A comparative study on safety and efficacy of tolperisone with etodolac and thiocolchicoside with etodolac in patients of acute low back pain with musculoskeletal spasm

ABSTRACT

Background: Low back pain is one of the most common health problems in society which leads to considerable disability, loss of work days, and puts a huge burden on socioeconomic and healthcare system. It is often associated with musculoskeletal spasm. The aim of the study was to compare the efficacy and safety of tolperisone and thiocolchicoside in combination with etodolac in patients of acute low back pain associated with musculoskeletal spasm.Methods: it was a prospective, randomized, open label study which included patients of either sex between age 18-50 years of acute low back pain with musculoskeletal spasm. Patients were allocated in two groups. Patients in 慓roup A� were given tolperisone 150 mg + etodolac 400 mg twice a day and patients in 慓roup B� were given thiocolchicoside 4 mg + etodolac 400 mg twice a day. Efficacy of two drugs was assessed by decrease in finger to floor distance (FFD), decrease in pain as per visual analog scale (VAS) and global assessment of efficacy of treatment by physician. Follow-up of the patients was done on day 3 and 7 of treatment. Various side effects reported by patients in both the groups were also recorded and compared.Results: Both tolperisone and thiocolchicoside caused significant decrease in FFD, reduced pain score thus indicating decrease in pain and spasm. Side effects reported in both groups were mild and did not result in discontinuation of therapy.Conclusions: Tolperisone was found to have efficacy similar to that of thiocolchicoside though number of side effects reported was more with tolperisone.