Randomised clinical trial: mesalazine (Salofalk granules) for uncomplicated diverticular disease of the colon – a placebo‐controlled study. Issue 7 (17th February 2013)

• Record Type: Journal Article
• Authors: Kruis, W.; Meier, E.; Schumacher, M.; Mickisch, O.; Greinwald, R.; Mueller, R.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 37:Issue 7(2013)
• Page Start: 680
• Page End: 690
• Publication Date: 2013-02-17
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.12248
• Languages: English
• ISSNs: 0269-2813

Abstract

<abstract abstract-type="main" id="apt12248-abs-0001"> <title>Summary</title> <sec id="apt12248-sec-0001" sec-type="section"> <title>Background</title> <p>Robust evidence regarding medical intervention for symptomatic uncomplicated colonic diverticular disease (DD) is sparse.</p> </sec> <sec id="apt12248-sec-0002" sec-type="section"> <title>Aim</title> <p>To investigate mesalazine (Salofalk granules) in this setting.</p> </sec> <sec id="apt12248-sec-0003" sec-type="section"> <title>Methods</title> <p>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).</p> </sec> <sec id="apt12248-sec-0004" sec-type="section"> <title>Results</title> <p>Median change in lower abdominal pain with mesalazine vs. placebo was −37 (<italic>n </italic>= 56) vs. −33 (<italic>n </italic>= 61) [<italic>P</italic> = 0.374; 95% CI (−11; 4)] in the intent‐to‐treat (ITT) population, and −41 (<italic>n </italic>= 40) vs. −33 (<italic>n </italic>= 51) [<italic>P</italic> = 0.053; 95% CI (−18; 0)] in the per‐protocol (PP) population, i.e. the primary endpoint was not significantly different. <italic>Post hoc</italic> adjustment for confounding factors ('baseline pain intensity', 'baseline symptom score (Brodribb)', and 'localisation of diverticula in the descending colon') resulted in <italic>P</italic> = 0.111 [ITT, 95% CI (−15.4; 1.6)] and <italic>P</italic> = 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, <italic>P</italic> = 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 [<italic>P</italic> = 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 (<italic>P</italic> = 0.119). Safety was comparable.</p> </sec> <sec id="apt12248-sec-0005" sec-type="section"> <title>Conclusions</title> <p>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.</p> </sec> </abstract>