BACKGROUND: Robust evidence regarding medical intervention for symptomatic uncomplicated colonic diverticular disease (DD) is sparse. AIM: To investigate mesalazine (Salofalk granules) in this setting. METHODS: In a double-blind, placebo-controlled, multicentre, 6-week trial, patients were randomised to mesalazine 1000 mg three times daily or placebo. Primary efficacy endpoint was change in lower abdominal pain to week 4 (baseline defined using pain score from 7 days pre-treatment). RESULTS:Median change in lower abdominal pain with mesalazine vs. placebo was -37 (n = 56) vs. -33 (n = 61) [P = 0.374; 95% CI (-11; 4)] in the intent-to-treat (ITT) population, and -41 (n = 40) vs. -33 (n = 51) [P = 0.053; 95% CI (-18; 0)] in the per-protocol (PP) population, i.e. the primary endpoint was not significantly different. Post hoc adjustment for confounding factors ('baseline pain intensity', 'baseline symptom score (Brodribb)', and 'localisation of diverticula in the descending colon') resulted in P = 0.111 [ITT, 95% CI (-15.4; 1.6)] and P = 0.005 [PP, 95% CI (-19.7; -3.5)]. Between-group differences increased using pain score on day 1 as baseline, and reached significance for the PP population [mesalazine -42, placebo -26, P = 0.010; 95% CI (-25; -3)]. Median change in combined symptom score from baseline to week 4 was 257 mm with mesalazine vs. 198 mm with placebo [P = 0.064; 95% CI (-3; 105)]. More placebo-treated patients received analgesic/spasmolytic concomitant medication (34.4% vs. mesalazine 21.4%), indicating improved pain relief with mesalazine (P = 0.119). Safety was comparable. CONCLUSIONS: A daily dose of 3.0 g mesalazine may relieve pain during a symptomatic flare of uncomplicated DD. In this, the first placebo-controlled double-blind trial in acute uncomplicated DD, mesalazine showed promising therapeutic efficacy.
RCT Entities:
BACKGROUND: Robust evidence regarding medical intervention for symptomatic uncomplicated colonic diverticular disease (DD) is sparse. AIM: To investigate mesalazine (Salofalk granules) in this setting. METHODS: In a double-blind, placebo-controlled, multicentre, 6-week trial, patients were randomised to mesalazine 1000 mg three times daily or placebo. Primary efficacy endpoint was change in lower abdominal pain to week 4 (baseline defined using pain score from 7 days pre-treatment). RESULTS: Median change in lower abdominal pain with mesalazine vs. placebo was -37 (n = 56) vs. -33 (n = 61) [P = 0.374; 95% CI (-11; 4)] in the intent-to-treat (ITT) population, and -41 (n = 40) vs. -33 (n = 51) [P = 0.053; 95% CI (-18; 0)] in the per-protocol (PP) population, i.e. the primary endpoint was not significantly different. Post hoc adjustment for confounding factors ('baseline pain intensity', 'baseline symptom score (Brodribb)', and 'localisation of diverticula in the descending colon') resulted in P = 0.111 [ITT, 95% CI (-15.4; 1.6)] and P = 0.005 [PP, 95% CI (-19.7; -3.5)]. Between-group differences increased using pain score on day 1 as baseline, and reached significance for the PP population [mesalazine -42, placebo -26, P = 0.010; 95% CI (-25; -3)]. Median change in combined symptom score from baseline to week 4 was 257 mm with mesalazine vs. 198 mm with placebo [P = 0.064; 95% CI (-3; 105)]. More placebo-treated patients received analgesic/spasmolytic concomitant medication (34.4% vs. mesalazine 21.4%), indicating improved pain relief with mesalazine (P = 0.119). Safety was comparable. CONCLUSIONS: A daily dose of 3.0 g mesalazine may relieve pain during a symptomatic flare of uncomplicated DD. In this, the first placebo-controlled double-blind trial in acute uncomplicated DD, mesalazine showed promising therapeutic efficacy.
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