Somatic characteristics and cardiovascular risk factors in growth hormone deficiency: A randomized, double-blind, placebo-controlled study of the effect of treatment with recombinant human growth hormone

• Published in: American journal of human biology Vol. 16; no. 5; pp. 533 - 543
• Main Authors: Bell, W., Davies, J.S., Evans, W.D., Scanlon, M.F., Mullen, R.
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 01-09-2004
• Subjects: Adult; Age Distribution; Anthropometry; Body Composition - drug effects; Body Height - drug effects; Cardiovascular Diseases - epidemiology; Cardiovascular Diseases - prevention & control; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Growth Disorders - diagnosis; Growth Disorders - drug therapy; Human Growth Hormone - deficiency; Human Growth Hormone - therapeutic use; Humans; Incidence; Male; Middle Aged; Multivariate Analysis; Probability; Reference Values; Risk Assessment; Risk Factors; Sex Distribution; Treatment Outcome
• ISSN: 1042-0533; 1520-6300
• DOI: 10.1002/ajhb.20055

The purpose of the present study was to identify the effect of treatment with recombinant human growth hormone (rhGH) on seven somatic characteristics and eight clinical cardiovascular risk factors. Twenty‐seven male and 24 female patients between the ages of 21 and 60 years were examined. The investigation was a double‐blind, placebo‐controlled study of 12 months duration. Patients were assigned randomly to treatment (T) and placebo (P) groups. In the first 6 months group T received rhGH and group P placebo. In the second 6 months both groups received rhGH. Complete data were available for 23 males and 20 females. Increments were calculated between 6 months –BL (increment 1) and 12–6 months (increment 2) in both T and P groups. Apart from the somatotype, data were analysed with a 2 × 2 mixed analysis of variance (ANOVA) using treatment (rhGH and placebo) and time (increments 1 and 2). Somatotype data were analysed using a 2 × 3 multivariate ANOVA. Three significant interactions were identified in males: waist circumference (P = 0.006), trunk fat (P = 0.0001), and conicity index (P = 0.001). The only significant interaction in females was trunk fat (P = 0.006). In general, treatment and placebo groups responded differently by time and treatment. Responses were similar in males and females. In the first 6 months when group P was on placebo, waist circumference, trunk fat, and conicity index increased slightly; with group T on rhGH somatic variables declined markedly. In the second 6 months when both groups received rhGH there was a marked decline in group P and a continued decline (but less steeply) in group T. In males there were significant decreases in endomorphy in group T and increases in mesomorphy in group P. In females the somatotype remained stable. There were no significant interactions in clinical cardiovascular risk factors in either males or females. Favourable responses occurred in male and female lipid profiles, although these were not significant. It was concluded that in males waist circumference, trunk fat, conicity index, and somatotype responded significantly to treatment with rhGH; in females the only significant response was trunk fat. Am. J. Hum. Biol. 16:533–543, 2004. © 2004 Wiley‐Liss, Inc.