Effect of Progesterone Administration on Prognosis of Patients With Diffuse Axonal Injury Due to Severe Head Trauma

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 TBI with diffuse axonal injury (DAI) and Glasgow coma score (GCS) ≤8 diagnoses. Methods and Materials: A total of 76 patients who arrived within 8 hours of injury with a GCS≤8 were enrolled in the study. Of 76 patients randomized, 38 received progesterone (1 mg/kg per 12 h for 5 d) and 38 did not. The primary endpoint was the Glasgow outcome scale score 3 months after brain injury. Results: The mean GCS scores increased progressively in the 2 groups till the time of discharge, with no apparent differences among the treatment groups. There was a better recovery rate and Glasgow outcome scale 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 was not 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 2 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). Conclusions: 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≤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.