A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the metabolic and respiratory effects of growth hormone in children with cystic fibrosis.
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| Title: | A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the metabolic and respiratory effects of growth hormone in children with cystic fibrosis. |
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| Authors: | Schnabel D (AUTHOR), Grasemann C (AUTHOR), Staab D (AUTHOR), Wollmann H (AUTHOR), Ratjen F (AUTHOR), German Cystic Fibrosis Growth Hormone Study Group (CORPORATE AUTHOR) |
| Source: | Pediatrics. Jun2007, Vol. 119 Issue 6, pe1230-8. 1p. |
| Abstract: | OBJECTIVE: Positive effects of growth hormone therapy on growth, nutritional status, and lung function have been observed in patients with cystic fibrosis, but the current evidence is based on unblinded studies that involved a small number of patients. This trial was designed as a multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy and safety of 2 dosages of growth hormone in cystic fibrosis. METHODS: Sixty-three dystrophic patients with cystic fibrosis were randomly assigned for 24 weeks to 1 of 3 treatment arms: growth hormone dosage of 0.11 IU/kg body weight per day, growth hormone dosage of 0.21 IU/kg body weight per day, or placebo. The 24-week double-blind period was followed by an open treatment period of 24 weeks. The primary outcome measure was the change in forced expiratory volume in 1 second in percentage predicted from baseline. Secondary outcome measures were changes in height, weight, and exercise tolerance. RESULTS: Height, growth velocity, and growth factors (insulin-like growth factor 1 and insulin-like growth factor-binding protein 3) increased significantly in both treatment groups, whereas weight gain did not differ between the growth hormone groups and placebo. A trend toward improvement in absolute forced vital capacity was observed in patients who received the higher growth hormone dosage, whereas forced expiratory volume in 1 second did not change significantly with growth hormone treatment. Maximal oxygen uptake during peak exercise increased significantly in treated patients. There were no significant differences in the frequency or severity of adverse effects or in the incidence of abnormalities in glucose metabolism. CONCLUSIONS: These data suggest that in the group investigated, growth hormone therapy was well tolerated and had positive metabolic effects but did not result in short-term improvement of lung function in patients with cystic fibrosis. [ABSTRACT FROM AUTHOR] |
| Copyright of Pediatrics is the property of American Academy of Pediatrics and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
| FullText | Text: Availability: 0 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 106135415 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the metabolic and respiratory effects of growth hormone in children with cystic fibrosis. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Schnabel+D%22">Schnabel D</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Grasemann+C%22">Grasemann C</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Staab+D%22">Staab D</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wollmann+H%22">Wollmann H</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ratjen+F%22">Ratjen F</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22German+Cystic+Fibrosis+Growth+Hormone+Study+Group%22">German Cystic Fibrosis Growth Hormone Study Group</searchLink> (CORPORATE AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Pediatrics%22">Pediatrics</searchLink>. Jun2007, Vol. 119 Issue 6, pe1230-8. 1p. – Name: Abstract Label: Abstract Group: Ab Data: OBJECTIVE: Positive effects of growth hormone therapy on growth, nutritional status, and lung function have been observed in patients with cystic fibrosis, but the current evidence is based on unblinded studies that involved a small number of patients. This trial was designed as a multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy and safety of 2 dosages of growth hormone in cystic fibrosis. METHODS: Sixty-three dystrophic patients with cystic fibrosis were randomly assigned for 24 weeks to 1 of 3 treatment arms: growth hormone dosage of 0.11 IU/kg body weight per day, growth hormone dosage of 0.21 IU/kg body weight per day, or placebo. The 24-week double-blind period was followed by an open treatment period of 24 weeks. The primary outcome measure was the change in forced expiratory volume in 1 second in percentage predicted from baseline. Secondary outcome measures were changes in height, weight, and exercise tolerance. RESULTS: Height, growth velocity, and growth factors (insulin-like growth factor 1 and insulin-like growth factor-binding protein 3) increased significantly in both treatment groups, whereas weight gain did not differ between the growth hormone groups and placebo. A trend toward improvement in absolute forced vital capacity was observed in patients who received the higher growth hormone dosage, whereas forced expiratory volume in 1 second did not change significantly with growth hormone treatment. Maximal oxygen uptake during peak exercise increased significantly in treated patients. There were no significant differences in the frequency or severity of adverse effects or in the incidence of abnormalities in glucose metabolism. CONCLUSIONS: These data suggest that in the group investigated, growth hormone therapy was well tolerated and had positive metabolic effects but did not result in short-term improvement of lung function in patients with cystic fibrosis. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Pediatrics is the property of American Academy of Pediatrics and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1542/peds.2006-2783 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 1 StartPage: e1230 Titles: – TitleFull: A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the metabolic and respiratory effects of growth hormone in children with cystic fibrosis. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Schnabel D – PersonEntity: Name: NameFull: Grasemann C – PersonEntity: Name: NameFull: Staab D – PersonEntity: Name: NameFull: Wollmann H – PersonEntity: Name: NameFull: Ratjen F – PersonEntity: Name: NameFull: German Cystic Fibrosis Growth Hormone Study Group IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 06 Text: Jun2007 Type: published Y: 2007 Identifiers: – Type: issn-print Value: 00314005 Numbering: – Type: volume Value: 119 – Type: issue Value: 6 Titles: – TitleFull: Pediatrics Type: main |
| ResultId | 1 |
