RESUMEN
BACKGROUND AND OBJECTIVE: The benefits of progesterone have been demonstrated in the animal models of traumatic brain injury (TBI). However, the results of clinical studies are conflicting. Considering the heterogenic nature of TBI, the effect of progesterone in patients with diffuse axonal injury (DAI) was investigated in a clinical trial. METHODS: In this study, 48 patients with DAI and Glasgow Coma Scale of 3-12, admitted within 4 hours after injury, were randomly assigned to the progesterone or control group. The dose of progesterone administration was 1 mg kg-1 per 12 hours for 5 days. The effect of progesterone was investigated using extended-Glasgow Outcome Scale (GOS-E), functional independence measure (FIM) scores and also mortality within the follow-up period. RESULTS: The progesterone group exhibited higher GOS-E and FIM scores in comparison to the control group at 6 months post-injury (p < 0.01 and p < 0.05, respectively). Mortality was also found in the control group (p < 0.05). The adverse events attributed to the progesterone administration were not found throughout the study. CONCLUSIONS: Findings of this study suggest that progesterone may be neuroprotective in patients with DAI. However, large clinical trials are needed to assess progesterone as a promising drug in DAI.