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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.
Med Sci Monit. 2004 Nov; 10(11):PI126-31.MS

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 Balsalazide with or without VSL#3 was better tolerated than mesalazine: two group C patients were withdrawn from the study because of severe side-effects; 1 group A (3.33%), 3 group B (10%) and 4 group C (13.33%) patients experienced slight side-effects.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

Digestive Endoscopy Unit, Lorenzo Bonomo Hospital, Andria (BA), Italy. antotursi@tiscali.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15507864

Citation

Tursi, Antonio, et al. "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." Medical Science Monitor : International Medical Journal of Experimental and Clinical Research, vol. 10, no. 11, 2004, pp. PI126-31.
Tursi A, Brandimarte G, Giorgetti GM, et al. 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. Med Sci Monit. 2004;10(11):PI126-31.
Tursi, A., Brandimarte, G., Giorgetti, G. M., Forti, G., Modeo, M. E., & Gigliobianco, A. (2004). 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. Medical Science Monitor : International Medical Journal of Experimental and Clinical Research, 10(11), PI126-31.
Tursi A, et al. 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. Med Sci Monit. 2004;10(11):PI126-31. PubMed PMID: 15507864.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Tursi,Antonio, AU - Brandimarte,Giovanni, AU - Giorgetti,Gian Marco, AU - Forti,Giacomo, AU - Modeo,Maria Ester, AU - Gigliobianco,Andrea, Y1 - 2004/10/26/ PY - 2004/02/12/received PY - 2004/04/14/accepted PY - 2004/10/28/pubmed PY - 2005/1/14/medline PY - 2004/10/28/entrez SP - PI126 EP - 31 JF - Medical science monitor : international medical journal of experimental and clinical research JO - Med. Sci. Monit. VL - 10 IS - 11 N2 - 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. SN - 1234-1010 UR - https://www.unboundmedicine.com/medline/citation/15507864/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_ L2 - https://www.medscimonit.com/download/index/idArt/11819 DB - PRIME DP - Unbound Medicine ER -