Objective: Neuroprotective effect of estrogen in traumatic brain injury (TBI) has been shown in many animal studies. This clinical trial was designed to investigate the effect of estrogen on neurological outcome in diffuse axonal injury (DAI).Materials and Methods: Frothy- eight male patients 18-60 years with moderate to severe DAI admitted within the first 4 hours of injury were randomly divided into control and estrogen groups. The estrogen group received orally 1.25 mg conjugated estrogen within four hours of brain injury and four days consecutive in addition to standard treatment.
Glasgow coma scale (GCS) assessment was performed at the time of admission, six days after injury and the day of discharge, while functional independence measure (FIM) and
Glasgow coma scale (GOS) at the time of admission and the third and sixth months after injury.Results: Although there was no significant difference in GCS between the control and estrogen groups at six days’ post injury, this score in the estrogen group was higher than the control group at the time of discharge (P <0.05). There was an increase in GOS score in the estrogen group compared to the control group at three and six months after DAI (P <0.05). FIM score was not significant between the control and estrogen groups at three and six months after injury. This score increased in the estrogen group at six months after injury compared to three months after injury (P <0.001). Unlike the control group, no death occurred in the estrogen group.Conclusion: The findings of this study showed the treatment of estrogen could probably improve neurological outcome in male patients with DAI. A study with larger sample size is needed to confirm the efficacy of estrogen in DAI. The mechanism of the effect of estrogen in DAI will be examined in a future study.