A randomized controlled study of mesalamine after acute diverticulitis: Results of the DIVA trial

Neil Stollman, Simon Magowan, Fergus Shanahan, Eamonn Martin Quigley

Research output: Contribution to journalArticle

105 Scopus citations

Abstract

BACKGROUND/AIMS:: 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.

Original languageEnglish (US)
Pages (from-to)621-629
Number of pages9
JournalJournal of Clinical Gastroenterology
Volume47
Issue number7
DOIs
StatePublished - Aug 1 2013

Keywords

  • antiinflammatory
  • diverticular disease
  • diverticulitis
  • mesalamine

ASJC Scopus subject areas

  • Gastroenterology

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