165 A Randomized Placebo Controlled Trial of Progesterone With or Without Hypothermia in Patients With Severe Traumatic Brain Injury-Analysis of Preliminary Data

Samson, Neha; Sinha, Sumit; Tandon, Vivek; Bhaoi, Sanjeev; Subramanian, Arulselvi; Sharma, Pushpa; Mahapatra, AK; Bs, Sharma

doi:10.1227/01.neu.0000432756.38655.f1

Cited by 3 publications

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“…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.…”

Section: Resultsmentioning

confidence: 99%

“…Considering the fact that unpublished studies were mostly those with negative results, unpublished data might only strengthen rather than alter the negative results of this systematic review [ 45 ]. According to our retrieval results, one randomized placebo controlled trial of progesterone with or without hypothermia in patients with severe TBI was excluded for lack of detail data to perform meta-analysis, whose preliminary results revealed that progesterone group had the worst GOS outcomes while the hypothermia group had the best outcomes at 6 months after injury [ 16 ]. The preliminary results were consistent with this systematic review.…”

Section: Discussionmentioning

confidence: 99%

“…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 – 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 – 16 ]. The limited evidence from a Cochrane systematic review published in 2012 revealed that progesterone might improve the neurologic outcome of acute TBI patients [ 17 ].…”

Section: Introductionmentioning

confidence: 99%

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

Zeng

Zhang

et al. 2015

PLoS ONE

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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.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%