BACKGROUND: 5-Aminosalicylates are the standard treatment for induction and maintenance of remission in mild-to-moderate ulcerative colitis. In recent years, the 5-aminosalicylic acid-containing pro-drug balsalazide has been the focus of attention. AIM: To compare the efficacy and tolerance of balsalazide and mesalazine by meta-analysis. METHODS: Pubmed, Embase, Scopus, Web of Science, and the Cochrane Central Register of Controlled Trials were searched for studies comparing the efficacy and/or tolerance of balsalazide with mesalazine in the management of UC. The search terms were: "mesalazine" or "5-aminosalicylic acid" and "balsalazide" and "ulcerative colitis." Data were collected from 1966 to 2007 (up to February). There was no language restriction. "Symptomatic remission," "complete remission," "relapse rate," "total adverse events," and "withdrawals because of adverse events" were the key outcomes of interest. RESULTS: Six randomized placebo-controlled clinical trials met our criteria and were included in the meta-analysis. In these "symptomatic remission," "complete remission," "relapse rate," "total adverse events," and "withdrawals because of adverse events" were evaluated in three, three, two, five, and six of the trials, respectively. They included 653 patients consisting of 55.4% men and 44.6% women randomized to receive either balsalazide or mesalazine. Pooling of three trials for symptomatic remission yielded a significant relative risk (RR) of 1.23 (95% confidence interval of 1.03-1.47, P = 0.02). The summary RR for complete remission in three trials was 1.3 (95% CI of 1.002-1.68, P = 0.048). Pooling of two trials for the outcome of relapse yielded a non-significant RR of 0.77 (95% CI of 0.56-1.07, P = 0.12). Pooling five studies from which data for any adverse events were extracted, yielded a non-significant RR of 0.87 (95% CI of 0.75-1.001, P = 0.53). The summary RR for withdrawals because of adverse events in six trials was 0.69, a non-significant RR (95% CI of 0.37-1.29, P = 0.24). CONCLUSION: Balsalazide is more effective than mesalazine in induction of remission, but balsalazide has no benefit compared with mesalazine in preventing relapse in the population selected. The number of patients with any adverse events and withdrawals because of severe adverse events is similar for mesalazine and balsalazide.
BACKGROUND:5-Aminosalicylates are the standard treatment for induction and maintenance of remission in mild-to-moderate ulcerative colitis. In recent years, the 5-aminosalicylic acid-containing pro-drug balsalazide has been the focus of attention. AIM: To compare the efficacy and tolerance of balsalazide and mesalazine by meta-analysis. METHODS: Pubmed, Embase, Scopus, Web of Science, and the Cochrane Central Register of Controlled Trials were searched for studies comparing the efficacy and/or tolerance of balsalazide with mesalazine in the management of UC. The search terms were: "mesalazine" or "5-aminosalicylic acid" and "balsalazide" and "ulcerative colitis." Data were collected from 1966 to 2007 (up to February). There was no language restriction. "Symptomatic remission," "complete remission," "relapse rate," "total adverse events," and "withdrawals because of adverse events" were the key outcomes of interest. RESULTS: Six randomized placebo-controlled clinical trials met our criteria and were included in the meta-analysis. In these "symptomatic remission," "complete remission," "relapse rate," "total adverse events," and "withdrawals because of adverse events" were evaluated in three, three, two, five, and six of the trials, respectively. They included 653 patients consisting of 55.4% men and 44.6% women randomized to receive either balsalazide or mesalazine. Pooling of three trials for symptomatic remission yielded a significant relative risk (RR) of 1.23 (95% confidence interval of 1.03-1.47, P = 0.02). The summary RR for complete remission in three trials was 1.3 (95% CI of 1.002-1.68, P = 0.048). Pooling of two trials for the outcome of relapse yielded a non-significant RR of 0.77 (95% CI of 0.56-1.07, P = 0.12). Pooling five studies from which data for any adverse events were extracted, yielded a non-significant RR of 0.87 (95% CI of 0.75-1.001, P = 0.53). The summary RR for withdrawals because of adverse events in six trials was 0.69, a non-significant RR (95% CI of 0.37-1.29, P = 0.24). CONCLUSION:Balsalazide is more effective than mesalazine in induction of remission, but balsalazide has no benefit compared with mesalazine in preventing relapse in the population selected. The number of patients with any adverse events and withdrawals because of severe adverse events is similar for mesalazine and balsalazide.
Authors: J C Mansfield; M H Giaffer; P A Cann; D McKenna; P C Thornton; C D Holdsworth Journal: Aliment Pharmacol Ther Date: 2002-01 Impact factor: 8.171
Authors: W Kruis; S Schreiber; D Theuer; J W Brandes; E Schütz; S Howaldt; B Krakamp; J Hämling; H Mönnikes; I Koop; M Stolte; D Pallant; U Ewald Journal: Gut Date: 2001-12 Impact factor: 23.059
Authors: J R Green; A J Lobo; C D Holdsworth; R J Leicester; J A Gibson; G D Kerr; H J Hodgson; K J Parkins; M D Taylor Journal: Gastroenterology Date: 1998-01 Impact factor: 22.682
Authors: J R Green; J A Gibson; G D Kerr; E T Swarbrick; A J Lobo; C D Holdsworth; J P Crowe; K J Schofield; M D Taylor Journal: Aliment Pharmacol Ther Date: 1998-12 Impact factor: 8.171
Authors: Golshid Jahanshahi; Vian Motavasel; Ali Rezaie; Ali A Hashtroudi; Naser E Daryani; Mohammad Abdollahi Journal: Dig Dis Sci Date: 2004 Nov-Dec Impact factor: 3.487
Authors: Roja Rahimi; Amir Baghaei; Maryam Baeeri; Gholamreza Amin; Mohammad Reza Shams-Ardekani; Mahnaz Khanavi; Mohammad Abdollahi Journal: World J Gastroenterol Date: 2013-03-28 Impact factor: 5.742
Authors: Mahnaz Khanavi; Mansoureh Sabbagh-Bani-Azad; Amir Hossein Abdolghaffari; Mahdi Vazirian; Isa Isazadeh; Mohammad Amin Rezvanfar; Maryam Baeeri; Azadeh Mohammadirad; Roja Rahimi; Mohammad Reza Shams-Ardekani; Mohammad Abdollahi Journal: Arch Med Sci Date: 2014-12-22 Impact factor: 3.318