Comparative, open, randomized trial of the efficacy and tolerance of slow-release 5-ASA suppositories once daily versus conventional 5-ASA suppositories twice daily in the treatment of active cryptogenic proctitis: French Pentasa Study Group.
OBJECTIVE
The efficacy and tolerance of slow-release 5-ASA suppositories (Pentasa 1 g/day) were compared with those of conventional 5-ASA suppositories (Rowasa 0.5 g b.i.d.).


METHODS
Two hundred and fifty-one (251) patients presenting with an exacerbation of cryptogenic proctitis were randomized. Clinical activity and rectal lesions were measured at days 1 and 14 (and at day 21 for patients not in remission at day 14), and each patient had to fill out a daily diary card (checklist).


RESULTS
Results are given for slow-release and classical suppositories, respectively. The reduction in symptoms and lesions was identical in both groups. Treatment was continued until day 21 in 36% versus 33% of the patients, and minor or moderate side effects occurred in 5.6% versus 6.3% (NS). The tolerance of the suppositories was rated as satisfactory every day by 77% versus 54% (p = 0.001), and early suppository expulsion occurred in 0.5% versus 3.4% (p = 0.001).


CONCLUSIONS
The treatments were equally effective and both were well tolerated. However, the advantages of the slow-release suppositories were that patients exhibited greater tolerance and early expulsion was less frequent.
Marteau
P
P
Gastroenterology Department, Laënnec Hospital AP-HP, Paris, France.
Florent
C
C
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D011349:Proctitis / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D013488:Suppositories
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D013488:Suppositories; D019804:Mesalamine