There is no significant improvement in either functional or cognitive status among patients with traumatic brain injury (TBI) taking citicoline compared with placebo, according to a study published in the Nov. 21 issue of the Journal of the American Medical Association.
Ross D. Zafonte, DO, from Harvard Medical School in Boston, and colleagues conducted a phase 3 randomized trial, the Citicoline Brain Injury Treatment Trial, in which 1,213 patients with complicated mild, moderate, or severe TBI at eight U.S. level 1 trauma centers were randomized to receive a 90-day regimen of daily enteral or oral citicoline (2,000 mg) or placebo. The TBI-Clinical Trials Network Core Battery was used to assess functional and cognitive status at 90 days.
The researchers found that, at the 90-day evaluation, the citicoline and placebo groups did not differ significantly with respect to function and cognitive status (global odds ratio [OR], 0.98; 95% confidence interval [CI], 0.83 to 1.15). There was no significant treatment effect by severity (global ORs, 1.14 [95% CI, 0.88 to 1.49] for moderate/severe and 0.89 [95% CI, 0.72 to 1.49] for complicated mild TBI). Similarly, the citicoline and placebo groups did not differ significantly with respect to the primary outcome at the 180-day evaluation (global OR, 0.87; 95% CI, 0.72 to 1.04).
"In conclusion, this large, randomized, blinded study showed that acute and subacute treatment with citicoline did not result in improvement in functional and cognitive status," the authors write. "These findings call into question the use of citicoline for patients with TBI."
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