Document Detail

Dose-ranging study of mesalamine (PENTASA) enemas in the treatment of acute ulcerative proctosigmoiditis: results of a multicentered placebo-controlled trial. The U.S. PENTASA Enema Study Group.
MedLine Citation:
PMID:  9589293     Owner:  NLM     Status:  MEDLINE    
The safety and efficacy of mesalamine enemas were determined ina dose-ranging study enrolling 287 patients with ulcerative proctitis and proctosigmoiditis in a double-blind, placebo-controlled, multicenter trial. Patients were randomized to receive placebo, 1, 2, or 4 g in 100 ml mesalamine (PENTASA) enemas h.s. for 8 weeks. Efficacy was assessed by clinical, sigmoidoscopic, and histologic improvement, as well as by induction of remission. Sixty-seven percent, 65%, and 75% of patients receiving 1-, 2-, and 4-g enemas were markedly improved according to the physician's global assessment compared with 27% of patients treated with placebo. The mean improvement in sigmoidoscopic index was 5.8, 5.9, and 6.4 points (on a 15-point scale) for the 1-, 2-, and 4-g enema groups compared with a decrease of 1.8 points for the placebo group. Improvement in biopsy scores was observed in 47, 55, and 59% of 1-, 2-, and 4-g groups contrasted with 27% of the placebo-treated patients. All three doses were significantly more effective than placebo in reducing symptoms and trips to the toilet compared with placebo. No dose-response relation was demonstrated. The safety profile was similar to that of placebo. In conclusion, mesalamine enemas are effective as a single agent in the short-term treatment of distal ulcerative colitis without an apparent dose response between 1 and 4 g nightly.
S B Hanauer
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Inflammatory bowel diseases     Volume:  4     ISSN:  1078-0998     ISO Abbreviation:  Inflamm. Bowel Dis.     Publication Date:  1998 May 
Date Detail:
Created Date:  1998-07-24     Completed Date:  1998-07-24     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  9508162     Medline TA:  Inflamm Bowel Dis     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  79-83     Citation Subset:  IM    
University of Chicago Medical Center, Illinois 60637, USA.
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MeSH Terms
Acute Disease
Analysis of Variance
Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
Colitis, Ulcerative / diagnosis,  drug therapy*
Dose-Response Relationship, Drug
Double-Blind Method
Logistic Models
Mesalamine / administration & dosage*
Middle Aged
Proctocolitis / diagnosis,  drug therapy
Prospective Studies
Treatment Outcome
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 89-57-6/Mesalamine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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