title: A randomized controlled trial of growth hormone in active pediatric Crohn disease.
abstract: OBJECTIVE
  Growth hormone (GH) may reduce symptoms and improve growth in Crohn disease (CD). The effect on mucosal inflammation is not known. We hypothesized that GH would improve both clinical and mucosal disease activity and stimulate linear growth in pediatric CD.
  
  
  METHODS
  Twenty patients ages 7 to 18 receiving corticosteroids (CTX) for active CD were randomized to begin GH, 0.075 mg x kg(-1) x day(-1) (group A), or continue CTX alone (group B). Clinical and endoscopic disease activities were assessed after 12 weeks. Group B began GH at 12 weeks, and clinical disease activity was assessed at 24 weeks. Subjects who experienced a clinical response after 12 weeks of GH therapy continued treatment for an additional 52 weeks, and linear growth was assessed.
  
  
  RESULTS
  Sixty-five percent of patients receiving GH achieved clinical remission, compared with 20% treated with CTX alone (P = 0.03). Although endoscopic disease activity trended toward an improvement at week 12 in group A, this did not differ between the groups. Sixty-one percent of week 12 GH responders maintained their clinical response through week 64. Mean (95th confidence interval) height z score on GH increased from -1.1 (-1.6, -0.6) to -0.4 (-1, 0.2), P = 0.004 during this 52-week extension phase. GH was well tolerated with no unexpected safety signals.
  
  
  CONCLUSIONS
  The addition of GH to CTX therapy did not induce a reduction in mucosal inflammation, relative to CTX alone. However, GH was safe and effective as an adjunct to CTX for treatment of clinical disease activity and growth failure in pediatric CD.
authors.affiliation: Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center and the University of Cincinnati College of Medicine, Cincinnati, OH, USA. lee.denson@cchmc.org
authors.forename: Lee A
authors.initials: LA
authors.lastname: Denson
authors.forename: Mi-Ok
authors.initials: MO
authors.lastname: Kim
authors.forename: Ramona
authors.initials: R
authors.lastname: Bezold
authors.forename: Rebecca
authors.initials: R
authors.lastname: Carey
authors.forename: Bankole
authors.initials: B
authors.lastname: Osuntokun
authors.forename: Cade
authors.initials: C
authors.lastname: Nylund
authors.forename: Tara
authors.initials: T
authors.lastname: Willson
authors.forename: Erin
authors.initials: E
authors.lastname: Bonkowski
authors.forename: Dandan
authors.initials: D
authors.lastname: Li
authors.forename: Edgar
authors.initials: E
authors.lastname: Ballard
authors.forename: Margaret
authors.initials: M
authors.lastname: Collins
authors.forename: M Susan
authors.initials: MS
authors.lastname: Moyer
authors.forename: David J
authors.initials: DJ
authors.lastname: Klein
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D002648:Child; D003106:Colon / Q000187:drug effects* / Q000473:pathology; D003113:Colonoscopy; D003424:Crohn Disease / Q000188:drug therapy* / Q000473:pathology; D004359:Drug Therapy, Combination; D005260:Female; D019382:Human Growth Hormone / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects* / Q000473:pathology; D008297:Male; D012074:Remission Induction; D016037:Single-Blind Method
chemical_list: D000305:Adrenal Cortex Hormones; D019382:Human Growth Hormone
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