[Comparative randomized open study of the efficacy and tolerance of enemas with 2 gr of 4-amino-salicylic acid (4-ASA) and 1 gr of 5-amino-salicylic acid (5-ASA) in distal forms of hemorrhagic rectocolitis].
OBJECTIVE
The aim of this multicentre, randomized open trial was to compare the efficacy and tolerance of 4-ASA vs 5-ASA enemas in the treatment of distal moderately active ulcerative colitis. Fifty patients were randomized to receive enemas in 100 mL suspension of 4-ASA (2 g, n = 26), or 5-ASA (1 g, n = 24). The subjects filled a daily questionnaire on enema retention duration, and tolerance. Clinical and endoscopic evaluations were performed at baseline and after 2 and 4 weeks.


RESULTS
Significant clinical and endoscopic improvements occurred in both groups. Efficacy and enema retention time did not differ between groups. Tolerance was significantly better for 4-ASA: score 0.46 +/- 0.77 vs 1.00 +/- 0.73, P = 0.03.


CONCLUSIONS
Efficacy of both treatments was equivalent, but 4-ASA enemas were better tolerated than 5-ASA in this open trial.
Marteau
P
P
Service de Gastroentérologie, Hôpital Saint-Lazare, France.
Halphen
M
M
D000328:Adult; D010131:Aminosalicylic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000636:Aminosalicylic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy*; D016099:Endoscopy, Gastrointestinal; D004733:Enema / Q000379:methods*; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000188:drug therapy / Q000209:etiology*; D006801:Humans; D008297:Male; D019804:Mesalamine; D008875:Middle Aged; D011859:Radiography
D000636:Aminosalicylic Acids; D019804:Mesalamine; D010131:Aminosalicylic Acid
Etude comparative ouverte randomisée de l'efficacité et de la tolérance de lavements de 2 g d'acide 4-amino-salicylique (4-ASA) et de 1 g d'acide 5-amino-salicylique (5-ASA) dans les formes basses de rectocolite hémorragique.