Comparison The Safety and The Efficacy between the Group of using Pelubiprofen Tab. and the Group of using Aceclofenac Tab. on Back Pain Patients: Multi Institution, Double Blind, Random Sample

ABSTRACT

STUDY DESIGN: Multi institution, double blind, random sample. OBJECTIVES: We conducted a comparative study with Aceclofenac Tab, which is widely used in the clinical field in order to observe the Pelubiprofen Tab's clinical efficiency in patients with back pain. SUMMARY OF LITERATURE REVIEW Among the numerous literatures regarding the chronic back pain, there is are few studies with Pelubiprofen Tab's clinical efficiency. MATERIALS AND METHODS: We computed an experimental model through a case control study, practiced from January, 2010 to January, 2011, and thereby, 298 back pain patients were selected. This study was conducted through a multi institution, double blind, and random sample. We compared the experimental and control groups' clinical efficiency that was estimated by VAS after 28 days of medication. Also, we compared the treatment efficiency of both drugs by using a variation of Oswestry Disability Index (ODI) and Physician's Global assessment, with a total usage of relief medicine. Also, the side effect and clinical pathologic result were tested. Statistical analysis was done with three different methods, Safety method, ITT (Intent-To-Treat), and PP (Per Protocol). Logistic regression model was used, and this result was compared by a Chi-square or Fisher's Exact test. RESULTS: Comparing the VAS of both groups, VAS decreased with statistical significance. Both groups didn't show a significant difference in VAS (p=0.6764). As the decrement of the total dosage of relief medicine, the decrease in the control group was rather higher, but the difference didn't show any statistical significance (p=0.9955). The experimental group was not inferior than that of the control group in ODI and PGA variation. Analyzing the side effect, both groups didn't show any significant difference (p=0.9843). CONCLUSIONS: As a result of the clinical trial, Pelubiprofen Tab. applied to back pain patients was not inferior to that of aceclofenac Tab., in terms of efficiency, and didn't show any significant difference in safety.