Double-blind, placebo-controlled evaluation of 5-ASA suppositories in active distal proctitis and measurement of extent of spread using 99mTc-labeled 5-ASA suppositories.
Patients with active distal proctitis received either 5-aminosalicylic (5-ASA) acid or identical placebo suppositories, 500 mg t.i.d. for 6 weeks. Activity at 3 and 6 wks was assessed using a Disease Activity Index (DAI), derived from four categories: number of daily evacuations more than usual, evacuations containing blood, sigmoidoscopy appearance, and physician's overall assessment. Each category was graded 0-3. There was thus 0-12 points scored ranging from complete remission to severe disease. A minimum score of 3 from two categories was necessary for study entry. Of 27 patients randomized, 14 received active medication and 13 placebo. Of the 14 patients, with initial mean DAI 7.1 +/- 1.8, 11 were in complete remission at 6 wks (78.6%). Whereas, there was no significant change in the placebo group, with initial mean DAI 7.1 +/- 1.8. An additional 6 patients with inflammatory bowel disease and 6 healthy volunteers were given 99mTc-labelled 5-aminosalicylic acid suppositories. The extent of spread was limited to the rectum, and the suppositories were retained for 3 hours. There was no absorbed radioactivity. 5-ASA suppositories are safe, well-tolerated, and effective treatment for active distal proctitis.
Williams
C N
CN
Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
Haber
G
G
Aquino
J A
JA
D000285:Administration, Rectal; D000328:Adult; D000636:Aminosalicylic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine; D011349:Proctitis / Q000188:drug therapy*; D011446:Prospective Studies; D011877:Radionuclide Imaging; D011897:Random Allocation; D012007:Rectum / Q000000981:diagnostic imaging; D013488:Suppositories; D013667:Technetium; D013997:Time Factors
D000636:Aminosalicylic Acids; D013488:Suppositories; D019804:Mesalamine; D013667:Technetium