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Randomized Controlled Trial
. 2019 Jul 27;21(1):179.
doi: 10.1186/s13075-019-1960-5.

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

Y Henrotin  1   2   3 , M Malaise  4 , R Wittoek  5 , K de Vlam  6 , J-P Brasseur  7 , F P Luyten  8 , Q Jiangang  9 , M Van den Berghe  10 , R Uhoda  11 , J Bentin  12 , T De Vroey  13 , L Erpicum  14 , A F Donneau  15 , Y Dierckxsens  16
Affiliations
Randomized Controlled Trial

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

Y Henrotin et al. Arthritis Res Ther. .

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).

Keywords: Biomarkers; Curcumin; Osteoarthritis.

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Conflict of interest statement

YH is a consultant for Tilman SA and the founder and chairman of Artialis SA, a spin-off company of the University of Liège developing biomarkers. Artialis SA is the manufacturer of coll2-1 immunoassay. YD is an employee of Tilman SA. All other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Disposition of patients. BCL, bio-optimized Curcuma longa; FAS, full analysis set; ITT, intention to treat; PP, per-protocol; AE, adverse event
Fig. 2
Fig. 2
a Patients Global Assessment of Disease Activity (PGADA) assessed with a VAS evolution with time. b Comparison of the absolute difference of PGADA between T0 and T1 in the placebo and pooled low- and high-dose BCL groups. c Comparison of the absolute difference of PGDA between T0 and T3 in the placebo and pooled low- and high-dose BCL groups
Fig. 3
Fig. 3
a Serum levels of Coll2-1 evolution with time. b Comparison of the absolute difference of sColl2-1 between T0 and T1 in the placebo and pooled low- and high-dose BCL groups. c Comparison of the absolute difference of sCOll2-1 between T0 and T1 in the placebo and pooled low- and high-dose BCL groups
Fig. 4
Fig. 4
Knee pain assessment with a VAS evolution with time
Fig. 5
Fig. 5
Curcumin levels in the serum of patient receiving daily doses of BCL or placebo
See this image and copyright information in PMC

Comment in

References

    1. Nelson AE. Osteoarthritis year in review 2017: clinical. Osteoarthritis Cartilage. 2018;26:319–325. doi: 10.1016/j.joca.2017.11.014. - DOI - PMC - PubMed
    1. Martel-Pelletier J, Barr AJ, Cicuttini FM, et al. Osteoarthritis. Nat Rev Dis Primers. 2016;2:16072. doi: 10.1038/nrdp.2016.72. - DOI - PubMed
    1. Mendy Angelico, Park JuYoung, Vieira Edgar Ramos. Osteoarthritis and risk of mortality in the USA: a population-based cohort study. International Journal of Epidemiology. 2018;47(6):1821–1829. doi: 10.1093/ije/dyy187. - DOI - PMC - PubMed
    1. Zhang W, Nuki G, Moskowitz RW, et al. OARSI recommendations for the management of hip and knee osteoarthritis: part III: changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthr Cartil. 2010;18:476–499. doi: 10.1016/j.joca.2010.01.013. - DOI - PubMed
    1. Jordan KM, Arden NK, Doherty M, et al. Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR recommendations: an evidence-based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT) Ann Rheum Dis. 2003;62:1145–1155. doi: 10.1136/ard.2003.011742. - DOI - PMC - PubMed

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