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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

Mortality at the end of follow-up period.Forrest plots of meta-analysis of mortality for progesterone compared with placebo administrated to acute TBI patients (A) and sensitivity analysis of the impact of progesterone on the mortality of acute TBI patients (B).
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pone.0140624.g002: Mortality at the end of follow-up period.Forrest plots of meta-analysis of mortality for progesterone compared with placebo administrated to acute TBI patients (A) and sensitivity analysis of the impact of progesterone on the mortality of acute TBI patients (B).

Mentions: Five of the six studies provided sufficient data to evaluate the impact of progesterone on the mortality of acute TBI patients at the end of follow-up period. As shown in Fig 2A, the pooled RR of the 5 RCTs suggested no difference in mortality between progesterone group and placebo group (RR = 0.83, 95% CI = 0.57–1.20), which was confirmed by the results of sensitivity analysis (RR = 0.88, 95% CI = 0.60–1.28) (Fig 2B).


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

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

Mortality at the end of follow-up period.Forrest plots of meta-analysis of mortality for progesterone compared with placebo administrated to acute TBI patients (A) and sensitivity analysis of the impact of progesterone on the mortality of acute TBI patients (B).
© Copyright Policy
Related In: Results  -  Collection

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

pone.0140624.g002: Mortality at the end of follow-up period.Forrest plots of meta-analysis of mortality for progesterone compared with placebo administrated to acute TBI patients (A) and sensitivity analysis of the impact of progesterone on the mortality of acute TBI patients (B).
Mentions: Five of the six studies provided sufficient data to evaluate the impact of progesterone on the mortality of acute TBI patients at the end of follow-up period. As shown in Fig 2A, the pooled RR of the 5 RCTs suggested no difference in mortality between progesterone group and placebo group (RR = 0.83, 95% CI = 0.57–1.20), which was confirmed by the results of sensitivity analysis (RR = 0.88, 95% CI = 0.60–1.28) (Fig 2B).

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