Treatment of acute low back pain with the COX-2-selective anti-inflammatory drug nimesulide - Results of a randomized, double-blind comparative trialversus ibuprofen

Study Design. A prospective, randomized double-blind comparative trial. Objectives. To evaluate the efficacy and tolerability of nimesulide, a cycl ooxygenase (COX)-2-selective anti-inflammatory agent versus ibuprofen in pa tients with acute lumbosacral back pain. Summary of Background Data. Nonsteroidal anti-inflammatory drugs (NSAIDs) h ave been more effective than placebo in patients with uncomplicated acute l ow back pain in previous randomized controlled trials. The efficacy and tol erability 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 pai n were enrolled. The patients were randomly allocated either to oral nimesu lide (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 aver age of the pain intensity and the pain relief, stiffness in the back, funct ional status, and the results of physical examinations. All side effects we re recorded at each visit. Results, With both study therapies, there was a clear improvement in all me asured parameters of the pain and;back function parameters measured from th e third day of treatment onward. The patients' capacity for daily Tasks, sh owed improvement in both groups (P < 0.001), but a statistically significan t difference was found between the two groups in favor of the nimesulide gr oup (P < 0.05) after 10 days. Nimesulide was more effective than ibuprofen in improved lateral bending measurements (P = 0.026). Nimesulide and ibupro fen provided similar degrees of improvement in the modified Schober tests a nd in the pain intensity and back stiffness scores. More gastrointestinal s ide effects were reported with ibuprofen than nimesulide, and the compariso n showed a trend (P = 0.067). Ten Side effects occurred in the nimesulide g roup in 7 (13%) patients and 13 in the ibuprofen group in 11 (21%) patients , Conclusions. The results confirmed that the COX-2-selective inhibitor nimes ulide is an effective and well-tolerated agent for use in general practices to treat acute low back pain. the incidence of gastrointestinal of gastroi ntestinal side effects seems to be lower with nimesulide than with ibuprofe n.