Randomised clinical trial: Mesalazine and/or probiotics in maintaining remission of symptomatic uncomplicated diverticular disease - A double-blind, randomised, placebo-controlled study

A. Tursi, G. Brandimarte, W. Elisei, M. Picchio, G. Forti, G. Pianese, S. Rodino, T. D'Amico, N. Sacca, P. Portincasa, E. Capezzuto, R. Lattanzio, A. Spadaccini, S. Fiorella, F. Polimeni, N. Polimeni, V. Stoppino, G. Stoppino, G. M. Giorgetti, F. AielloS. Danese

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Abstract

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 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). Conclusion 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).

Original languageEnglish
Pages (from-to)741-751
Number of pages11
JournalAlimentary Pharmacology and Therapeutics
Volume38
Issue number7
DOIs
Publication statusPublished - Oct 2013

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Mesalamine
Probiotics
Lactobacillus casei
Randomized Controlled Trials
Placebos
Recurrence
Diverticulitis
Abdominal Pain
Colon
Therapeutics

ASJC Scopus subject areas

  • Pharmacology (medical)

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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. / 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.

In: Alimentary Pharmacology and Therapeutics, Vol. 38, No. 7, 10.2013, p. 741-751.

Research output: Contribution to journalArticle

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, GM, Aiello, F & Danese, S 2013, 'Randomised clinical trial: Mesalazine and/or probiotics in maintaining remission of symptomatic uncomplicated diverticular disease - A double-blind, randomised, placebo-controlled study', Alimentary Pharmacology and Therapeutics, vol. 38, no. 7, pp. 741-751. https://doi.org/10.1111/apt.12463
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. / Randomised clinical trial : Mesalazine and/or probiotics in maintaining remission of symptomatic uncomplicated diverticular disease - A double-blind, randomised, placebo-controlled study. In: Alimentary Pharmacology and Therapeutics. 2013 ; Vol. 38, No. 7. pp. 741-751.
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abstract = "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 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). Conclusion 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).",
author = "A. Tursi and G. Brandimarte and W. Elisei and M. Picchio and G. Forti and G. Pianese and S. Rodino and T. D'Amico and N. Sacca and P. Portincasa and E. Capezzuto and R. Lattanzio and A. Spadaccini and S. Fiorella and F. Polimeni and N. Polimeni and V. Stoppino and G. Stoppino and Giorgetti, {G. M.} and F. Aiello and S. Danese",
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T1 - Randomised clinical trial

T2 - Mesalazine and/or probiotics in maintaining remission of symptomatic uncomplicated diverticular disease - A double-blind, randomised, placebo-controlled study

AU - Tursi, A.

AU - Brandimarte, G.

AU - Elisei, W.

AU - Picchio, M.

AU - Forti, G.

AU - Pianese, G.

AU - Rodino, S.

AU - D'Amico, T.

AU - Sacca, N.

AU - Portincasa, P.

AU - Capezzuto, E.

AU - Lattanzio, R.

AU - Spadaccini, A.

AU - Fiorella, S.

AU - Polimeni, F.

AU - Polimeni, N.

AU - Stoppino, V.

AU - Stoppino, G.

AU - Giorgetti, G. M.

AU - Aiello, F.

AU - Danese, S.

PY - 2013/10

Y1 - 2013/10

N2 - 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 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). Conclusion 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).

AB - 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 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). Conclusion 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).

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