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Progesterone for Acute Traumatic Brain Injury: A Systematic Review of Randomized Controlled Trials.

Zeng Y, Zhang Y, Ma J, Xu J - PLoS ONE (2015)

Bottom Line: 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).

View Article: PubMed Central - PubMed

Affiliation: Department of Neurosurgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan, People's Republic of China.

ABSTRACT

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.

No MeSH data available.


Related in: MedlinePlus

Flow diagram showing selection of studies.
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pone.0140624.g001: Flow diagram showing selection of studies.

Mentions: A total of 332 studies were initially identified after duplicates removed through the prespecified search strategy, and 37 studies were retrieved for full-text after abstract screening. There were 1 ongoing study in recruiting phase and 1 conference abstract without sufficient information and therefore they were excluded [16, 29]. Another 27 studies were excluded because they were not randomized controlled trials. After full-text reading, 1 study included in the former Cochrane systematic review was excluded, because the participants recruited from March 2003 to December 2005 were considered to overlap those of another study that were recruited from March 2003 to February 2007 at the same hospital [10]. According to the inclusion criteria, one more study was excluded because the intervention was medroxyprogesterone rather than natural progesterone [15]. Finally, a total of 6 studies met all the inclusion criteria and were included in meta-analysis as shown in Fig 1 [11–14, 18, 19].


Progesterone for Acute Traumatic Brain Injury: A Systematic Review of Randomized Controlled Trials.

Zeng Y, Zhang Y, Ma J, Xu J - PLoS ONE (2015)

Flow diagram showing selection of studies.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4608716&req=5

pone.0140624.g001: Flow diagram showing selection of studies.
Mentions: A total of 332 studies were initially identified after duplicates removed through the prespecified search strategy, and 37 studies were retrieved for full-text after abstract screening. There were 1 ongoing study in recruiting phase and 1 conference abstract without sufficient information and therefore they were excluded [16, 29]. Another 27 studies were excluded because they were not randomized controlled trials. After full-text reading, 1 study included in the former Cochrane systematic review was excluded, because the participants recruited from March 2003 to December 2005 were considered to overlap those of another study that were recruited from March 2003 to February 2007 at the same hospital [10]. According to the inclusion criteria, one more study was excluded because the intervention was medroxyprogesterone rather than natural progesterone [15]. Finally, a total of 6 studies met all the inclusion criteria and were included in meta-analysis as shown in Fig 1 [11–14, 18, 19].

Bottom Line: 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).

View Article: PubMed Central - PubMed

Affiliation: Department of Neurosurgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan, People's Republic of China.

ABSTRACT

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.

No MeSH data available.


Related in: MedlinePlus