A randomized, double blind, dose-response comparison of balsalazide (6.75 g), balsalazide (2.25 g), and mesalamine (2.4 g) in the treatment of active, mild-to-moderate ulcerative colitis.
Abstract | OBJECTIVE: METHODS: A multicenter, randomized, active control, double-blind, double-dummy, dose-response, parallel-group study was performed comparing balsalazide (6.75 g daily), balsalazide (2.25 g daily), and mesalamine (2.4 g daily), administered for 8 wk to 154 patients with active, mild-to-moderate ulcerative colitis as verified by sigmoidoscopy. RESULTS: Eight weeks of treatment with 6.75 g of balsalazide daily provided significantly greater improvement than did balsalazide (2.25 g daily) in rectal bleeding (64.7% [6.75-g balsalazide] vs 32.4% [2.25-g balsalazide], p < 0.006), stool frequency (58.8% vs 29.4%, p < 0.006), sigmoidoscopic score (78.9% vs 52.5%, p < 0.015), and Physician's Global Assessment (73.7% vs 51.3%, p < 0.03). The efficacy of balsalazide showed a significantly more rapid onset of action than that of mesalamine (2.4 g daily) (2-wk sigmoidocopic score improvement, 54.7% [6.75-g balsalazide] vs 29.4% [2.4-g mesalamine], p = 0.006) with numerically greater improvement at 8 wk in five of seven measured signs and symptoms. Balsalazide (6.75 g daily) was well tolerated, and the safety profile did not differ significantly from that of balsalazide (2.25 g daily) or mesalamine. CONCLUSIONS:
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Authors | Douglas S Levine, Dennis S Riff, Ronald Pruitt, Lawrence Wruble, George Koval, David Sales, John K Bell, Lorin K Johnson |
Journal | The American journal of gastroenterology
(Am J Gastroenterol)
Vol. 97
Issue 6
Pg. 1398-407
(Jun 2002)
ISSN: 0002-9270 [Print] United States |
PMID | 12094857
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Aminosalicylic Acids
- Anti-Inflammatory Agents, Non-Steroidal
- Anti-Ulcer Agents
- Phenylhydrazines
- Mesalamine
- balsalazide
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Aminosalicylic Acids
(administration & dosage, adverse effects, therapeutic use)
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage, adverse effects, blood, therapeutic use)
- Anti-Ulcer Agents
(administration & dosage, adverse effects, blood, therapeutic use)
- Colitis, Ulcerative
(drug therapy, physiopathology)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Homeostasis
- Humans
- Male
- Mesalamine
(administration & dosage, adverse effects, blood, therapeutic use)
- Middle Aged
- Phenylhydrazines
- Safety
- Severity of Illness Index
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