Abstract
INTRODUCTION: 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.
Similar content being viewed by others
References
SB Hanauer (1996) ArticleTitleDrug therapy N Engl J Med 334 841–848
M Safdi M DeMicco C Sninsky et al. (1997) ArticleTitleA double blind comparison of oral versus rectal mesalamine versus combination therapy in the treatment of distal ulcerative colitis Am J Gastroenterol 92 1867–1871
M Campieri P Gionchetti A Belluzzi (1991) ArticleTitleOptimum dosage of 5-aminosalicylic acid as rectal enema in patients with ulcerative colitis Gut 32 929–931
A Danielsson R Lofberg T Persson et al. (1992) ArticleTitleA steroid enema, budesonide, lacking systemic effects for the treatment of distal ulcerative colitis or proctitis Scand J Gastroenterol 27 9–12
WS Ruddell RJ Dickinson MF Dixon AT Axon (1980) ArticleTitleTreatment of distal ulcerative colitis (proctosigmoiditis) in relapse Gut 21 885–889
RL Sutherland F Martin S Greer et al. (1987) ArticleTitle5-aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis Gastroenterology 92 1894–1898
JH Baron AM Conell JE Lennard-Jones (1964) ArticleTitleVariation between observers in describing mucosal appearances in proctitis BMJ 1 89–92
CH Floren C Benoni R Willen (1987) ArticleTitleHistological and colonoscopic assessment of disease extension in ulcerative colitis Scand J Gastroenterol 22 459–462
G Löfberg O Ostergard Thomsen et al. (1994) ArticleTitleBudesonide versus prednisolone retention enemas in active distal ulcerative colitis Aliment Pharmacol Ther 8 623–629
J Ejderhamn L Browaldh G Oldaeus R Saalman L Stenhammar (1999) ArticleTitleTreatment with glucocorticosteroid enemas in children with ulcerative colitis; a randomised single-blind multicenter comparison between budesonide and prednisolone [abstract] Gut 45 170–629
G Bianchi Porro C Prantera M Campieri et al. (1994) ArticleTitleComparative trial of methylprednisolone and budesonide enemas in active distal ulcerative colitis Eur J Gastroenterol Hepatol 6 125–130
M Lémann A Galian P Rutgeerts et al. (1995) ArticleTitleComparison of budesonide and 5-aminosalicylic acid enemas in active distal ulcerative colitis Aliment Pharmacol Ther 9 557–562
SB Hanauer M Robinson R Pruitt et al. (1998) ArticleTitleBudesonide enema for the treatment of active, distal ulcerative colitis and proctitis: a dose-ranging study. U. S. Budesonide enema study group Gastroenterology 115 525–532
Author information
Authors and Affiliations
About this article
Cite this article
Bar-Meir, S., Fidder, H.H., Faszczyk, M. et al. Budesonide Foam vs. Hydrocortisone Acetate Foam in the Treatment of Active Ulcerative Proctosigmoiditis. Dis Colon Rectum 46, 929–936 (2003). https://doi.org/10.1007/s10350-004-6687-x
Issue Date:
DOI: https://doi.org/10.1007/s10350-004-6687-x