Short report: comparison of two doses of balsalazide in maintaining ulcerative colitis in remission over 12 months.
In a four-centre prospective double-blind trial, 108 patients with ulcerative colitis in remission were randomized to receive balsalazide in doses of 3 g or 6 g/day for 12 months. The patients were assessed at 3-monthly intervals clinically, sigmoidoscopically and with routine haematology and biochemistry. Remission rates of 77% (3 g/day) and 68% (6 g/day) at 12 months were not significantly different. Intolerance reactions leading to withdrawal from the study occurred in only 9 patients (8%), all occurring in the first 7 weeks of the study. Balsalazide is therefore both highly effective in maintaining remission in ulcerative colitis and well tolerated in both conventional and high dosage (the latter equivalent to 5.5 g/day of sulphasalazine). In this study no distinct advantage in maintenance of remission has been found for the higher dose of balsalazide.
Green
J R
JR
North Staffs Hospital Centre, Stoke-on-Trent, UK.
Swan
C H
CH
Rowlinson
A
A
Gibson
J A
JA
Brown
P
P
Kerr
G D
GD
Swarbrick
E T
ET
Thornton
P
P
D000328:Adult; D000368:Aged; D000636:Aminosalicylic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine; D008875:Middle Aged; D010659:Phenylhydrazines; D011446:Prospective Studies; D013997:Time Factors
D000636:Aminosalicylic Acids; D010659:Phenylhydrazines; D019804:Mesalamine; C038637:balsalazide