Effect of budesonide enema on remission and relapse rate in distal ulcerative colitis and proctitis.
BACKGROUND
Glucocorticosteroid enemas are equally effective as 5-ASA enemas in the treatment of active distal ulcerative colitis (UC). With the introduction of budesonide, the risk of systemic side effects may be reduced. We investigated whether budesonide enema, 2 mg/100 ml, administered twice daily (b.i.d.) could increase the remission rate in comparison with the once daily (o.d.) standard regimen. Furthermore, we evaluated whether 2 mg budesonide enema, given twice weekly, could have a relapse preventing effect.


METHODS
149 patients with active distal UC were treated in a controlled, double-blind multicentre study with two parallel groups: placebo enema in the morning and budesonide enema in the evening (i.e. 2 mg/day) or budesonide enema b.i.d. (i.e. 4 mg/day) until remission (absence of clinical symptoms and endoscopic healing) or at most 8 weeks. Patients in remission were randomized to either budesonide enema or placebo enema twice weekly for 24 weeks or until relapse.


RESULTS
The remission rates at 4 weeks were 33% for o.d. and 41% for b.i.d. regimens (NS) and correspondingly 51% and 54% at 8 weeks (NS). The b.i.d. group had an increased frequency of impaired adrenal function, 32% versus 4.8% (P = 0.001). The relapse rates during maintenance treatment with budesonide enema and placebo were 15% versus 24% after 8 weeks, 31% versus 27% after 16 weeks and 41% versus 51% after 24 weeks (NS).


CONCLUSIONS
Budesonide enema 2 mg o.d. appears to be the optimal dosage in active distal UC. We could not show that budesonide enema twice weekly is sufficient to maintain remission.
Lindgren
S
S
Dept. of Medicine of University Hospital MAS, Malmö, Stockholm, Sweden. Stefan.Lindgren@medfork.mas.lu.se
Löfberg
R
R
Bergholm
L
L
Hellblom
M
M
Carling
L
L
Ung
K A
KA
Schiöler
R
R
Unge
P
P
Wallin
C
C
Ström
M
M
Persson
T
T
Suhr
O B
OB
D000293:Adolescent; D000328:Adult; D000368:Aged; D001707:Biopsy, Needle; D019819:Budesonide / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004733:Enema / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011349:Proctitis / Q000188:drug therapy* / Q000473:pathology; D012008:Recurrence; D012720:Severity of Illness Index; D016896:Treatment Outcome
D019819:Budesonide