Budesonide foam vs. hydrocortisone acetate foam in the treatment of active ulcerative proctosigmoiditis.
BACKGROUND
Rectal administration of corticosteroids is advocated in patients with proctosigmoiditis who have failed therapy with mesalamine enema. Foam offers patients better tolerability than an enema. In this study the efficacy and adverse effects of a new budesonide foam are compared with the presently available hydrocortisone foam.


METHODS
Two hundred fifty-one patients with proctosigmoiditis were randomly assigned to receive either budesonide foam or hydrocortisone foam for eight weeks.


RESULTS
Remission rates were comparable in the budesonide and hydrocortisone groups, 53 and 52 percent, respectively. The mean disease activity index for the two groups decreased to a similar extent, from 7.2 +/- 1.9 and 7 +/- 2 to 3.6 +/- 3.1 and 3.9 +/- 3.4 in the budesonide and hydrocortisone groups, respectively. In a subgroup of patients who had not responded to rectal administration of mesalamine, 23 of 44 (52 percent) patients who received budesonide responded favorably to the foam, as compared with 14 of 38 (37 percent) patients who received hydrocortisone (P = not significant). Low plasma cortisol occurred in 3 percent of the budesonide group and in none of the hydrocortisone patients.


CONCLUSIONS
This trial demonstrates a similar efficacy and safety of the two foams in patients with proctosigmoiditis.
Bar-Meir
Simon
S
Department of Gastroenterology, Chaim Sheba Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Hashomer, Israel.
Fidder
Herma H
HH
Faszczyk
Mark
M
Bianchi Porro
Gabriele
G
Sturniolo
Giacomo C
GC
Mickisch
Oliver
O
Müller
Ralph
R
Greinwald
Roland
R
Chowers
Yehuda
Y
Grobeta
Volker
V
D000285:Administration, Rectal; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004304:Dosage Forms; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D011350:Proctocolitis / Q000188:drug therapy*
D000893:Anti-Inflammatory Agents; D004304:Dosage Forms; C021650:hydrocortisone acetate; D019819:Budesonide; D006854:Hydrocortisone