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Table 9.9 Interventions for Growth Hormone Deficiency Post ABI

Author, Year Country Study Design Sample Size Methods Outcome
Dubiel et al. (2018) United States RCT PEDro=7 N=40 Population: Mean age=31.1yr; Gender: Male=34, Female=6; Mean Time Post-injury=64.1d. GCS: mild=4, Moderate=3, Severe=32, unknown=1. Intervention: Individuals were randomized to receive either recombinant human growth hormone or placebo. Follow-up was at 1-mo, 3-mo, 6-mo and 12-mo. 1-mo and 3-mo follow-up was only taken for IGF-1 concentrations. Outcome Measure: Disability rating scale scores (DRS), Functional Independence Measure (FIM) motor, FIM Cognitive, FIM total, IGF-1, Peak L-Arginine, California Verbal Learning Test (CVLT), Trail making test-A, Trail Making test-B. 1.        At 3-mo and 6-mo follow-up the rhGH group had significantly higher IGF-1 concentrations (p=0.035, p=0.005), these were not observed at 1-mo or 12-mo follow-up. 2.        At 6-mo follow-up the rhGH group had a significantly higher positive change in FIM motor scores (p=0.02), FIM cognitive scores (p=0.02), and total change in FIM scores (p=0.02). There were no other significant differences at 6-mo. At 12-mo follow-up the rhGH group had maintained significantly higher positive scores in FIM motor scores (p=0.02), and total FIM change (p=0.01). There were no other significant differences at 12-mo follow-up.
Hatton et al. (1997) USA RCT PEDro=5 N=33   Population: TBI; Intervention Group (n=17): Mean Age=27.6yr; Gender: Male=14, Female=3; Mean GCS=7; Mean Time Post Injury=56.5hr; Control Group (n=16): Mean Age=27.8yr; Gender: Males=14, Females=2; Mean GCS=6.1; Mean Time Post Injury=57.1 hr. Intervention: Patients were randomly allocated to receive either continuous IV IGF-1 (0.01mg/kg/hr, treatment) or no IV treatment (control). IGF-I treatment began within 72hr of injury and continued for up to 14d. Both groups received nutritional support and neurosurgical intensive care. Patient assessments were made on 15d, 30d, discharge, and 3 and 6mo follow-up. Outcome Measure: Glasgow Outcome Scale (Klionsky et al.), Weight Loss, Glucose Concentrations, Nitrogen Balance. 1.        IGF-1 treatment resulted in lower daily glucose concentration and nitrogen output (p=0.03) when compared to placebo. 2.        Patients receiving IGF-1 treatment showed weight gain while those receiving placebo showed significant weight loss (p=0.02). 3.        In patients with GCS=5-7, those receiving IGF-1 showed better outcome on GOS than those receiving placebo (p=0.06).
Mossberg et al. (2017) United States Pre-Post N=15   Population: TBI=15: Mean Age=45.5yr; Gender: Males=10, Females=5; Mean Time Post-Injury=11.2yr. Intervention: Daily injections of recombinant human growth hormone (rhGH) for 12 mo. Outcome Measure: Cardiorespiratory symptoms, Muscle force testing, Body composition, Cognitive function (BDI, Fatigue Severity Scale (FSS)). 1.        There were no significant differences between pre and post measures of cardiorespiration (oxygen uptake, heart rate, minute ventilation, respiratory exchange ratio, oxygen pulse). 2.        Although skeletal muscle fatigue did not decrease over the course of treatment, there was a strong trend for a decrease in perceived fatigue (p=0.06). 3.        There was a strong trend for an increase in lean mass (p=0.06) post-treatment. 4.        There was a significant improvement in both BDI (p=0.019) and FSS (p=0.039) scores post-treatment.
Gardner et al. (2015) Sweden Case Control N=1429 Population: TBI (n=161): Mean Age=42.6yr; Gender: Male=93, Female=68. Tumour (n=1268): Mean Age=53.2yr; Gender: Male=786, Female=482. Intervention: Participants diagnosed with GHD and treated with GH therapy were included in retrospective analysis. Outcome Measures: Quality of Life Assessment of GHD in Adults (QOL-AGHDA). 1.        At baseline, mean QOL-AGHDA scores were significantly worse in the TBI group than in the Tumour group (p<0.0001) 2.        After 1yr of treatment, mean improvement in QOL-AGHDA was greater in the TBI group than in the Tumour group (p=0.04), but the score remained worse in the TBI group. 3.        Over 8yr of treatment, mean improvement in QOL-AGHDA was maintained in both groups, but the score remained worse in the TBI group.
Devesa et al. (2013) Spain Pre-Post N=12 Population: TBI; Mean Age=28.4yr; Gender: Male=8, Female=4; Mean Time Post Injury=5.3yr. Intervention: Participants received GH therapy (1mg/d, 5d/wk, 8mo) and clinical rehabilitation (3-4hr/d, 5d/wk, 6-12mo). Diagnosis of GHD was made by the following criteria: plasma GH <7ng/mL. Outcome Measures: Plasma IGF-1. 1.        GHD was diagnosed in 42% of participants. 2.        Before treatment, mean plasma IGF-1 levels were significantly lower in the GHD group than in the non-GHD group (p<0.05). 3.        After treatment, mean plasma IGF-1 levels significantly increased in both the GHD group (p<0.01) and non-GHD group (p<0.05), such that the two groups were no longer significantly different (p>0.05). Percentage increase in IFG-1 levels was significantly higher in the GHD group than in the non-GHD group (p<0.01).
Moreau et al. (2013) France PCT N=50 Population:  TBI; Intervention Group (TG, n=23): Mean Age=37.9yr; Gender: Male=19, Female=4; Mean Time Post Injury=7.8yr; Mean GCS=8.1. Control Group (CG, n=27): Mean Age=37.1yr; Gender: Male=24, Female=3; Mean Time Post Injury=5.5yr; Mean GCS=9.4. Intervention: Participants were allocated to receive GH therapy (TG, 0.2-0.6mg/d) or no treatment (CG) for 1yr. GHD was diagnosed with an insulin tolerance test or GHRH assay. Outcomes were assessed before and after treatment. Outcome Measures: Quality of Life Brain Injury (QOLBI); Activities of Daily Living (ADL); Cognitive Function. 1.        The TG showed significantly greater improvement in QOLBI functional (p=0.023) and personal (p=0.019) subscores. No significant differences between groups were found for ADL or tests of cognitive function.