Effect of citicoline on cognitive function and functional recovery in patients with mild-to-moderate traumatic brain injury: a randomized placebo-controlled trial.

Traumatic brain injury (TBI) is a major cause of persistent cognitive and functional impairment. Citicoline has been investigated as a neuroprotective therapy after TBI, but its clinical efficacy remains uncertain. This single-center, triple-blind, randomized, placebo-controlled pilot trial evaluated the effects of citicoline on 90-day cognitive and functional outcomes in adults with mild-to-moderate TBI. Sixty patients were randomly assigned in a 1:1 ratio to receive citicoline 1000 mg/day or matched placebo for 90 days. The primary outcome was the Mini-Mental State Examination (MMSE) score at 90 days. Secondary outcomes were the Barthel Index and Glasgow Outcome Scale-Extended (GOS-E) scores at 90 days and safety outcomes. At 90 days, MMSE scores were higher in the citicoline group than in the placebo group (25.2 ± 2.1 vs. 21.5 ± 3.4; P < 0.001). The citicoline group also had higher Barthel Index scores (85.0 ± 0.5 vs. 70.0 ± 0.8; P < 0.001) and GOS-E scores (5.2 ± 1.3 vs. 3.6 ± 0.8; P < 0.001). New or exacerbated intracerebral hemorrhage occurred in two patients receiving citicoline and three receiving placebo (P = 0.65). These preliminary findings suggest that citicoline may be associated with better 90-day cognitive and functional outcomes after mild-to-moderate TBI. Confirmation in adequately powered multicenter randomized trials is required.