만성 요통에 대한 Tramadol 37.5 mg/Acetaminophen 325mg 복합제제와 Cyclo-Oxygenase-2{Celecoxib} 억제제의 유효성 및 안전성 비교 연구 -다기관,무작위 배정,비교 임상 연구-

Abstract

Study Design: This is a multicenter, randomized comparative outpatient study on a 8-week administration of Tramadol 37.5 mg/Acetaminophen and 325 mg (Tramadol/APAP) combination tablets and Cyclo-Oxygenase-2 inhibitor (Celecoxib).

Objectives: We wanted to evaluate the efficacy and safety of Tramadol/APAP combination tablets and Celecoxib for the treatment of chronic low back pain.

Summary of the Literature Review:Tramadol/APAP combination tablets have an analgesic efficacy for the treatment of chronic low back pain. The conditions for which COX-2 inhibitors were be used included a variety of musculoskeletal conditions. However, further analyses are needed to determine the efficacy and safety of Tramadol/APAP combination tablets and Celecoxib for the treatment of chronic low back pain.

Materials and Methods: One hundred twenty-five patients with chronic low back pain (pain visual analogue scale [VAS] scores >40 mm on 100 mm scale) were randomized to take the Tramadol/APAP combination tablets or Celecoxib for 8 weeks. The primary outcome measure was the pain VAS score, pain relief score and the Korean-version of Oswestry Disability Index (KODI).

Results: The study enrolled 125 patients (56 in the Tramadol/APAP tablets group and 69 in the Celecoxib group). There were no significant differences between Tramadol/APAP combination tablets and Celecoxib with regard to the pain VAS scores (VAS; 27.99+/-21.22 vs 24.56+/-16.58, respectively, p>0.05), the pain relief score and the mean decreased disability score on the KODI (0.42+/-0.59 vs 0.46+/-0.05, respectively). The adverse drug reactions showed a statistically significant difference (p<0.05).

Conclusions: The results of this study suggest that Tramadol/APAP combination tablets are just as effective as celecoxib for relieving chronic low back pain.