omized , at 1 month of follow-up 28 patients received ciprofloxacin and 19 received placebo . The mean entry CDAI scores were not significantly different : 187 for the ciprofloxacin group versus 230 for the placebo group ( p = 0.638 ) . Mean CDAI scores at the completion of study were 112 for the ciprofloxacin group ( n = 25 ) and 205 for the placebo group ( n = 12 ) , ( p < 0.001 ) . 
    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: This paper reports a double‐blind placebo‐controlled trial of oral tobramycin in acute ulcerative colitis . Eighty‐four patients with an acute relapse of ulcerative colitis were r and omized to receive oral tobramycin or placebo for 1 week as an adjunct to steroid therapy . At endpoint , 31 of 42 ( 74 % ) in the tobramycin group achieved complete symptomatic remission compared with 18 of 42 ( 43 % ) in the placebo group ( P= 0.008 ) . The tobramycin group achieved better histological scores ( P < 0.05 ) at endpoint . These findings show that treatment with oral tobramycin improves the short‐term outcome of patients with ulcerative colitis in relapse A double blind study compared the efficacy of metronidazole in two doses ( 20 mg/kg , 10 mg/kg ) with placebo in patients with Crohn 's disease . One hundred and five patients participated but only 56 completed the 16 week study -21 were withdrawn for deterioration of symptoms , 17 for adverse experiences , and 11 for protocol violation . Significant improvement in disease activity as measured by the Crohn 's disease activity index  ( metronidazole 20 mg/kg , 97 units ; metronidazole 10 mg/kg , 67 units ; placebo -1 unit , p = 0.002 ) and serum orosomucoid  ( metronidazole 20 mg/kg/day , 49 ; 10 mg/kg/day , 38 ; placebo , -9 , p = 0.001 ) ) were detected . Changes in C reactive protein concentrations did not achieve significance when all three groups were considered but were significant when all metronidazole treated patients were grouped and compared with the placebo treated patients ( 0.8 v -0.9 , p less than 0.05 ) . Although patients receiving metronidazole 20 mg/kg/day had a greater improvement in disease activity than those receiving 10 mg/kg/day ( difference 30 units ( 95 % confidence intervals -27 - 87 ) , the small sample size may have precluded the detection of statistical significance . Preliminary analysis suggests that metronidazole was more effective in patients with disease confined to the large intestine or affecting both small and large bowel than in those with small bowel disease only . There were no differences in remission rates between metronidazole and placebo treated patients . We conclude that metronidazole warrants further assessment in the treatment of patients with active Crohn 's disease A mycobacterial infection may be the cause of Crohn ’s disease in some patients . Measurement of intestinal permeability may identify Crohn ’s disease patients with a high likelihood of relapse and may quantify the severity of intestinal injury BACKGROUND & AIMS Although antibiotics are frequently used to treat Crohn 's disease , this practice is not supported by strong evidence from r and omized trials . METHODS We conducted a double-blind multicenter study of patients with active Crohn 's disease of the ileum , right colon , or both . Patients were r and omized to receive oral ciprofloxacin and metronidazole , both 500 mg twice daily , or placebo for 8 weeks . All patients received oral budesonide 9 mg once daily . The primary efficacy measure was the proportion of patients in remission at week 8 . RESULTS Of the 134 patients who were r and omized , 130 were evaluated for efficacy ; 66 received placebo , and 64 received antibiotics . At week 8 , 21 patients ( 33 % ) assigned to antibiotics were in remission as compared with 25 patients ( 38 % ) in the placebo group ( P = 0.55 ; absolute difference , -5 % ; 95 % confidence interval , -21 % to 11 % ) . An interaction ( P = 0.025 ) between treatment allocation and disease location on treatment response was identified . Among patients with disease of the colon , 9 of 17 ( 53 % ) were in remission after treatment with antibiotics , compared with 4 of 16 ( 25 % ) of those who