Safety and tolerability of growth hormone therapy in multiple system atrophy: a double-blind, placebo-controlled study - PubMed (original) (raw)
Randomized Controlled Trial
. 2007 Jun 15;22(8):1138-44.
doi: 10.1002/mds.21501.
Affiliations
- PMID: 17469198
- DOI: 10.1002/mds.21501
Randomized Controlled Trial
Safety and tolerability of growth hormone therapy in multiple system atrophy: a double-blind, placebo-controlled study
Björn Holmberg et al. Mov Disord. 2007.
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.
Similar articles
- Safety and efficacy of growth hormone (GH) during extended treatment of adult Japanese patients with GH deficiency (GHD).
Chihara K, Kato Y, Kohno H, Takano K, Tanaka T, Teramoto A, Shimatsu A. Chihara K, et al. Growth Horm IGF Res. 2008 Aug;18(4):307-17. doi: 10.1016/j.ghir.2007.12.001. Epub 2008 Feb 20. Growth Horm IGF Res. 2008. PMID: 18282776 Clinical Trial. - Longitudinal one-year study of levels and stoichiometry of neurofilament heavy and light chain concentrations in CSF in patients with multiple system atrophy.
Petzold A, Thompson EJ, Keir G, Quinn N, Holmberg B, Dizdar N, Wenning GK, Rascol O, Tolosa E, Rosengren L. Petzold A, et al. J Neurol Sci. 2009 Apr 15;279(1-2):76-9. doi: 10.1016/j.jns.2008.12.037. Epub 2009 Feb 4. J Neurol Sci. 2009. PMID: 19195665 Clinical Trial. - Use of physiological doses of human growth hormone in haematological patients receiving intensive chemotherapy promotes haematopoietic recovery: a double-blind randomized, placebo-controlled study.
Sirohi B, Powles R, Morgan G, Treleaven J, Kulkarni S, Horton C, Saso R, Rolfe D, Cook G, Shaw C, Wass J. Sirohi B, et al. Bone Marrow Transplant. 2007 Jan;39(2):115-20. doi: 10.1038/sj.bmt.1705545. Epub 2006 Dec 4. Bone Marrow Transplant. 2007. PMID: 17143302 Clinical Trial. - A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the metabolic and respiratory effects of growth hormone in children with cystic fibrosis.
Schnabel D, Grasemann C, Staab D, Wollmann H, Ratjen F; German Cystic Fibrosis Growth Hormone Study Group. Schnabel D, et al. Pediatrics. 2007 Jun;119(6):e1230-8. doi: 10.1542/peds.2006-2783. Pediatrics. 2007. PMID: 17545356 Clinical Trial. - Treatment of adult short bowel syndrome with recombinant human growth hormone: a review of clinical studies.
Messing B, Blethen S, Dibaise JK, Matarese LE, Steiger E. Messing B, et al. J Clin Gastroenterol. 2006 May-Jun;40 Suppl 2:S75-84. doi: 10.1097/01.mcg.0000212677.06549.80. J Clin Gastroenterol. 2006. PMID: 16770166 Review.
Cited by
- The effect of growth hormone on motor findings and dendrite morphology in an experimental Parkinson's disease model.
Kirazli O, Ozkan M, Verimli U, Gulhan R, Arman A, Sehirli US. Kirazli O, et al. Anat Sci Int. 2024 Jul 31. doi: 10.1007/s12565-024-00790-6. Online ahead of print. Anat Sci Int. 2024. PMID: 39085683 - Multiple system atrophy: an update and emerging directions of biomarkers and clinical trials.
Liu M, Wang Z, Shang H. Liu M, et al. J Neurol. 2024 May;271(5):2324-2344. doi: 10.1007/s00415-024-12269-5. Epub 2024 Mar 14. J Neurol. 2024. PMID: 38483626 Free PMC article. Review. - Recent Advances in Clinical Trials in Multiple System Atrophy.
Bendetowicz D, Fabbri M, Sirna F, Fernagut PO, Foubert-Samier A, Saulnier T, Le Traon AP, Proust-Lima C, Rascol O, Meissner WG. Bendetowicz D, et al. Curr Neurol Neurosci Rep. 2024 Apr;24(4):95-112. doi: 10.1007/s11910-024-01335-0. Epub 2024 Feb 28. Curr Neurol Neurosci Rep. 2024. PMID: 38416311 Review. - Disease-Modifying Therapies for Multiple System Atrophy: Where Are We in 2022?
Sidoroff V, Bower P, Stefanova N, Fanciulli A, Stankovic I, Poewe W, Seppi K, Wenning GK, Krismer F. Sidoroff V, et al. J Parkinsons Dis. 2022;12(5):1369-1387. doi: 10.3233/JPD-223183. J Parkinsons Dis. 2022. PMID: 35491799 Free PMC article. Review. - Nocebo effect in multiple system atrophy: systematic review and meta-analysis of placebo-controlled clinical trials.
Wang ZX, Zhang NN, Zhao HX, Song J. Wang ZX, et al. Neurol Sci. 2022 Feb;43(2):899-905. doi: 10.1007/s10072-021-05758-2. Epub 2022 Jan 1. Neurol Sci. 2022. PMID: 34973075 Free PMC article. Review.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources