A Comparative Study of Efficacy and Tolerability of Fixed-Dose Combination of Etoricoxib and Thiocolchicoside versus Thiocolchicoside alone in Patients with Painful Muscle Spasms

Abstract

Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) and muscle relaxants are widely prescribed for the highly prevalent painful muscle spasms. But there appears to be lack of published clinical study comparing the efficacy and tolerability with the intended study drugs. Aim: To compare the efficacy and tolerability of the fixed-dose combination (FDC) of Etoricoxib-Thiocolchicoside versus Thiocolchicoside alone in patients with painful muscle spasms. Materials and Methods: A prospective, open-label, randomized comparative study of 100 eligible outpatients with painful muscle spasms of either gender aged between 18 to 65 years were randomly assigned to receive oral medications b.i.d for 7 days of either FDC of Etoricoxib(60mg)-Thiocolchicoside(4mg)(GROUP-1) or Thiocolchicoside(4mg)(GROUP-2) alone. Results: The primary efficacy endpoint assessed by the percentage reduction in the intensity of pain utilizing a 10 cm Visual Analogue Scale (VAS) on movement and at rest was significant in both groups (p<0.0001) but more pronounced with GROUP-1 than GROUP-2 (p<0.05) on day 7 compared to day 1. The secondary efficacy endpoint assessed by patient and clinician using Global Assessment of Response to Therapy (GART) on a 5 point scale showed significantly larger number of patients with excellent to a very good response for GROUP-1 compared to GROUP-2. Though both the groups were well tolerated, the GART score for tolerability was more excellent in GROUP-2 than GROUP-1.Any adverse events during the study period was also recorded. Conclusion: The Etoricoxib -Thiocolchicoside combination is more effective with faster pain relief and less tolerable than Thiocolchicoside monotherapy, in treating patients with painful muscle spasms.