RESUMEN
Background: Aceclofenac is a non steroidal anti-inflammatory drug commonly prescribed in patients with acute low back pain. Thiocolchicoside is a skeletal muscle relaxant which is used in combination with NSAIDs. The efficacy of a combination of aceclofenac and thiocolchicoside has to be proved over aceclofenac alone in patients with acute low back pain. Objective of this study was to compare the safety and efficacy of a combination of aceclofenac and thiocolchicoside against aceclofenac alone in patients with acute low back pain.Methods: This study was undertaken as a prospective comparative study. Patients with acute low back pain receiving either aceclofenac 100 mg or a combination of aceclofenac 100 mg and thiocolchicoside 4 mg twice daily were enrolled in the study and were divided into two groups of 50 each. The primary efficacy parameter was pain intensity measured on a visual analogue scale. Adverse effects if any were monitored at the follow up visit.Results: At the start of the study, pain intensity, measured on visual analogue scale was comparable in both the groups. At the end point, there was a reduction in pain intensity in both the groups and the reduction was more significant in the combination group (p <0.001). Adverse effects reported in both the groups were found to be comparable.Conclusions: Combination of aceclofenac and thiocolchicoside is superior to aceclofenac alone in patients with acute low back pain.