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

• Published in: Journal of international medical research Vol. 37; no. 6; pp. 1789 - 1802
• Main Authors: O'Donnell, JB, Ekman, EF, Spalding, WM, Bhadra, P, McCabe, D, Berger, MF
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01.12.2009
• Subjects: Adolescent; Adult; Aged; Analgesics, Opioid - adverse effects; Analgesics, Opioid - therapeutic use; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Causality; Celecoxib; Chronic Disease; Cyclooxygenase 2 Inhibitors - adverse effects; Cyclooxygenase 2 Inhibitors - therapeutic use; Demography; Double-Blind Method; Female; Humans; Low Back Pain - drug therapy; Male; Middle Aged; Pyrazoles - adverse effects; Pyrazoles - therapeutic use; Sulfonamides - adverse effects; Sulfonamides - therapeutic use; Tramadol - adverse effects; Tramadol - therapeutic use; Treatment Outcome; Young Adult; Chronic low-back pain; Cyclo-oxygenase-2 (COX-2); Celecoxib; Tramadol; Opioids; Non-steroidal anti-inflammatory drugs
• ISSN: 0300-0605; 1473-2300
• DOI: 10.1177/147323000903700615

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.