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David J Bjorkman - One of the best experts on this subject based on the ideXlab platform.
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systematic review short term adverse effects of 5 aminosalicylic acid agents in the treatment of ulcerative colitis
Alimentary Pharmacology & Therapeutics, 2004Co-Authors: Edward V Loftus, Sunanda V Kane, David J BjorkmanAbstract:AIM To determine whether there is a difference in short-term adverse events in patients with ulcerative colitis treated with Mesalazine, olsalazine or balsalazide. METHODS MEDLINE was searched for articles published until 2002. Randomized trials of oral Mesalazine, olsalazine or balsalazide for the treatment of active disease or the maintenance of remission were included. Outcomes of interest were the frequencies of patients experiencing adverse events and those withdrawn due to adverse events. RESULTS Forty-six trials were included. One study of Mesalazine vs. sulfasalazine for active colitis showed significantly fewer patients with adverse events with Mesalazine. Both balsalazide vs. sulfasalazine studies for active disease showed significantly fewer withdrawals with balsalazide. One trial of balsalazide vs. sulfasalazine for maintenance showed significantly fewer patients with adverse events with balsalazide. Otherwise, no significant differences in safety outcomes were noted. CONCLUSION All three 5-aminosalicylic acid agents are safe in the short term. In Mesalazine-treated patients, the frequencies of adverse events or withdrawals due to adverse events were comparable with those in placebo-treated patients and lower than those in sulfasalazine-treated patients. Overall, adverse events or withdrawals were not significantly more frequent with olsalazine than with placebo or sulfasalazine. Adverse events and study withdrawals on balsalazide were less frequent than those on sulfasalazine.
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short term adverse effects of 5 aminosalicylic acid agents in the treatment of ulcerative colitis
Alimentary Pharmacology & Therapeutics, 2004Co-Authors: Edward V Loftus, Sunanda V Kane, David J BjorkmanAbstract:Summary Aim : To determine whether there is a difference in short-term adverse events in patients with ulcerative colitis treated with Mesalazine, olsalazine or balsalazide. Methods : MEDLINE was searched for articles published until 2002. Randomized trials of oral Mesalazine, olsalazine or balsalazide for the treatment of active disease or the maintenance of remission were included. Outcomes of interest were the frequencies of patients experiencing adverse events and those withdrawn due to adverse events. Results : Forty-six trials were included. One study of Mesalazine vs. sulfasalazine for active colitis showed significantly fewer patients with adverse events with Mesalazine. Both balsalazide vs. sulfasalazine studies for active disease showed significantly fewer withdrawals with balsalazide. One trial of balsalazide vs. sulfasalazine for maintenance showed significantly fewer patients with adverse events with balsalazide. Otherwise, no significant differences in safety outcomes were noted. Conclusion : All three 5-aminosalicylic acid agents are safe in the short term. In Mesalazine-treated patients, the frequencies of adverse events or withdrawals due to adverse events were comparable with those in placebo-treated patients and lower than those in sulfasalazine-treated patients. Overall, adverse events or withdrawals were not significantly more frequent with olsalazine than with placebo or sulfasalazine. Adverse events and study withdrawals on balsalazide were less frequent than those on sulfasalazine.
William J Sandborn - One of the best experts on this subject based on the ideXlab platform.
