Henrotin et al. BMC Musculoskeletal Disorders https://doi.org/10.1186/s12891-022-05612-2
RESEARCH Rubus idaeus extract improves symptoms in knee osteoarthritis patients: results from a phase II double‑blind randomized controlled trial Yves Henrotin 1,2,3* , Romain Le Cozannet 4 , Pascale Fança‑Berthon 4 , Romain Truillet 5 , Martine Cohen‑Solhal 6 , Gillian DunnGalvin 7 , Jean‑Marie Grouin 8 and Andrea Doolan 7 Abstract Background: Osteoarthritis (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. Objective: This study aimed to evaluate the effects of a 12-weeks intervention with an ethanolic extract from Rubus idaeus leaf on symptoms of knee osteoarthritis. Method: The 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 Activ‑ ity 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. Results: In 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.
*Correspondence: firstname.lastname@example.org 1 musculoSKeletal 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 Full list of author information is available at the end of the article
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