Low Pentasa dosage versus hydrocortisone in the topical treatment of active ulcerative colitis: a randomized, double-blind study.
OBJECTIVE
To compare a low dosage (1 g/day) rectal preparation of 5-aminosalicylic acid in slightly acidic, buffered suspension (Pentasa) with a hydrocortisone 100 mg/day enema (Cortenema).


METHODS
Fifty-two patients with mild to moderate distal ulcerative colitis were randomized under double-blind conditions to receive a rectal preparation of either Pentasa (1 g/day) or Cortenema (100 mg/day) for 3 wk.


RESULTS
After 3 wk, both types of treatment resulted in statistically significant improvements in clinical and endoscopic activity. No significant difference was observed between the two drugs in any of the parameters considered, although a statistical trend in favor of Pentasa was evident when analysis was limited to clinical activity (p = 0.07). No side effects were reported in either group.


CONCLUSIONS
Our experience confirms that short term topical treatment with a low dosage 5-aminosalicylic acid is at least as effective as 100-mg hydrocortisone enemas in treating mild to moderate distal ulcerative colitis and is generally well tolerated.
Bianchi Porro
G
G
Gastrointestinal Unit, L. Sacco Hospital, Milan, Italy.
Ardizzone
S
S
Petrillo
M
M
Fasoli
A
A
Molteni
P
P
Imbesi
V
V
D000285:Administration, Rectal; D000293:Adolescent; D000328:Adult; D000636:Aminosalicylic Acids / Q000008:administration & dosage*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D004733:Enema; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage*; D008297:Male; D019804:Mesalamine; D008875:Middle Aged
D000636:Aminosalicylic Acids; D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine; D006854:Hydrocortisone