Combination treatment of patients with metabolic phenotype of osteoarthritis: an exploratory study

Treatment of osteoarthritis (OA) patients with comorbidities can be challenging due to adverse events and non-sufficient efficacy of modern drugs. A safe and effective alternative could be the methods of traditional medicine and their combinations. The aim of this study was to evaluate efficacy and safety of combination of curcuma-based parapharmaceutical preparation and acupuncture in metabolic phenotype of OA (MPOA). The trial design was pilot open-label “before – after” study with the duration of 12 weeks. The patients with MPOA received parapharmaceutical preparation Epigenorm Antivir in a daily dose of 1000 mg and underwent 15-20 sessions of classical acupuncture. We enrolled twenty three women with metabolic syndrome (MS), clinical and radiographic signs of gonarthrosis, mean age 66.5 years, mean body mass index 34.5. At the end of treatment there was a decrease in pain levels according to visual analogue scale (VAS) (before 65 (12.7), after 24.6 (21.0), р=0.001), WOMAC pain scale (before 210.6 (102.2), after 103 (80.8), p = 0.014), KOOS (before 47.8 (12.1), after 66.7 (16.2), р = 0.001). The treatment resulted in statistically significant improvement of daily and social activities, role functioning, and quality of life. The results were clinically significant as evidenced by the moderate (Cohen d > 0.5) and large (Cohen d > 0.8) effect sizes of most outcome changes in accordance with the Cohen classification. The clinical improvement was accompanied by the decrease in MS components – LDL cholesterol (before 3.26 (0.26) mmol/l, after 2.43 (0.2) mmol/l, р = 0.001), triglycerides (before 2.02 (0.16) mmol/l, after 1.31 (0.1) mmol/l, р = 0.005). The treatment resulted in the reduction of systemic inflammation as evidenced by the decrease in the concentrations of TNFα (before 15.9 (1.2) pg/ml, after 12.4 (0.8), р = 0.002), histamine (before 1.6 (0.2) ng/ml, after 0.7 (0.2) pg/ml, р = 0.034), IL-18 (before 208.8 (32.6 ) pg/ml, after 160.0 (26.0) pg/ml, р = 0.002) and CRP (before 6.05 (1.3) mg/l, after 3.2 (0.7) mg/l, р = 0.022). At the same time there was an increase of concentration of IL-10 (before 1.5 (0.7) pg/ml, after 3.8 (1.2), р = 0,006) and adiponectin (before 34.0 (5.6) pg/ml, after 40.0 (6.9), р = 0.034). The treatment was well tolerated, no serious adverse events were registered. The pleiotropic actions of combination treatment occured probably due to synergistic effects of herbal therapies and acupunctures. The results provide a rationale for larger scale, randomized controlled double-blind clinical trials.