Treatment of acute low back pain with the COX-2-selective anti-inflammatory drug nimesulide: results of a randomized, double-blind comparative trial versus ibuprofen.
METHODS
A prospective, randomized double-blind comparative trial.


OBJECTIVE
To evaluate the efficacy and tolerability of nimesulide, a cyclooxygenase (COX)-2-selective anti-inflammatory agent versus ibuprofen in patients with acute lumbosacral back pain.


BACKGROUND
Nonsteroidal anti-inflammatory drugs (NSAIDs) have been more effective than placebo in patients with uncomplicated acute low back pain in previous randomized controlled trials. The efficacy and tolerability of a new COX-2-selective anti-inflammatory drug have not yet been established.


METHODS
One hundred four patients aged 18-65 years with acute low back pain were enrolled. The patients were randomly allocated either to oral nimesulide (100 mg twice daily for 10 days) or oral ibuprofen (600 mg three times daily for 10 days). Outcome measures on a visual analog scale were an average of the pain intensity and the pain relief, stiffness in the back, functional status, and the results of physical examinations. All side effects were recorded at each visit.


RESULTS
With both study therapies, there was a clear improvement in all measured parameters of the pain and back function parameters measured from the third day of treatment onward. The patients' capacity for daily tasks, showed improvement in both groups (P < 0. 001), but a statistically significant difference was found between the two groups in favor of the nimesulide group (P < 0.05) after 10 days. Nimesulide was more effective than ibuprofen in improved lateral bending measurements (P = 0.026). Nimesulide and ibuprofen provided similar degrees of improvement in the modified Schober tests and in the pain intensity and back stiffness scores. More gastrointestinal side effects were reported with ibuprofen than nimesulide, and the comparison showed a trend (P = 0.067). Ten side effects occurred in the nimesulide group in 7 (13%) patients and 13 in the ibuprofen group in 11 (21%) patients.


CONCLUSIONS
The results confirmed that the COX-2-selective inhibitor nimesulide is an effective and well-tolerated agent for use in general practices to treat acute low back pain. The incidence of gastrointestinal side effects seems to be lower with nimesulide than with ibuprofen.
Pohjolainen
T
T
Jorvi Hospital, Rehabilitation Unit, Espoo, Finland. timo.pohjolainen@kela.memonet.fi
Jekunen
A
A
Autio
L
L
Vuorela
H
H
D000208:Acute Disease; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects; D051546:Cyclooxygenase 2; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage* / Q000009:adverse effects; D007527:Isoenzymes / Q000494:pharmacology*; D007700:Kinetics; D016014:Linear Models; D017116:Low Back Pain / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008565:Membrane Proteins; D008875:Middle Aged; D009068:Movement / Q000502:physiology; D011446:Prospective Studies; D011451:Prostaglandin-Endoperoxide Synthases / Q000494:pharmacology*; D013131:Spine / Q000502:physiology; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors; D007527:Isoenzymes; D008565:Membrane Proteins; D013449:Sulfonamides; D051546:Cyclooxygenase 2; C496540:PTGS2 protein, human; D011451:Prostaglandin-Endoperoxide Synthases; C012655:nimesulide; D007052:Ibuprofen