received placebo ( P = 0.10 ) . Discontinuation of therapy because of adverse events occurred in 13 of 66 ( 20 % ) patients treated with antibiotics , compared with 0 of 68 in the group who received placebo ( P < 0.001 ) . CONCLUSIONS In patients with active Crohn 's disease of the ileum , the addition of ciprofloxacin and metronidazole to budesonide is an ineffective intervention , but this antibiotic combination may improve outcome when there is involvement of the colon BACKGROUND & AIMS Mycobacterium avium subspecies paratuberculosis has been proposed as a cause of Crohn 's disease . We report a prospect i ve , parallel , placebo-controlled , double-blind , r and omized trial of 2 years of clarithromycin , rifabutin , and clofazimine in active Crohn 's disease , with a further year of follow-up . METHODS Two hundred thirteen patients were r and omized to clarithromycin 750 mg/day , rifabutin 450 mg/day , clofazimine 50 mg/day or placebo  , in addition to a 16-week tapering course of prednisolone . Those in remission ( Crohn 's Disease Activity Index < or=150 ) at week 16 continued their study medications in the maintenance phase of the trial . Primary end points were the proportion of patients experiencing at least 1 relapse at 12 , 24 , and 36 months . RESULTS At week 16 , there were significantly more subjects in remission in the antibiotic arm ( 66 % ) than the placebo arm ( 50 % ; P=.02 ) . Of 122 subjects entering the maintenance phase , 39 % taking antibiotics experienced at least 1 relapse between weeks 16 and 52 , compared with 56 % taking placebo ( P=.054 ) . At week 104 , the figures were 26 % and 43 % , respectively ( P=.14 ) . During the following year , 59 % of the antibiotic group and 50 % of the placebo group relapsed ( P=.54 ) . CONCLUSIONS Using combination antibiotic therapy with clarithromycin , rifabutin , and clofazimine for up to 2 years , we did not find evidence of a sustained benefit . This finding does not support a significant role for Mycobacterium avium subspecies paratuberculosis in the pathogenesis of Crohn 's disease in the majority of patients . Short-term improvement was seen when this combination was added to corticosteroids , most likely because of nonspecific antibacterial effects OBJECTIVES The aim of this prospect i ve , r and omized , controlled trial was to evaluate the role of ciprofloxacin as an adjunct to corticosteroids in acute ulcerative colitis . METHODS Seventy consecutive patients with mild ( n = 37 ) or moderately active ( n = 33 ) ulcerative colitis were r and omized to receive oral ciprofloxacin ( 250 mg b.i.d . , n = 34 ) or placebo ( n = 36 ) for 14 days . In addition , they were given oral prednisolone ( initial dose 20 or 40 mg for mild and moderately active ulcerative colitis , respectively ) and rectal betamethasone enemas ( 2 g at night ) for 7 - 9 weeks . All patients were receiving olsalazine ( 0.5 g twice daily ) . At study entry , the groups were similar with respect to age , sex , extent , duration , and severity of disease , and previous treatments . Patients were assessed clinical ly , endoscopically , and histologically before , at the end of the trial ( day 14 ) , and on completion of steroid treatment , or at any time worsening of symptoms or a complication of ulcerative colitis occurred . RESULTS At the end of the study , 24 patients ( 70.5 % ) in the ciprofloxacin group and 26 patients ( 72 % ) in the placebo group achieved remission ( p > 0.1 , Yates chi 2 ) . Ten patients in each group necessitated higher doses of oral ( n = 12 ) or intravenous ( n = 8) steroids . Of the latter patients , two underwent emergency colectomy without perioperative deaths . Clostridium difficile toxin A was not detected in nonresponders to ciprofloxacin treatment . CONCLUSIONS A short course of oral ciprofloxacin treatment does not seem to increase the proportion of patients with active ulcerative colitis going into remission We have undertaken a prospect i ve r and omized trial of one month 's antimicrobial therapy for patients with symptomatic relapse of Crohn 's disease . Criteria for entry included two major symptoms : fever , abdominal pain , diarrhea , weight loss , abdominal mass or complications ( excluding perianal disease ) ; and two hematologic abnormalities : hemoglobin , ESR , albumin , C reactive protein , iron , or total iron binding capacity . Patients were monitored for the aforementioned clinical and hematologic ( hemoglobin , albumin , CRP ) parameters over six weeks and for changes in fecal flora . R and omization was to four groups : metronidazole alone ( M ) , cotrimoxazole alone ( C ) , metronidazole and cotrimoxazole ( C plus M ) , or double placebo ( P ) . Seventy-two patients entered the study ( 18=M , 16=C 21=C plus M , 17=P ) . After two weeks , improvement was reported as follows : M=67 percent , C=17 percent , C plus M=71 percent , P=35 percent . In the metronidazole group , two patients required surgery and one had trouble-some side effects . In the cotrimoxazole group , two had side effects . In the combined group ( C plus M ) , four had troublesome side effects and two of the placebo group ( P ) required operation . By four weeks , there was no difference in response among the groups : ( M=44 percent , C=62 percent , C plus M=57 percent , P=41 percent ) . Antimicrobials had no effect on fecal flora or hematologic parameters . These results indicate that antimicrobials have little therapeutic potential for relapse of intestinal Crohn 's disease OBJECTIVES The aim of this study was to evaluate the role of metronidazole and tobramycin as an adjunct to corticosteroids in acute , severe ulcerative colitis . METHODS Thirty-nine consecutive patients with severe ulcerative colitis were r and omized on admission to the hospital to receive intravenously either metronidazole ( 0.5 g tid ) and tobramycin ( 4 mg/kg tid ) ( n = 19 ) , or placebo ( n = 20 ) . In addition , they were given parenteral nutrition , intravenous hydrocortisone ( 100 mg qid ) and hydrocortisone enemas ( 100 mg bid ) . All patients were assessed after 10 days of continuous treatment , or at any time a severe complication occurred . RESULTS Twelve of 19 patients ( 63.15 % ) treated with antibiotics and 13/20 patients ( 65 % ) with placebo showed substantial improvement . Seven patients in each group did not improve ( n = 9 ) , or developed complications ( n = 5 ) and underwent emergency colectomy without perioperative deaths or late deaths . CONCLUSIONS These results do not support the routine use of intravenous tobramycin and metronidazole in the treatment of severe ulcerative colitis Twenty-two patients with active Crohn 's disease treated with salazosulfapyridin or prednisone  , were in addition given metronidazole 1.000 mg daily or placebo for two months each in a double-blind cross-over study . No statistically significant effect was observed on the overall clinical condition in the 20 patients who completed the trial , although haemoglobin rose and ESR fell significantly in the metronidazole periods . In the 6 patients with colonic involvement only an improvement was registered both in symptoms and laboratory values Based on limited reports of the successful use of antibiotics in the treatment of Crohn 's disease ( CD ) and on the possibility that intestinal bacteria may be one of the etiologic factors playing a role in the pathogenesis of this condition , we undertook a study to evaluate the use of a broad-spectrum antibiotic in CD . Our team studied the efficacy of adding the antibiotic ciprofloxacin to the treatment of moderately active , but resistant cases of CD . Forty-seven adults with moderately active CD were r and omly assigned treatment with ciprofloxacin 500 mg twice daily versus placebo twice daily for 6 months . The primary endpoint was the change in scores on the Crohn 's Disease Activity Index ( CDAI ) from baseline to month 6 . Although 47 patients were r and omized , at 1 month of follow-up 28 patients received ciprofloxacin and 19 received placebo . The mean entry CDAI scores were not significantly different : 187 for the ciprofloxacin group versus 230 for the placebo group ( p = 0.638 ) . Mean CDAI scores at the completion of study were 112 for the ciprofloxacin group ( n = 25 ) and 205 for the placebo group ( n = 12 ) , ( p < 0.001 ) . 
    Output:
    