Comparison of the administration of progesterone versus progesterone and vitamin D in improvement of outcomes in patients with traumatic brain injury: A randomized clinical trial with placebo group

Abstract

Background:Due to the heterogeneity of traumatic brain injury (TBI), many of single treatments have not been successful in prevention and cure of these kinds of injuries. The neuroprotective effect of progesterone drug on severe brain injuries has been identified, and recently, the neuroprotective effect of vitamin D has also been studied as the combination of these two drugs has shown better effects on animal samples in some studies. This study was conducted to examine the effect of vitamin D and progesterone on brain injury treatment after brain trauma.Materials and Methods:This study was performed on patients with severe brain trauma (Glasgow Coma Scale (GCS) ≤ 8) from April to September, 2011. The patients were divided to 3 groups (placebo, progesterone, progesterone-vitamin D), each with 20 people. Upon the patients’ admission, their GCS and demographic information were recorded. After 3 months, they were reassessed, and their GCS and GOS (Glasgow outcome scale) were recorded. The collected data were analyzed using SPSS 18 software (SPSS Inc., Chicago IL, USA).Results:Before intervention, GCS mean of the placebo, progesterone, and progesterone-vitamin D groups were 6.3 ± 0.88, 6.31 ± 0.87, and 6 ± 0.88, respectively. They increased to 9.16 ± 1.11, 10.25 ± 1.34, and 11.27 ± 2.27, respectively 3 months after intervention. There was a significant difference among GCS means of the 3 groups (P-value = 0.001). GOS was classified to 2 main categories of favorable and unfavorable recovery, of which, favorable recovery in placebo, progesterone, and progesterone-vitamin D was 25%, 45%, and 60%, respectively which showed a statistical significant difference among the groups (P-value = 0.03).Conclusion:The results showed that recovery rate in patients with severe brain trauma in the group receiving progesterone and vitamin D together was significantly higher than that of progesterone group, which was in turn higher than that of placebo group.

Traumatic Brain Injury Pathophysiology and Treatments: Early, Intermediate, and Late Phases Post-Injury

“…As alluded to earlier, rodent studies have suggested vitamin D together with progesterone has synergistic benefits. In agreement, patients administered intramuscular progesterone followed by vitamin D within 8 h of TBI had elevated recovery rates, GOS outcomes, and reduced mortality [118]. More positive studies are needed to fully warrant the use of progesterone.…”

Treatments for traumatic brain injury with emphasis on transcranial near-infrared laser phototherapy

“…Omega-3 fatty acids may enhance brain repair and recovery, based on animal and clinical studies. 71 Similarly, vitamin D may offer neuroprotective and restorative benefits 72 in the acute TBI setting. In chronic TBI, vitamin D and omega-3 fatty acids may work synergistically, as they both may reduce neuroinflammation, apoptosis, and oxidative stress.…”

Efficacy of progesterone for moderate to severe traumatic brain injury: a meta-analysis of randomized clinical trials

“…These seven studies, with 2492 total participants (Sample size, from 40 to 1179), compared progesterone with placebo in the treatment of acute TBI. Of these, only patients with severe TBI (Glasgow Coma Scale (GCS) ≤8) were included in five studies 8 9 10 11 12 , and in another 2 studies patients were recruited with moderate-to-severe TBI (GCS ≤12) 13 14 . All female patients were excluded in one included study 12 .…”