Progesterone for Traumatic Brain Injury: A Meta-Analysis Review of Randomized Controlled Trials

OBJECTIVE: To conduct a meta-analysis to determine whether progesterone, compared with placebo or no treatment, influences mortality and neurologic outcome in traumatic brain injury (TBI). METHODS: To identify eligible studies, systematic searches for randomized controlled trials of progesterone treatment in TBI were conducted in PubMed, Web of Science, EMBASE, Cochrane Library, and ClinicalTrials. gov databases. The search yielded 8 studies that were included in the meta-analysis. Included data were study characteristics, patient demographics, baseline characteristics, progesterone treatment protocol, main outcome of mortality, and secondary neurologic outcome evaluated using the Glasgow Outcome Scale. RESULTS: The 8 studies comprised 2585 patients. The meta-analysis indicated that there was no evidence that progesterone treatment decreased the risk of mortality in patients with TBI; the overall risk ratio was 0.852 (95% confidence interval, 0.632-1.144; P = 0.284). In the secondary outcome analysis, progesterone had no neuroprotective role in improving neurologic outcome; the overall risk ratio was 1.151 (95% confidence interval, 0.0991-1.338; P = 0.06). Subgroup analysis according to the degree of injury assessed by the Glasgow Coma Scale demonstrated similar results. CONCLUSIONS: This study is the largest meta-analysis conducted to date to determine whether progesterone is effective in the treatment of TBI. The findings indicate that progesterone treatment does not decrease mortality or improve neurologic outcome in patients with TBI.