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.
O'Donnell
J B
JB
Department of Orthopedic Surgery, Union Memorial Hospital, Baltimore, Maryland, USA. jbr30@msn.com
Ekman
E F
EF
Spalding
W M
WM
Bhadra
P
P
McCabe
D
D
Berger
M F
MF
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