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

Abstract

Objectives Comparison of two doses of bio-optimized Curcuma longa extract (BCL) in the management of symptomatic knee osteoarthritis (OA). Methods A 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. Results One 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). Conclusions BCL 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). Electronic supplementary material The online version of this article (10.1186/s13075-019-1960-5) contains supplementary material, which is available to authorized users.

Clusters of Responders and Predictive Factors for Response to Supplementation With Boswellia, Turmeric, and Red Algae Extracts in Painful Knee Osteoarthritis: A Prospective Observational Study Using an Arsenal of Patient Centred-measures

“…The ability of boswellia (Boswellia serrata) and turmeric (Curcuma longa) extracts (alone or in combination) to relieve patients with KOA has been largely described in the literature [9][10][11][12][13][14][15][16][17][18][19][20]. However, to the best of our knowledge, this is the rst and unique study reporting data where their combination with red algae extracts is used.…”

“…Most studies evaluating treatment effect in KOA usually focused on pain intensity and physical function [9][10][11][12][13][14][15][16][17][18][19][20]. In these studies, pain intensity was commonly assessed using a VAS and physical function using the Western Ontario McMaster Arthritis Index (WOMAC), a self-administered 24-item questionnaire [10,12,13,[15][16][17]20].…”

“…Traditional medicines using natural derived compounds may offer this safe alternative [3]. Numerous studies, including several randomised clinical trials versus placebo or NSAIDs, have shown that boswellia (Boswellia serrata) and turmeric (Curcuma longa) extracts (alone or in combination) may relieve patients [9][10][11][12][13][14][15][16][17][18][19][20]. Their e cacy was supported by the presence of active ingredients with anti-in ammatory and/or antinociceptive properties such as boswellic acids [21][22][23] or curcumin [3,24,25].…”

Alternative and complementary therapies in osteoarthritis and cartilage repair

“…A trial of bio-optimized curcuma in the treatment of knee OA was reported in 2019 [67]. After 3 months of treatment, there were no statistical differences in intention to treat analyses for curcuma efficacy comparing the treatment to placebo arms for the co-primary endpoints (which are not included in those recommended by the European Medicines Agency or scientific societies).…”

Responses to “Bio-optimized Curcuma longa extract is efficient on knee osteoarthritis pain: a double-blind multicenter randomized placebo controlled three-arm study”: authors’ reply

“…The paper published by Henrotin et al [1] reported the results from a double-blind multi-center randomized placebo controlled study of bio-optimized Curcuma longa (BCL) extract in patients with symptomatic knee osteoarthritis (OA). This bio-optimized curcuma extract is a widely used food supplement.…”