title: A randomized controlled study of mesalamine after acute diverticulitis: results of the DIVA trial.
abstract: OBJECTIVE
  We evaluated the efficacy of mesalamine (Asacol) in reducing gastrointestinal symptoms after an acute attack of diverticulitis.
  
  
  METHODS
  This was a 1-year double-blind, randomized, placebo-controlled study in which patients with computed tomography scan confirmed acute diverticulitis received placebo, mesalamine, or mesalamine+Bifidobacterium infantis 35624 (Align) for 12 weeks and followed for 9 additional months. Efficacy was assessed using a global symptom score (GSS) of 10 symptoms (abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus, urgency, painful straining, and dysuria). Patients were required to have a GSS≥12 at baseline, including an abdominal pain score >2.
  
  
  RESULTS
  One hundred seventeen patients (placebo, 41; mesalamine, 40; mesalamine+probiotic, 36) were randomized and treated. GSS decreased in all groups during treatment without a statistically significant difference between mesalamine and placebo, however; scores were consistently lower for mesalamine at all time points. The rate of complete response (GSS=0) was significantly higher with mesalamine than placebo at weeks 6 and 52 (P<0.05), and was particularly high for rectosigmoid symptoms at weeks 6, 12, 26, and 52. Recurrence of diverticulitis was low and comparable across groups. Probiotic in combination with mesalamine did not provide additional efficacy.
  
  
  CONCLUSIONS
  In the first US randomized placebo-controlled trial of anti-inflammatory treatment after a documented case of diverticulitis, mesalamine demonstrated a consistent trend in reducing symptoms. Addition of probiotic did not increase mesalamine efficacy. This study supports further investigation into the use of anti-inflammatory agents, such as mesalamine, in the long-term management of diverticulitis. ClinicalTrials.gov NCT00554099.
authors: Division of Gastroenterology, Department of Medicine, University of California San Francisco, Oakland, CA, USA. neil@stollman.com
authors: Neil
authors: N
authors: Stollman
authors: Simon
authors: S
authors: Magowan
authors: Fergus
authors: F
authors: Shanahan
authors: Eamonn M M
authors: EM
authors: Quigley
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D001644:Bifidobacterium; D003108:Colonic Diseases / Q000175:diagnosis / Q000188:drug therapy*; D004238:Diverticulitis / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D012720:Severity of Illness Index; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014481:United States
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine