Role of Cerebrolysin in cervical spondylotic myelopathy patients: a prospective randomized study.

BACKGROUND CONTEXT: Cerebrolysin is a mixture containing 85% free amino acids and 15% biologically active low-molecular weight peptides that is believed to mimic the effects of endogenous neurotrophic factors to interact with the pathologic process cascade of neurodegenerative diseases. No study has examined the effect of Cerebrolysin on cervical myelopathic patients.

PURPOSE: The objective of this study was to evaluate the effect of Cerebrolysin as a conservative modality on cervical spondylotic myelopathic patients.

STUDY DESIGN: This is a prospective randomized study.

PATIENT SAMPLE: A total of 192 patients with cervical spondylotic myelopathy (CSM) were subdivided blindly into two equal groups.

OUTCOME MEASURES: Followed-up was performed at 1, 3, and 6 months comparing the recovery rate Japanese Orthopaedic Association (JOA) score for cervical myelopathy between the two groups.

METHODS: Group I received Cerebrolysin and Group II received placebo for 4 weeks; both groups received celecoxib 200 mg for 4 weeks.

RESULTS: Myelopathy improved in 92% and 52% of patients at 1 month in Groups I and II, respectively; these changed at 6 months to 87% and 33%; the remaining 13% in Group I neither improved nor deteriorated, whereas 60% in Group II neither improved nor deteriorated and 7% deteriorated with statistically significant differences when comparing the mean JOA recovery rate between the 2 groups at 1, 3, and 6 months.

CONCLUSIONS: Cerebrolysin over 4 weeks is safe and effective for the improvement of CSM as compared with placebo, with no reported cases of neurologic deterioration over 6 months of follow-up.