Evidence map›Paper›PMID 38777590›Full record

ArticleBMJ open2024

Efficacy and safety of pentosan polysulfate sodium in people with symptomatic knee osteoarthritis and dyslipidaemia: protocol of the MaRVeL trial.

Md Abu Bakar Siddiq, Xiaoqian Liu, Tatyana Fedorova, Karen Bracken, Sonika Virk, Venkatesha Venkatesha, Abdolhay Farivar, Win Min Oo, James Linklater, David Cullis Hill and 1 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. Review
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

11 authors.

Md Abu Bakar SiddiqDepartment of Rheumatology, Royal North Shore Hospital, Northern Clinical School, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia msid8426@uni.sydney.edu.au.ORCID 0000-0001-9964-599X
Xiaoqian LiuDepartment of Rheumatology, Royal North Shore Hospital, Northern Clinical School, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.
Tatyana FedorovaThe University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.
Karen BrackenSydney Musculoskeletal Health, The University of Sydney, Sydney, New South Wales, Australia, Kolling Institute of Medical Research, St Leonards, New South Wales, Australia.
Sonika VirkDepartment of Rheumatology, Royal North Shore Hospital, Northern Clinical School, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.
Venkatesha VenkateshaRheumatology Department, Royal North Shore Hospital, St Leonards, New South Wales, Australia.
Abdolhay FarivarDepartment of Rheumatology, Royal North Shore Hospital, Northern Clinical School, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.
Win Min OoRheumatology, Kolling Institute of Medical Research, St Leonards, New South Wales, Australia.
James LinklaterCastlereagh Imaging, St Leonard, NSW, St Leonard, New South Wales, Australia.
David Cullis HillArthropharm Pty Ltd, St Leonard, New South Wales, Australia.
David J HunterDepartment of Rheumatology, Royal North Shore Hospital, Northern Clinical School, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.ORCID 0000-0003-3197-752X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionKnee osteoarthritis (OA) is the most prevalent arthritis type and a leading cause of chronic mobility disability. While pain medications provide only symptomatic pain relief; growing evidence suggests pentosan polysulfate sodium (PPS) is chondroprotective and could have anti-inflammatory effects in knee OA. This study aims to explore the efficacy and safety of oral PPS in symptomatic knee OA with dyslipidaemia. METHODS AND ANALYSIS: MaRVeL is a phase II, single-centre, parallel, superiority trial which will be conducted at Royal North Shore Hospital, Sydney, Australia. 92 participants (46 per arm) aged 40 and over with painful knee OA and mild to moderate structural change on X-ray (Kellgren and Lawrence grade 2 or 3) will be recruited from the community and randomly allocated to receive two cycles of either oral PPS or placebo for 5 weeks starting at baseline and week 11. Primary outcome will be the 16-week change in overall average knee pain severity measured using an 11-point Numeric Rating Scale. Main secondary outcomes include change in knee pain, patient global assessment, physical function, quality of life and other structural changes. A biostatistician blinded to allocation groups will perform the statistical analysis according to the intention-to-treat principle. ETHICS AND DISSEMINATION: The protocol has been approved by the NSLHD Human Research Ethics Committee (HREC) (2021/ETH00315). All participants will provide written informed consent online. Study results will be disseminated through conferences, social media and academic publications. TRIAL REGISTRATION NUMBERS: Australian New Zealand Clinical Trial Registry (ACTRN12621000654853); U1111-1265-3750.

Indexed as

DyslipidemiasOsteoarthritis, KneePentosan Sulfuric PolyesterAdultAustraliaClinical Trials, Phase II as TopicEquivalence Trials as TopicFemaleHumansMaleMiddle AgedPain MeasurementQuality of LifeTreatment OutcomePentosan Sulfuric PolyesterClinical TrialKneeOsteoarthritisPAIN MANAGEMENTPhase II as Topic

Identifiers

PMID38777590
PMCPMC11116866

What OpenQuestion holds

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Registered trials

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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.