title: Budesonide foam vs. hydrocortisone acetate foam in the treatment of active ulcerative proctosigmoiditis.
abstract: 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.
authors.affiliation: Department of Gastroenterology, Chaim Sheba Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Hashomer, Israel.
authors.forename: Simon
authors.initials: S
authors.lastname: Bar-Meir
authors.forename: Herma H
authors.initials: HH
authors.lastname: Fidder
authors.forename: Mark
authors.initials: M
authors.lastname: Faszczyk
authors.forename: Gabriele
authors.initials: G
authors.lastname: Bianchi Porro
authors.forename: Giacomo C
authors.initials: GC
authors.lastname: Sturniolo
authors.forename: Oliver
authors.initials: O
authors.lastname: Mickisch
authors.forename: Ralph
authors.initials: R
authors.lastname: Müller
authors.forename: Roland
authors.initials: R
authors.lastname: Greinwald
authors.forename: Yehuda
authors.initials: Y
authors.lastname: Chowers
authors.forename: Volker
authors.initials: V
authors.lastname: Grobeta
mesh_terms: 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*
chemical_list: D000893:Anti-Inflammatory Agents; D004304:Dosage Forms; C021650:hydrocortisone acetate; D019819:Budesonide; D006854:Hydrocortisone