Abstract | OBJECTIVE: METHODS: A total of 173 patients with sigmoidoscopically verified ulcerative colitis were randomized to 8 wk of double-blind treatment with balsalazide 6.75 g/day or mesalamine 2.4 g/day. Both treatments provided 2.4 g/day of oral 5-aminosalicylic acid. Patients maintained symptom diaries throughout the treatment period. RESULTS: Overall, 46% of balsalazide- and 44% of mesalamine-treated patients achieved symptomatic remission. Higher response rates were noted in newly diagnosed patients with < or = 40 cm of disease (68% vs 61%) than in recently relapsed patients with >40 cm of disease (36% vs 25%). The median time to symptomatic remission was 12 days shorter with balsalazide (25 days) than with mesalamine (37 days). Significantly more balsalazide patients showed sigmoidoscopic (p = 0.002), stool frequency (p = 0.006), rectal bleeding (p = 0.006), and physician's global assessment score (p = 0.013) improvement by 14 days than did mesalamine patients. Similar proportions of patients reported adverse events (54% vs 64%), which were most commonly related to the gastrointestinal and central and peripheral nervous systems. CONCLUSIONS:
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Authors | Ronald Pruitt, John Hanson, Michael Safdi, Lawrence Wruble, Robert Hardi, John Johanson, George Koval, Dennis Riff, Barry Winston, Amanda Cross, Pamela Doty, Lorin K Johnson |
Journal | The American journal of gastroenterology
(Am J Gastroenterol)
Vol. 97
Issue 12
Pg. 3078-86
(Dec 2002)
ISSN: 0002-9270 [Print] United States |
PMID | 12492193
(Publication Type: Clinical Trial, 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 |
- Acute Disease
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Aminosalicylic Acids
(adverse effects, therapeutic use)
- Anti-Inflammatory Agents, Non-Steroidal
(adverse effects, therapeutic use)
- Anti-Ulcer Agents
(adverse effects, therapeutic use)
- Child
- Colitis, Ulcerative
(drug therapy, physiopathology)
- Double-Blind Method
- Humans
- Mesalamine
(adverse effects, therapeutic use)
- Middle Aged
- Phenylhydrazines
- Safety
- Treatment Outcome
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