Mesalazine in treating diverticular disease of the colon

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Author: Antonio Tursi
Date: July 2013
Publisher: Expert Reviews Ltd.
Document Type: Report
Length: 2,335 words
Lexile Measure: 1350L

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Author(s): Antonio Tursi [*] 1



diverticular disease; mesalazine; placebo; randomized trial

Summary of methods & results


A double-blind, randomized, placebo-controlled, parallel-group trial was recently performed at 17 centers in Germany. The primary end point of the study was to investigate the efficacy and safety of mesalazine granules (Salofalk granules, Dr Falk Pharma GmbH) 1 gm three-times daily versus placebo in patients with lower abdominal pain as a symptom of uncomplicated diverticular disease (DD) [1] .

Patients were enrolled who had a minimum of four diverticula observed on endoscopy examination at baseline, and at least four out of eight specified symptoms present for at least the previous 2 days before inclusion and still present at study inclusion were reported: abdominal pain localized mainly in the lower left part of the abdomen; abdominal pain enhanced after meals; abdominal pain decreased after defecation or wind; bloating; constipation (defined as two defecations/week); diarrhea (defined as >three loose stools/day); a sensation of incomplete evacuation after defecation and painful lower left abdomen (at palpation). All patients were instructed to follow nutritional recommendations including consumption of meals rich in fiber and adequate intake of liquids (at least 2 l/day).

No concomitant administration of any other drugs for the treatment of GI tract disorders was permitted that could affect the results or interfere with the study medication, with the exception of short-acting spasmolytics (e.g., butylscopolaminiumbromide) and short-acting analgesics (e.g., paracetamol). Opioids were prohibited.

Patients were assessed at baseline (day 1) and at weeks 2, 4 and 6. The primary end point was assessed by a daily diary from day 1 onwards, which was checked at all visits and included daily scoring of the most severe lower abdominal pain intensity experienced, which was to be completed by the patient at the end of each day using a 5-point scale (from 1: 'no pain' to 5: 'most severe pain'), the number of daily stools and the main stool consistency. The combined symptom score according to Brodribb was assessed at each visit, using the sum of seven visual analog scales (VAS; 100 mm) for seven questions.


The primary end point

The sum of differences in lower abdominal pain intensity from baseline to week 4 calculated over the first 4 weeks of treatment did not show a significant difference on intention-to-treat (ITT) analysis (p = 0.374; Hodges-Lehmann difference: -3.5). However, the per-protocol (PP) analysis found the difference significant when baseline score was defined on day 1 of treatment (p = 0.010; Hodges, Lehmann difference: -14). When data were adjusted for the intake of analgesic or spasmolytic medication by increasing the pain score to the maximum value and for the other confounder 'baseline lower abdominal pain intensity (median from day 7 to 1)', 'localization of diverticula in the descending colon' and 'baseline combined symptom score (Brodribb)' in the ANCOVA model, the resulting p-values for the between group differences in the primary end point decreased strongly both under ITT (p = 0.111; adjusted difference: 6.9) and under PP analysis (p = 0.005;...

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Source Citation   

Gale Document Number: GALE|A339495922