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Randomised clinical trial: mesalazine (Salofalk granules) for uncomplicated diverticular disease of the colon – a placebo‐controlled study
Author(s) -
Kruis W.,
Meier E.,
Schumacher M.,
Mickisch O.,
Greinwald R.,
Mueller R.
Publication year - 2013
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.12248
Subject(s) - medicine , mesalazine , placebo , abdominal pain , clinical endpoint , population , diverticular disease , gastroenterology , placebo controlled study , randomized controlled trial , surgery , inflammatory bowel disease , disease , double blind , alternative medicine , environmental health , pathology
Summary 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.