title: Randomised clinical trial: mesalazine and/or probiotics in maintaining remission of symptomatic uncomplicated diverticular disease--a double-blind, randomised, placebo-controlled study.
abstract: BACKGROUND
  Placebo-controlled studies in maintaining remission of symptomatic uncomplicated diverticular disease (SUDD) of the colon are lacking.
  
  
  OBJECTIVE
  To assess the effectiveness of mesalazine and/or probiotics in maintaining remission in SUDD.
  
  
  METHODS
  A multicentre, double-blind, placebo-controlled study was conducted. Two hundred and ten patients were randomly enrolled in a double-blind fashion in four groups: Group M (active mesalazine 1.6 g/day plus Lactobacillus casei subsp. DG placebo), Group L (active Lactobacillus casei subsp. DG 24 billion/day plus mesalazine placebo), Group LM (active Lactobacillus casei subsp. DG 24 billion/day plus active mesalazine), Group P (Lactobacillus casei subsp. DG placebo plus mesalazine placebo). Patients received treatment for 10 days/month for 12 months. Recurrence of SUDD was defined as the reappearance of abdominal pain during follow-up, scored as ≥5 (0: best; 10: worst) for at least 24 consecutive hours.
  
  
  RESULTS
  Recurrence of SUDD occurred in no (0%) patient in group LM, in 7 (13.7%) patients in group M, in 8 (14.5%) patients in group L and in 23 (46.0%) patients in group P (LM group vs. M group, P = 0.015; LM group vs. L group, P = 0.011; LM group vs. P group, P = 0.000; M group vs. P group, P = 0.000; L group vs. P group, P = 0.000). Acute diverticulitis occurred in six group P cases and in one group L case (P = 0.003).
  
  
  CONCLUSIONS
  Both cyclic mesalazine and Lactobacillus casei subsp. DG treatments, particularly when given in combination, appear to be better than placebo for maintaining remission of symptomatic uncomplicated diverticular disease. (ClinicalTrials.gov: NCT01534754).
authors: Gastroenterology Service, ASL BAT, Andria (BT), Italy. antotursi@tiscali.it
authors: A
authors: A
authors: Tursi
authors: G
authors: G
authors: Brandimarte
authors: W
authors: W
authors: Elisei
authors: M
authors: M
authors: Picchio
authors: G
authors: G
authors: Forti
authors: G
authors: G
authors: Pianese
authors: S
authors: S
authors: Rodino
authors: T
authors: T
authors: D'Amico
authors: N
authors: N
authors: Sacca
authors: P
authors: P
authors: Portincasa
authors: E
authors: E
authors: Capezzuto
authors: R
authors: R
authors: Lattanzio
authors: A
authors: A
authors: Spadaccini
authors: S
authors: S
authors: Fiorella
authors: F
authors: F
authors: Polimeni
authors: N
authors: N
authors: Polimeni
authors: V
authors: V
authors: Stoppino
authors: G
authors: G
authors: Stoppino
authors: G M
authors: GM
authors: Giorgetti
authors: F
authors: F
authors: Aiello
authors: S
authors: S
authors: Danese
mesh_terms: D015746:Abdominal Pain / Q000209:etiology; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D004241:Diverticulum, Colon / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007778:Lactobacillus; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D019936:Probiotics / Q000627:therapeutic use*; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine