Bioavailable turmeric extract for knee osteoarthritis: a randomized, non-inferiority trial versus paracetamol
Open Access
- 30 January 2021
- journal article
- research article
- Published by Springer Science and Business Media LLC in Trials
- Vol. 22 (1), 1-11
- https://doi.org/10.1186/s13063-021-05053-7
Abstract
Background To compare the efficacy and safety of bioavailable turmeric extract versus paracetamol in patients with knee osteoarthritis (OA). Methods In this randomized, non-inferiority, controlled clinical study, patients of knee OA were randomized to receive bioavailable turmeric extract (BCM-95®) 500 mg capsule two times daily or paracetamol 650 mg tablet three times daily for 6 weeks. The primary outcome measure was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. The secondary outcome measures were WOMAC total, WOMAC stiffness, and WOMAC physical function scores. Responder analysis of individual patients at different levels (≥ 20%, ≥ 50%, and ≥ 70%) for WOMAC score was calculated. TNF alpha and CRP levels were evaluated and adverse events (AE) were also recorded. Results Seventy-one and seventy-three knee OA patients, respectively in bioavailable turmeric extract and paracetamol groups, completed the study. Non-inferiority (equivalence) test showed that WOMAC scores were equivalent in both the groups (p value < 0.05) in all the domains within the equivalence limit defined by effect size (Cohen’s d) of 0.5 whereas CRP and TNF-α were better reduced with turmeric extract than paracetamol. After 6 weeks of treatment, WOMAC total score, pain, stiffness, and function scores got a significant improvement of 23.59, 32.09, 28.5, and 20.25% respectively with turmeric extract. In the turmeric extract group, 18% of patients got more than 50% improvement and 3% of patients got more than 70% improvement in WOMAC pain and function/stiffness score and none of the patients in the paracetamol group met the criteria. CRP and TNF-α got significantly reduced (37.21 and 74.81% respectively) in the turmeric extract group. Adverse events reported were mild and comparatively less in the turmeric extract group (5.48%) than in the paracetamol group (12.68%). Conclusion The results of the study suggest that bioavailable turmeric extract is as effective as paracetamol in reducing pain and other symptoms of knee osteoarthritis and found to be safe and more effective in reducing CRP and TNF-α. Trial registration Clinical Trials Registry – India CTRI/2017/02/007962. Registered on 27 February 2017Keywords
This publication has 36 references indexed in Scilit:
- Clinical evaluation of a formulation containing Curcuma longa and Boswellia serrata extracts in the management of knee osteoarthritisMolecular Medicine Reports, 2013
- Aging processes and the development of osteoarthritisCurrent Opinion in Rheumatology, 2013
- American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and kneeArthritis Care & Research, 2012
- Osteoarthritis: A disease of the joint as an organArthritis & Rheumatism, 2012
- The Role of Turmerones on Curcumin Transportation and P-Glycoprotein Activities in Intestinal Caco-2 CellsJournal of Medicinal Food, 2012
- Comparative Absorption of a Standardized Curcuminoid Mixture and Its Lecithin FormulationJournal of Natural Products, 2011
- A pilot cross-over study to evaluate human oral bioavailability of BCM-95®CG (BiocurcumaxTM), a novel bioenhanced preparation of curcuminIndian Journal of Pharmaceutical Sciences, 2008
- Estimates of the prevalence of arthritis and other rheumatic conditions in the United States: Part IIArthritis & Rheumatism, 2007
- Update on guidelines for the treatment of chronic musculoskeletal painClinical Rheumatology, 2006
- Development of criteria for the classification and reporting of osteoarthritis: Classification of osteoarthritis of the kneeArthritis & Rheumatism, 1986