ROLE OF CITICOLINE IN TRAUMATIC BRAIN INJURY:  A RANDOMIZED CONTROLLED STUDY

Deepak Krishna; I. D. Chaurasia; Umesh Jethwani

ROLE OF CITICOLINE IN TRAUMATIC BRAIN INJURY: A RANDOMIZED CONTROLLED STUDY

Deepak Krishna, I. D. Chaurasia, Umesh Jethwani

Abstract

Introduction: Traumatic brain injuries (TBI) are a leading cause of morbidity, mortality, disability and socioeconomic losses in India. It is estimated that nearly 1.5 to 2 million people are injured in which 35,000 persons die and 1,25,000 persons are disabled every year. Despite numerous prior clinical trials no standard pharmacotherapy for the treatment of TBI has been established. Cytidine-5-diphosphocoline (Citicoline), a naturally occurring endogenous compound, offers the potential of neuroprotection, neurorecovery, and neurofacilitation to enhance recovery after TBI.

Materials and Methods: This study was undertaken at surgical unit of medical College hospital to evaluate the effect of citicoline on functional and cognitive outcome in patient with moderate and severe TBI with age group 13-70 yrs in a randomized, single-blind, placebo-controlled ,single-center, prospective trials of 90 days. In all, 100 patient recruited over an estimated 12 months from single clinical site with random assignment to citicoline (1000 mg twice a day) or placebo (twice a day), administered enterally or orally for 60 days. Functional and cognitive outcomes are assessed at discharge, 30, 90 days. The primary outcomes include survival, rate of recovery and toxicity. The secondary outcome disability assessed by modified Rankin test for disability and Glasgow outcome score.

Results: Mean duration of stay in control group is 9.28 days versus 7.81 days in study group (p=0.09). In study group patients gain full conscious mean days 4.83 versus 6.25; (p=0.045) than control group. At 1 month in study group 20 (60%) of 30 patients versus 28 (93%) of 30 patients (p<0.001.) in control group having cognitive symptoms.

Conclusion: Rate of recovery is earlier in study group in prospect of less duration of stay, early gaining of full consciousness and relief from cognitive symptoms. No significant difference found in primary outcome (survival) and disability measurements.

Keywords

Citicoline, Clinical trial, Traumatic brain injury, TBI, Cytidine-5-diphosphocoline, Brain injury.

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