Low-dose balsalazide plus a high-potency probiotic preparation is more effective than balsalazide alone or mesalazine in the treatment of acute mild-to-moderate ulcerative colitis.

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 flare-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 medium-dose 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 Balsalazide with or without VSL#3 was better tolerated than mesalazine: two group C patients were withdrawn from the study because of severe side-effects; 1 group A (3.33%), 3 group B (10%) and 4 group C (13.33%) patients experienced slight side-effects.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.

• Authors: Antonio Tursi, Giovanni Brandimarte, Gian Marco Giorgetti, Giacomo Forti, Maria Ester Modeo, Andrea Gigliobianco
• Journal: Medical science monitor : international medical journal of experimental and clinical research (Med Sci Monit) Vol. 10 Issue 11 Pg. PI126-31 (Nov 2004) ISSN: 1234-1010 [Print] United States
• PMID: 15507864 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Aminosalicylic Acids
• Phenylhydrazines
• Mesalamine
• balsalazide

Topics

• Adult
• Aged
• Aminosalicylic Acids (administration & dosage, therapeutic use)
• Colitis, Ulcerative (drug therapy)
• Drug Therapy, Combination
• Female
• Humans
• Male
• Mesalamine (therapeutic use)
• Middle Aged
• Phenylhydrazines
• Probiotics (therapeutic use)