Prospective Randomized Control Trial to Compare the Role of Injection Cerebrolysin for 10 Days Duration Against Placebo in Operated Cases of Degenerative Cervical Myelopathy

Abstract

Study Design. 

Prospective randomized control trial.

Objective. 

To analyze outcomes following the injection of cerebrolysin in surgically treated patients with degenerative cervical myelopathy (DCM).

Summary of Background Data. 

Previous research has concluded that superior functional outcomes are achieved with the use of cerebrolysin in surgically treated patients of DCM for 21 days. Our study has been conducted to analyze the use of this drug for a shorter duration (10 days) and compare its clinical efficacy.

Methods. 

Ninety operated cases of mild to severe DCM were randomized into two groups. Sixty patients received the injection Cerebrolysin for 10 days postoperatively. The remaining 30 patients received a placebo. Functional outcomes were measured using modified Japanese Orthopaedic Association (mJOA) scores and visual analogue scale (VAS). The American Spinal Injury Association (ASIA) scale was used to document neurological recovery. Hand function was assessed by measuring the grip strength and the upper limb function score the upper extremity motor mJOA plus upper extremity sensory mJOA score. Assessments were performed and preoperatively and postoperatively and at one-month, three-month, six-month, and one-year following surgery.

Results. 

Preoperative mJOA and VAS scores were comparable in both groups (P>0.05). Both groups experienced an improvement in mJOA and VAS scores at all time-points during follow-up as compared with preoperative scores. However, the cerebrolysin group demonstrated significantly greater mJOA scores (16.37±1) when compared with the placebo (15.2±1.8) at one-year follow-up (P<0.0001). Neurological improvement with cerebrolysin therapy was also superior (P=0.04). No significant adverse reactions were documented.

Conclusion. 

Injection cerebrolysin, when administered for 10 days postoperatively, can result in significantly greater neurological improvement and hand function in patients with DCM who also receive surgery.