Introduction: Although in-vitro models suggest GH-induced differentiation, migration and survival of astrocytes and oligodendrocytes, no studies had been published in-vivo. We want to evaluate the efficacy and safety of GH associated with physical therapy compared to placebo in patients with complete spine injury (SI) and associated GH deficiency (GHD).
Methods: Eighteen Patients with complete SI were screened for GHD (glucagon test). 12 severe (GH<3 ng/ml) or partial (<10 ng/ml) GHD were randomized in a double-blind placebo-controlled study. Motor and sensory ASIA scale, SCIM-III (spinal cord injury independence measure), Ashworth (spasticity), Neuropathic Pain Scale and Quantitative Sensory tests were assessed. Patients received subcutaneous injections of placebo or GH (Nutropin®) 6 days/week IGF1- adjusted, in addition to intensive physical therapy 2 h/day, for 6 months. Both groups were similar according to age, sex, BMI, waist circumference.
Results: Significant (P=0.05) improvement was observed in SCIM-III score at 3 months: 55.6 (14.4 S.D.) vs 74 (2.8 S.D.) and 6 months: 55.4 (14.2 S.D.) vs 73.5 (2.1 S.D.), comparing GH-treated group with placebo. A significant improvement in the electrical perception threshold from the 1st up to the 5th metamera below the SI site was observed on both sides after 6 months of treatment in the GH, but not in the placebo group. These differences were observed intra-individually (P=0.04 Friedmans test) and between groups (5th left level (P=0.023) and 5th right level (P=0.031), mixed linear model). No correlations with IGF1 were observed. No GH-related adverse events were reported.
Conclusions: Not studied so far, GHD seems very prevalent in SI. This is the first trial with complete SI and concomitant GHD. GH added to intense physical rehabilitation improved functional parameters (SCIM) and changes in sensory quantification up to 5 levels below SI. Larger studies should be performed to confirm a GH beneficial effect on sensitive pathways in SI.
20 - 23 May 2017
European Society of Endocrinology