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Abstract
BACKGROUND: Traumatic brain injury (TBI) is a major cause of death and disability worldwide. Progesterone has been shown to improve neurologic outcome in multiple experimental models and two early-phase trials involving patients with TBI. METHODS: We conducted a single-blinded, randomized, controlled clinical trial, in which patients with severe acute TBI (Glasgow Coma Scale of 4 to 9, with lower scores indicating a lower level of consciousness) were randomly assigned to receive intramuscular progesterone or placebo. Treatment was initiated within 12hours after injury and administrated for 5 consecutive days. The primary end points were the Glasgow Outcome Scale score at 14 days after injury, and measurement of serum TNF- alpha. RESULTS: Our results indicate no statistically significant difference in Glasgow outcome scale (GOS), or in the decrease of TNF alpha level between study and placebo groups (P > 0.05). CONCLUSIONS: This clinical trial did not show a benefit of progesterone over placebo in the improvement of outcomes in patients with acute TBI