Improved maintenance of remission in ulcerative colitis by balsalazide 4 g/day compared with 2 g/day.
The efficacy of two doses of balsalazide for the maintenance of remission in patients with ulcerative colitis was compared in a double-blind multicentre trial. Sixty-five patients received a 2 g daily dose, and 68 a 4 g dose. The patient groups were similar at entry for sex, age, and disease distribution. Clinical assessment was carried out at 3-monthly intervals, with sigmoidoscopy, rectal biopsy, and blood tests on entry and at 26 and 52 weeks. Clinical relapse over twelve months was significantly less common on the 4 g dose (36%), than on the 2 g dose (55%), P less than 0.01. There were eight withdrawals on 2 g daily and 13 on 4 g daily, six and nine respectively being mainly due to gastrointestinal intolerance. It is concluded that balsalazide is a well-tolerated drug, and is effective for the maintenance of remission in patients with ulcerative colitis, the optimal dose being greater than 2 g daily.
Royal Hallamshire Hospital, Sheffield, UK.
M H
MH
Giaffer
C D
CD
Holdsworth
J E
JE
Lennard-Jones
C A
CA
Rodrigues
P B
PB
McIntyre
S
S
Manjunatha
J H
JH
Baron
I G
IG
Barrison
R J
RJ
Polson
A M
AM
Hoare
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000636:Aminosalicylic Acids / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; 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; D012460:Sulfasalazine / Q000009:adverse effects
D000636:Aminosalicylic Acids; D010659:Phenylhydrazines; D012460:Sulfasalazine; D019804:Mesalamine; C038637:balsalazide