Randomized Controlled Trial to Determine the Efficacy of Long-Term Growth Hormone Treatment in Severely Burned Children
*Ludwik K Branski, David N. Herndon, *Gabriela A Kulp, *Gordon L Klein, *Felicia N. Williams, *David L. Chinkes, Marc G. Jeschke
University of Texas Medical Branch and Shriners Burns Hospital for Children, Galveston, TX
OBJECTIVE(S): Recovery from a massive burn is characterized by catabolic and hypermetabolic responses that persist up to 1-2 years, impairing patients rehabilitation and reintegration. The objective of this study was to determine the efficacy of long term treatment with recombinant human Growth Hormone (rhGH) on growth, body composition, bone metabolism, and scarring in a large prospective randomized controlled clinical trial.
METHODS: One hundred and ninety-six pediatric patients with massive burns over 40% total body surface area were prospectively enrolled between 1998 and 2008. Patients were randomized to receive either placebo (n=95) or long-term rhGH at various doses (n=101). Changes in height, weight, body composition, bone metabolism, hormones, and scar development were measured at 6, 9, 12, 18, and 24 months post burn. Statistical analysis was performed using Tukey’s t-test or ANOVA followed by Bonferroni’s correction. Significance was accepted at p<0.05.
RESULTS: RhGH administration markedly improved height and lean body mass, significantly increased serum GH, IGF-I, and IGFBP-3, while fat content significantly decreased when compared with placebo, p<0.05. Subset analysis revealed most pronounced height increase in the 0.05 mg/kg group and most LBM gain in the 0.2 mg/kg group, p<0.05. Bone mineral content showed an unexpected decrease in the 0.2 mg/kg group, along with decreased PTH and increased Osteocalcin, as well as bone turnover, p<0.05. RhGH administration at 0.2 mg/kg significantly decreased scar blood flow and improved scarring, p<0.05.
CONCLUSIONS: In this large prospective clinical trial we showed that long-term treatment with rhGH effectively enhances recovery of severely burned pediatric patients.