THE EFFICACY AND SAFETY OF CARMOLIS GEL IN THE COMBINATION THERAPY OF KNEE OSTEOARTHRITIS: RESULTS OF A MULTICENTER CLINICAL TRIAL

Abstract

Osteoarthritis (OA) is one of the most common rheumatic diseases. Knee OA is particularly frequently encountered among all forms of OA, the prevalence of knee OA being about 25% in the general population. Despite multiple guidelines for the management of knee OA, which have been prepared by the European League Against Rheumatism (EULAR), the American College of Rheumatology (ACR), and the Osteoarthritis Research Society International (OARSI), many problems of its treatment policy remain to be solved. The same holds true for not only the symptomatic and disease-modifying effects of chondroprotectors, but also topical therapy options. Objective : to evaluate the clinical efficacy and safety of Carmolis gel in patients with knee OA. Subjects and methods. The trial included 280 patients with knee OA (a study group consisted of 190 patents; a control group comprised 90 patients). The mean age was 58.3±9.3 years in the study group and 59±10.5 years in the control group. The disease duration was 10.3±5.5 and 10.1±4.1 years, respectively. Carmolis gel was applied to the region of the most painful knee joint up to 4–5 times daily, followed by massage of this skin area. The treatment cycle lasted for 2 weeks. No therapy was performed in the control patients. The clinical efficacy was determined by the changes in joint pains at rest or on movement and palpation, according to a visual analogue scale (VAS), WOMAC questionnaire, the synovitis intensity (assessed by ultrasonography), patient and physician global assessments of disease activity (Likert scale), and the possibility of reducing the daily dosage of nonsteroidal anti-inflammatory drugs (NSAIDs). The onset the therapeutic effect of the gel and the duration of its action were recorded. Results and discussion. The topical application of Carmolis gel caused a statistically significant reduction in joint pain at rest and on movement from 57.7±6.8 to 12±1.8 mm (р < 0.01) and from 52±5.3 to 17±2.7 mm, respectively (р<0.01). The WOMAC showed similar pain changes. In the study group, the WOMAC pain level averaged 210±20.5 mm at baseline and reduced to 101±12.8 mm after the treatment (p < 0.01).The control group also exhibited pain relief, but to a much lesser degree than did the study group. There were no statistically significant differences between the groups in motor and day-to-day activity changes. After treatment, the patients of both groups had reduction in the signs of synovitis; however, no differences were found between the groups. The dose of NSAIDs could be decreased in 99 (52.1%) of the 190 patients in the study group and only in 15 (16.6%) of the 90 patients in the control group (p<0.05). Carmolis gel was well tolerated. No adverse events were observed in 184 patients. Local cutaneous reactions and itch were noted in 6 (3.2%) patients; however, they were short-term and did not required drug discontinuation. Conclusion. The findings suggest that the incorporation of Carmolis gel into the combination therapy of OA ensures a significant reduction in joint pain and allows the dose of NSAIDS to be decreased, making the treatment safer.