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Combined Diosmectite and Mesalazine Treatment for Mild-to-Moderate Ulcerative Colitis: A Randomized, Placebo-Controlled Study
- Source :
- Medical Science Monitor : International Medical Journal of Experimental and Clinical Research
- Publication Year :
- 2015
- Publisher :
- International Scientific Information, Inc., 2015.
-
Abstract
- Background The relapse rate of ulcerative colitis (UC) is high. The efficacy of combined diosmectite and mesalazine treatment for active mild-to-moderate UC was investigated. Material/Methods A total of 120 patients with UC were enrolled in this randomized, single-blind, placebo-controlled study. Sixty patients were assigned to the Diosmectite group (diosmectite and mesalazine) and 60 were assigned to Placebo group (placebo and mesalazine). In the induction phase, the primary end point was the clinical remission rate at 8 weeks; secondary end points were clinical response, endothelial mucosal healing, Mayo score, erythrocyte sedimentation rate, C-reactive protein levels, and defecation frequency. In the maintenance phase, the primary end point was clinical remission at 52 weeks; secondary end points were clinical response, endothelial mucosal healing, Mayo score, erythrocyte sedimentation rate, and defecation frequency. Results At 8 weeks, the Diosmectite group had a significantly higher clinical remission rate (68.3% vs. 50%) and mucosal healing rate (66.7% vs. 48.3%) compared with the Placebo group. There were no significant differences in clinical response rates, Mayo score, erythrocyte sedimentation rate, C-reactive protein, or defecation frequency. At 52 weeks, the Diosmectite group had a significantly higher clinical remission rate (61.7% vs. 40%) and mucosal healing rate (60% vs. 38.3%) compared with the Placebo group. Defecation frequency was lower, but this was not significant. Conclusions Combined diosmectite and mesalazine treatment successfully induced and maintained the treatment of active mild-to-moderate UC as indicated by higher rates of clinical remission and mucosal healing.
- Subjects :
- Adult
Male
medicine.medical_specialty
Adolescent
Placebo-controlled study
Blood Sedimentation
Placebo
Severity of Illness Index
Gastroenterology
Diosmectite
Young Adult
chemistry.chemical_compound
Mesalazine
Internal medicine
medicine
Clinical endpoint
Humans
Single-Blind Method
Prospective Studies
Intestinal Mucosa
Mesalamine
Defecation
Aged
medicine.diagnostic_test
business.industry
Silicates
Remission Induction
General Medicine
Middle Aged
Inflammatory Bowel Diseases
medicine.disease
Ulcerative colitis
C-Reactive Protein
Treatment Outcome
chemistry
Erythrocyte sedimentation rate
Colitis, Ulcerative
Drug Therapy, Combination
Female
business
Drug Controlled Studies
Subjects
Details
- ISSN :
- 16433750
- Volume :
- 21
- Database :
- OpenAIRE
- Journal :
- Medical Science Monitor
- Accession number :
- edsair.doi.dedup.....607fbb01014ca242e45169d9234ad65c