This is what is in CerAxon that Diane from
Pink House on the Corner thought helped Bob.
A positive review for stroke
here:
So ask your doctor why it would be helpful for stroke but not TBI.
http://www.medpagetoday.com/CriticalCare/HeadTrauma/36050
Citicoline -- a chemical that occurs naturally in the body and is
available in the U.S. as a nutraceutical -- did not improve outcomes
among patients with traumatic brain injury, the randomized COBRIT trial
showed.
Functional and cognitive outcomes assessed with a battery of tests 90
days after the injury were not significantly different between the
patients who received citicoline and those who received placebo,
according to Ross Zafonte, DO, of Harvard Medical School in Boston, and
colleagues.
There were also no differences in any secondary outcome, including
survival, the researchers reported in the Nov. 21 issue of the
Journal of the American Medical Association.
The findings call into question the use of citicoline around the world, they said.
The agent is approved for use in patients with traumatic brain
injuries in 59 countries. Preclinical studies and some small clinical
trials have suggested that citicoline has potential neuroprotective
effects and may enhance neurological repair after a brain injury, but
most randomized trials in patients with traumatic brain injury have
failed to show any benefit.
"The absence of an effect in prior trials and in COBRIT may be
attributable either to the therapy simply being ineffective or to the
heterogeneous pathophysiological nature of traumatic brain injury,"
Zafonte and colleagues wrote. "This would suggest that the mechanisms of
action of drugs used in future ... trials would need to be tested in
specific subtypes of traumatic brain injury, where they are likely to
have a positive effect."
The COBRIT trial was a phase III, double-blind, randomized trial that
included 1,213 patients treated at one of eight U.S. level 1 trauma
centers for a nonpenetrating traumatic brain injury. The seriousness of
the injuries ranged from complicated mild traumatic brain injury to
severe injury.
The patients received either daily enteral or oral citicoline 2,000
mg or matching placebo starting within 24 hours of the injury.
The primary outcome was a global measure of functional and cognitive
status -- the TBI Clinical Trials Network Core Battery, which includes
nine scales -- at 90 days.
The trial was stopped for futility at the fourth interim analysis.
The primary outcome was no different between the citicoline and placebo
groups at 90 days (OR 0.98, 95% CI 0.83 to 1.15). The severity of injury
did not affect the results.
The rate of a favorable outcome for each of the nine scales of the
assessment ranged from 35.4% to 86.5% in the citicoline group and from
35.6% to 84% in the placebo group, with no between-group differences.
In an accompanying editorial, Robert Ruff, MD, PhD, and Ronald
Riechers II, MD, of the Cleveland VA Medical Center, noted that among
the possible reasons citicoline did not improve outcomes was the fact
that there are many different mechanisms of injury involved in brain
trauma.
"Traumatic brain injury can have regional pathology attributable to
hematomas, edema, infarction, penetrating injury, and cerebral
contusions. Diffuse injury mechanisms include diffuse edema, activation
of inflammatory cytokines, release of excitatory neurotransmitters,
extracellular potassium-induced membrane depolarization, and diffuse
axonal injury," they wrote.
"Hence, optimal treatment ... may require that multiple agents and
modalities be used to address all of the regional and widespread injury
processes that occur in traumatic brain injury," they wrote.
