Clinical trial: Controlled, open, randomized multicentre study comparing the effects of treatment on quality of life, safety and efficacy of budesonide or mesalazine enemas in active left-sided ulcerative colitis

Alimentary Pharmacology and Therapeutics

Volumn 32, Issue 3, 2010, Pages 368-376

  Hartmann, F ^a,b   Stein, J ^b,c  

^a St Marien Hospital   (Germany)

^b Crohn Colitis Center Rhein Main   (Germany)

^c GOETHE UNIVERSITY   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

BUDESONIDE; ENEMA; MESALAZINE; OLSALAZINE; SALAZOSULFAPYRIDINE;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; CLINICAL TRIAL; COMMON COLD; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FLATULENCE; GERMANY; HISTOLOGY; HUMAN; MAJOR CLINICAL STUDY; MALE; MIGRAINE; MULTICENTER STUDY; NAUSEA AND VOMITING; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; REMISSION; ULCERATIVE COLITIS; VIRUS INFECTION;

ADOLESCENT; ADULT; AGED; ANTI-INFLAMMATORY AGENTS; BUDESONIDE; COLITIS, ULCERATIVE; ENEMA; FEMALE; HUMANS; MALE; MESALAMINE; MIDDLE AGED; QUALITY OF LIFE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77954326942     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2010.04354.x     Document Type: Article

References (23)

1. Campieri M, Paoluzzi P, D'Albasio G, et al. Better quality of therapy with 5-ASA colonic foam in active ulcerative colitis. Dig Dis Sci 1993 38:1843 1850.
2. Campieri M, Gionchetti P, Belluzzi A, et al. Optimum dosage of 5-aminosalicylic acid as rectal enemas in patients with active ulcerative colitis. Gut 1991 32:929 931.
3. Campieri M, Lanfranchi GA, Bazzocchi G, et al. Treatment of ulcerative colitis with high dose 5-aminosalicylic acid enema. Lancet 1981 2:270 271. (Pubitemid 11042737)
4. Marshall JK, Irvine EJ. Rectal aminosalicylate therapy for distal ulcerative colitis: a meta-analysis. Gut 1997 40:775 781.
5. Cohen RD, Voseth DM, Thisted RA, et al. A meta-analysis and over view of the literature on treatment options for left sided ulcerative colitis and ulcerative proctitis. Am J Gastroenterol 2000 95:1263 7126.
6. Friedman LS, Richter JM, Kirkham SE, DeMonaco HJ, May RJ. 5-aminosalicylic acid enemas in refractory distal ulcerative colitis: a randomized controlled trial. Am J Gastroenterol 1986 81:412 418.
7. Sutherland LR, Martin F, Greer S, et al. 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis and proctitis. Gastroenterology 1987 92:1894 1898.
8. Danielsson A, Hellers G, Lyrenäs E, et al. A controlled randomized trial of budesonide versus prednisolone retention enemas in active distal ulcerative colitis. Scand J Gastroenterol 1987 22:987 992.
9. Bianchi Porro G, Prantera C, Camperieri M, et al. Comparative trial of methylprednisolone and budesonide enemas in active distal ulcerative colitis. Eur J Gastroenterol 1994 6:125 130.
10. Löfberg R, Ostergaard Thomsen O, Langholz E, et al. Budesonide versus prednisolone retention enemas in active distal ulcerative colitis. Aliment Pharmacol Ther 1994 8:623 629.
11. Marshall JK, Irvine EJ. Rectal corticosteroids versus alternative treatments in ulcerative colitis: a meta-analysis. Gut 1997 40:775 781.
12. Lémann M, Galian A, Rutgeerts P, et al. Comparison of budesonide and 5-aminosalicy acid enemas in active distal ulcerative colitis. Aliment Pharrnacol Ther 1995 9:557 562.
13. Rufle W, Frühmorgen P, Huber W, Kimmig JM. Budesonide foam as a new therapeutic concept in the therapy of distal ulcerative colitis in comparison to mesalazine enemas. An open, controlled, randomized and prospective multicenter pilot study. Z Gastroenterol 2000 38:287 293.
14. Rachmilewitz D. Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial. BMJ 1989 298:82 6.
15. Floren CH, Benoni C, Willen R. Histologic and colonoscopic assessment of disease extension in ulcerative colitis. Scand J Gastroenterol 1987 22:459 462.
16. Irvine EJ, Feagan B, Rochon J, et al. Quality of life: a valid and reliable measure of therapeutic effcacy in the treatment of inflammatory bowel disease. Gastroenterology 1994 106:287 296.
17. Malchow H, Gertz B, the Clafoam Study Group. A new mesalazine foam enema (Claversal foam) compared with a standard liquid enema in patients with active distal ulcerative colitis. Aliment Pharmacol Ther 2002 16:415 423.
18. Pokrotnieks J, Marlicz K, Paradowski L, Margus B, Zaborowski P, Greinwald R. Efficacy and tolerability of mesalazine foam (Salofalk foam) for distal ulcerative colitis: a double-blind, randomized, placebo controlled study. Aliment Pharmacol Ther 2000 14:1191 1198.
19. Eliakim R, Tulassay Z, Kupcinskas L, et al. Clinical trial: randomized-controlled clinical study comparing the efficacy and safety of a low-volume vs. a high-volume mesalazine foam in active distal ulcerative colitis. Aliment Pharmacol Ther 2007 26:1237 1249.
20. Gross V, Bar-Meir S, Lavy A, et al. Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis. Aliment Pharmacol Ther 2006 23:303 312.
21. Hanauer SB, Robinson M, Pruitt R, et al. Budesonide enema for the treatment of active, distal ulcerative colitis and proctitis: a dose-ranging study. U.S. Budesonide enema study group. Gastroenterology 1998 115:525 532.
22. Biancone L, Gionchetti P, Blanco Gdel V, et al. Beclomethasone dipropionate versus mesalazine in distal ulcerative colitis: a multicenter, randomized, double-blind study. Dig Liver Dis 2007 39:329 337.
23. Gionchetti P, D'Arienzo A, Rizzello F, et al. Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine: a single-blind randomized controlled trial. J Clin Gastroenterol 2005 39:291 297.