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TUMOUR NECROSIS ALPHA-BLOCKING AGENT (ETANERCEPT): A TRIPLE BLIND RANDOMISED CONTROLLED TRIAL OF ITS USE IN TREATMENT OF SCIATICA



Abstract

Introduction: Etanercept is a selective competitor of TNF alpha which is a pro-inflammatory cytokine. It is currently used alone or in combination with other medication for the treatment of chronic inflammatory disease.

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

Method: Triple blind randomised controlled study. Inclusion criteria were acute unilateral radicular leg pain secondary to herniated nucleus pulposus confirmed on MRI 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 post treatment. Oswestry Disability Index (ODI) and Visual analogue scores (VAS) were among the assessment criteria.

Results: 15 patients were recruited in a 4 year period with a 3 month follow up of 80%. The Etanercept group had 8 patients whilst the placebo group had 7. The average ODI for the Etanercept group pre-intervention was higher than that in the placebo group (56.1 vs. 50.4) and this remained the same after 6 weeks (50.5 vs 31) and 3 months of follow up (39.2 vs. 27.3). VAS was also higher in the Etanercept group vs. placebo; pre-injection (8.5 vs. 7.4), 6 weeks (5.6 vs. 3.8), and 3 months (7.0 vs. 4.5).

Conclusion: Small numbers of trial participants limited statistical analysis. The trend appears to show no benefit to the use of Etanercept over placebo in the pharmacological treatment of sciatica.

Correspondence should be addressed to SBPR at the Royal College of Surgeons, 35–43 Lincoln’s Inn Fields, London WC2A 3PE, England.