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 language | English |
|---|---|
| Pages (from-to) | 741-751 |
| Number of pages | 11 |
| Journal | Alimentary Pharmacology and Therapeutics |
| Volume | 38 |
| Issue number | 7 |
| DOIs | |
| Publication status | Published - Oct 2013 |
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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 journal › Article
}
TY - JOUR
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).
UR - http://www.scopus.com/inward/record.url?scp=84883475412&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84883475412&partnerID=8YFLogxK
U2 - 10.1111/apt.12463
DO - 10.1111/apt.12463
M3 - Article
C2 - 23957734
AN - SCOPUS:84883475412
VL - 38
SP - 741
EP - 751
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
SN - 0269-2813
IS - 7
ER -