Olsalazine versus placebo in the treatment of mild to moderate ulcerative colitis: a randomised double blind trial.

Abstract

SUMMARY The effect of olsalazine, an analogue of sulphasalazine, consisting of two molecules 5-aminosalicylic acid linked by an azobond has been investigated for the treatment of ulcerative colitis. In a randomised double blind trial we compared 2 g olsalazine with placebo for four weeks. Of the 105 patients, with mild to moderate ulcerative colitis, entered in the trial 52 received olsalazine, and 53 placebo. Treatment had to be terminated prematurely because of untoward effects of olsalazine (mainly diarrhoea) in three patients and treatment failure -that is, increased rectal bleeding in four patients (olsalazine group: one placebo group: three). After four weeks' treatment, a statistically significant improvement in the endoscopic findings in rectum and a positive trend in the reduction of rectal mucus and blood discharge was observed in the patients treated with olsalazine. No statistically significant difference was found for other factors, including stool frequency, consistency, urge to defecate, abdominal pain, and biopsy findings. A comparison between these clinical and endoscopic parameters at study entry and those at study completion (within drug evaluation) showed significant improvement in six of 10 parameters during treatment with olsalazine and in two of 10 during placebo treatment. This difference suggests the significant effect of olsalazine. We conclude that 2 g olsalazine was tolerated as well as placebo, apart from causing diarrhoea in some patients and was slightly superior to placebo during four weeks' treatment of mild to moderate ulcerative colitis. A study with 3 or 4 g olsalazine per day may show a more definite effect.

How effective are the usual treatments for ulcerative colitis?

“…We identified nine placebo-controlled trials of 5-ASA compounds in the treatment of active ulcerative colitis, [12][13][14][15][16][17][18][19][20] (Table 2) helped by the Cochrane Library. 21 None studied sulfasalazine.…”

Voting with Their Feet (VWF) Endpoint: A Meta-Analysis of an Alternative Endpoint in Clinical Trials, Using 5-ASA Induction Studies in Ulcerative Colitis

“…Meyers et al 18 did not include specific information about how many subjects left the study for failure of the experimental drug versus placebo. Feurle et al 10 and Hetzel et al 13 used olsalazine and did not clearly differen-tiate between diarrhea caused by olsalazine versus lack of treatment effect. Sutherland et al 17 did not specify exactly how many patients left the study for lack of efficacy in each arm.…”

“…1. ) Five studies 10,11,13,17,18 were excluded because they were either unavailable in full text format, used a low (Ͻ2 g/d) dose of 5-ASA, or they did not report the data required to perform the analysis. The Mesalamine Study Group trial 11 was excluded because the dosage of mesalamine used for the study was less than 2 g/day, in order to maximize the homogeneity of the studies in the metaanalyses.…”

Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

“…Five studies compared olsalazine to placebo, all with findings of statistically significant clinical improvement in the olsalazine treatment groups. 68,83,105,126,131 When compared to sulphasalzine, all 3 studies showed non-inferiority of olsalazine. 66,117,130 There was one study that compared olsalazine 3 g/d to Eudragit-L mesalazine 3 g/d and found similar rates of endoscopic remission.…”