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Sulfasalazine Revisited: A Meta-Analysis of 5-Aminosalicylic Acid in the Treatment of Ulcerative Colitis

Lloyd R. Sutherland, MD; Gary R. May, MD; and Eldon A. Shaffer, MD
[+] Article and Author Information

From the University of Calgary, Calgary, Alberta, Canada. Requests for Reprints: Lloyd Sutherland, MD, Room 1751, 3330 Hospital Drive NW, Calgary, AB, Canada T2N 4N1. Grant Support: In part by a grant from the Calgary Gastroenterology Research and Education Foundation. Dr. May was a Canadian Association of Gastroenterology/Merck Frosst Canada Research Fellow.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1993;118(7):540-549. doi:10.7326/0003-4819-118-7-199304010-00009
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Purpose: To assess the effectiveness of the newer 5-aminosalicylic acid (5-ASA) delivery systems compared with placebo or sulfasalazine for the treatment of active ulcerative colitis and for the maintenance of remission.

Data Sources: Pertinent studies were selected using the MEDLINE and BIOS (1981 to 1992) data bases, reference lists from published articles, reviews, symposia proceedings, and abstracts from major gastrointestinal meetings.

Study Selection: Randomized controlled trials of 5-ASA compared with placebo or sulfasalazine of a minimum of 4 weeks duration for active disease and a minimum of 6 months for maintenance of disease remission. Sixteen trials of 5-ASA for active disease, published either in abstract or full manuscript, were available. Eleven trials of 5-ASA for maintenance of remission were also reviewed.

Data Extraction: Crude rates for either induction of remission (active disease studies) or maintenance of remission (relapse-prevention trials) based on the intention-to-treat principle were extracted from the studies by two independent observers. Each study was given a quality score, based on predetermined criteria.

Results: Studies were placed in three groups: 5-ASA compared with placebo, 5-ASA compared with sulfasalazine for active disease, and 5-ASA compared with sulfasalazine for maintenance of remission. 5-Aminosalicylic acid was superior to placebo in the treatment of active ulcerative colitis (pooled odds ratio, 2.02; 95% CI, 1.50 to 2.72). A dose-response effect for 5-ASA existed (P < 0.001). For active disease, the pooled odds ratio for 5-ASA compared with sulfasalazine was 1.15 (CI, 0.83 to 1.61). When 5-ASA was compared with sulfasalazine for maintenance of disease remission, the pooled odds ratio was 0.85 (CI, 0.64 to 1.15). Withdrawal rates and reported side effects were similar for 5-ASA compared with placebo- or sulfasalazine-treated patients.

Conclusions: Although the newer 5-ASA preparations in a dose of at least 2 g/d are more effective than placebo in the treatment of ulcerative colitis, insufficient evidence exists to suggest that they are superior to sulfasalazine. Although they offer a benefit to the sulfasalazine-sensitive patient, use of 5-ASA preparations instead of sulfasalazine in the treatment of ulcerative colitis cannot yet be substantiated.

Figures

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Figure 1.
Randomized, controlled studies of various 5-aminosalicylic acid preparations (all study arms) compared with placebo in active ulcerative colitis.

Odds ratios (log scale) along with 95% CI for each study are shown. Values greater than one indicate a therapeutic benefit compared with placebo. The pooled odds ratio for complete remission is 2.02 (95% CI, 1.5 to 2.72).

Grahic Jump Location
Grahic Jump Location
Figure 2.
Randomized, controlled studies of various 5-aminosalicylic acid (5-ASA) preparations (all study arms) compared with sulfasalazine in active ulcerative colitis.

Odds ratios (log scale) along with 95% CI for each study are shown. Values greater than one indicate a therapeutic benefit for 5-ASA compared with sulfasalazine. The pooled odds ratio is 1.15 (95% CI, 0.83 to 1.61.

Grahic Jump Location
Grahic Jump Location
Figure 3.
Randomized, controlled studies of various 5-aminosalicylic acid (5-ASA) preparations (all study arms) compared with sulfasalazine for maintenance of remission of ulcerative colitis.

Odds ratios along with 95% CI for each study are shown. Values less than one indicate a benefit for sulfasalazine compared with 5-ASA. The pooled odds ratio is 0.85 (95% CI, 0.64 to 1.15.

Grahic Jump Location

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