Traumatic brain injury (TBI) results from a blow or jolt to the head or a penetrating head injury that disrupts brain function. As reported on Brainline, of the 1.7 million people in the U.S. who suffer TBI every year, 52,000 die, 275,000 are hospitalized, and 1.365 million are treated in emergency rooms and released. Severe TBI can cause unconsciousness or amnesia and may result in long-term independent function problems for victims.
Hopes for Progesterone and TBI in the Scientific Community
Progesterone is a female hormone involved in menstrual cycles and reproduction that can also be found in the brains of both males and females. According to a Life Extension Magazine article, neuroscientist Donald G. Stein, PhD, and some of his colleagues noted that some females recover more completely and quickly from brain injury than males do, and began investigating the neuroprotective effects of progesterone more than 30 years ago.
Studies with animals have indicated that progesterone may reduce damage to the brain and improve recovery from TBI. As reported in the Life Extension article, Dr. Stein’s successful experiments using progesterone to alleviate the effects of brain injury to rats eventually led to clinical trials using progesterone to treat humans suffering from TBI.
In 2012, the National Institutes of Health (NIH) published the findings of a study conducted to assess the safety and effectiveness of progesterone for treating patients with acute TBI. Data for the study was obtained from 3 randomized controlled trials of progesterone versus placebo for treatment of a total of 315 acute TBI patients. This study concluded that progesterone may improve neurologic outcome for TBI victims, but that evidence was insufficient and further controlled trials would be required.
Disappointing Results of Further Clinical Trials
On December 25, 2014, the New England Journal of Medicine published the results of a double-blind clinical trial in which 882 patients with moderate, moderate-to-severe, or severe acute brain injury were randomly given either progesterone or a placebo within 4 hours after injury, with treatments continuing for 96 hours. Most of the patients received their injuries through motor vehicle accidents.
The results of the trial were disappointing, to say the least. There was no significant difference in favorable outcomes for patients treated with progesterone as compared to those treated with a placebo. The conclusion of the study was that progesterone has no clinical benefit for acute TBI patients.
According to a February 10, 2015 Health News article, the study, which was funded by NIH and known as Pro TECT-III, began in April 2009 and continued to October 2013. The University of Cincinnati Medical Center was among the 49 trauma centers that participated in the study and enrolled 85 of the 882 patients involved. Patients were followed closely by researchers for 6 months after treatment.
As reported in the Health News article, Jordon Bonomo, M.D., lead investigator for the trial in Cincinnati, said that the research team was disappointed to learn that progesterone was not as helpful as had been hoped. Dr. Bonomo also commented on the importance of developing new therapies to treat TBI.
- Brainline: Facts about Traumatic Brain Injury
- Life Extension: Progesterone May Improve Outcomes from Brain Injury
- NIH: Progesterone for Acute Traumatic Brain Injury
- New England Journal of Medicine: Very Early Administration of Progesterone for Acute Traumatic Brain Injury
- Health News: Progesterone Does Not Improve Outcome After Traumatic Brain Injury