title: Double-blind dose-finding study of olsalazine versus sulphasalazine as maintenance therapy for ulcerative colitis.
abstract: OBJECTIVE
  To determine the therapeutic efficacy and safety of three doses of olsalazine compared with the standard dose of sulphasalazine.
  
  
  METHODS
  Randomized double-blind multicentre 6-month study comparing three doses of olsalazine (0.5, 1.25 and 2.0 g daily) and sulphasalazine 2.0 g daily for maintaining remission in patients with ulcerative colitis.
  
  
  METHODS
  Public hospitals and private practices in Germany, Austria and Switzerland.
  
  
  METHODS
  A total of 162 patients with ulcerative colitis in remission.
  
  
  RESULTS
  According to intention-to-treat analysis, the failure rates of the different treatment groups were not significantly different (36, 49 and 24% for 0.5, 1.25 and 2.0 g olsalazine daily and 32% for 2.0 g sulphasalazine daily). Olsalazine and sulphasalazine showed a tendency towards lower failure rates in extended (28%) than in distal disease (44%). The withdrawal rate due to adverse effects was 4%, the most frequent single event being diarrhoea (2.5, 5.2 and 11.7% for 0.5, 1.25 and 2.0 g olsalazine daily and 0% for sulphasalazine daily).
  
  
  CONCLUSIONS
  This study found no significant differences between the therapeutic efficacy or safety of 0.5-2.0 g olsalazine daily. Because of its sulpha-free formulation olsalazine may, however, be preferred to sulphasalazine.
authors.affiliation: Evangelisches Krankenhaus Köln-Kalk, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Kruis
authors.forename: G
authors.initials: G
authors.lastname: Judmaier
authors.forename: L
authors.initials: L
authors.lastname: Kayasseh
authors.forename: M
authors.initials: M
authors.lastname: Stolte
authors.forename: D
authors.initials: D
authors.lastname: Theuer
authors.forename: C
authors.initials: C
authors.lastname: Scheurlen
authors.forename: E
authors.initials: E
authors.lastname: Hentschel
authors.forename: P
authors.initials: P
authors.lastname: Kratochvil
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000636:Aminosalicylic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000517:prevention & control*; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction; D012449:Safety; D012460:Sulfasalazine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000636:Aminosalicylic Acids; D012460:Sulfasalazine; C032587:olsalazine