Does progesterone improve outcome in diffuse axonal injury?

References

• Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. The Journal of Head Trauma Rehabilitation 2006;21:375–378.
   PubMed Web of Science ®Google Scholar
• UNICEF. Road traffic injuries in Iran and their prevention, a worrying picture [Internet]. [cited 2015]. Available from http://www.unicef.org/iran/media_4783.html.
   Google Scholar
• Faul M, Xu L, Wald M.M, Coronado V. Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths, 2002–2006. Atlanta (GA): CDC, National Center for Injury Prevention and Control; 2010.
   Google Scholar
• VanLandingham JW, Cekic M, Cutler S, Hoffman SW, Stein DG. Neurosteroids reduce inflammation after TBI through CD55 induction. Neuroscience Letters 2007;425:94–98.
   PubMed Web of Science ®Google Scholar
• Saatman KE, Duhaime A-C, Bullock R, Maas AI, Valadka A, Manley GT. Classification of traumatic brain injury for targeted therapies. Journal of Neurotrauma 2008;25:719–738.
   PubMed Web of Science ®Google Scholar
• Finnie J. Neuroinflammation: beneficial and detrimental effects after traumatic brain injury. Inflammopharmacology 2013;21:309–320.
   PubMed Web of Science ®Google Scholar
• Roof RL, Hall ED. Gender differences in acute CNS trauma and stroke: neuroprotective effects of estrogen and progesterone. Journal of Neurotrauma 2000;17:367–388.
   PubMed Web of Science ®Google Scholar
• Schumacher M, Robel P, Baulieu E. Development and regeneration of the nervous system: a role for neurosteroids (Paart 2 of 2). Developmental Neuroscience 1996;18:14–21.
   Web of Science ®Google Scholar
• Sarkaki AR, Khaksari Haddad M, Soltani Z, Shahrokhi N, Mahmoodi M. Time- and dose-dependent neuroprotective effects of sex steroid hormones on inflammatory cytokines after a traumatic brain injury. Journal of Neurotrauma 2013;30:47–54.
   PubMed Web of Science ®Google Scholar
• Khaksari M, Soltani Z, Shahrokhi N, Moshtaghi G, Asadikaram G. The role of estrogen and progesterone, administered alone and in combination, in modulating cytokine concentration following traumatic brain injury. Canadian Journal of Physiology & Pharmacology 2011;89:31–40.
   PubMed Web of Science ®Google Scholar
• Shahrokhi N, Khaksari M, Soltani Z, Mahmoodi M, Nakhaee N. Effect of sex steroid hormones on brain edema, intracranial pressure, and neurologic outcomes after traumatic brain injury. Canadian Journal of Physiology & Pharmacology 2010;88:414–421.
   PubMed Web of Science ®Google Scholar
• Deutsch ER, Espinoza TR, Atif F, Woodall E, Kaylor J, Wright DW. Progesterone’s role in neuroprotection, a review of the evidence. Brain Research 2013;1530:82–105.
   PubMed Web of Science ®Google Scholar
• Wright DW, Kellermann AL, Hertzberg VS, Clark PL, Frankel M, Goldstein FC, Salomone JP, Dent LL, Harris OA, Ander DS. ProTECT: a randomized clinical trial of progesterone for acute traumatic brain injury. Annals of Emergency Medicine 2007;49:391–402. e392.
   PubMed Web of Science ®Google Scholar
• Xiao G, Wei J, Yan W, Wang W, Lu Z. Improved outcomes from the administration of progesterone for patients with acute severe traumatic brain injury: a randomized controlled trial. Critical Care 2008;12:R61.
   PubMed Web of Science ®Google Scholar
• Wright DW, Yeatts SD, Silbergleit R, Palesch YY, Hertzberg VS, Frankel M, Goldstein FC, Caveney AF, Howlett-Smith H, Bengelink EM. Very early administration of progesterone for acute traumatic brain injury. New England Journal of Medicine 2014;371:2457–2466.
