Abstract
Growth hormone deficiency (GHD) results in an impaired health-related quality of life (HrQoL) and cognitive impairment in the attention and memory domain. GHD is assumed to be a frequent finding after brain injury due to traumatic brain injury (TBI), aneurysmal subarachnoid hemorrhage (SAH) or ischemic stroke. Hence, we set out to investigate the effects of growth hormone (GH) replacement therapy in patients with isolated GHD after brain injury on HrQoL, cognition, and abdominal fat composition. In total, 1,408 patients with TBI, SAH or ischemic stroke were screened for inclusion. Of those, 54 patients (age 18–65 years) were eligible, and 51 could be tested for GHD with GHRH-L-arginine. In 6 patients (12%), GHD was detected. All patients with isolated GHD (n = 4 [8%], male, mean age ± SD: 49.0 ± 9.8 years) received GH replacement therapy for 6 months at a daily dose of 0.2–0.5 mg recombinant GH depending on age. Results were compared with an untreated control group of patients without hormonal insufficiencies after brain injury (n = 6, male, mean age ± SD: 49.5 ± 13.6 years). HrQoL as well as mood and sleep quality assessed by self-rating questionnaires (Beck Depression Index, Pittsburgh Sleep Quality Index) did not differ between baseline and 6 months within each group or between the two groups. Similarly, cognitive performance as assessed by standardized memory and attention tests did not show significant differences within or between groups. Body mass index was higher in the control vs. the GH replacement group at baseline (p = 0.038), yet not different at 6 months and within groups. Visceral-fat-by-total-fat-ratio measurements obtained from magnetic resonance imaging in 2 patients and 5 control subjects exhibited no consistent pattern. In conclusion, this single center study revealed a prevalence of GHD of about 12% (8% with isolated GHD) in brain injury patients which was lower compared with most of the previously reported cohorts. As a consequence, the sample size was insufficient to conclude on a benefit or no benefit of GH replacement in patients with isolated GHD after brain injury. A higher number of patients will be necessary to draw conclusions in future studies.Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT01397500.
Highlights
Pituitary insufficiency is assumed to be a frequent finding after traumatic brain injury (TBI) and subarachnoid hemorrhage (SAH) [1,2,3,4]
Exclusion criteria were pregnancy and lactation period, woman of childbearing potential not using an adequate method of birth control, men who are not willing to use an adequate method of birth control, previous or concomitant medication with growth hormone (GH), suspected or known hypersensitivity to GH treatment, substance abuse, any condition which in the opinion of the investigator makes the patient unsuitable for inclusion, participation in another clinical trial with an investigational new drug, planned treatment or changes in established treatment with any other drug which might significantly influence the GH axis or cognitive function, nonability to perform testing, presence of any other condition listed in the contraindications or warnings in the local Summary of Product Characteristics of GH, and onset of Growth hormone deficiency (GHD) before brain injury
54 patients were enrolled in the study the first step of which was to test for GHD
Summary
Pituitary insufficiency is assumed to be a frequent finding after traumatic brain injury (TBI) and subarachnoid hemorrhage (SAH) [1,2,3,4]. In a systematic review of 19 studies that included 1,137 patients, the pooled prevalences of hypopituitarism in the chronic phase after TBI and SAH were 27.5 and 47%, respectively [2]. In one study pituitary dysfunction was detected in 37.5% of patients with ischemic stroke [1]. We have shown that neuroendocrine disturbances often persist over years after TBI or SAH [5] with the highest prevalence being observed 1–2 years post-injury. Transient deficiency is a known phenomenon, and patients may potentially recover from gonadotropic and somatotropic insufficiency [6]
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