title: Clinical trial: oral prednisolone metasulfobenzoate (Predocol) vs. oral prednisolone for active ulcerative colitis.
abstract: BACKGROUND
  Systemic corticosteroids are effective in ulcerative colitis but commonly cause side effects.
  
  
  OBJECTIVE
  To compare the safety and efficacy of a sparingly absorbed formulation of prednisolone metasulfobenzoate (Predocol) with a conventional tapering course of oral prednisolone.
  
  
  METHODS
  In a double-blind randomized study, 59 active ulcerative colitis patients received Predocol 40 mg/day for 6 months, 61 received Predocol 60 mg/day for 6 months and 61 received prednisolone 40 mg/day for 2 weeks, tapered to week 8, followed by placebo until 6 months.
  
  
  RESULTS
  Steroid-related side effects assessed using a 10-cm visual analogue scale were fewer at 2 months with Predocol 40 mg [VAS 8.1 cm (2.6), mean (s.d.)], or 60 mg [8.1 (2.1)] compared with prednisolone [6.7 (2.7); P = 0.01]. Mood changes affected 43% receiving prednisolone at 4 weeks vs. 8% for Predocol 40 mg (P = 0.001). Remission rates (Powell-Tuck < or =2) at 2 months were Predocol 40 mg 46%, Predocol 60 mg 28% and tapering prednisolone 41% (P = 0.13). Visual analogue scale for efficacy also showed non-inferiority for Predocol 40 mg/day. Remission rates at 6 months were Predocol 40 mg 51%, Predocol 60 mg 38% and tapering prednisolone 32% (P = 0.08).
  
  
  CONCLUSIONS
  Predocol 40 mg/day has similar efficacy but markedly fewer side effects than a conventional tapering prednisolone regimen (ISRCTN14133410).
authors.affiliation: School of Clinical Science, University of Liverpool, Liverpool, UK. rhodesjm@liverpool.ac.uk
authors.forename: J M
authors.initials: JM
authors.lastname: Rhodes
authors.forename: R
authors.initials: R
authors.lastname: Robinson
authors.forename: I
authors.initials: I
authors.lastname: Beales
authors.forename: S
authors.initials: S
authors.lastname: Pugh
authors.forename: R
authors.initials: R
authors.lastname: Dickinson
authors.forename: M
authors.initials: M
authors.lastname: Dronfield
authors.forename: C J
authors.initials: CJ
authors.lastname: Speirs
authors.forename: P
authors.initials: P
authors.lastname: Wilkinson
authors.forename: S P
authors.initials: SP
authors.lastname: Wilkinson
mesh_terms: D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D020551:Pulse Therapy, Drug; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; C013218:prednisolone 21-3-sulfobenzoate; D011239:Prednisolone