The effect of combination therapy with erythropoietin and methylprednisolone in patients with traumatic cervical spinal cord injury: a pilot randomized controlled trial.

STUDY DESIGN Pilot double-blinded randomized controlled trial. OBJECTIVES To investigate the additive effect of recombinant human erythropoietin (rhEPO) on functional outcome and disability in patients with traumatic cervical spinal cord injury (TCSCI). SETTINGS University-affiliated hospital in Mashhad, Iran. METHODS Patients with acute TCSCI admitted within 8 h after injury were randomly assigned to receive only methylprednisolone (M group) or rhEPO 500 IU/mL plus methylprednisolone (M + E group). All the patients underwent surgery within the next several days. Neurological function was assessed on admission, and at 6th and 12th months after the injury according to the sphincter function and American spinal cord injury association (ASIA) scale. RESULTS Overall, 54 patients (mean age: 39.7 ± 13.3 years) including 46 (85%) males were studied in two groups of 27. The likelihood of developing adverse neurological outcomes (ASIA impairment score of A compared to D or E) was not significantly different between the groups after 6 (OR = 0.39, 95% CI = 0.03-4.80, P = 0.46) and 12 months (OR = 0.83, 95% CI = 0.11-6.11, P = 0.86). The groups also showed no significant difference in 1-year mortality (OR = 0.83, 95% CI = 0.25-2.74, P = 0.76). CONCLUSIONS It is not clear whether combination therapy with erythropoietin compared to methylprednisolone alone improves neurological functions of patients with TCSCI. Our study provides interim data to guide future larger definitive trials.