Progesterone for acute traumatic brain injury.
BACKGROUND
Traumatic brain injury (TBI) is a leading cause of death and disability. Progesterone is a potential neuroprotective drug to treat patients with TBI.


OBJECTIVE
To assess the effectiveness and safety of progesterone in people with acute TBI.


METHODS
We searched: the Cochrane Injuries Group's Specialised Register (13 July 2012), Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 7, 2012), MEDLINE (Ovid) (1950 to August week 1, 2012), EMBASE (Ovid) (1980 to week 32 2012), LILACS (12 August 2012), Zetoc (13 July 2012), Clinicaltrials.gov (12 August 2012), Controlled-trials.com (12 August 2012).


METHODS
We included published and unpublished randomised controlled trials (RCTs) of progesterone versus no progesterone (or placebo) for the treatment of people with acute TBI.


METHODS
Two review authors independently screened search results to identify the full texts of potentially relevant studies for inclusion. From the results of the screened searches two review authors independently selected trials meeting the inclusion criteria, with no disagreement.


RESULTS
Three studies were included with a total of 315 people. Two included studies were of high methodological quality, with low risk of bias in allocation concealment, blinding and incomplete outcome data. One study did not use blinding and had unclear risk of bias in allocation concealment and incomplete outcome data. All three studies reported the effects of progesterone on mortality. The pooled risk ratio (RR) for mortality at end of follow-up was 0.61, 95% confidence interval (CI) 0.40 to 0.93. Three studies measured disability and found the RR of death or severe disability in patients treated with progesterone to be 0.77, 95% CI 0.62 to 0.96. Data from two studies showed no difference in mean intracranial pressure or the rate of adverse and serious adverse events among people in either group. One study presented blood pressure and temperature data, and there were no differences between the people in the progesterone or control groups. There was no substantial evidence for the presence of heterogeneity.


CONCLUSIONS
Current clinical evidence from three small RCTs indicates progesterone may improve the neurologic outcome of patients suffering TBI. This evidence is still insufficient and further multicentre randomised controlled trials are required.
Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, China.
Junpeng
J
Ma
Siqing
S
Huang
Shu
S
Qin
Chao
C
You
D001930:Brain Injuries / Q000188:drug therapy* / Q000401:mortality*; D004185:Disability Evaluation; D015600:Glasgow Coma Scale; D006801:Humans; D007427:Intracranial Pressure / Q000187:drug effects; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D011374:Progesterone / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012306:Risk
D018696:Neuroprotective Agents; D011374:Progesterone