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development of interim patient reported outcome measures for the assessment of ulcerative colitis disease activity in clinical trials
Alimentary Pharmacology & Therapeutics, 2015Co-Authors: Vipul Jairath, William J Sandborn, Reena Khanna, Guangyong Zou, Larry Stitt, Mahmoud Mosli, Margaret K Vandervoort, Geert DhaensAbstract:SummaryBackground Patient-reported outcomes (PROs) have an increasingly important role in the evaluation of new therapies for inflammatory bowel disease. The US Food and Drug Administration has issued formal guidance to describe the role of PRO instruments in evaluation of claims for product labelling. However, no validated PRO exists for ulcerative colitis. Aim To investigate whether the PROs from the Mayo Clinic Score (MCS) for UC can be modified, to develop an interim PRO for use in clinical trials, alone or in combination with endoscopy. Methods Data from an induction trial of a Mesalazine (mesalamine) formulation were used to compare effect sizes between Mesalazine and placebo for PRO items (stool frequency and rectal bleeding) alone and in combination with endoscopy. The operating properties of the PRO were validated using data from a phase 2 trial of MLN02, a humanised antibody to the α4β7 integrin in patients with UC. Results A two-item PRO (PRO2) consisting of rectal bleeding = 0 and stool frequency ≤1 or ≤2, combined with an endoscopy subscore ≤1 yielded statistically significant differences between active drug and placebo. This combination yielded the most similar effect sizes and placebo rates for remission, compared to the primary trials. Use of PRO items alone yielded high placebo remission rates in both data sets, although rates were lower when the items were combined and remission defined as PRO2 = 0. Conclusion Patient-reported outcomes items derived from the Mayo Clinic Score combined with endoscopy as a co-primary endpoint may be an appropriate interim outcome measure for ulcerative colitis trials.
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early symptomatic response and mucosal healing with Mesalazine rectal suspension therapy in active distal ulcerative colitis additional results from two controlled studies
Alimentary Pharmacology & Therapeutics, 2011Co-Authors: William J Sandborn, Gary R Lichtenstein, Stephen B Hanauer, Michael Safdi, M Edeline, Scott M HarrisAbstract:Aliment Pharmacol Ther 2011; 34: 747–756 Summary Background Rapid resolution of symptoms and endoscopic inflammation in ulcerative colitis (UC) represent important treatment goals. Aims To establish times to bleeding cessation and endoscopic healing for topical and oral Mesalazine in active distal UC, a post hoc analysis of two published studies was performed. Methods Study I (Sutherland 1987) compared Mesalazine rectal suspension to placebo, while Study II (Safdi 1997) compared topical suspensions, either alone or in combination with oral Mesalazine, and oral alone. Cessation of rectal bleeding (RB) was defined as absence of bleeding on four consecutive days. Endoscopic remission was defined as DAI mucosal healing (MH) subscore = 0 and clinical remission as MH subscore = 0–1 and ≥ 1-point improvement, plus RB subscore = 0. Results Study I: By Day 2, 31.4% of subjects using topical monotherapy reported no RB vs. 5.5% in the placebo arm (P < 0.0006); median time to RB cessation was 8 days. Significantly higher rates of endoscopic (25.0% vs. 7.8%, P < 0.005) and clinical remission (48.6% vs. 9.6%, P < 0.0001) were observed at Week 3. Study II: A significantly higher proportion of subjects achieved RB cessation with combination therapy vs. oral therapy, commencing by Day 8. By Week 3, a significantly higher proportion of subjects using combination therapy achieved clinical remission compared to oral therapy alone (57.9% vs. 18.2%, P < 0.05). Conclusions Topical Mesalazine suspension, either alone or in combination with oral Mesalazine, led to earlier rectal bleeding cessation and mucosal healing. These data support use of topical therapy for more rapid treatment benefit in active distal ulcerative colitis.
