Research Reports - Does progesterone improve outcome in diffuse axonal injury?
Brain Inj. 2016 Nov 7:1-8. [Epub ahead of print]
Soltani Z(1), Shahrokhi N(2), Karamouzian S(3), Khaksari M(4), Mofid B(3),
Nakhaee N(2), Reihani H(3).
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.