Evidence map›Paper›PMID 31351488›Full record

Trial reportArthritis research & therapy2019

Bio-optimized Curcuma longa extract is efficient on knee osteoarthritis pain: a double-blind multicenter randomized placebo controlled three-arm study.

Y Henrotin, M Malaise, R Wittoek, K de Vlam, J-P Brasseur, F P Luyten, Q Jiangang, M Van den Berghe, R Uhoda, J Bentin and 4 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02909621 (Evaluation of Efficacy, Tolerance, and Dose Effects of a Curcuma Extract), which is not on this map. Cited by 60 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 11 pooled it
12.0field-weighted citation impact, top 1% 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.

NCT02909621 nacompletednot on this map

Evaluation of Efficacy, Tolerance, and Dose Effects of a Curcuma Extract (FLEXOFYTOL®) Versus PLACEBO in Patients With Knee osteoARthritis (COPRA)

TypeinterventionalSponsorTilman S.A.Ran2014 to 2017Enrolled150ConditionsOsteoarthritisArmsFLEXOFYTOL®, PLACEBO
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 11 syntheses or guidelines pooled it, 106 citations in OpenAlex.

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  8. Efficacy and Safety of Curcumin andFrontiers in immunology · 2022
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  20. Pharmacological Insights and Technological Innovations inPharmaceuticals (Basel, Switzerland) · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 9 institutions in 1 country.

Y HenrotinBone and Cartilage Research Unit, Arthropôle Liège, Institute of Pathology, Level 5, CHU Sart-Tilman, University of Liège, 4000, Liège, Belgium. yhenrotin@uliege.be.ORCID 0000-0002-2846-4398
M MalaiseRheumatology Department, CHU Sart-Tilman, Liège, Belgium.
R WittoekRheumatology Department, UZ Gent, Ghent, Belgium.
K de VlamRheumatology Department, ZNA Jan Palfijn, Merksem, Belgium.
J-P BrasseurRheumatology Department, CHU UCL Namur, Yvoir, Belgium.
F P LuytenRheumatology Department, University Hospitals Leuven, Leuven, Belgium.
Q JiangangRheumatology and Physical Medicine Department, Hôpitaux Iris Sud, Bruxelles, Belgium.
M Van den BergheRheumatology Department, Algemeen Stedelijk Ziekenhuis, Aalst, Belgium.
R UhodaPhysical Medicine and Rehabilitation Department, Centre Hospitalier du Bois de l'Abbaye, Seraing, Belgium.
J BentinRheumatology Department, CHU Brugmann, Bruxelles, Belgium.
T De VroeyPhysical Medicine, UZA, Antwerpen, Belgium.
L Erpicum, Anthisnes, Belgium.
A F DonneauPublic health Science Department, University of Liège, Liège, Belgium.
Y DierckxsensTilman SA, Baillonville, Belgium.
University of Liège · BEAntea Group (Belgium) · BEAZ Sint-Jan · BECentre Hospitalier Universitaire Brugmann · BECentre Hospitalier Universitaire de Liège · BECHU Dinant Godinne UCL Namur · BEGhent University Hospital · BEHôpitaux Iris Sud · BEKU Leuven · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesComparison of two doses of bio-optimized Curcuma longa extract (BCL) in the management of symptomatic knee osteoarthritis (OA).

methodsA prospective, randomized, 3-month, double-blind, multicenter, three-group, placebo-controlled trial assessing Patient Global Assessment of Disease Activity (PGADA) and serum sColl2-1, a biomarker of cartilage degradation, as co-primary endpoints. Pain on visual analog scale (VAS), Knee injury and Osteoarthritis Outcome Score (KOOS), and paracetamol/non-steroidal anti-inflammatory drug (NSAID) consumption were used as secondary endpoints.

resultsOne hundred fifty patients with knee OA were followed for 90 days. Low and high doses of BCL showed a greater decrease of PGADA than placebo. Analysis of sColl2-1 showed in the placebo and BCL low-dose groups, but not in the BCL high-dose group, a transient but non-significant increase of sColl2-1 between T0 and T1. Thereafter, in all groups, sColl2-1 decreased between T1 and T3 (all p < 0.01), but no difference between the groups was found. Pain reduction at day 90 in the low- and high-dose BCL groups (- 29.5 mm and - 36.5 mm) was higher than that in the placebo (- 8 mm; p = 0.018). The global KOOS significantly decreased overtime, but changes were comparable across treatment arms. The ratio of patients with adverse events (AE) related to the product was similar in the placebo and treatment groups, but the number of AE linked to the product was higher in the high-dose BCL group compared to the placebo (p = 0.012).

conclusionsBCL appeared safe and well-tolerated with no evidence of severe adverse effects. Efficacy analysis suggested positive trends for measurements of PGADA and serum levels of an OA biomarker and showed a rapid and significant decrease of pain in knee OA (Trial registration: ISRCTN, ISRCTN12345678. Registered 21 September 2016-retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02909621?term=osteoarthritis+curcumin&rank=5-Evaluation of FLEXOFYTOL® Versus PLACEBO (COPRA) NCT02909621).

Indexed as

AgedAged, 80 and overAntioxidantsArthralgiaCurcumaDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedOsteoarthritis, KneePain MeasurementPlant ExtractsProspective StudiesTreatment OutcomeAntioxidantsPlant Extractsturmeric extractBiomarkersCurcuminOsteoarthritis

Identifiers

PMID31351488
PMCPMC6661105
OpenAlexW2965857448

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.