   PubMed Web of Science ®Google Scholar
• Skolnick BE, Maas AI, Narayan RK, van der Hoop RG, MacAllister T, Ward JD, Nelson NR, Stocchetti N. A clinical trial of progesterone for severe traumatic brain injury. New England Journal of Medicine 2014;371:2467–2476.
   PubMed Web of Science ®Google Scholar
• Bullock R, Chesnut R, Clifton G, Ghajar J, Marion D, Narayan R, Newell D, Pitts L, Rosner M, Wilberger J. Guidelines for the management of severe head injury. European Journal of Emergency Medicine 1996;3:109–127.
   PubMedGoogle Scholar
• Wilson JL, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. Journal of Neurotrauma 1998;15:573–585.
   PubMed Web of Science ®Google Scholar
• Jennett B, Bond M. Assessment of outcome after severe brain damage: a practical scale. The Lancet 1975;305:480–484.
   Google Scholar
• Brooks JC, Strauss DJ, Shavelle RM, Paculdo DR, Hammond FM, Harrison-Felix CL. Long-term disability and survival in traumatic brain injury: results from the National Institute on Disability and Rehabilitation Research Model Systems. Archives of Physical Medicine and Rehabilitation 2013;94:2203–2209.
   PubMed Web of Science ®Google Scholar
• Marklund N, Hillered L. Animal modelling of traumatic brain injury in preclinical drug development: where do we go from here? British Journal of Pharmacology 2011;164:1207–1229.
   PubMed Web of Science ®Google Scholar
• Leker RR, Shohami E. Cerebral ischemia and trauma–different etiologies yet similar mechanisms: neuroprotective opportunities. Brain Research Reviews 2002;39:55–73.
   PubMed Web of Science ®Google Scholar
• Sobrado M, Lopez M, Carceller F, Garcia A, Roda J. Combined nimodipine and citicoline reduce infarct size, attenuate apoptosis and increase bcl-2 expression after focal cerebral ischemia. Neuroscience 2003;118:107–113.
   PubMed Web of Science ®Google Scholar
• Coronado VG, McGuire LC, Sarmiento K, Bell J, Lionbarger MR, Jones CD, Geller AI, Khoury N, Xu L. Trends in traumatic brain injury in the US and the public health response: 1995-2009. Journal of Safety Research 2012;43:299–307.
   PubMed Web of Science ®Google Scholar
• Attella MJ, Nattinville A, Stein DG. Hormonal state affects recovery from frontal cortex lesions in adult female rats. Behavioral and Neural Biology 1987;48:352–367.
   PubMedGoogle Scholar
• Goldfien A. The gonadal hormones and inhibitors: Basic and Clinical Pharmacology 1998;4:493–516.
   Google Scholar
• Pettus EH, Wright DW, Stein DG, Hoffman SW. Progesterone treatment inhibits the inflammatory agents that accompany traumatic brain injury. Brain Research 2005;1049:112–119.
   PubMed Web of Science ®Google Scholar
• Shakeri M, Boustani MR, Pak N, Panahi F, Salehpour F, Lotfinia I, Meshkini A, Daghighi S, Khani M, Taghiloo D. Effect of progesterone administration on prognosis of patients with diffuse axonal injury due to severe head trauma. Clinical Neurology & Neurosurgery 2013;115:2019–2022.
   PubMed Web of Science ®Google Scholar
• Wright DW, Ritchie JC, Mullins RE, Kellermann AL, Denson DD. Steady‐State serum concentrations of progesterone following continuous intravenous infusion in patients with acute moderate to severe traumatic brain injury. The Journal of Clinical Pharmacology 2005;45:640–648.
   PubMed Web of Science ®Google Scholar
• Mungenast AE, Tsai L-H. Cognitive function in health and disease: the role of epigenetic mechanisms. Neurodegenerative Diseases 2012;10:191–194.
