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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

Subgroup analysis.Forrest plots of subgroup analysis according to TBI severity (A, B) and therapeutic regimens (C, D).
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pone.0140624.g005: Subgroup analysis.Forrest plots of subgroup analysis according to TBI severity (A, B) and therapeutic regimens (C, D).

Mentions: According to the severity of TBI, the subgroup analysis suggested neither moderate nor severe TBI patients could benefit from progesterone administration, because the mortality or unfavorable outcomes did not differ significantly between progesterone group and placebo group as shown in Fig 5A and 5B. When stratified by therapeutic regimens, intravenously administrated progesterone did not reduce the mortality or unfavorable outcomes of acute TBI patients while beneficial effect of progesterone was observed in acute TBI patients when administrated intramuscularly (RR = 0.55, 95% CI = 0.34–0.90 for mortality and RR = 0.70, 95% CI = 0.58–0.88 for unfavorable outcomes, respectively) (Fig 5C and 5D).


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

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

Subgroup analysis.Forrest plots of subgroup analysis according to TBI severity (A, B) and therapeutic regimens (C, D).
© Copyright Policy
Related In: Results  -  Collection

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

pone.0140624.g005: Subgroup analysis.Forrest plots of subgroup analysis according to TBI severity (A, B) and therapeutic regimens (C, D).
Mentions: According to the severity of TBI, the subgroup analysis suggested neither moderate nor severe TBI patients could benefit from progesterone administration, because the mortality or unfavorable outcomes did not differ significantly between progesterone group and placebo group as shown in Fig 5A and 5B. When stratified by therapeutic regimens, intravenously administrated progesterone did not reduce the mortality or unfavorable outcomes of acute TBI patients while beneficial effect of progesterone was observed in acute TBI patients when administrated intramuscularly (RR = 0.55, 95% CI = 0.34–0.90 for mortality and RR = 0.70, 95% CI = 0.58–0.88 for unfavorable outcomes, respectively) (Fig 5C and 5D).

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