Progesterone given immediately after serious brain injuries did not reduce the effects of those injuries. This was the conclusion of two major studies and both the reports were published in the Wednesday issue of New England Journal of Medicine.
The results were obtained from two studies. The first one was conducted under the aegis of doctors at Emory University in Atlanta. It was named Protect III and involved 882 patients. The second study was headed by doctors at North Shore University Hospital in Manhasset, N.Y. The second study was named Synapse and involved 1,195 patients.
The findings were contrary to the range of studies on animals which showed that progesterone had a “neuroprotective” effect, preserving brain function despite injury. Scientists associated with the study found, 6 months after the injury, patients who were given progesterone did not show any advantages over those patients who were given placebo when they were evaluated by measuring the functional outcomes which includes disability and recovery. The assessment was done on a scale known as the Glasgow Coma Scale. The progesterone hormone was administered within four hours of the injury.
Researchers from Emory and other hospitals in the Protect III study wrote, “This clinical trial did not show a benefit of progesterone over placebo in the improvement of outcomes.”
Originally the study projected to include 1,140 patients who were assigned to progesterone or placebo, but was stopped after 882 because of little impact
Another study revealed that progesterone had scant effect in the clinical outcome when it is given acutely to patients who have suffered a traumatic brain injury or TBI.
Raj K. Narayan, MD, executive director, North Shore-LIJ’s Cushing Neuroscience Institute said that regardless of experimental support in animal models and also promising preliminary data from single center trials, the study did not show any benefit of administering progesterone immediately after a severe TBI.