title: Intermittent treatment with mesalazine in the prevention of diverticulitis recurrence: a randomised multicentre pilot double-blind placebo-controlled study of 24-month duration.
abstract: OBJECTIVE
  Recurrence of diverticulitis is frequent within 5 years from the uncomplicated first attack, and its prophylaxis is still unclear. We have undertaken a multicentre, randomised, double-blind, placebo-controlled pilot study in order to evaluate the role of mesalazine in preventing diverticulitis recurrence as well as its effects on symptoms associated to diverticular disease.
  
  
  METHODS
  Ninety-six patients with the recent first episode of uncomplicated diverticulitis were randomised to receive mesalazine 800 mg twice daily for 10 days every month or placebo for 24 months. The primary efficacy end point was the diverticulitis recurrence at intention to treat analysis. Clinical evaluations were performed using the Therapy Impact Questionnaire (TIQ) for physical condition and quality of life at admission and at 3-month intervals. Treatment tolerability and routine biochemistry parameters as well as the use of additional drugs were also evaluated.
  
  
  RESULTS
  Ninety-two patients (mean age, 61.5) completed the study, 45 of whom received mesalazine, and 47, placebo. Diverticulitis relapse incidence in mesalazine-treated group was 5/45 (11%) at the 12th month and 6/45 (13%) at the 24th month; in the placebo-treated group, the correspondent rates were 13% (6/47) and 28% (13/47), respectively. Mean values of TIQ at 24 months were significantly better in mesalazine-treated group than in placebo-treated group (p = 0.02); in addition, average additional drug consumption was significantly lower (-20.4%, p < 0.03) in mesalazine than in placebo.
  
  
  CONCLUSIONS
  Diverticulitis recurrence occurred in as many as 28% of patients under placebo within 24 months from the initial episode. Intermittent prophylaxis with mesalazine did not significantly reduce the risk of relapse but induced a significant improvement of patients' physical conditions and significantly lowered the additional consumption of other gastrointestinal drugs.
authors.affiliation: Gastrointestinal Unit, Gastroenterology and Digestive Endoscopy Division, Ospedale "A. Manzoni", Via dell'Eremo 9/11, 23900, Lecco, Italy, f.parente@ospedale.lecco.it.
authors.forename: F
authors.initials: F
authors.lastname: Parente
authors.forename: S
authors.initials: S
authors.lastname: Bargiggia
authors.forename: A
authors.initials: A
authors.lastname: Prada
authors.forename: A
authors.initials: A
authors.lastname: Bortoli
authors.forename: A
authors.initials: A
authors.lastname: Giacosa
authors.forename: B
authors.initials: B
authors.lastname: Germanà
authors.forename: A
authors.initials: A
authors.lastname: Ferrari
authors.forename: G
authors.initials: G
authors.lastname: Casella
authors.forename: G
authors.initials: G
authors.lastname: De Pretis
authors.forename: G
authors.initials: G
authors.lastname: Miori
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016001:Confidence Intervals; D003710:Demography; D004238:Diverticulitis / Q000188:drug therapy* / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D019804:Mesalamine / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010865:Pilot Projects; D010919:Placebos; D012008:Recurrence; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010919:Placebos; D019804:Mesalamine