WEDNESDAY, Dec. 10, 2014 (HealthDay News) -- Treatment with the hormone progesterone doesn't benefit patients with traumatic brain injury, a new study finds. "These results are plainly disappointing," lead investigator Dr. David Wright, an associate professor and vice chair for research in emergency medicine at Emory University School of Medicine, said in a university news release. "The preclinical data on progesterone's neuroprotective effects are compelling, but we were not able to translate them to a multi-center clinical trial with human traumatic brain injury," he added. The study was conducted at 49 trauma centers across the United States and was originally meant to include 1,140 patients who would receive either progesterone or an inactive placebo. However, enrollment was halted after 882 patients because of the disappointing results. Before it was stopped, the study showed that favorable outcomes occurred in 51 percent of patients who were given progesterone and in 56 percent of those given the placebo. The average age of the study patients was 35, and most of the injuries were due to motor vehicle accidents. Death rates after six months were close to 19 percent in the progesterone group and nearly 16 percent in the placebo group, according to the … Continue reading →

PUBLIC RELEASE DATE: 10-Dec-2014 Contact: Holly Korschun hkorsch@emory.edu 404-727-3990 Emory Health Sciences @emoryhealthsci Treatment of acute traumatic brain injury with the hormone progesterone provides no significant benefit to patients when compared with placebo, a NIH-funded phase III clinical trial has concluded. The results are scheduled for publication Dec. 10 in the New England Journal of Medicine. The study, named ProTECT III, involved 49 trauma centers across the United States between July 2009 and November 2013. The study was originally planned to include 1,140 patients, but was stopped after 882 patients because safety monitors determined that additional enrollment would be futile. Survival and favorable outcomes, measured by improvements in patients' Glasgow Coma Scores, were not significantly different in the progesterone-treated group than in the placebo-treated group. Favorable outcomes occurred in 51 percent of those who received progesterone and 56 percent of those who received placebo. Mortality after six months was 18.8 percent for progesterone and 15.7 percent for placebo. "These results are plainly disappointing," says David Wright, MD, associate professor and vice chair for research in emergency medicine at Emory University School of Medicine, who served as lead investigator for the national study. "The preclinical data on progesterone's neuroprotective effects are … Continue reading →

Giving people with fresh traumatic brain injuries the hormone progesterone does no good, two major studies have found. The results dash some high hopes for treating a problem that hits millions each year, from combat troops to car crash victims. Brain injuries account for more than 2 million hospitalizations or emergency room visits each year in the United States and often cause major disabilities. Roadside bombs have increased the number of troops suffering closed-head injuries, too. Some drugs can reduce symptoms, such as swelling, but none are known to improve long-term recovery and prevent disability. Work in animals and two very encouraging small trials in people suggested progesterone might. It is a female sex hormone that is thought to protect nerves and brain cells in a variety of ways, including curbing inflammation that causes swelling after an injury. The two new studies were meant to be definitive tests. In one, funded by the National Institutes of Health and led by doctors at Emory University and Grady Memorial Hospital in Atlanta, dozens of trauma centres around the U.S. aimed to enrol 1,140 patients with moderate to severe brain injuries mostly car crash victims. They were given infusions of progesterone or a … Continue reading →

Giving people with fresh traumatic brain injuries the hormone progesterone does no good, two major studies have found. The results dash some high hopes for treating a problem that hits millions each year, from combat troops to car crash victims. Brain injuries account for more than 2 million hospitalizations or emergency room visits each year in the United States and often cause major disabilities. Roadside bombs have increased the number of troops suffering closed-head injuries, too. Some drugs can reduce symptoms, such as swelling, but none are known to improve long-term recovery and prevent disability. Work in animals and two very encouraging small trials in people suggested progesterone might. It is a female sex hormone that is thought to protect nerves and brain cells in a variety of ways, including curbing inflammation that causes swelling after an injury. The two new studies were meant to be definitive tests. In one, funded by the National Institutes of Health and led by doctors at Emory University and Grady Memorial Hospital in Atlanta, dozens of trauma centers around the U.S. aimed to enroll 1,140 patients with moderate to severe brain injuries ? mostly car crash victims. They were given infusions of progesterone or … Continue reading →