POS0281 RUBUS IDAEUS LEAF EXTRACT IMPROVES SYMPTOMS IN KNEE OSTEOARTHRITIS PATIENTS: RESULTS FROM A DOUBLE BLIND RANDOMIZED CLINICAL STUDY

Abstract

Background: Osteoarthritis (OA) is the most common cause of disability in older adults. Currently, the aim of the patient management is to reduce symptoms and to improve quality of life using therapeutic modalities with no adverse effects (1). Unfortunately, the first line treatments of OA symptoms remain nonsteroidal anti‐inflammatory drugs (NSAIDS) and paracetamol which if long‐term administration are associated with severe adverse effects. Therefore, we need of save alternative to manage chronic OA symptoms. One candidate is Rubus idaeus (raspberry) leaf extract rich in flavonoids and phenols known to inhibit inflammatory responses. Objectives: The aim of this study was to investigate the effects of a 12‐weeks intervention with an ethanolic extract from Rubus idaeus leaf on symptoms of knee OA. Methods: The study was a randomized, double‐blind, placebo‐controlled, monocentric trial of 198 subjects with femoro‐tibial OA. Subjects were randomized equally to receive one daily treatment during 3 months either of 1 cap of Rubus idaeus leaf extract 400 mg, or 200 mg or placebo (maltodextrine). The main objective of this first exploratory study was to assess pain reduction over time. Pain was measured using different scales from the Western Ontario McMaster osteoarthritis index (WOMAC) to the knee pain VAS. Results: In the ITT population, Rubus idaeus leaf extract 400 mg and 200 mg after 12 weeks of treatment reduced pain measured by the VAS respectively of ‐10.93 (1.95) mm and ‐8.51 (1.92) mm compared to baseline, while placebo group had a ‐3.84 (1.89) mm reduction. The mean pain decrease induced by Rubus ideaus leaf extract was over ‐7 mm which is clinically relevant, and reached clinically statistical difference compared to placebo with the highest dose (p=0.017; 95% CI, ‐13.11 to ‐1.07). Interestingly, subgroup analysis on the participants with a BMI>25, highlighted clinically relevant pain reduction for the 400 and 200 mg doses compared to baseline of respectively ‐13.36 (2.26) mm and ‐11.25 (2.14) mm (placebo = ‐0.37(2.16) mm). The reduction was statistically different versus placebo for both doses (400 mg p<0.0001; 95% CI, (‐19.95 to ‐6.04) and 200 mg p=0.0008; 95% CI, (‐17.64 to ‐4.12). There was no effect on the WOMAC subscale of pain. Conclusion: Rubus idaeus leaf extract, even at the low dose of 200 mg, was effective to relieve pain at short‐term in‐patient with knee OA. As Rubus idaeus leaf extract is well tolerated, it could be an alternative to nonsteroidal anti‐inflammatory drugs and paracetamol to relieve knee joint pain in OA patients.