Progesterone shows promise as treatment for traumatic brai...( rty days after injury objective rating...),Health

In an earlier paper, the researchers reported that progesterone can be reliably given intravenously and achieve predictable levels in the bloodstream. The new paper reports the team's findings about drug safety and effectiveness.

"We found encouraging evidence that progesterone is safe in the setting of TBI, with no evidence of side effects or serious harmful events," says David Wright, MD, assistant professor in the Department of Emergency Medicine at Emory and lead author of the study. "In addition, we found a 50 percent reduction in the rate of death in the progesterone-treated group. Furthermore, we found a significant improvement in the functional outcome and level of disability among patients who were enrolled with a moderate brain injury." The researchers evaluated disability using the Disability Rating Scale, an objective measurement tool, and assessed functional outcome using the highly validated Glasgow Outcome Scale.

The researchers found no significant differences in the rate of adverse events among patients who received progesterone compared to those who received placebo. About 30 percent of patients given placebo died within 30 days of head injury, compared to only 13 percent of those given progesterone. Most patients who died had a severe TBI. Because more severe TBI patients in the progesterone group survived, it is not surprising that they had a higher average level of disability at 30 days than survivors in the placebo group. One-year outcomes will be reported at a later date.

Progesterone is a promising treatment because it is inexpensive, widely available and has a long track record of safe use in humans to treat other diseases. The team previously reported that IV progesterone can be easily administered in an arm or hand vein rather than through a central IV line in the neck,
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Contact: Janet Christenbury
jmchris@emory.edu
404-727-8599
Emory University Health Sciences Center
2-Oct-2006