Randomised clinical trial: mesalazine and/or probiotics in maintaining remission of symptomatic uncomplicated diverticular disease – a double‐blind, randomised, placebo‐controlled study. Issue 7 (19th August 2013)

• Record Type: Journal Article
• Authors: 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.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 38:Issue 7(2013)
• Page Start: 741
• Page End: 751
• Publication Date: 2013-08-19
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.12463
• Languages: English
• ISSNs: 0269-2813

Abstract

<abstract abstract-type="main" id="apt12463-abs-0001"> <title>Summary</title> <sec id="apt12463-sec-0001" sec-type="section"> <title>Background</title> <p>Placebo‐controlled studies in maintaining remission of symptomatic uncomplicated diverticular disease (SUDD) of the colon are lacking.</p> </sec> <sec id="apt12463-sec-0002" sec-type="section"> <title>Aim</title> <p>To assess the effectiveness of mesalazine and/or probiotics in maintaining remission in SUDD.</p> </sec> <sec id="apt12463-sec-0003" sec-type="section"> <title>Methods</title> <p>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 <italic>Lactobacillus casei</italic> subsp. <italic>DG</italic> placebo), Group L (active <italic>Lactobacillus casei</italic> subsp. <italic>DG</italic> 24 billion/day plus mesalazine placebo), Group LM (active <italic>Lactobacillus casei</italic> subsp. <italic>DG</italic> 24 billion/day plus active mesalazine), Group P (<italic>Lactobacillus casei</italic> subsp. <italic>DG</italic> 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.</p> </sec> <sec id="apt12463-sec-0004" sec-type="section"> <title>Results</title> <p>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, <italic>P</italic> = 0.015; LM group vs. L group, <italic>P</italic> = 0.011; LM group vs. P group, <italic>P</italic> = 0.000; M group vs. P group, <italic>P</italic> = 0.000; L group vs. P group, <italic>P</italic> = 0.000). Acute diverticulitis occurred in six group P cases and in one group L case (<italic>P</italic> = 0.003).</p> </sec> <sec id="apt12463-sec-0005" sec-type="section"> <title>Conclusion</title> <p>Both cyclic mesalazine and <italic>Lactobacillus casei</italic> subsp. <italic>DG</italic> treatments, particularly when given in combination, appear to be better than placebo for maintaining remission of symptomatic uncomplicated diverticular disease. (ClinicalTrials.gov: NCT01534754).</p> </sec> </abstract>