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mmx multi matrix system Mesalazine for the induction of remission in patients with mild to moderate ulcerative colitis a combined analysis of two randomized double blind placebo controlled trials
Alimentary Pharmacology & Therapeutics, 2007Co-Authors: William J Sandborn, Gary R Lichtenstein, Michael A Kamm, Todd Butler, Andrew Lyne, Raymond E JosephAbstract:Summary Background MMX™ Mesalazine [LIALDA™ (US), MEZAVANT™ XL (UK and Ireland) MEZAVANT™ (elsewhere)] utilizes MMX Multi Matrix System® (MMX) technology which delivers Mesalazine throughout the colon. Two phase III studies have already evaluated MMX Mesalazine in patients with active, mild-to-moderate ulcerative colitis. Aim To provide more precise estimates of the efficacy of MMX Mesalazine over placebo by combining the patient populations from the two phase III studies. Methods Combined data from two 8-week, double-blind, placebo-controlled trials were analyzed. Patients randomized to MMX Mesalazine 2.4 g/day (once daily or 1.2 g twice daily), 4.8 g/day (once daily) or placebo were reviewed. The primary end point was clinical and endoscopic remission (modified Ulcerative Colitis-Disease Activity Index of ≤1 calculated as: rectal bleeding and stool frequency scores of 0, a combined Physician’s Global Assessment and sigmoidoscopy score of ≤1, no mucosal friability and a ≥1-point reduction in sigmoidoscopy score from week 0). Results Data from 517 patients were analysed. 8-week remission rates were 37.2% and 35.1% in the MMX Mesalazine 2.4 g/day and 4.8 g/day groups, vs. 17.5% on placebo (P < 0.001, both comparisons). 8-week complete mucosal healing rates were 32% in both MMX Mesalazine groups compared with 16% on placebo. Adverse event frequency was similar in all groups. Conclusion MMX Mesalazine is effective and generally well tolerated for inducing clinical and endoscopic remission of active, mild-to-moderate ulcerative colitis.
Abed M Zaitoun - One of the best experts on this subject based on the ideXlab platform.
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a mechanistic multicentre parallel group randomised placebo controlled trial of Mesalazine for the treatment of ibs with diarrhoea ibs d
Gut, 2016Co-Authors: Ching Lam, Wei Tan, Matthew Leighton, Margaret Hastings, Melanie Lingaya, Yirga Falcone, Xiaoying Zhou, P J Whorwell, Andrew F Walls, Abed M ZaitounAbstract:Introduction Immune activation has been reported in the mucosa of IBS patients with diarrhoea (IBS-D), and some small studies have suggested that Mesalazine may reduce symptoms. We performed a double-blind, randomised placebo-controlled trial of 2 g Mesalazine twice daily versus placebo for 3 months in patients with Rome III criteria IBS-D. Primary outcome was daily average stool frequency during weeks 11–12; secondary outcomes were abdominal pain, stool consistency, urgency and satisfactory relief of IBS symptoms. Methods Participants were randomised after a 2-week baseline stool diary. All participants completed a 12-week stool diary and at the end of each week recorded the presence of ‘satisfactory relief of IBS symptoms’. Results 136 patients with IBS-D (82 women, 54 men) were randomised, 10 patients withdrew from each group. Analysis by intention to treat showed the daily average stool frequency during weeks 11 and 12 were mean (SD), 2.8 (1.2) in Mesalazine and 2.7 (1.9) in the placebo group with no significant group difference, (95% CI) 0.1 (−0.33 to 0.53), p=0.66. Mesalazine did not improve abdominal pain, stool consistency nor percentage with satisfactory relief compared with placebo during the last two-weeks follow-up. Conclusions This study does not support any clinically meaningful benefit or harm of Mesalazine compared with placebo in unselected patients with IBS-D. More precise subtyping based on underlying disease mechanisms is needed to allow more effective targeting of treatment in IBS. Trial registration number NCT01316718.
