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Randomised clinical trial: mesalazine and/or probiotics in maintaining remission of symptomatic uncomplicated diverticular disease – a double‐blind, randomised, placebo‐controlled study
Author(s) -
Tursi A.,
Brandimarte G.,
Elisei W.,
Picchio M.,
Forti G.,
Pianese G.,
Rodino S.,
D'Amico T.,
Sacca N.,
Portincasa P.,
Capezzuto E.,
Lattanzio R.,
Spadaccini A.,
Fiorella S.,
Polimeni F.,
Polimeni N.,
Stoppino V.,
Stoppino G.,
Giorgetti G. M.,
Aiello F.,
Danese S.
Publication year - 2013
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.12463
Subject(s) - mesalazine , medicine , placebo , lactobacillus casei , gastroenterology , placebo controlled study , abdominal pain , randomized controlled trial , surgery , inflammatory bowel disease , double blind , disease , pathology , alternative medicine , food science , fermentation , chemistry
Summary Background Placebo‐controlled studies in maintaining remission of symptomatic uncomplicated diverticular disease ( SUDD ) of the colon are lacking. Aim 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 L actobacillus casei subsp. DG placebo), Group L (active L actobacillus casei subsp. DG 24 billion/day plus mesalazine placebo), Group LM (active L actobacillus casei subsp. DG 24 billion/day plus active mesalazine), Group P ( L actobacillus 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). Conclusion Both cyclic mesalazine and L actobacillus 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: NCT 01534754).