Tumor necrosis alpha-blocking agent (etanercept): a triple blind randomized controlled trial of its use in treatment of sciatica.
METHODS
Triple blind randomized controlled study.


OBJECTIVE
To establish the treatment effect of etanercept in acute sciatica secondary to lumbar disc herniation.


BACKGROUND
Etanercept is a selective competitor of tumor necrosis factor-alpha which is a proinflammatory cytokine. It is currently used alone or in combination with other medication for the treatment of chronic inflammatory disease.


METHODS
Inclusion criteria were acute unilateral radicular leg pain secondary to herniated nucleus pulposus confirmed on magnetic resonance imaging scan. Exclusions were previous back surgery, spinal stenosis and any contraindications to the use of etanercept such as immunosuppression. The patient, the injector, and assessor were blinded to the agent being used. Follow-up was at 6 weeks and 3 months posttreatment. Oswestry disability index and visual analog scores were among the assessment criteria.


RESULTS
Fifteen patients were recruited in a 4 years period with a 3 months follow-up of 80%. The etanercept group had 8 patients whereas the placebo group had 7. The average Oswestry disability index for the etanercept group preintervention was higher than that in the placebo group (53.6 vs. 50.4) and this remained the same after 6 weeks (46.1 vs. 31.2) and 3 months of follow-up (37 vs. 35). Visual analog score was also higher in the etanercept group versus placebo; preinjection (8.6 vs. 7.4), 6 weeks (5.0 vs. 3.8), and 3 months (4.8 vs. 4.5).


CONCLUSIONS
Small numbers of trial participants limited statistical analysis. The trend appears to show no benefit to the use of etanercept over placebo in the pharmacologic treatment of sciatica.
Okoro
Tosan
T
Department of Orthopaedics and Trauma, University Hospitals Leicester, Leicester, UK.
Tafazal
Suhayl I
SI
Longworth
Stephen
S
Sell
Philip J
PJ
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D004185:Disability Evaluation; D004311:Double-Blind Method; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000009:adverse effects; D007249:Inflammation / Q000188:drug therapy / Q000473:pathology / Q000503:physiopathology; D007405:Intervertebral Disc Displacement / Q000150:complications; D008297:Male; D010147:Pain Measurement; D010919:Placebos; D011843:Radiculopathy / Q000188:drug therapy / Q000473:pathology / Q000503:physiopathology; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage*; D018401:Sample Size; D012585:Sciatica / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D013126:Spinal Nerve Roots / Q000187:drug effects / Q000473:pathology / Q000503:physiopathology; D055009:Spondylosis / Q000150:complications; D017211:Treatment Failure; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors* / Q000378:metabolism
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007074:Immunoglobulin G; D010919:Placebos; D018124:Receptors, Tumor Necrosis Factor; D014409:Tumor Necrosis Factor-alpha; D000068800:Etanercept