Growth hormone to improve short bowel syndrome intestinal autonomy: a pediatric randomized open-label clinical trial.

Background: The ability of growth hormone (GH) to promote the weaning-off of parenteral nutrition (PN) in short bowel syndrome (SBS) is unclear. No randomized controlled study is available in children. This study was undertaken to determine if GH could enhance the weaning off of PN in PN-dependent children with SBS. Methods: A prospective randomized open-label multicenter study was performed in 14 patients (mean age, 9 +/- 1.4 years) with SBS (average small bowel length, 33 cm) and long-term PN dependency (8 years) on an unrestricted diet. A standardized PN decrease with and without GH (0.14 mg/kg/d) was conducted. The patients were randomized to either a GH group (4 months of GH) or a control (CTR) group (4 months without GH, followed by 4 months with GH). Blood tests and a nutrition assessment of enteral and parenteral intakes were performed. Groups were compared with the Wilcoxon test. Results: Treatment with GH did not improve the weaning off of PN (decrease in PN caloric intake of 32.5% +/- 9.6% in the GH group vs 35.2% +/- 8.7% in the CTR group, nonsignificant). In the CTR group, GH treatment induced an additional but not statistically significant decrease of 8.8% +/- 12.4% in daily calories. Parenteral needs returned to near basal rates 6 months after GH discontinuation (GH: 77.6% +/- 10.6% vs CTR: 73.2% +/- 7.4%). Weight decreased slightly in both groups. No biological parameters varied significantly. Conclusions: GH did not improve the weaning off of PN in PN-dependent children with SBS. (JPEN J Parenter Enteral Nutr. 2011;35:723-731)