Juliane Léger1,2, Anne Fjellestad-Paulsen1, Anne Bargiacchi3, Justine Pages4, Didier Chevenne5, Marianne Alison6, Corinne Alberti4,7, Sophie Guilmin-Crepon4,7. 1. Assistance Publique-Hôpitaux de Paris, Robert Debré University Hospital, Endocrinology-Diabetology Department, Reference Center for Growth and Development Endocrine Diseases, Paris, France. 2. Université de Paris; NeuroDiderot, Institut National de la Santé et de la Recherche Médicale (INSERM) UMR 1141, Paris, France. 3. Assistance Publique-Hôpitaux de Paris, Robert Debré University Hospital, Child and Adolescent Psychiatry Department, Reference Center for Growth and Development Endocrine Diseases, Paris, France. 4. Assistance Publique-Hôpitaux de Paris, Robert Debré University Hospital, Clinical Epidemiology Unit, Paris, France. 5. Assistance Publique-Hôpitaux de Paris, Biochemistry Unit, Robert Debré University Hospital, Paris, France. 6. Assistance Publique-Hôpitaux de Paris, Robert Debré University Hospital, Pediatric Radiology Department, Paris, France. 7. Inserm, CIC-EC 1426, Paris, France.
Abstract
CONTEXT: Children with anorexia nervosa (AN) are at risk of adult height deficit due to prolonged low height velocity (HV). OBJECTIVE: To investigate the effects of human growth hormone (GH) injections on HV in children with AN and severe growth impairment. DESIGN AND PARTICIPANTS: In this prospective, randomized, double-blind, single-center, proof-of-concept trial, children with AN and low HV (≤2 cm/year) for at least 18 months, and a bone age ≤12 years for girls and ≤14 years for boys, were randomized to receive daily subcutaneous injections of human GH (0.050 mg/kg/day) or placebo for 12 months. MAIN OUTCOME MEASURES: Change in HV after 12 months. RESULTS: In total, 8 patients were assigned to the GH group and 6 to the placebo group. Patients had a median (25th-75th percentile) HV of 1.0 (0.5;1.5) cm/year. The effect of GH treatment increased strongly after 6 months, with a height gain after 12 months of 9.65 (8.0;11.6) cm for the GH group vs 3.85 (1.7;7.3) cm for the placebo group, with an absolute median (2.5th-97.5th percentile) difference between the groups of 5.8 (-1.85;9.68) cm after bootstrapping. The percentage of patients with a HV > 5 cm/year during the study period was higher in the GH group than in the placebo group (100% vs 50%, P = 0.05). Adverse events occurred in similar numbers in the 2 groups, were mild or nonfatal, and did not lead to treatment being stopped. CONCLUSION:GH administration to improve HV is a potentially valid option for increasing HV in children with AN and prolonged severe growth failure.
RCT Entities:
CONTEXT: Children with anorexia nervosa (AN) are at risk of adult height deficit due to prolonged low height velocity (HV). OBJECTIVE: To investigate the effects of humangrowth hormone (GH) injections on HV in children with AN and severe growth impairment. DESIGN AND PARTICIPANTS: In this prospective, randomized, double-blind, single-center, proof-of-concept trial, children with AN and low HV (≤2 cm/year) for at least 18 months, and a bone age ≤12 years for girls and ≤14 years for boys, were randomized to receive daily subcutaneous injections of human GH (0.050 mg/kg/day) or placebo for 12 months. MAIN OUTCOME MEASURES: Change in HV after 12 months. RESULTS: In total, 8 patients were assigned to the GH group and 6 to the placebo group. Patients had a median (25th-75th percentile) HV of 1.0 (0.5;1.5) cm/year. The effect of GH treatment increased strongly after 6 months, with a height gain after 12 months of 9.65 (8.0;11.6) cm for the GH group vs 3.85 (1.7;7.3) cm for the placebo group, with an absolute median (2.5th-97.5th percentile) difference between the groups of 5.8 (-1.85;9.68) cm after bootstrapping. The percentage of patients with a HV > 5 cm/year during the study period was higher in the GH group than in the placebo group (100% vs 50%, P = 0.05). Adverse events occurred in similar numbers in the 2 groups, were mild or nonfatal, and did not lead to treatment being stopped. CONCLUSION: GH administration to improve HV is a potentially valid option for increasing HV in children with AN and prolonged severe growth failure.
Authors: Kerstin Albertsson-Wikland; Aimon Niklasson; Lars Gelander; Anton Holmgren; Andreas F M Nierop Journal: BMC Pediatr Date: 2022-04-30 Impact factor: 2.567