Comparison of budesonide and 5-aminosalicylic acid enemas in active distal ulcerative colitis.
BACKGROUND
Budesonide is a new corticosteroid with high topical anti-inflammatory activity but little systemic effect. The aim of the present study was to compare the efficacy and safety of budesonide enema (2 mg/100 mL) and 5-ASA enema (mesalazine 1 g/100 mL) given for 4 weeks in the treatment of active distal ulcerative colitis and proctitis.


METHODS
Ninety-seven patients were studied in a multicentre single-blind randomized group-comparative trial. The primary efficacy variables were endoscopy and histopathology scores obtained at 0, 2 and 4 weeks. Clinical symptoms were the secondary efficacy variables. Haematology, chemistry and adverse events were the safety variables.


RESULTS
Budesonide and 5-ASA enemas both resulted in a significant improvement in endoscopy and histopathology scores but no difference could be demonstrated between the two treatment groups. There was also a significant improvement of symptoms (number of bowel movements per day, quality of stools, presence of blood and mucus, and state of well-being) within both groups but no difference between the two treatment groups. The clinical remission rate at 4 weeks was, however, 38% for patients treated with budesonide enema but 60% for those treated with 5-ASA enema (P = 0.03). No adverse events attributed to the study drugs were recorded in either of the groups.


CONCLUSIONS
Budesonide enema 2 mg/100 mL appears to be as efficient and well-tolerated as 5-ASA enema in the treatment of active distal ulcerative colitis and proctitis.
Lémann
M
M
Department of Hepato-Gastroenterology, Hôpital Saint-Louis, Paris, France.
Galian
A
A
Rutgeerts
P
P
Van Heuverzwijn
R
R
Cortot
A
A
Viteau
J M
JM
Elewaut
A
A
Belaiche
J
J
Froguel
E
E
Modigliani
R
R
D000328:Adult; D000368:Aged; D000636:Aminosalicylic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019819:Budesonide; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003113:Colonoscopy; D004733:Enema; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011282:Pregnenediones / Q000008:administration & dosage / Q000627:therapeutic use*; D016037:Single-Blind Method; D016896:Treatment Outcome
D000636:Aminosalicylic Acids; D000893:Anti-Inflammatory Agents; D011282:Pregnenediones; D019819:Budesonide