Abstract
ObjectiveTo evaluate the efficacy and safety of progesterone administrated in patients with acute traumatic brain injury (TBI).MethodsPubMed/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.ResultsA 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).ConclusionsDespite 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.
Highlights
Traumatic brain injury (TBI) is one of the leading causes of mortality and disability worldwide especially among young adults, which exerts great influence on human health and social economy [1]
The results of meta-analysis indicated progesterone did not reduce the mortality (RR = 0.83, 95% confidence interval (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
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)
Summary
Traumatic brain injury (TBI) is one of the leading causes of mortality and disability worldwide especially among young adults, which exerts great influence on human health and social economy [1]. A plenty of experimental studies investigated the impact of progesterone on central nervous system with various animal models, and growing evidence suggested that progesterone exerted neuroprotective properties by decreasing vasogenic cerebral edema, protecting and rebuilding the blood-brain barrier, improving neuronal survival, modulating the inflammatory cascade and limiting cellular necrosis and apoptosis after acute TBI [7,8,9]. Based on the encouraging preliminary outcomes, a series of clinical trials were conducted to evaluate the efficacy and safety of progesterone administrated in patients with TBI [10,11,12,13,14,15,16].
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
