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KMID : 0388720050120040299
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Journal of Korean Society of Spine Surgery
2005 Volume.12 No. 4 p.299 ~ p.309
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Comparative Study of the Safety and Effectiveness of Tramadol 37.5 mg/Acetaminophen 325 mg Combined Tablets and Cyclo-Oxygenase-2 (Celecoxib) Inhibitor for the Treatment of Chronic Low Back Pain: A Multicenter, Randomized, Comparative Clinical Study
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Jeon Chang-Hoon
Lee Hwan-Mo
Shin Dong-Eun
Kim Hak-Sun
Park Heui-Jeon
Kim Dong-Jae
Kim Dong-Jun
Min Han-Ter
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Abstract
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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.
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KEYWORD
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Chronic low back pain, Tramadol/Acetaminophen, COX-2 inhibitor
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