Evidence map›Paper›PMID 28543263›Full record

Trial reportAlimentary pharmacology & therapeutics2017

Randomised clinical trial: mesalazine versus placebo in the prevention of diverticulitis recurrence.

W Kruis, V Kardalinos, T Eisenbach, M Lukas, T Vich, I Bunganic, J Pokrotnieks, J Derova, J Kondrackiene, R Safadi and 15 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 23 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 5 pooled it
7.4field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00695643 phase3terminatednot on this map

Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis

TypeinterventionalSponsorDr. Falk Pharma GmbHRan2008 to 2012Enrolled345ConditionsDiverticulitisArmsMesalazine, Placebo
NCT01038739 phase3terminatednot on this map

Double-blind, Dose-response, Randomised, Placebo-controlled, Parallel Group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis

TypeinterventionalSponsorDr. Falk Pharma GmbHRan2010 to 2013Enrolled330ConditionsDiverticulitisArmsMesalazine, Placebo
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 5 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Mesalamine (5-ASA) for the prevention of recurrent diverticulitis.The Cochrane database of systematic reviews · 2017
    Pooled it
  6. Trial
  7. Review
  8. Review
  9. Article
  10. [Diagnosis and Treatment of Colonic Diverticular Disease].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2022
    Review
  11. [Diverticular disease. Clinical appearance, conservative treatment, primary and secondary prophylaxis].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2021
    Review
  12. Diverticulitis: An Update From the Age Old Paradigm.Current problems in surgery · 2020
    Review
  13. Observational
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 6 institutions in 4 countries.

W KruisCologne, Germany.
V KardalinosStuhr, Germany.
T EisenbachLeverkusen, Germany.
M LukasPraha, Czech Republic.
T VichHranice, Czech Republic.
I BunganicPresov, Slovakia.
J PokrotnieksRiga, Latvia.
J DerovaRiga, Latvia.
J KondrackieneKaunas, Lithuania.
R SafadiNazareth, Israel.
D TuculanuTimisoara, Romania.
Z TulassayBudapest, Hungary.
J BanaiBudapest, Hungary.
A CurtinLismore, NSW, Australia.
A E DorofeyevDonetsk, Ukraine.
S F ZakkoBristol, CT, USA.
N FerreiraHagerstown, MD, USA.
S BjörckGothenburg, Sweden.
M M Diez AlonsoAlcalá de Henares, Spain.
J MäkeläOulu, Finland.
N J TalleyCallaghan, NSW, Australia.
K DilgerFreiburg, Germany.
R GreinwaldFreiburg, Germany.
R MohrbacherFreiburg, Germany.ORCID 0000-0002-4976-3629
R SpillerNottingham, UK.
Bristol Hospital · USCidem Hranice (Czechia) · CZHagerstown Community College · USLismore Base Hospital · AUUniversity of Newcastle Australia · AUUniversity of Nottingham · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious studies have reached conflicting conclusions regarding the efficacy of mesalazine in the prevention of recurrent diverticulitis.

aimTo investigate the efficacy and safety of mesalazine granules in the prevention of recurrence of diverticulitis after acute uncomplicated diverticulitis.

methodsTwo phase 3, randomised, placebo-controlled, double-blind multicentre trials (SAG-37 and SAG-51) investigated mesalazine granules in patients with prior episodes (<6 months) of uncomplicated left-sided diverticulitis. Patients were randomised to receive either 3 g mesalazine once daily or placebo (SAG-37, n=345) or to receive either 1.5 g mesalazine once daily, 3 g once daily or placebo for 96 weeks (SAG-51, n=330). The primary endpoint was the proportion of recurrence-free patients during 48 weeks (SAG-37 and SAG-51) or 96 weeks (SAG-51) of treatment.

resultsMesalazine did not increase the proportion of recurrence-free patients over 48 or 96 weeks compared to placebo. In SAG-37, the proportion of recurrence-free patients during 48 weeks was 67.9% with mesalazine and 74.4% with placebo (P=.226). In SAG-51, the proportion of recurrence-free patients over 48 weeks was 46.0% with 1.5 g mesalazine, 52.0% with 3 g mesalazine and 58.0% with placebo (P=.860 for 3 g mesalazine vs placebo) and over 96 weeks 6.9%, 9.8% and 23.1% respectively (P=.980 for 3 g mesalazine vs placebo). Patients with only one diverticulitis episode in the year prior to study entry had a lower recurrence risk compared to >1 episode. Safety data revealed no new adverse events.

conclusionMesalazine was not superior to placebo in preventing recurrence of diverticulitis.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalDiverticulitisDouble-Blind MethodFemaleHumansMaleMesalamineMiddle AgedRecurrenceTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalMesalamine

Identifiers

PMID28543263
PMCPMC5518301
OpenAlexW2618119087

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.