   PubMed Web of Science ®Google Scholar
• Stein D. Concepts of central nervous system plasticity and their implications for recovery after brain damage. In: Zasler ND, Katz DI, Zafonte RD, Arciniegas DB, Bullock MR, Kreutzer JS, editors. Brain injury medicine: principles and practice. ABPP; 2012. p 162–174.
   Google Scholar
• Roof RL, Duvdevani R, Heyburn JW, Stein DG. Progesterone rapidly decreases brain edema: treatment delayed up to 24 hours is still effective. Experimental Neurology 1996;138:246–251.
   PubMed Web of Science ®Google Scholar
• Johnson V, Meaney D, Cullen D, Smith D. Animal models of traumatic brain injury. Handbook of Clinical Neurology 2014;127:115–128.
   Google Scholar
• Shear DA, Galani R, Hoffman SW, Stein DG. Progesterone protects against necrotic damage and behavioral abnormalities caused by traumatic brain injury. Experimental Neurology 2002;178:59–67.
   PubMed Web of Science ®Google Scholar
• Maghool F, Khaksari M. Differences in brain edema and intracranial pressure following traumatic brain injury across the estrous cycle: involvement of female sex steroid hormones. Brain Research 2013;1497:61–72.
   PubMed Web of Science ®Google Scholar
• Roozenbeek B, Maas AI, Menon DK. Changing patterns in the epidemiology of traumatic brain injury. Nature Reviews Neurology 2013;9:231–236.
   PubMed Web of Science ®Google Scholar
• Manley GT, Maas AI. Traumatic brain injury: an international knowledge-based approach. Journal of the American Medical Association 2013;310:473–474.
   PubMed Web of Science ®Google Scholar
• Narayan RK, Michel ME, Ansell B, Baethmann A, Biegon A, Bracken MB, Bullock MR, Choi SC, Clifton GL, Contant CF. Clinical trials in head injury. Journal of Neurotrauma 2002;19:503–557.
   PubMed Web of Science ®Google Scholar
• Stein D, Geddes R, Sribnick E. Recent developments in clinical trials for the treatment of traumatic brain injury. Handbook of Clinical Neurology 2014;127:433–451.
   Google Scholar
• Wali B, Ishrat T, Won S, Stein DG, Sayeed I. Progesterone in experimental permanent stroke: a dose-response and therapeutic time-window study. Brain 2014;137:486–502.
   PubMed Web of Science ®Google Scholar
• Yousuf S, Atif F, Sayeed I, Tang H, Stein DG. Progesterone in transient ischemic stroke: a dose-response study. Psychopharmacology 2014;231:3313–3323.
   PubMed Web of Science ®Google Scholar
• Howard RB, Sayeed I, Stein D. Suboptimal dosing parameters as possible factors in the negative Phase III clinical trials of progesterone in TBI. Journal of Neurotrauma 2015. DOI:10.1089/neu.2015.4179
   Google Scholar
• Goss CW, Hoffman SW, Stein DG. Behavioral effects and anatomic correlates after brain injury: a progesterone dose-response study. Pharmacology Biochemistry and Behavior 2003;76:231–242.
   PubMed Web of Science ®Google Scholar
• Zarrow M, Shoger R, Lazo-Wasem E. The rate of disappearance of exogenous progesterone from the blood. The Journal of Clinical Endocrinology & Metabolism 1954;14:645–652.
   PubMed Web of Science ®Google Scholar
• Stein DG. Lost in translation: understanding the failure of the progesterone/traumatic brain injury Phase III trials. Future Neurology 2016;11:9–13.
   Google Scholar
• Raheja A, Sinha S, Samson N, Bhoi S, Subramanian A, Sharma P, Sharma BS. Serum biomarkers as predictors of long-term outcome in severe traumatic brain injury: analysis from a randomized placebo-controlled Phase II clinical trial. Journal of Neurosurgery 2016;125:631–641.
   PubMed Web of Science ®Google Scholar
• Roof RL, Hoffman SW, Stein DG. Progesterone protects against lipid peroxidation following traumatic brain injury in rats. Molecular and Chemical Neuropathology 1997;31:1–11.
   Google Scholar