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Table 9.11 Progesterone Interventions Post ABI

Author Year Country Study Design Sample Size Methods Outcome
Soltani et al. (2017) Iran RCT PEDro=7 N=48 Population: 48 men with TBI and diffuse axonal injury (DAI). Experimental Group (n=20): Mean age=27.85yr; Mean GCS=7.7. Control Group (n=24): Mean Age=30.37yr; Mean GCS=7.7. Intervention: 1 mg/kg of Progesterone was given intramuscularly every 12 hours for 5 days to the experimental group, while the control group received no treatment. Participants received treatment within 12 hours of initial trauma. Outcome Measure: Glasgow Outcome Scale-Extended (GOS-E), Functional Independence Measure (FIM), serum progesterone levels, mortality. 1.        There were no significant differences between groups at 3 mo post-trauma based on treatment. However, at 6 mo post-trauma the progesterone group had significantly higher GOS-E scores (p=0.03), with only 1 death in the progesterone group compared to 7 in the control group. 2.        FIM scores showed a similar trend with no significant difference between groups at 3 mo but 6 mo post-trauma the progesterone group had significantly higher FIM scores (p<0.05). 3.        At baseline there was no significant difference between groups in terms of serum progesterone levels, however after the initiation of treatment the progesterone group maintained significantly higher progesterone levels until the end of the trial (p<0.05). The control group experienced significantly higher mortality compared to the progesterone group (p<0.05).
Wright et al., (2014) USA RCT PEDro= NInitial=882, NFinal=882   Population: 882 patients with moderate to severe TBI (73.7% men). Experimental group (n=442); median age=36yr; injury severity= 29.2% moderate, 52.9% moderate-to-severe, 17.9% severe. Control group (n=440); median age=34yr; injury severity= 28.4% moderate, 54.1% moderate-to-severe, 17.5% severe. Intervention: 0.05 mg/kg/mL of intravenous progesterone was infused continuously over 96 hours (1 hour loading dose, 14.53mL/hr; 71 hour maintenance dose, 10mL/hr; 8 hour taper, reducing dose by 2.5mL per hour); control subjects received a matched appearance placebo. Participants received treatment within 4 hours of admission. Outcome Measures: Glasgow Outcome Scale-Extended (GOS-E) at 6mos; secondary outcomes were mortality, Disability Rating Scale score, and safety data. 1.        Trial was stopped early due to lack of benefit (882 of planned 1140 participants) 2.        Early administration of progesterone did not improve functional outcomes (Glasgow Outcome Scale) at 6mos. 3.        There was no significant difference in mortality between the progesterone and placebo groups. 4.        There was no significant difference in Disability Rating Scale scores at 6mos. 5.        Progesterone was not associated with greater frequency of safety or adverse events.