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Safety and tolerability of growth hormone therapy in multiple system atrophy: a double-blind, placebo-controlled study.

Abstract
The objective of this study was to investigate tolerability and possible neurotrophic effects of growth hormone (GH) in treatment of multiple system atrophy (MSA). In this double-blind pilot study, MSA patients were randomized to recombinant human growth hormone (r-hGH, n = 22), 1 mg every second day (6 months) followed by alternating daily injections of 1 mg and 0.5 mg (6 months), or matched placebo (n = 21). Safety analysis demonstrated no obvious between-group differences. In both groups, there was progressive worsening of Unified Parkinson's Disease Rating Scale total score, which tended to be less in r-hGH-treated patients (12.9% at 6 months, 25.3% at 12 months) than in placebo (17.0% and 35.7%). Similarly, there was a trend to less worsening in Unified MSA Rating Scale total score with r-hGH (13.2% and 21.2%) than with placebo (21.1% and 36.5%). Cardiovascular reflex autonomic testing also tended to show less deterioration with r-hGH than with placebo at 12 months. However, 95% CI did not indicate treatment differences for any efficacy measures. In conclusion, r-hGH administration in MSA patients for up to 1 year appears safe and might influence disease symptoms, signs and, possibly, progression. The results support further studies utilizing higher doses in more patients.
AuthorsBjörn Holmberg, Jan-Ove Johansson, Werner Poewe, Gregor Wenning, Niall P Quinn, Chris Mathias, Eduardo Tolosa, Adriana Cardozo, Nil Dizdar, Olivier Rascol, Tarik Slaoui, Growth-Hormone MSA Study Group, European MSA Study Group
JournalMovement disorders : official journal of the Movement Disorder Society (Mov Disord) Vol. 22 Issue 8 Pg. 1138-44 (Jun 15 2007) ISSN: 0885-3185 [Print] United States
PMID17469198 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Human Growth Hormone
Topics
  • Body Mass Index
  • Constipation (chemically induced, epidemiology)
  • Double-Blind Method
  • Drug Tolerance
  • Female
  • Heart Rate (drug effects)
  • Human Growth Hormone (adverse effects, therapeutic use)
  • Humans
  • Male
  • Middle Aged
  • Multiple System Atrophy (drug therapy, pathology)

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