[Use of ARTRA MSM FORTE in patients with knee osteoarthritis: Results of a randomized open-label comparative study of the efficacy and tolerability of the drug].

AIM

To study the clinical efficacy and safety of the combined medication ARTRA MSM FORTE (400 mg chondroitin sulfate, 500 mg glucosamine hydrochloride, 300 mg methylsulfonylmethane (MSM), and 10 mg sodium hyaluronate calculated with reference to hyaluronic acid) in patients with knee osteoarthritis (OA).

SUBJECTS AND METHODS

The study enrolled 100 patients with Kellgren-Lawrence grades 2-3 knee OA with obvious pain syndrome (pain intensity scores on a visual analog scale (VAS)) equal or greater than 40 mm during walking. The patients were examined monthly; changes in WOMAC index scores, Get-Up and Go test results, the efficiency of therapy in the opinion of a physician and a patient, and quality of life according to the EQ-5D questionnaire were estimated. They were randomized into 2 groups: 1) 50 patients took ARTRA MSM as 2 tablets daily for one month, then 1 tablet daily; 2) 50 received ARTRA in accordance with the same scheme. Clinical examination was performed before and at 30, 60, 90 and 120 days of the study.

RESULTS

All the 100 patients completed treatment. Analysis of the results showed a significant decrease in pain on VAS in both groups. Reduced pain intensity was observed by the end of the first month of therapy and remained throughout the follow-up. Both medications diminished stiffness just after a month of therapy. They alleviated joint function and reduced total WOMAC scores at Visit 2. Analysis of Get-Up and Go test results indicated significantly less spent time in both groups; however, these differences reached the statistical significance in the ARTRA MSM group just at Visit 2 and in the ARTRA group only at Visit 3. The effect ARTRA MSM occurred more rapidly. This was confirmed by the patient and physician evaluations of the efficiency of treatment, which indicated that its positive effect occurred more rapidly in the ARTRA MSM group (p=0.02). Estimation of EQ-5D scores also showed positive results: there was a significant improvement of these indicators in the two compared groups at Visit 3. Both medications were very well tolerated and caused no adverse reactions; therapy was not discontinued.

CONCLUSION

ARTRA MSM is rapider in its effect: a significant improvement in Get-Up and Go test results and patient and physician evaluations of the efficiency of treatment. Additional interviews of the patients taking ARTRA MSM demonstrated that 36 (72%) of them reported a prompter pain relief than the ARTRA-treated patients. ARTRA MSM may be recommended for the treatment of OA in clinical practice.