Posttraumatic Osteoarthritis. Effective Combination of Non-steroidal Anti-inflammatory Drugs and SYSADOA

Abstract

Osteoarthritis (OA) is the most frequent joint desease and is the leading cause of the functional loss and disability among older patients. The heterogeneity of OA determines the absence of a 100% effective therapeutic strategy for all patients. In addition, this heterogeneity may be the main reason for the failure of clinical trials of therapeutic agents designed to restore cartilage. The SYSADOA group of drugs, in particular – glucasamine and chondroitin, is among the most studied compounds, have a good safety profile and showed proven efficacy in the early stages of osteoarthritis. The use of these drugs in combination with non-steroidal anti-inflammatory drugs (NSAIDs) is widespread in the world and is included in the recommendations of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis – ESCEO. The objective: to assess the clinical efficacy and safety of the combination of diclofenac potassium 50 mg, chondroitini sulfatis 400 mg and glucosamini sulfatis 500 mg; chondroitini sulfatis 400 mg and glucosamini sulfatis 500 mg in treatment of patients with knee and ankle post-traumatic osteoarthritis in the early stages (I–II according to Kelgren and Lawrence). Materials and methods. The study was designed as a randomized comparative prospective placebo-controlled in parallel groups. The level of evidence for this study is II-B. Patients of the main group N1 underwent surgical treatment for joint trauma and had a radiographically and clinically confirmed diagnosis: post-traumatic osteoarthritis stage I-II (according to Kelgren and Lawrence) of the ankle (N1.1=15) and knee (N1.2=15) joints. Time from injury and surgery was 14.3±2.3 months. Patients from main group received combination of diclofenac potassium, chondroitini sulfatis and glucosamini sulfatis for 10 days at the begining of the treatment course, and followed with combination of chondroitin and glucosamin for 3 months further. The comparison group included similar patients in terms of the number, gender, age and the nature of OA (N2.1=15; N2.2=15), these patients were prescribed diclofenac potassium 50 mg 2 times a day (for the first 10 days of treatment), and further followed with placebo (for the next 3 months). All enrolled patients also were prescribed basic non-pharmacological treatment, which included body weight control, physical therapy, mechanotherapy, exercises, together with orthopedic devices to unload and stabilize the affected joint. The results of treatment were assessed clinically at 3 months and 6 months after the start of treatment using VAS, functional state of the ankle (according to AOFAS) and knee (according to Lysholm scale); on each visit information about adverse reactions was collected. Results. After 3 months, the intensity of pain according to VAS in the N1.1 group was 24.8±2.1 points, and in the N2.1 group 29.2±3.2 (p<0.05). After 6 months, the VAS results were accordingly 15.1±3.4 vs 26.7±0.9 (p<0.01). The functional capacity of the ankle joint, evaluated by AOFAS, after 3 months in N1.1 group achieved 81.7±4.3 and 68.4±5.6 points in N2.1 group (p<0.01). At 6 months, the AOFAS score was 93.9±3.8 vs 79.4±4.1 (p<0.05). After 3 months VAS score in patients with early stages of knee OA (group N1.2 and N2.2) was 21.2±1.9 vs 28.3±3.1 mm (p<0.05); after 6 months – 14.7±1.4 vs 23.9±2.8 mm (p<0.01). The level of functional activity after 3 months of treatment according to the Lysholm scale achieved 86.8±2.9 points versus 68.4±5.6 points (p<0.05) and after 6 months - continued to grow and got to 97.4±1.2 vs 86.2±2.9 points (p<0.01). There were no statistical differences in number and intensity of the adverse events in the studied groups (p>0.5). Conclusions. In the early stages of post-traumatic osteoarthritis of the knee and ankle joints (I–II according to Kelgren and Lawrence), a 3-month course of treatment with combination of NSAID and SYSADOA (diclofenac with chondroitin and glucosamin), followed by further treatment with SYSADOA (chondroitin and glucosamine) demonstrated superior efficacy compared to the placebo/standard treatment with the same level of safety.