Abstract

Background: Balsalazide is well tolerated and effective in treating acute ulcerative colitis. VSL#3 is a probiotic cocktail proven to be effective in preventing fl are-ups of chronic pouchitis. We compared the efficacy and safety of low-dose balsalazide (2.25 g/day) plus 3 g/day VLS#3 (group A) with mediumdose balsalazide alone (group B) and with mesalazine (group C) in the treatment of mild-to-moderate active ulcerative colitis.
Material/Methods: Ninety patients (30 per group) were randomly enrolled, with a treatment duration of 8 weeks. Efficacy was assessed by symptoms assessment, endoscopic appearance, and histological evaluation.
Results: Balsalazide/VSL#3 was significantly superior to balsalazide alone and to mesalazine in obtaining remission: 24 patients of group A were in remission [per-protocol: 85.71% (C.I.95%: 62–96), on intention-to-treat: 80% (C.I.95%: 59–91)], while 21 group B [per-protocol: 80.77% (C.I. 95%: 51–82), on intention-to-treat: 77% (C.I.95%: 43–81)] and 16 group C patients [per-protocol: 72.73% (C.I. 95%:30–75), on intention-to-treat: 53.33% (C.I.95%: 42–62)] were in remission (p<0.02). Balsalazide with or without VSL#3 was better tolerated than mesalazine: two group C patients were withdrawn from the study because of severe side-effects; 1 group A (3.33%), 3 group B (10%) and 4 group C (13.33%) patients experienced slight side-effects. The balsalazide/VSL#3 combination was faster in obtaining remission than balsalazide alone or mesalazine (4, 7.5, and 13 days in groups A, B and C, respectively) and also better in improving all parameters evaluated.
Conclusions: Balsalazide/VSL#3 may be a very good choice in the treatment of active mild-to-moderate active ulcerative colitis instead of balsalazide alone or mesalazine.

Keywords: Aminosalicylic Acids - administration & dosage, Aminosalicylic Acids - therapeutic use, Colitis, Ulcerative - drug therapy, Drug Therapy, Combination, Mesalamine - therapeutic use, Phenylhydrazines, Probiotics - therapeutic use, Aminosalicylic Acids - therapeutic use, Colitis, Ulcerative - drug therapy, Drug Therapy, Combination, Mesalamine - therapeutic use, Phenylhydrazines, Probiotics - therapeutic use