A double-blind comparison of balsalazide, 6.75 g daily, and sulfasalazine, 3 g daily, in patients with newly diagnosed or relapsed active ulcerative colitis.
BACKGROUND
Sulfasalazine is well established in the treatment of active ulcerative colitis. Intolerance to sulfasalazine, however, is a common problem. Balsalazide has been designed to deliver 5-aminosalicylic acid to the colon without the poor tolerability of sulfasalazine.


OBJECTIVE
To compare the safety and efficacy of balsalazide, 6.75 g daily, with sulfasalazine, 3 g daily, in the treatment of active ulcerative colitis of all grades of severity.


METHODS
Balsalazide and sulfasalazine were compared in a multicentre, double-blind, parallel group study over 12 weeks. Patients were stratified for disease severity and topical and/or oral steroids were co-administered where clinically necessary.


RESULTS
Fifty-seven patients were randomized: 28 to receive balsalazide and 29 to receive sulfasalazine. Significantly fewer patients withdrew from the balsalazide group due to adverse events (2/28 vs. 9/29, P=0.041). These data confirm that balsalazide is better tolerated than sulfasalazine. In patients able to tolerate the treatment, similar improvements were recorded in clinical, sigmoidoscopic and histological assessments in both treatment groups.


CONCLUSIONS
This study confirms the better tolerability of balsalazide compared to sulfasalazine, and supports the use of balsalazide in ulcerative colitis of all grades of severity.
Green
J R B
JR
Department of Gastroenterology, City General Hospital, Stoke-on-Trent, UK.
Mansfield
J C
JC
Gibson
J A
JA
Kerr
G D
GD
Thornton
P C
PC
D000284:Administration, Oral; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000636:Aminosalicylic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D008297:Male; D019804:Mesalamine; D008875:Middle Aged; D010659:Phenylhydrazines; D012720:Severity of Illness Index; D012812:Sigmoidoscopy; D012460:Sulfasalazine / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D000636:Aminosalicylic Acids; D000897:Anti-Ulcer Agents; D005765:Gastrointestinal Agents; D010659:Phenylhydrazines; D012460:Sulfasalazine; D019804:Mesalamine; C038637:balsalazide