Progesterone Fails to Help Recovery from Traumatic Brain Injuries: Study
Two new studies suggest that treating severe concussions with progesterone does not help patients recover from a traumatic brain injury, contradicting the findings of prior research.
In the latest issue of The New England Journal of Medicine, research from two separate studies compared the difference of administering progesterone or a placebo to patients who suffered severe head trauma or brain injury.
Prior early phase experimental model studies have concluded that progesterone, a key hormone linked to pregnancy, breast development and other reproductive functions, may improve neurologic outcome in patients who suffered traumatic brain injury. This prompted researchers to investigate the effect further.
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In the first study, researchers gave progesterone or a placebo to nearly 900 patients within four hours after suffering a traumatic brain injury. The progesterone was administered for a total of 96 hours.
Researchers found early administration of the hormone did not help patient recovery from severe brain injury. The double-blind trial was stopped early because the effects researchers hoped to see were not exhibited and other side effects were seen.
Many of the progesterone patients experienced phlebitis, inflammation of the leg or arm veins, and thrombophlebitis, inflammation of veins caused by blood clots; more so than the placebo group.
The majority of the patients were men and the most frequent mechanism of injury was a motor vehicle accident.
Research published earlier this year revealed men may take longer to recover after experiencing traumatic brain injury. The findings indicated men averaged one month longer to recover after brain injury compared to women.
In both studies, patients were categorized as severe, moderate-to-severe, or moderate acute traumatic brain injuries based on the Glasgow Coma Scale.
Larger Study, Same Results
The second multinational placebo-controlled clinical trial, also examined the early administration of progesterone to patients who experienced traumatic brain injury.
The progesterone or placebo was administered to nearly 1,200 patients within eight hours of injury and continued for 120 hours. Patients ranged in ages from 16 years to 70 years with a Glasgow score of 8 or less and had at least one reactive pupil.
The study revealed progesterone was not effective as a treatment for traumatic brain injury. The proportion of patients with a favorable outcome in the progesterone group was 50.4 percent, in the placebo group 50.5 percent, virtually identical.
Researchers hoped mortality rates would drop in the progesterone group considering the findings of a study that revealed survivors of TBI may be three times more likely to face premature death. Yet, mortality rates were similar in both placebo and progesterone groups.
Both studies concluded that there was no difference between the group given progesterone and the group given a placebo.
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