Doctors have found an unexpected ally in efforts to save people who suffer serious head trauma — the hormone progesterone.
Progesterone found to help brain trauma
In a study released today, doctors in a small study at Grady Memorial Hospital in Atlanta report giving progesterone, a steroid often associated with pregnancy and sex drives, to patients with serious head injuries.
What they found, according to the study online in the Annals of Emergency Medicine, is that progesterone is safe and that more patients who got progesterone survived moderate head injuries than did those who were given a placebo.
"This is very exciting. This is one of the great research frontiers that is left," says Arthur Kellermann, emergency department chairman at Emory University School of Medicine, one of the study authors. "We can fix a lot of things in the body, but we do not have a drug that fixes damaged brains."
Traumatic brain injuries — from a gunshot wound to a blow to the head during a football game — can cause anything from a brief spell of dizziness to coma or death.
Brain injury is the signature wound of the war in Iraq. According to the Pentagon, at least 250 soldiers have returned from war zones in recent years with head wounds that left them, even briefly, unable to respond to people or to care for themselves.
In the USA, falls, car crashes and firearms contribute to more than 1 million head injuries each year, according to the Centers for Disease Control and Prevention.
Progesterone has a wide range of uses, from helping women through the first trimester of pregnancy to cutting a pedophile's sex drive. The most common use is as part of hormone-replacement therapy for women after menopause.
Because progesterone receptors are widely distributed in the central nervous system, and because progesterone appears to reduce brain swelling and prevent the loss of some nerve cells in animals studied after brain injury, researchers believe it will help humans with head trauma. Sexual effects wear off hours after the drug is administered. ("People are not interested in having sex in the intensive-care unit, anyway," Kellermann quips.)
In the human study, patients got progesterone for three days. Some patients with moderate brain injury were more likely to have better neurological outcomes if they got progesterone, the study found. A patient who got the drug might respond with confused speech to a friend, for instance, while a patient who did not get the steroid might remain unresponsive. Patients on progesterone had a lower 30-day mortality rate.
Because the study involved only 100 patients, the researchers say, a larger study is needed to determine the exact benefit. "If this drug works as well in 1,000 patients as it did in 100, it would be a landmark discovery," Kellermann says.
Edward Sloan, an emergency medicine professor at the University of Illinois College of Medicine in Chicago, praised the research. "It's difficult to find a single drug that can take us that next step beyond our best care today," he says.
Before researchers can launch a multi-center trial, they must address the issue of waiving informed consent, which will be the subject of a Food and Drug Administration public hearing in suburban Washington, D.C., next week.
Advances in emergency medicine require that some scientific questions be answered in real time amid an individual crisis, researchers and health officials say.
Because the Grady researchers set out to study only the safety of progesterone, an hours-long delay in starting treatment until doctors got consent from family members (known as "proxy consent") was acceptable.
But Kellermann says the next study must be designed to administer the drug as quickly as possible after a head injury, which would require the controversial waiver of patient consent.
For 10 years, federal rules have allowed experimental interventions without patient consent under strict circumstances. But critics say no patients should become test subjects without their consent.
The FDA expects to hear from patient advocates, researchers and others about how those rules might be changed to better protect patients while still allowing research. Kellermann says the next step in determining whether progesterone saves brain tissue may depend on the FDA.
"This could be a case study for that process," Kellermann says. "This is what waived consent is for."