Oral 5-aminosalicylic acid for the treatment of active ulcerative colitis

Sutherland LR, MacDonald JK

Published Online:

September 8, 2010

Sulfasalazine (SASP) has been used for treating ulcerative colitis for decades. SASP is made up of 5-aminosalicylic acid (5-ASA) linked to a sulfur molecule. Up to a third of patients treated with SASP have reported side effects, which are thought to be related to the sulfur part of the molecule. Newer 5-ASA drugs have been developed to avoid the side effects associated with SASP. Although oral 5-ASA drugs are effective for treating active ulcerative colitis, they are no more effective than SASP therapy. However, the side effects of 5-ASA are notably less than those associated with SASP. Male infertility is associated with SASP and not with 5-ASA, so 5-ASA may be preferred for patients concerned about fertility. 5-ASA compounds are more expensive than SASP, so SASP may be the preferred option where cost is an important factor.

Abstract (click to read)

Background:

The newer 5-ASA preparations were intended to avoid the adverse effects of SASP while maintaining its therapeutic benefits. The efficacy and safety of 5-ASA preparations have been evaluated in numerous clinical trials that have often lacked sufficient statistical power to arrive at definitive conclusions. Previously, it was found that newer 5-ASA drugs in doses of at least 2 g/day, were more effective than placebo but no more effective than SASP in inducing remission in ulcerative colitis. This updated review includes more recent studies and evaluates the effectiveness, dose-responsiveness, and safety of 5-ASA preparations in terms of more precise outcome measures.

Objectives:

To assess the efficacy, dose-responsiveness and safety of the newer release formulations of 5-aminosalicylic acid (5-ASA) compared to placebo or sulfasalazine (SASP) for the induction of remission in active ulcerative colitis.

Search strategy:

A computer-assisted literature search for relevant studies (1981-2005) was performed using MEDLINE, BIOS, the Cochrane Controlled Trials Register, the Cochrane IBD/FBD group specialized trials register and the Science Citation Index, followed by a manual search of reference lists from previously retrieved articles, review articles, symposia proceedings, and abstracts from major gastrointestinal conferences.

Selection criteria:

Studies were accepted for analysis if they were randomized, double-blinded, and controlled clinical trials of parallel design, with treatment durations of a minimum of four weeks.

Data collection and analysis:

Based on an intention to treat principle, the outcomes of interest in the treatment of active disease were the failure to induce global/clinical remission, global/clinical improvement, endoscopic remission, or endoscopic improvement.

Main results:

5-ASA was superior to placebo with regard to all measured outcome variables. For the failure to induce global/clinical improvement or remission, the pooled Peto odds ratio was 0.40 (95% CI, 0.30 to 0.53). A dose-response trend for 5-ASA was also observed. When 5-ASA was compared to SASP, the pooled Peto odds ratio was 0.83 (95% CI 0.60 to 1.13) for the failure to induce global/clinical improvement or remission, and 0.66 (95% CI 0.42 to 1.04) for the failure to induce endoscopic improvement. SASP was not as well tolerated as 5-ASA.

Authors' conclusions:

The newer 5-ASA preparations were superior to placebo and tended towards therapeutic benefit over SASP. However, considering their relative costs, a clinical advantage to using the newer 5-ASA preparations in place of SASP appears unlikely. This review updates the existing review of oral 5-aminosalicylic acid for induction of remission in ulcerative colitis which was published in the Cochrane Library (Issue 1, 2006).

This record should be cited as:

Sutherland LR, MacDonald JK. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis. Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD000543. DOI: 10.1002/14651858.CD000543.pub2

Assessed as up to date:

February 13, 2006

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Primary Review Group:

Inflammatory Bowel Disease and Functional Bowel Disorders Group

Health topics:

Gastroenterology > Inflammatory bowel disease > Ulcerative colitis: induction of remission

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Independent high-quality evidence for health care decision making

Oral 5-aminosalicylic acid for the treatment of active ulcerative colitis

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