Neuroprotective Effects of Progesterone in Diffuse Axonal Injury

Abstract

Background: Severe traumatic brain injury (TBI) has a major role in mortality rate among the other types of trauma. Progesterone’s neuroprotective effect has been confirmed on animals, although there are a number of animal models of TBI using progesterone for head injury, the effects of progesterone on neurologic outcome of acute TBI human patients remain unclear. The aim of the present clinical study was to assess the longer-term efficacy of progesterone on the improvement in neurologic outcome of patients with acute severe TBI. In this study we examined the pharmacotherapy effect of progesterone in patients suffering from traumatic brain injury with DAI and GCS ≤ 8 diagnoses.Materials and Methods: A total of 76 patients who arrived within 8 hours of injury with a Glasgow Coma Score ≤ 8 were enrolled in the study. Of 76 patients randomized, 38 received progesterone (1mg/kg per 12 hour for 5 days) and 38 didn't. The primary endpoint was the Glasgow Outcome Scale score 3 months after brain injury. Results: The mean GCS scores increased progressively in the two groups till the time of discharge, with no apparent differences among the treatment groups. There was a better recovery rate and GOS score for the patients who were given progesterone than for those in the control group at 3-month follow-up (50% vs. 21%) but this wasn't significant from the point of statistical analysis (p = 0.08) however subgroup analysis showed a significant difference in the percentage of favorable outcome between the two groups with GCS of 5 to 8 (p = 0.03).But there was no significant difference, however, in dichotomized outcomes in the group with GCS of 3 to 5 (P > 0.05).

Conclusion: The present study indicated that the use of progesterone may significantly improve neurologic outcome of patients suffering severe TBI up to 3 months after injury, especially those with 5-4; GCS<8, providing a potential benefit to the treatment of acute severe TBI patients. As there is no significant side effect of this drug, progesterone could be used in patients with severe TBI as a neuroprotective drug.

 Keywords : GCS; GOS score; TBI; Progesterone; DAI.