P170 - Bio-Optimized Curcuma Longa Extract Is Efficient On Knee Osteoarthritis Pain
Abstract
Purpose
Herein, we report results from a study of pharmaceutical-grade bio-optimized curcuma longa extract in patients with symptomatic knee OA, which, to our knowledge, is the first ever to have been conducted in full accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use (ICHE6).
Methods and Materials
A prospective, randomized, 3-months, double blind, multicenter, placebo-controlled trial assessing Patient Global Assessment of Disease Activity (PGADA) and serum sColl2-1, a biomarker of cartilage degradation as coprimary endpoints. Pain on Visual Analog Scale (VAS), Knee injury and Osteoarthritis Outcome Score (KOOS) and Paracetamol/Non-Steroidal Anti-inflammatory Drugs (NSAIDS) consumption were used as secondary endpoints.
Results
150 patients with knee OA were followed for 90 days. Analysis of sColl2-1 showed in placebo and BCL low dose groups, but not in BCL high dose group, a transient but non significant increase of sColl2-1 between T0 and T1. Thereafter, in all group sColl2-1 decreased between T1 and T3 (all p < 0.01), but no difference between groups was found. Low and high doses of BCL showed a greater decrease of PGADA than placebo. Pain reduction at day 90 in the low and high dose BCL groups (-29.5 mm and -36.5 mm) was higher than in placebo ((-8 mm); p=0.018). The global KOOS score significantly decreased overtime but changes were comparable across treatment arms. The ratio of patients with adverse events (AE) related to the product were similar in placebo and treatment groups but the number of AE linked to the product was higher in the high dose BCL group compared to placebo (p=0.012).
Conclusion
BCL induced a rapid symptomatic relief in knee OA at 3 months, decreased serum levels of a OA biomarker and demonstrated an excellent safety profile (Trial registration: ISRCTN, ISRCTN12345678. Registered 21 September 2016 - Retrospectively registered, http://www.isrctn.com/ISRCTN12345678 -Evaluation of FLEXOFYTOL® Versus PLACEBO (COPRA)NCT02909621).
