OBJECTIVE
To analyze clinical efficacy of tolperisone hydrochloride sustained release tablets 450 mg daily in patients with acute or exacerbation of chronic musculoskeletal pain.
MATERIAL AND METHODS
Thirty patients with acute or exacerbation of chronic musculoskeletal pain were enrolled (mean age 44.7±3.8 years). The study was conducted according to a registered indication for Mydocalm Long (treatment of painful muscle spasm associated with musculoskeletal disorders). Patients received Mydocalm Long once a day after meal for 14 days. All patients underwent clinical examination before intake of the drug, 7 and 14 days later. We used visual and verbal analogue scales, the Roland-Morris functional impairment scale, the muscle syndrome index, the EQ-5D-3L quality of life questionnaire (Russian version) and assessment of treatment effectiveness with Global Clinical Impression.
RESULTS
Analgesic effect of Mydocalm Long was significant by the 7th day of treatment while maximum effect of therapy was noted after 14 days. After 7 days, Roland-Morris functional impairment score decreased by 47%, after 14 days — by 85%. Muscle syndrome index (median before treatment — 12) was 7 after 7 days and 2 after 14 days (p<0.001). Analysis of EQ-5D-3L data showed increase in the quality of life that was manifested by significant change in each of 5 indicators of this questionnaire. Assessment of global clinical impression showed a positive trend. Significant clinical effect was observed in most patients by the 14th day of Mydocalm Long therapy.
CONCLUSION
We have demonstrated clinical efficacy of tolperisone hydrochloride sustained release tablets 450 mg in patients with acute or exacerbation of chronic musculoskeletal pain.