Evidence map›Paper›PMID 35799169›Full record

Trial reportBMC musculoskeletal disorders2022

Rubus idaeus extract improves symptoms in knee osteoarthritis patients: results from a phase II double-blind randomized controlled trial.

Yves Henrotin, Romain Le Cozannet, Pascale Fança-Berthon, Romain Truillet, Martine Cohen-Solhal, Gillian DunnGalvin, Jean-Marie Grouin, Andrea Doolan

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03703024 (A Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy of Raspberry Extract to Alleviate Symptoms of Osteoarthritis in the Knee), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 34% 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.

NCT03703024 nacompletednot on this map

A Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy of Raspberry Extract to Alleviate Symptoms of Osteoarthritis in the Knee

TypeinterventionalSponsorAtlantia Food Clinical TrialsRan2017 to 2018Enrolled195ConditionsOsteoarthritis, KneeArmsRaspberry Leaf Extract, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Metabolites · 2023
    Article
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

8 authors at 5 institutions in 3 countries.

Yves HenrotinmusculoSKeletal Innovative Research Lab (mSKIL), The Center for Interdisciplinary Research On Medicines (CIRM), Department of Motricity Center, Institute of Pathology, University of Liège, CHU Sart-Tilman, level 5, 4000, Liège, Belgium. yhenrotin@uliege.be.
Romain Le CozannetNaturex SA, Avignon, France.
Pascale Fança-BerthonNaturex SA, Avignon, France.
Romain TruilletAtlanstat SA, Les Espaces Océane, 3, rue Jules Verne, 44400, Rezé, France.
Martine Cohen-SolhalBIOSCAR Inserm U1132 and Department of Rheumatology, Université de Paris, Hôpital 10 Lariboisière, 75010, Paris, France.
Gillian DunnGalvinAtlantia Clinical Trials, Heron House Offices, Blackpool, T23 R50R, Cork, Ireland.
Jean-Marie GrouinDepartment of Statistics, Rouen University, Rouen, France.
Andrea DoolanAtlantia Clinical Trials, Heron House Offices, Blackpool, T23 R50R, Cork, Ireland.
Atlantia Food Clinical Trials · IENaturex (France) · FRInserm · FRUniversité de Rouen Normandie · FRUniversity of Liège · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOsteoarthritis (OA) is the most frequent cause of disability in elderly people. In daily practice, the main objective of the physician is to reduce patient symptoms using treatments without adverse effects. However, the most prescribed treatment to manage OA symptoms remains nonsteroidal anti-inflammatory drugs which are associated with severe adverse effects. Therefore, we need a safe alternative to managing OA. One candidate is Rubus idaeus leaf extracts known to inhibit inflammatory responses.

objectiveThis study aimed to evaluate the effects of a 12-weeks intervention with an ethanolic extract from Rubus idaeus leaf on symptoms of knee osteoarthritis.

methodThe study was a randomized, double-blind, placebo-controlled, monocentric trial of 198 participants with femorotibial osteoarthritis. Participants were randomized equally to receive one daily during 3 months either 1 capsule of Rubus idaeus leaf extract 400 mg, 1 capsule of Rubus idaeus leaf extract 200 mg, or 1 capsule of placebo. The participants were assessed at baseline and after one and three months of treatment. The primary endpoint was an absolute change of the Western Ontario McMaster osteoarthritis index (WOMAC) pain subscale. The secondary endpoints were WOMAC global score, stiffness and function sub-scales, knee pain VAS score at walking, the Short Form (SF)-36, the Short Physical Performance Battery (SPPB), the 20-m walk test, and the International Physical Activity Questionnaire (IPAQ) and Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) responders rate. Statistical analyses were conducted on the intent-to-treat (ITT) population.

resultsIn the Intention-to-treat population, WOMAC pain was not significantly modified by Rubus idaeus leaf extract compared to placebo. In contrast, Rubus idaeus leaf extract 400 mg after 12 weeks of treatment significantly reduced pain measured by the VAS. The mean pain decrease induced by Rubus ideaus leaf extract was over -7 mm which is clinically relevant and reached a clinically statistical difference compared to placebo with the highest dose. Rubus Ideaus was not significantly more efficient than the placebo on WOMAC global score, stiffness, and physical function subscores, IPAQ, SF-36, walking distance in treadmill test, SPPB, and evaluation of associated treatments needed to manage OA.

conclusionRubus idaeus leaf extract was well tolerated and effective to relieve pain in a patient with knee osteoarthritis.

trial registrationNCT03703024  (11/10/2018).

Indexed as

Osteoarthritis, KneeRubusAgedDouble-Blind MethodHumansPainPlant ExtractsTreatment OutcomePlant ExtractsClinical trialKneeOsteoarthritisPainRubus idaeus

Identifiers

PMID35799169
PMCPMC9261022
OpenAlexW4284688592

What OpenQuestion holds

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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.