title: Combined oral and rectal mesalazine for the treatment of mild-to-moderately active ulcerative colitis: rapid symptom resolution and improvements in quality of life.
abstract: OBJECTIVE
  Mesalazine (5-aminosalicylic acid) is the standard first-line therapy for mild-to-moderate ulcerative colitis. In the PINCE study, remission rates were significantly greater with combined oral/enema vs. oral/placebo treatment at 8 weeks (64% vs. 43%, respectively; p=0.030). In this analysis, we explored early response, mucosal healing rates, cessation of rectal bleeding, and quality of life in PINCE.
  
  
  METHODS
  Patients with extensive mild-to-moderately active ulcerative colitis received 8weeks of oral mesalazine 4 g/day, plus 4 weeks of daily active (1g mesalazine) or placebo enema. Early response was assessed using the abbreviated ulcerative colitis disease activity index. Mucosal healing was assessed by disease activity index endoscopic mucosal appearance score. Cessation of bleeding (patient diaries), quality of life (EQ-5D), and patient acceptability (questionnaire) were also assessed.
  
  
  RESULTS
  Combined mesalazine oral/enema treatment achieved a significantly higher rate of improvement in abbreviated ulcerative colitis disease activity index (score decrease ≥ 2) within 2 weeks, compared with oral-only treatment (p = 0.032). Bleeding ceased significantly more quickly with combination vs. oral therapy (p = 0.003). More patients showed mucosal healing (disease activity index endoscopic mucosal appearance score 0/1) with combination vs. oral therapy, which was significantly different between groups at week 4 (p = 0.052). Both groups showed quality of life improvements, with a significant benefit for combination vs. oral therapy at week 4 in multiple domains. Most patients reported finding the treatment acceptable.
  
  
  CONCLUSIONS
  Rapid cessation of symptoms was seen with combination therapy, which is particularly important to patients and may improve quality of life.
authors.affiliation: Department of Gastroenterology, University of Liverpool, Liverpool, UK. Electronic address: Chris.Probert@liverpool.ac.uk.
authors.forename: Christopher S J
authors.initials: CS
authors.lastname: Probert
authors.affiliation: Department of Gastroenterology, Hepatology and Oncology, Agaplesion Markus Hospital, Frankfurt, Germany.
authors.forename: Axel U
authors.initials: AU
authors.lastname: Dignass
authors.affiliation: Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden; Department of Gastroenterology, University Hospital Skane, Malmö, Sweden.
authors.forename: Stefan
authors.initials: S
authors.lastname: Lindgren
authors.affiliation: Flevo Ziekenhuis, Hospitaalweg 1, Almere, The Netherlands.
authors.forename: Marco
authors.initials: M
authors.lastname: Oudkerk Pool
authors.affiliation: Department of Hepato-gastroenterology, AP-HP, Lariboisière Hospital, Paris, France; Denis Diderot Paris 7 University, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Marteau
mesh_terms: D000284:Administration, Oral; D000285:Administration, Rectal; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D003093:Colitis, Ulcerative / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D003113:Colonoscopy; D004311:Double-Blind Method; D004733:Enema; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007413:Intestinal Mucosa / Q000503:physiopathology; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage*; D011788:Quality of Life; D012002:Rectal Diseases / Q000188:drug therapy* / Q000209:etiology; D012720:Severity of Illness Index; D013997:Time Factors; D014945:Wound Healing / Q000187:drug effects; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine
keywords: Mesalazine; Mucosal healing; Oral; Rectal suspension; Ulcerative colitis