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a mechanistic multi centre parallel group randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea ibs d
Gut, 2015Co-Authors: Ching Lam, Wei Tan, Matthew Leighton, Margaret Hastings, Melanie Lingaya, Yirga Falcone, Xiaoying Zhou, P J Whorwell, Andrew F Walls, Abed M ZaitounAbstract:Introduction: Immune activation has been reported in the mucosa of irritable bowel syndrome patients with diarrhoea (IBS-D) and some small studies have suggested that Mesalazine may reduce symptoms. We performed a double blind, randomised placebo controlled trial of 2g Mesalazine twice daily versus placebo for 3 months in Rome III criteria IBS-D patients. Primary outcome was daily average stool frequency during weeks 11-12; secondary outcomes were abdominal pain, stool consistency, urgency and satisfactory relief of IBS symptoms. Methods: Participants were randomised after a 2-week baseline stool diary. All participants completed a 12-week stool diary and at the end of each week recorded the presence of “satisfactory relief of IBS symptoms”. Results: 136 patients with IBS-D (82 F, 54 M) were randomised, 10 patients withdrew from each group. Analysis by intention to treat showed the daily average stool frequency during weeks 11 and 12 were mean (SD), 2.8 (1.2) in Mesalazine and 2.7 (1.9) in placebo group with no significant group difference (95% confidence interval) 0.1 (-0.33,0.53); p=0.66. Mesalazine did not improve abdominal pain, stool consistency nor percentage with satisfactory relief compared to placebo during the last 2 weeks follow up. Conclusion: This study does not support any clinically meaningful benefit or harm of Mesalazine compared with placebo in unselected IBS with diarrhoea. More precise subtyping based on underlying disease mechanisms is needed to allow more effective targeting of treatment in IBS. (ClinicalTrials.gov number NCT01316718)
Gary R Lichtenstein - One of the best experts on this subject based on the ideXlab platform.
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early symptomatic response and mucosal healing with Mesalazine rectal suspension therapy in active distal ulcerative colitis additional results from two controlled studies
Alimentary Pharmacology & Therapeutics, 2011Co-Authors: William J Sandborn, Gary R Lichtenstein, Stephen B Hanauer, Michael Safdi, M Edeline, Scott M HarrisAbstract:Aliment Pharmacol Ther 2011; 34: 747–756 Summary Background Rapid resolution of symptoms and endoscopic inflammation in ulcerative colitis (UC) represent important treatment goals. Aims To establish times to bleeding cessation and endoscopic healing for topical and oral Mesalazine in active distal UC, a post hoc analysis of two published studies was performed. Methods Study I (Sutherland 1987) compared Mesalazine rectal suspension to placebo, while Study II (Safdi 1997) compared topical suspensions, either alone or in combination with oral Mesalazine, and oral alone. Cessation of rectal bleeding (RB) was defined as absence of bleeding on four consecutive days. Endoscopic remission was defined as DAI mucosal healing (MH) subscore = 0 and clinical remission as MH subscore = 0–1 and ≥ 1-point improvement, plus RB subscore = 0. Results Study I: By Day 2, 31.4% of subjects using topical monotherapy reported no RB vs. 5.5% in the placebo arm (P < 0.0006); median time to RB cessation was 8 days. Significantly higher rates of endoscopic (25.0% vs. 7.8%, P < 0.005) and clinical remission (48.6% vs. 9.6%, P < 0.0001) were observed at Week 3. Study II: A significantly higher proportion of subjects achieved RB cessation with combination therapy vs. oral therapy, commencing by Day 8. By Week 3, a significantly higher proportion of subjects using combination therapy achieved clinical remission compared to oral therapy alone (57.9% vs. 18.2%, P < 0.05). Conclusions Topical Mesalazine suspension, either alone or in combination with oral Mesalazine, led to earlier rectal bleeding cessation and mucosal healing. These data support use of topical therapy for more rapid treatment benefit in active distal ulcerative colitis.
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review article delivery and efficacy of topical 5 aminosalicylic acid Mesalazine therapy in the treatment of ulcerative colitis
Alimentary Pharmacology & Therapeutics, 2011Co-Authors: M S Harris, Gary R LichtensteinAbstract:Aliment Pharmacol Ther 2011; 33: 996–1009 Summary Background The use of topical therapy in the treatment of ulcerative colitis has declined in recent years despite evidence of good efficacy. Aims To review US prescription trends for 5-aminosalicylic acid (5-ASA) since the US approval of Asacol extended-release oral Mesalazine (mesalamine) in 1992; to estimate the optimal level of 5-ASA exposure in the distal colon; to determine factors influencing distal colonic exposures; and to compare the effectiveness of different 5-ASA formulations (oral, topical suspension, foam, suppositories) in clinical trials. Methods Review of clinical trials, physiologic studies and prescription trends of various Mesalazine formulations for treatment of distal ulcerative colitis. Results Between 1992 and 2009, prescriptions for oral Mesalazine increased sixfold, whereas topical suspensions declined by 10%. In clinical trials, topical therapy resulted in higher remission and clinical response rates than oral therapy, with trends to earlier improvement. The mucosal concentrations of 5-ASA achieved by topical agents in the distal colon were up to 200-fold higher than those achieved by oral administration alone. Despite active colitis, over 40% of a topically administered 4 g 5-ASA suspension (equal to 1.6 g) reached the sigmoid colon. This likely represents a therapeutic exposure of 5-ASA. Although topical therapies are less convenient than oral medications, treatment algorithms have failed to take into account quality of life improvements resulting from more rapid and complete treatment response. Conclusions Topical Mesalazine therapy is superior to oral therapy in distal ulcerative colitis for both therapeutic response and drug delivery. Practice patterns should be re-evaluated in light of this information.
