Progesterone, a hormone that has a role in female fertility, also has
characteristics that may make it useful in helping brain injured patients. A
new trial is about to begin that will explore the impact of progesterone
infusions on brain injured individuals who arrive for emergency treatment at
selected accident and emergency departments.
This large-scale trial, which will involve hospitals in 15 states, was
prompted by findings from several previous studies, including a recent small
study in which investigators found that administering progesterone soon
after a brain injury reduced the death rate by 50 percent and improved the
patients’ ability to recover.
Another earlier study conducted at Zhejiang University in China two years
ago found that patients with serious brain injuries who were given
progesterone were more likely to survive than those who received a placebo.
Among the patients who survived, those who had received progesterone had
made a good recovery at six months after treatment (58% of patients)
compared with those who had received placebo (42% of patients).
In the new trial, hospitals will randomly assign 1,140 patients who arrive
for emergency care within 11 hours of their brain injury to receive either
three days of infusion treatments with progesterone or placebo. Because it
appears the infusions are most effective if given within 11 hours of a
patient’s injury, it may not always be possible to obtain consent from next
of kin for a patient to take part in the trial. The Food and Drug
Administration has drawn up special rules to allow trials that involve
emergency medical treatments to proceed without consent.
Why progesterone? Although best known for its role in female fertility and
menstruation, small amounts of the sex hormone are also found in the brains
of both men and women. Brain tissue is loaded with progesterone receptors,
and studies suggest that the hormone plays a critical role in the normal
development of neurons in the brain and also protects damaged brain tissue.
In fact, Donald G. Stein, Asa G. Candler Professor of Emergency Medicine at
Emory School of Medicine and director of Emory’s Department of Emergency
Medicine Brain Research Laboratory, pioneered discoveries regarding the
effect of progesterone after brain injuries. More than 25 years ago he
discovered the ability of progesterone to protect brain cells in the
laboratory.
He also noted that women tended to respond to treatment and to recover
better than men after they suffered brain injury and stroke. Eventually he
and other researchers realized that progesterone, which is dominant in women
but also found in men, can perform in brain injured individuals the same way
it does during fetal development: it protects cells and tissues.
This new trial is the final step before researchers can apply for a license
to administer the hormone as standard treatment for brain injuries. If the
results of the trial are positive, it will become the first new treatment in
30 years that offers brain injured patients a better chance of survival and
recovery from major brain trauma.
The new three-to-six-year trial, which is known as proTECT III (for
progesterone for traumatic brain injury, experimental clinical treatment),
will be led by David Wright, MD, associate professor of emergency medicine
at Emory University School of Medicine. Atlanta’s Grady Memorial Hospital
has been designated the lead center, along with faculty from Emory School of
Medicine and Morehouse School of Medicine.
The possible introduction of progesterone as treatment for brain injured
patients will be most welcome by the medical community, as there have been
no effective treatments for such injuries. Approximately 1.4 million
children and adults experience a traumatic brain injury in the United States
every year, according to the Brain Injury Association of America. The result
is about 50,000 deaths, 235,000 hospitalizations, and 1.1 million people who
are treated and released from an emergency department. The Centers for
Disease Control and Prevention note that about 80,000 new cases of long-term
disability also result from these brain injuries.
SOURCES:
Brain Injury Association of America
Emory University, Feb. 19, 2010
Emory University news release, June 23, 2009
