This double-blind, placebo controlled, multicentre, parallel trial assessed the efficacy of two oral doses of a new formulation of 5-aminosalicylic acid (5-ASA) targeted to release in the cecum which was given for six weeks to 136 patients with active ulcerative colitis. Seven centres participated (two Canadian, five American). Patients were randomly assigned to one of three treatment groups (4 g 5-ASA, 2 g 5-ASA or placebo). Medication was dispensed as 250 mg identically appearing tablets containing either 5-ASA or placebo to be taken four times a day. Subjects were assessed at baseline and after three and six weeks of treatment. Assessments included a disease activity index, physician's global assessment and flexible sigmoidoscopy. Compliance was assessed through pill count. A total of 136 patients participated ( 4 7 on 4 g 5-ASA, 45 on 2 g 5-ASA, and 44 on placebo). The three groups were similar in terms of age, weight, distribution of disease, extent of disease, and previous use of steroids or sulphasalazine. Ninety patients completed the six week study. Of the 46 dropouts, 38 (82.6%) left because of insufficient efficacy ( most on either place ho or 2 g 5-ASA), four (8.7%) had adverse reactions (all on 5-ASA), the remaining four (8.7%) left for reasons not related to their ulcerative colitis. The disease activity index represents a composite score ( maximum of 12) with categories for number of daily stools, presence of bleeding, abdominal pain and physician's assessment of disease activity. Patients who received 4 g 5-ASA daily demonstrated significant declines in disease activity index within three weeks of therapy and maintained improvement until the end of the stuuy. Although disease activity index declined for patients receiving 2 g 5-ASA daily, these changes did not reach statistical significance when compared to placebo-treated patients. On a five point scale (much improved, somewhat improved, unchanged, somewhat worse, much worse) the physician's global assessment mirrored the changes in disease activity index. Patients randomized to receive 4 g 5-ASA tablets were consistently noted as being either much or somewhat improved compared to placebo-treated patients. Side effects were few and minor and 52% (4 g 5-ASA), 42% (2 g 5-ASA) and 37% (placebo) of patients had no complaints. Headache was the most commonly cited adverse reaction for 6.9% (4 g 5-ASA) and 9.4% (2 g 5-ASA) of treated patients but 3.5% of placebo-treated patients also complained of headache. In conclusion in this randomized double-blind, placebo controlled study, patients with active ulcerative colitis randomized to 4 g 5-ASA per day noted improvement in disease activity as measured by disease activity index and physician's global assessment when compared to placebo-treated patients. ln contrast, patients who received 2 g 5-ASA daily did not demonstrate significant differences compared to the placebo group.
The efficacy of 4 g 5-aminosalicylic acid (5-ASA, mesalamine) enemas was assessed in 666 patients with distal ulcerative colitis. Patients were enrolled in an open-label compassionate use program. One 4 g 5-ASA enema was administered each night for a period of four weeks and the disease activiry index was assessed at baseline and on days 14 and 28. On days 14 and 28, 78.0% and 88.1 % of patients, respectively, demonstrated an improvement in disease activiry index. The mean decline in disease activiry index on day 14 was 40. 7% (P=0.0001) and on day 28 it was 55.4% (P=0.0001). Efficacy was similar whether the disease was confined to or extended beyond 30 cm from the anus. There was no difference in efficacy in patients suffering their first episode of disease compared to patients suffering subsequent attacks.
Introduction Limited data is available on the disease specifi c risk factors and the impact of Clostridium diffi cile when patients are admitted with a fl are up of ulcerative colitis. We aimed to study a cohort of hospitalised patients admitted with acute severe colitis with concomitant C diffi cile infection in order to identify the disease specifi c risk factors and clinical outcomes. Methods From microbiology database over a 5-year period containing all C diffi cile positive results, patients with an established diagnosis of ulcerative colitis were included. Control group consisted of patients with acute severe colitis admitted to hospital during the same time period with a negative C diffi cile toxin assay result during the index admission. Demographic features, presence of predetermined risk factors, duration of hospital stay and outcomes were reviewed. Results 2612 patients with positive C diffi cile toxin were identifi ed over the 5 year period of which 48 (1.8%) had preexisting established diagnosis of ulcerative colitis. Among patients with UC and C. diffi cile infection (group A), 3 (6.3%) patients were tested to have positive C diffi cile toxin in outpatients preadmission. The remaining 45 (one patient excluded) had a positive test during hospitalisation. When compared with controls of UC patients without C. diffi cile (group B), group A patients were of older age (mean 44.6 years vs. 29.3 years, p= 0.001), had a longer history of colitis (mean 6.2 years vs 2.4 years, p= 0.01) and more had preexisting pan colitis (36/47 vs 23/47, p= 0.041). In addition, patients in group A had higher frequency of antibiotic use within six months (72% vs 15%, p= 0
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