The Efficacy And Safety Randomized, Controlled Clinical Study Of Cyclobenzaprine Hydrochloride Tablets In The Treatment Of Skeletal Muscle Spasm Pain

ObjectiveThis study is to evaluate efficacy and safety of cyclobenzaprine hydrochloride tablets in the treatment of patients with skeletal muscle spasm.MethodsA randomized, double-blind, positive drug, parallel-group multi-center clinical trial was conducted in patients aged18-65years with muscle spasm during march2010to march2011. A total of232patients were enrolled into the study:146males and86females. Patients were randomly assigned to receive cyclobenzaprine hydrochloride5mg in trial group and Eperisone Hydrochloride simulated agent TID in control group, and receive Eperisone Hydrochloride50mg and cyclobenzaprine hydrochloride simulated agent TID in control group for7days. The primary efficacy measures were patient’s rating of muscle spasm and the intensity of their pain on a100-mm visual analog scale (VAS) at baseline and day8after treatment. Secondary efficacy measures were pain in different situations, restriction in activities of daily living, restriction of movement, tenderness to palpation, daytime drowsiness, and quality of nighttime sleep. The evaluation indicators include Blood, urine, ECG, blood chemistry and other adverse effects. We use SAS9.2for statistical analysis.ResultsA total of111randomized patients in trial group and104in control group completed7days of treatment. The patients in each group were similar with regard to diagnosis and baseline pain score with no significant differences. Significant improvements in patient’s rating of muscle spasm and the intensity of their pain scores over time in two group(P<0.0001), and there no significant differences between the groups in any of efficacy (rating of muscle spasm, P=P=0.7468;VAS,P=0.2782). Pain significantly reduced under a variety of situations in both groups. There is no serious adverse event in this study. The rate of adverse effects of cyclobenzaprine hydrochloride (21.37%) was higher than Eperisone (10.53%) Hydrochloride (P=0.0247). The main adverse effects were drowsiness, sleepiness, dizziness and dry mouth. Most adverse effects were mild in intensity without special treatment.ConclusionThe trial proved that cyclobenzaprine hydrochloride tablets were effective in treating muscle spasm associated with painful musculoskeletal condition, were safe and well tolerated in the treatment of oral dose range.