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Table 16.54 Miscellaneous Outcomes – Progesterone for Acute Management Post ABI

by | 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).
  1. There was no significant difference in the GOS scores of patients with the worst prognosis between groups (n=393; p=0.36).
  2. There was no significant difference in the GOS scores of patients with intermediate prognosis between groups (n=394; p=0.82).
  3. 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.
  1. 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)
  2. Mortality at 6mo did not differ significantly between the two groups.
  3. 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).
  1. Admission and discharge GCS were not significantly different between groups.
  2. GOS scores at 3 mo follow-up showed no significant differences between groups in terms of favourable outcomes.
  3. 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).