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mmx multi matrix system Mesalazine for the induction of remission in patients with mild to moderate ulcerative colitis a combined analysis of two randomized double blind placebo controlled trials
Alimentary Pharmacology & Therapeutics, 2007Co-Authors: William J Sandborn, Gary R Lichtenstein, Michael A Kamm, Todd Butler, Andrew Lyne, Raymond E JosephAbstract:Summary Background MMX™ Mesalazine [LIALDA™ (US), MEZAVANT™ XL (UK and Ireland) MEZAVANT™ (elsewhere)] utilizes MMX Multi Matrix System® (MMX) technology which delivers Mesalazine throughout the colon. Two phase III studies have already evaluated MMX Mesalazine in patients with active, mild-to-moderate ulcerative colitis. Aim To provide more precise estimates of the efficacy of MMX Mesalazine over placebo by combining the patient populations from the two phase III studies. Methods Combined data from two 8-week, double-blind, placebo-controlled trials were analyzed. Patients randomized to MMX Mesalazine 2.4 g/day (once daily or 1.2 g twice daily), 4.8 g/day (once daily) or placebo were reviewed. The primary end point was clinical and endoscopic remission (modified Ulcerative Colitis-Disease Activity Index of ≤1 calculated as: rectal bleeding and stool frequency scores of 0, a combined Physician’s Global Assessment and sigmoidoscopy score of ≤1, no mucosal friability and a ≥1-point reduction in sigmoidoscopy score from week 0). Results Data from 517 patients were analysed. 8-week remission rates were 37.2% and 35.1% in the MMX Mesalazine 2.4 g/day and 4.8 g/day groups, vs. 17.5% on placebo (P < 0.001, both comparisons). 8-week complete mucosal healing rates were 32% in both MMX Mesalazine groups compared with 16% on placebo. Adverse event frequency was similar in all groups. Conclusion MMX Mesalazine is effective and generally well tolerated for inducing clinical and endoscopic remission of active, mild-to-moderate ulcerative colitis.
Mohammad Abdollahi - One of the best experts on this subject based on the ideXlab platform.
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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
Digestive Diseases and Sciences, 2009Co-Authors: Shekoufeh Nikfar, Roja Rahimi, Ali Rezaie, Mohammad AbdollahiAbstract: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.
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Comparison of Mesalazine and Balsalazide in Induction and Maintenance of Remission in Patients with Ulcerative Colitis: A Meta-Analysis
Digestive Diseases and Sciences, 2009Co-Authors: Roja Rahimi, Shekoufeh Nikfar, Ali Rezaie, Mohammad AbdollahiAbstract: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.
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comparison of Mesalazine and balsalazide in induction and maintenance of remission in patients with ulcerative colitis
2009Co-Authors: Roja Rahimi, Shekoufeh Nikfar, Ali Rezaie, Mohammad AbdollahiAbstract:Background 5-Aminosalicylates are the stan- dard 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 Sci- ence, 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 ''ulcer- ative colitis.'' Data were collected from 1966 to 2007 (up to February). There was no language restriction. ''Symp- tomatic 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 ran- domized 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 out- come 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 remis- sion, 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.