Progesterone versus combination therapy of progesterone, ω3 fatty acids, glutamine and vitamin D3 in improving clinical outcome in patients with traumatic brain injuries

Introduction Traumatic brain injury (TBI) is a major health problem. No single agent that can halt the progression of secondary injury exists. Progesterone, glutamine, ω3 fatty acids, and vitamin D3 are all immune modulators, which can prevent secondary brain insult. Aim The aim of this study was to evaluate and compare the efficacy of progesterone alone with a half dose of progesterone plus vitamin D3, ω3 fatty acids, and glutamine (combination therapy) on the outcome of patients with acute TBI. Settings and design This was a randomized, prospective, controlled study. Patients and methods Sixty adult patients of both sexes, with moderate or severe TBI [Glasgow coma score (GCS ) 4–12)] within 8 h of trauma, were equally randomly assigned to three groups: the control (C) group, which received the standard care and medications according to the guidelines of head trauma protocol; the progesterone (P) group, which received progesterone; and the combination therapy (T) group, which received a half dose of progesterone combined with vitamin D3, ω3 fatty acids, and glutamine. The GCS, ICU and hospital stay, computed tomography findings, mortality rate, and the Glasgow outcome scale (GOS) at 3 months after trauma were recorded and anal yzed. Results Significant improvement in GCS and computed tomography findings, significantly shorter ICUand hospital stay, lower mortality rate, and more favo rable GOS after 3 months were recorded among the therapeutic groups compared with the control group. Only ICU stay was significantly shorter on comparing the progesterone group with the T gr oup. Conclusion Both progesterone and the combination therapy improved outcome in acute TBI, although progesterone dose was halved in the latter.