The effectiveness of a weak opioid medication versus a cyclo-oxygenase-2 (COX-2) selective non-steroidal anti-inflammatory drug in treating flare-up of chronic low-back pain: Results from two randomized, double-blind, 6-week studies

John B. O'Donnell, E. F. Ekman, W. M. Spalding, P. Bhadra, D. McCabe, M. F. Berger

Research output: Contribution to journalArticlepeer-review

Abstract

Two 6-week studies compared the analgesic efficacy, tolerability and safety of a non-steroidal anti-inflammatory drug (celecoxib 200 mg twice a day [bid]) and an opioid (tramadol HCl 50 mg four times a day [qid]) in subjects with chronic low-back pain (CLBP). Successful responders (primary endpoint) were defined as subjects completing 6 weeks of treatment and having ≥ 30% improvement on the Numerical Rating Scale for pain. A total of 796 and 802 subjects were randomized to treatment in study 1 and study 2, respectively. A significantly greater percentage of celecoxib-treated subjects were successful responders compared with tramadol HCl-treated subjects (study 1: 63.2% versus 49.9%, respectively; study 2: 64.1% versus 55.1%, respectively). Fewer adverse events (AEs) and serious AEs were reported in the celecoxib-treated group. Overall, celecoxib 200 mg bid was more effective than tramadol HCl 50 mg qid in the treatment of CLBP, with fewer AEs reported.

Original languageEnglish (US)
Pages (from-to)1789-1802
Number of pages14
JournalJournal of International Medical Research
Volume37
Issue number6
DOIs
StatePublished - 2009

Keywords

  • Celecoxib
  • Chronic low-back pain
  • Cyclo-oxygenase-2 (COX-2)
  • Non-steroidal anti-inflammatory drugs
  • Opioids
  • Tramadol

ASJC Scopus subject areas

  • Biochemistry
  • Cell Biology
  • Biochemistry, medical

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