Research Reports - Progesterone for acute traumatic brain injury
PLoS One. 2015 Oct 16;10(10):e0140624. doi: 10.1371/journal.pone.0140624.
Zeng Y(1), Zhang Y(2), Ma J(1), Xu J(1).
OBJECTIVE: To evaluate the efficacy and safety of progesterone administrated in
patients with acute traumatic brain injury (TBI).
METHODS: PubMed/MEDLINE, EMBASE, Cochrane Database of Systematic Reviews,
Cochrane Central Register of Controlled Trials (CENTRAL), Clinicaltrials.gov,
ISRCTN registry and WHO International Clinical Trials Registry Platform (ICTRP)
were searched for randomized controlled trials (RCTs) comparing progesterone and
placebo administrated in acute TBI patients. The primary outcome was mortality
and the secondary outcomes were unfavorable outcomes and adverse events. A
meta-analysis was conducted to evaluate the efficacy and safety of progesterone
administrated in patients with acute TBI.
RESULTS: A total of 6 studies met inclusion criteria, involving 2,476 patients.
The risk of bias was considered to be low in 4 studies but high in the other 2
studies. The results of meta-analysis indicated progesterone did not reduce the
mortality (RR = 0.83, 95% CI = 0.57-1.20) or unfavorable outcomes (RR = 0.89, 95%
CI = 0.78-1.02) of acute TBI patients in comparison with placebo. Sensitivity
analysis yielded consistent results. Progesterone was basically safe and well
tolerated in TBI patients with the exception of increased risk of phlebitis or
thrombophlebitis (RR = 3.03, 95% CI = 1.96-4.66).
CONCLUSIONS: Despite some modest bias, present evidence demonstrated that
progesterone was well tolerated but did not reduce the mortality or unfavorable
outcomes of adult patients with acute TBI.