Researchers found that after five days of progesterone treatments patients with a traumatic brain injury did not show significant improvement.
The findings were made through a large prospective clinical trial, North Shore-Long Island Jewish (LIJ) Health System reported.
"Despite extensive experimental support in numerous animal models, as well as very promising preliminary data from smaller single center trials, this Phase III study failed to show benefit of progesterone in severe TBI," said Dr. Raj K. Narayan, executive director of North Shore-LIJ's Cushing Neuroscience Institute and one of the co-authors of the paper.
The trial included 1,195 patients between the ages of 16 and 70 who had suffered a severe TBI and were assigned to receive progesterone or placebo. The dosing began within eight hours of the injury and continued for 120 hours.
The proportion of patients who exhibited favorable outcomes were measured on the Glasgow Outcome Scale. The team found 50.4 percent of patients who took progesterone had favorable outcomes compared to 50.5 of the placebo patients. The mortality rates proved to be the same across both groups.
The study suggests that while promising factors associated with progesterone in early studies, it does not necessarily indicate clinical benefits.
"It also highlights the difficulty in demonstrating the efficacy of any drug in this complex disease since the outcome may be affected by many factors. Animal models usually replicate only one aspect of the injury, but human TBI patients can suffer multiple medical and surgical problems that can affect their ultimate outcome. The need to find better treatments for this severe injury remains as great as ever and what we have learned from this trial will help us better design future trials," concluded Brett E. Skolnick, adjunct associate professor of neurosurgery at the Hofstra North Shore-LIJ School of Medicine and lead author of the paper.
The findings were published Dec. 10 in The New England Journal of Medicine,
