The Effect of a Natural Oral Nutritional supplement on the Level of Intra-Articular Inflammatory Mediators in Patients with Osteoarthritis of the Knee

Abstract

Objective: To determine the clinical efficacy of a novel combination of natural agents with potential anti-inflammatory properties in patients with knee osteoarthritis. Design: A prospective, randomized, double-blind, multicenter study. Methods: Subjects with symptomatic knee osteoarthritis were randomized to one of two groups; Synogesic® (Group A) or placebo (Group B). Synogesic is a proprietary blend of Turmeric Extract, Ginger Root Extract, Boswellia Serrata Extract, Vitamin C, Vitamin D and Rutin. Patients were evaluated at baseline and 12 weeks after enrollment. Patient reported outcome measures (PROM) included Visual Analog Scale (VAS) for pain, Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Knee injury and Osteoarthritis Outcome Score (KOOS). Synovial fluid samples were obtained at baseline and at 12 weeks and sent for measurement of various inflammatory markers. Results: 43 patients (22 in Group A and 21 in Group B) completed the study. In Group A, VAS for pain improved by 46.8% (P<0.001), WOMAC by 23.4% (P=0.006), KOOS for pain and ADL by 19.8% and 14.9% respectively (P=0.008 and P=0.002). In Group B, there was no significant improvement in any of the PROM assessed. Synovial fluid inflammatory markers increased by 6.2% in Group A and 54.6% in Group B (P=0.02). Of the 41 pro-inflammatory markers examined, 26 (63.4%) decreased in Group A, while only 13 (31.7%) decreased in Group B (P = 0.008). Conclusion: In this study, the novel natural anti-inflammatory product reduced pain and improved function, likely through reduction of pro-inflammatory cytokines in synovial fluid in patients with knee osteoarthritis.