A Meta-Analysis of the Efficacy of Sulfasalazine in Comparison with 5-Aminosalicylates in the Induction of Improvement and Maintenance of Remission in Patients with Ulcerative Colitis

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A Meta-Analysis of the Efficacy of Sulfasalazine in Comparison with 5-Aminosalicylates in the Induction of Improvement and Maintenance of Remission in Patients with Ulcerative Colitis

Journal

Digestive Diseases and Sciences

Publisher

Springer Netherlands

ISSN

0163-2116 (Print) 1573-2568 (Online)

Category

Review

DOI

10.1007/s10-x

Subject Collection

Medicine

SpringerLink Date

Thursday, September 04, 2008

Review

A Meta-Analysis of the Efficacy of Sulfasalazine in Comparison with 5-Aminosalicylates in the Induction of Improvement and Maintenance of Remission in Patients with Ulcerative Colitis

Shekoufeh Nikfar1, Roja Rahimi2, Ali Rezaie3 and Mohammad Abdollahi2

(1)

Drug Selecting Committee, Food & Drug Organization, and Food & Drug Laboratory Research Center, Ministry of Health and Medical Education, Tehran, Iran

(2)

Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences (TUMS), Tehran, 14155-6451, Iran

(3)

Faculty of Medicine, University of Alberta, Edmonton, Canada

Received: 19 May 2008 Accepted: 24 July 2008 Published online: 4 September 2008

Abstract Background Historically, sulfasalazine (SSZ) and 5-aminosalicylates (5-ASAs) have been a mainstay of mild-to-moderate ulcerative colitis (UC) remission induction and maintenance therapy. Considering the pivotal role of intestinal microbial flora in pathophysiology of UC and antimicrobial activity of sulfapyridine, we hypothesized that SSZ might be more effective than 5-ASAs in the management of UC.

Aim To compare the efficacy and tolerability of SSZ with each of the 5-ASAs (mesalamine, olsalazine, and balsalazide) by a meta-analysis technique.

Methods Pubmed, Embase, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials were searched for studies compared efficacy and/or tolerability of SSZ with 5-ASAs in the management of UC. The search terms were: “sulfasalazine” or “sulfasalazine” and “5-aminosalicylic acid,” “mesalazine,” “mesalamine,” “olsalazine” or “balsalazide” and “ulcerative colitis.” Data were collected from 1966 to April 2008. There was no language restriction. “Overall improvement,” “relapse rate,” “total adverse events,” and “withdrawals because of adverse events” were the key outcomes of interest.

Results Twenty randomized placebo controlled trials met our criteria and were included in the meta-analysis. Comparison of SSZ with mesalamine yielded a nonsignificant relative risk (RR) of 1.04 (95% confidence interval of 0.89–1.21, P = 0.63) for overall improvement, a nonsignificant RR of 0.98 (95% CI 0.78–1.23, P = 0.85) for relapse, a nonsignificant RR of 0.76 (95% CI 0.54–1.07, P = 0.11) for any adverse events, and a nonsignificant RR of 0.78 (95% CI 0.46–1.3, P = 0.33) for withdrawals due to adverse events. Comparison of SSZ with olsalazine yielded a nonsignificant RR of 1.14 (95% CI 0.91–1.43, P = 0.25) for overall improvement, a nonsignificant RR of 0.93 (95% CI 0.77–1.12, P = 0.42) for relapse, a nonsignificant RR of 1.21 (95% CI 0.9–1.61, P = 0.20) for any adverse events, and a nonsignificant RR of 1.53 (95% CI 0.93–2.52, P = 0.09) for withdrawals due to adverse events. Comparison of SSZ with balsalazide yielded a nonsignificant RR of 1.3 (95% CI 0.93–1.81, P = 0.12) for overall improvement, and a significant RR of 0.17 (95% CI 0.06–0.49, P = 0.001) for withdrawals because of adverse events.

Conclusion SSZ does not differ from mesalamine or olsalazine in terms of efficacy and tolerability in UC. Withdrawal from study due to adverse events was significantly lower for balsalazide compared with SSZ. Convincing conclusions on the comparison of effectiveness and safety of balsalazide and SSZ in UC remains to be elucidated by further clinical trials. Considering the lower cost of treatment with SSZ and the equal rate of adverse events with other 5-ASAa, it is not surprising to suggest SSZ as a first-choice treatment for UC and reserve 5-ASAs for when SSZ intolerability occurs.

Keywords Meta-analysis - Sulfasalazine - Mesalazine - Mesalamine - Balsalazide - Olsalazine - Efficacy - Tolerability