Joint Dysfunctionality Alleviation along with Systemic Inflammation Reduction following Arthrocen Treatment in Patients with Knee Osteoarthritis: A Randomized Double-Blind Placebo‐Controlled Clinical Trial

Abstract

Background and objectives: Many mediators and cytokines are involved in the pathogenesis of osteoarthritis (OA). Some of these cytokines are spontaneously expressed by cultured fibroblast-like synoviocytes. Therefore, using serum samples, the efficacy and the effects of avocado/soy un-saponifiables, ASU, (Arthrocen) on cytokine changes were assessed in patients with knee OA (KOA). Materials and Methods: Experimental procedure: A randomized, double‐blind, placebo‐con-trolled clinical trial was conducted on patients with a diagnosis of mild to moderate OA who re-ceived either Arthrocen 300 mg/day (n = 61) or placebo (n = 58) for 3 months. Data collection was performed using questionnaires including the Western Ontario and McMaster Universities osteo-arthritis index (WOMAC), 20‐item short form survey (SF‐20), Lequesne index of severity for osteo-arthritis of the knee (LISOK), and three visual analog scales (VASs) as pain quality indices. The serum levels of interleukins 2 (IL‐2), IL‐4, IL‐10, IL‐17α, and TNF‐α were measured using an ELISA reader. Results: Both quality of life indices, pain sensation and scored by specialists (as VASs), re-spectively, including WOMAC and SF‐20, as well as joint dysfunctionality symptoms assessed by physicians were significantly improved (p < 0.05) in OA patients receiving Arthrocen. The serum levels of anti‐inflammatory interleukins 4 and 10 were also augmented, while levels of inflammatory IL‐17 and TNF‐ɑ cytokines were decreased significantly (p < 0.05) compared with the control groups during the 3‐ and 6‐month treatment. Conclusions: Arthrocen consumption may increase the quality of life in OA patients through amelioration of inflammation and improvement of functional activities without any adverse effects in the long term.