A dietary supplement sold as a brain stimulant failed to help head trauma patients improve in function and thinking in a study, challenging the drug’s use as a treatment option for the condition, researchers said.
Patients with traumatic brain injury who were given the supplement, citicoline, scored similarly on function and cognition tests as those given a placebo, according to the study published today in the Journal of the American Medical Association. Previous animal research and pilot clinical studies had suggested the supplement might reduce cerebral injury caused by head trauma, stroke or aging.
Citicoline, available as a supplement for more than a decade, is used mostly outside the U.S. for brain injury as well as in stroke and Alzheimer’s disease, said Ross Zafonte, the lead study author. Today’s findings call into question the supplement’s use for head trauma, he said.
“We were disappointed to find that it did not appear to make a difference in outcome at 90 and 180 days post-injury,” Zafonte, a professor and chairman of physical medicine and rehabilitation at Harvard Medical School in Boston and vice president of medical affairs at the Spaulding Rehabilitation Network, said in a Nov. 19 telephone interview. “We are heartened in some ways by the fact that we’ve taken a worldwide therapy that should now very much be questioned and we have now brought that into the light.”
Each year in the U.S., about 235,000 patients are hospitalized for nonfatal total brain injuries, 1.1 million are treated in emergency rooms and 53,000 die, according to an accompanying editorial. About 3.2 million Americans are living with a disability following hospitalization for head trauma, the authors of the editorial wrote.
Citicoline was thought to work by helping to protect and restore nerve cells after brain injury, Zafonte said. The treatment is an approved drug in 59 countries, he said. In the U.S., it is sold as a supplement over the counter.
The study included 1,213 patients at eight U.S. trauma centers who were given citicoline or a placebo for 90 days starting within 24 hours of the injury.
The researchers found that on the Glasgow Outcome Scale-Extended, which measures levels of function a person has after a brain injury, 35.4 percent of those in the citicoline group improved compared with 35.6 percent in the placebo group. For other scales of improvement the rates ranged from 37.3 percent to 86.5 percent in the citicoline group and from 42.7 percent to 84 percent in the placebo group.
The findings show that no single treatment may be sufficient to benefit patients with traumatic brain injuries, said Robert Ruff and Ronald Riechers, both doctors of neurology at the Cleveland VA Medical Center in Ohio, in the accompanying editorial.
“Future studies of traumatic brain injury should be designed to incorporate multiple treatment interventions and comprehensive traumatic brain injury rehabilitation strategies,” they wrote.
The study was sponsored by the U.S. National Institute of Child Health and Human Development. Spanish drugmaker, Ferrer Grupo, which makes citicoline, supplied the drug for the study.