Evidence map›Paper›PMID 36089595›Full record

ArticleTrials2022

Study protocol for a randomised controlled trial of diacerein versus placebo to treat knee osteoarthritis with effusion-synovitis (DICKENS).

Guoqi Cai, Graeme Jones, Flavia M Cicuttini, Anita E Wluka, Yuanyuan Wang, Catherine Hill, Helen Keen, Benny Antony, Xia Wang, Barbara de Graaff and 4 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.5field-weighted citation impact, top 17% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 2 countries.

Guoqi CaiDepartment of Epidemiology and Biostatistics, School of Public Health, Anhui Medical University, Hefei, Anhui, China. Guoqi.Cai@utas.edu.au.ORCID http://orcid.org/0000-0002-6481-704X
Graeme JonesMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Flavia M CicuttiniDepartment of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Anita E WlukaDepartment of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Yuanyuan WangDepartment of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Catherine HillThe Queen Elizabeth Hospital, University of Adelaide, Woodville, SA, Australia.
Helen KeenDepartment of Rheumatology, Fiona Stanley Hospital, Murdoch Drive, Murdoch, WA, Australia.
Benny AntonyMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Xia WangRheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, NSW, Australia.
Barbara de GraaffMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Michael ThompsonMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Tania WinzenbergMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Kathy ButtigiegMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Dawn AitkenMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
University of Tasmania · AUMonash University · AUQueen Elizabeth Hospital · AUThe University of Sydney · AUThe University of Western Australia · AU

Funding

National Health and Medical Research Council APP1147370
6 · The paper itself

Abstract

backgroundThere is an unmet need for treatments for knee osteoarthritis (OA). Effusion-synovitis is a common inflammatory phenotype of knee OA and predicts knee pain and structural degradation. Anti-inflammatory therapies, such as diacerein, may be effective for this phenotype. While diacerein is recommended for alleviating pain in OA patients, evidence for its effectiveness is inconsistent, possibly because studies have not targeted patients with an inflammatory phenotype. Therefore, we will conduct a multi-centre, randomised, placebo-controlled double-blind trial to determine the effect of diacerein on changes in knee pain and effusion-synovitis over 24 weeks in patients with knee OA and magnetic resonance imaging (MRI)-defined effusion-synovitis.

methodsWe will recruit 260 patients with clinical knee OA, significant knee pain, and MRI-detected effusion-synovitis in Hobart, Melbourne, Adelaide, and Perth, Australia. They will be randomly allocated to receive either diacerein (50mg twice daily) or identical placebo for 24 weeks. MRI of the study knee will be performed at screening and after 24 weeks of intervention. The primary outcome is improvement in knee pain at 24 weeks as assessed by a 100-mm visual analogue scale (VAS). Secondary outcomes include improvement in volumetric (ml) and semi-quantitative (Whole-Organ Magnetic Resonance Imaging Score, 0-3) measurements of effusion-synovitis using MRI over 24 weeks, and improvement in knee pain (VAS) at 4, 8, 12, 16, and 20 weeks. Intention-to-treat analyses of primary and secondary outcomes will be performed as the primary analyses. Per protocol analyses will be performed as the secondary analyses. DISCUSSION: This study will provide high-quality evidence to determine whether diacerein improves pain, changes disease trajectory, and slows disease progression in OA patients with effusion-synovitis. If diacerein proves effective, this has the potential to significantly benefit the substantial proportion (up to 60%) of knee OA patients with an inflammatory phenotype.

trial registrationAustralian and New Zealand Clinical Trial Registry ACTRN12618001656224 . Registered on 08 October 2018.

Indexed as

Osteoarthritis, KneeSynovitisAnthraquinonesAustraliaHumansMulticenter Studies as TopicPainRandomized Controlled Trials as TopicTreatment OutcomeAnthraquinonesdiacereinDiacereinEffusion-synovitisKnee painMagnetic resonance imaging (MRI)Osteoarthritis (OA)Randomised controlled trial

Identifiers

PMID36089595
PMCPMC9464426
OpenAlexW4295162448

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.