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.
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 > or = 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.
Department of Orthopedic Surgery, Union Memorial Hospital, Baltimore, Maryland, USA. jbr30@msn.com
J B
JB
O'Donnell
E F
EF
Ekman
W M
WM
Spalding
P
P
Bhadra
D
D
McCabe
M F
MF
Berger
D000293:Adolescent; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use; D015984:Causality; D000068579:Celecoxib; D002908:Chronic Disease; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use*; D003710:Demography; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011720:Pyrazoles / Q000009:adverse effects* / Q000627:therapeutic use*; D013449:Sulfonamides / Q000009:adverse effects* / Q000627:therapeutic use*; D014147:Tramadol / Q000009:adverse effects* / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D014147:Tramadol; D000068579:Celecoxib