BACKGROUND AND AIM: Recurrence of diverticulitis is frequent within 5 years from the uncomplicated first attack, and its prophylaxis is still unclear. We have undertaken a multicentre, randomised, double-blind, placebo-controlled pilot study in order to evaluate the role of mesalazine in preventing diverticulitis recurrence as well as its effects on symptoms associated to diverticular disease. METHODS:Ninety-six patients with the recent first episode of uncomplicated diverticulitis were randomised to receive mesalazine 800 mg twice daily for 10 days every month or placebo for 24 months. The primary efficacy end point was the diverticulitis recurrence at intention to treat analysis. Clinical evaluations were performed using the Therapy Impact Questionnaire (TIQ) for physical condition and quality of life at admission and at 3-month intervals. Treatment tolerability and routine biochemistry parameters as well as the use of additional drugs were also evaluated. RESULTS:Ninety-two patients (mean age, 61.5) completed the study, 45 of whom receivedmesalazine, and 47, placebo. Diverticulitis relapse incidence in mesalazine-treated group was 5/45 (11%) at the 12th month and 6/45 (13%) at the 24th month; in the placebo-treated group, the correspondent rates were 13% (6/47) and 28% (13/47), respectively. Mean values of TIQ at 24 months were significantly better in mesalazine-treated group than in placebo-treated group (p = 0.02); in addition, average additional drug consumption was significantly lower (-20.4%, p < 0.03) in mesalazine than in placebo. CONCLUSIONS:Diverticulitis recurrence occurred in as many as 28% of patients under placebo within 24 months from the initial episode. Intermittent prophylaxis with mesalazine did not significantly reduce the risk of relapse but induced a significant improvement of patients' physical conditions and significantly lowered the additional consumption of other gastrointestinal drugs.
RCT Entities:
BACKGROUND AND AIM: Recurrence of diverticulitis is frequent within 5 years from the uncomplicated first attack, and its prophylaxis is still unclear. We have undertaken a multicentre, randomised, double-blind, placebo-controlled pilot study in order to evaluate the role of mesalazine in preventing diverticulitis recurrence as well as its effects on symptoms associated to diverticular disease. METHODS: Ninety-six patients with the recent first episode of uncomplicated diverticulitis were randomised to receive mesalazine 800 mg twice daily for 10 days every month or placebo for 24 months. The primary efficacy end point was the diverticulitis recurrence at intention to treat analysis. Clinical evaluations were performed using the Therapy Impact Questionnaire (TIQ) for physical condition and quality of life at admission and at 3-month intervals. Treatment tolerability and routine biochemistry parameters as well as the use of additional drugs were also evaluated. RESULTS: Ninety-two patients (mean age, 61.5) completed the study, 45 of whom received mesalazine, and 47, placebo. Diverticulitis relapse incidence in mesalazine-treated group was 5/45 (11%) at the 12th month and 6/45 (13%) at the 24th month; in the placebo-treated group, the correspondent rates were 13% (6/47) and 28% (13/47), respectively. Mean values of TIQ at 24 months were significantly better in mesalazine-treated group than in placebo-treated group (p = 0.02); in addition, average additional drug consumption was significantly lower (-20.4%, p < 0.03) in mesalazine than in placebo. CONCLUSIONS:Diverticulitis recurrence occurred in as many as 28% of patients under placebo within 24 months from the initial episode. Intermittent prophylaxis with mesalazine did not significantly reduce the risk of relapse but induced a significant improvement of patients' physical conditions and significantly lowered the additional consumption of other gastrointestinal drugs.
Authors: Francesco Di Mario; Giovanni Aragona; Gioacchino Leandro; Giuseppe Comparato; Libera Fanigliulo; Lucas G Cavallaro; Giulia M Cavestro; Veronica Iori; Marta Maino; Alì M Moussa; Alessandro Gnocchi; Giancarlo Mazzocchi; Angelo Franzé Journal: Dig Dis Sci Date: 2005-03 Impact factor: 3.199
Authors: Rosario Cuomo; Giovanni Barbara; Fabio Pace; Vito Annese; Gabrio Bassotti; Gian Andrea Binda; Tino Casetti; Antonio Colecchia; Davide Festi; Roberto Fiocca; Andrea Laghi; Giovanni Maconi; Riccardo Nascimbeni; Carmelo Scarpignato; Vincenzo Villanacci; Bruno Annibale Journal: United European Gastroenterol J Date: 2014-10 Impact factor: 4.623
Authors: G A Binda; R Cuomo; A Laghi; R Nascimbeni; A Serventi; D Bellini; P Gervaz; B Annibale Journal: Tech Coloproctol Date: 2015-09-16 Impact factor: 3.781
Authors: Antonio Tursi; Giovanni Brandimarte; Francesco Di Mario; Maria L Annunziata; Mauro Bafutto; Maria A Bianco; Raffaele Colucci; Rita Conigliaro; Silvio Danese; Rudi De Bastiani; Walter Elisei; Ricardo Escalante; Roberto Faggiani; Luciano Ferrini; Giacomo Forti; Giovanni Latella; Maria G Graziani; Enio C Oliveira; Alfredo Papa; Antonio Penna; Piero Portincasa; Kjetil Søreide; Antonio Spadaccini; Paolo Usai; Stefanos Bonovas; Carmelo Scarpignato; Marcello Picchio; Piera G Lecca; Costantino Zampaletta; Claudio Cassieri; Alberto Damiani; Kari F Desserud; Serafina Fiorella; Rosario Landi; Elisabetta Goni; Maria A Lai; Flavia Pigò; Gianluca Rotondano; Giuseppe Schiaccianoce Journal: United European Gastroenterol J Date: 2015-11-13 Impact factor: 4.623