Table 16.54 Miscellaneous Outcomes – Progesterone for Acute Management Post ABI
by Camila | Dec 13, 2018
Table 16.54 Miscellaneous Outcomes – Progesterone for Acute Management Post ABI
Author/Year/ Country/ Study Design/N |
Methods |
Outcomes |
Skolnick et al.
(2014)
Belgium
RCT
PEDro=7
N=1195 |
Population: TBI; Progesterone (n=591): Median Age=35 yr; Gender: Male=464, Female=127; Median Time Post Injury=7 hr 4 min; GCS Range≤8. Placebo (n=588): Median Age=34 yr; Gender: Male=463, Female=125; Median Time Post Injury=7 hr 2 min; GCS≤8.
Intervention: Participants were randomized to receive either progesterone (0.71 mg/kg/hr loading dose, followed by a continuous maintenance infusion of 0.5 mg/kg/hr) or placebo for 120 hr. Outcomes were assessed at baseline and 6mo.
Outcome Measure: Glasgow Outcome Scale (GOS). |
- There was no significant difference in the GOS scores of patients with the worst prognosis between groups (n=393; p=0.36).
- There was no significant difference in the GOS scores of patients with intermediate prognosis between groups (n=394; p=0.82).
- There was no significant difference in the GOS scores of patients with the best prognosis between groups (n=392; p=0.38).
|
Wright et al.
(2014)
USA
RCT
PEDro=10
N=882 |
Population: TBI; Median Age=35 yr; Gender: Male=650, Female=232; Mean Time Post Injury=218.1 min; Severity: Moderate=254, Moderate to Severe=472, Severe=156.
Intervention: Participants were randomized to receive one of intravenous infusions of progesterone (n=442) or placebo (n=440). Progesterone was administered continuously at 14.3 mL/hr for 1 hr, then at 10 mL/hr for 71 hr. The dose was tapered by 2.5 mL/hr every 8hr, for total treatment duration of 96hr. Outcomes were assessed at 6mo.
Outcome Measure: Glasgow Outcome Scale Extended (GOSE), Mortality, Adverse Effects. |
- Favourable outcomes occurred in 51% of patients treated with progesterone and in 55.5% of the placebo group. Relative benefit was 0.95, meaning fewer favourable outcomes are expected in the progesterone group. (RR: 0.95)
- Mortality at 6mo did not differ significantly between the two groups.
- The frequency of adverse effects did not differ significantly between the two groups, with the exception of phlebitis or thrombophlebitis, which was higher in the progesterone group (17.2% versus. 5.7%; relative risk, 3.03).
|
Shakeri et al.
(2013)
Iran
RCT
PEDro=7
N=76 |
Population: TBI; Gender: Male=76, Female=0; Time Post Injury≤6 hr. Progesterone Group (n=38): Mean Age=33.97 yr; Mean GCS=5.74. Control Group (n=38): Mean Age=34.68 yr; Mean GCS=5.79.
Intervention: Participants were randomized to receive either progesterone (1 mg/kg every 12 hr for 3 days) or no treatment (control). Outcomes were assessed at 3mo.
Outcome Measure: GCS, Glasgow Outcome Scale (GOS). |
- Admission and discharge GCS were not significantly different between groups.
- GOS scores at 3 mo follow-up showed no significant differences between groups in terms of favourable outcomes.
- In patients with GCS=5-8, there was a significant difference in favourable outcomes between treatment and controls (16.67% versus 10%, p=0.03); this was not seen in patients with GCS<5.
|
PEDro=Physiotherapy Evidence Database rating scale score (Moseley et al., 2002).