Research Reports - Efficacy of progesterone for acute traumatic brain injury

Mol Neurobiol. 2016 Dec;53(10):7070-7077. Epub 2015 Dec 16.

Wang Z(1), Shi L(1), Ding W(1), Shao F(1), Yu J(2,)(3), Zhang J(1).

Progesterone, a steroid hormone, has been shown to have multifactorial
neuroprotective effects in a variety of animal models of acute traumatic brain
injury (TBI). Translation to humans showed positive effects in previous phase II
trials, but unfortunately, negative results were observed in two recent phase III
trials. The present study focuses on the efficacy of progesterone on acute TBI
based on the published data of randomized controlled trials (RCTs). MEDLINE,
EMBASE, and Cochrane Library were used to search from January 1980 to August 2015
for English language studies. The primary outcome was a favorable outcome in the
Glasgow outcome scale (GOS). The secondary outcomes included mortality and
adverse events. A total of 2396 patients from 5 RCTs were included in the present
study. There were no significant differences in favorable outcome (relative risk
(RR) 1.07, 95 % confidence interval (CI) 0.91 to 1.27, P = 0.41) and mortality
rate (RR 0.85, 95 % CI 0.65 to 1.13, P = 0.27) between progesterone and placebo
groups. In a subgroup analysis, favorable outcome (RR 1.45, 95 % CI 1.11 to 1.89,
P = 0.007) and decreased mortality rate (RR 0.58, 95 % CI 0.41 to 0.84,
P = 0.004) are only observed in the phase II RCTs. The included factors were the
severity of TBI, method of drug administration, and duration of observation and
had no influence on the observed outcomes. Sensitivity analysis showed that all
the outcomes were stable after excluding Shakeri (Clin Neurol Neurosurg 115:
2019-2022, 2013) or Wright (N Engl J Med 371: 2457-2466, 2014) trials. The
quality of the evidence was varied from high to low. In conclusion, progesterone
has no significant improvement in the functional recovery and mortality rate
after acute TBI. 

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