Double-blind, placebo-controlled evaluation of 5-ASA suppositories in active distal proctitis and measurement of extent of spread using /sup 99m/Tc-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 /sup 99m/Tc-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.
- Research Organization:
- Dalhousie Univ., Halifax, Nova Scotia
- OSTI ID:
- 5398285
- Journal Information:
- Dig. Dis. Sci.; (United States), Vol. 32, Issue S12
- Country of Publication:
- United States
- Language:
- English
Similar Records
A phase III randomized, placebo-controlled, double-blind study of misoprostol rectal suppositories to prevent acute radiation proctitis in patients with prostate cancer
Failure of 5-aminosalicylic acid enemas to improve chronic radiation proctitis
Related Subjects
PROCTITIS
CHEMOTHERAPY
SALICYLIC ACID
BIOLOGICAL EFFECTS
ISOMERIC NUCLEI
LABELLED COMPOUNDS
PATIENTS
RECTUM
TECHNETIUM 99
TRACER TECHNIQUES
BETA DECAY RADIOISOTOPES
BETA-MINUS DECAY RADIOISOTOPES
BODY
CARBOXYLIC ACIDS
DIGESTIVE SYSTEM
DIGESTIVE SYSTEM DISEASES
DISEASES
GASTROINTESTINAL TRACT
HOURS LIVING RADIOISOTOPES
HYDROXY ACIDS
INTERMEDIATE MASS NUCLEI
INTESTINES
ISOMERIC TRANSITION ISOTOPES
ISOTOPE APPLICATIONS
ISOTOPES
LARGE INTESTINE
NUCLEI
ODD-EVEN NUCLEI
ORGANIC ACIDS
ORGANIC COMPOUNDS
ORGANS
RADIOISOTOPES
TECHNETIUM ISOTOPES
THERAPY
YEARS LIVING RADIOISOTOPES
550901* - Pathology- Tracer Techniques