Cargando…
An open-label cohort study of the improvement of quality of life and pain in de novo cervical dystonia patients after injections with 500 U botulinum toxin A (Dysport)
OBJECTIVES: It remains to be determined whether the benefits of botulinum toxin type A (BoNT-A) on cervical dystonia (CD) motor symptoms extend to improvements in patient's quality of life (QoL). This analysis of a large, multicentre study was conducted with the aim of investigating changes in...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2013
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3641454/ https://www.ncbi.nlm.nih.gov/pubmed/23604344 http://dx.doi.org/10.1136/bmjopen-2012-001853 |
_version_ | 1782268026556514304 |
---|---|
author | Hefter, H Benecke, R Erbguth, F Jost, W Reichel, G Wissel, J |
author_facet | Hefter, H Benecke, R Erbguth, F Jost, W Reichel, G Wissel, J |
author_sort | Hefter, H |
collection | PubMed |
description | OBJECTIVES: It remains to be determined whether the benefits of botulinum toxin type A (BoNT-A) on cervical dystonia (CD) motor symptoms extend to improvements in patient's quality of life (QoL). This analysis of a large, multicentre study was conducted with the aim of investigating changes in QoL and functioning among de novo patients receiving 500 U BoNT-A (abobotulinumtoxinA; Dysport) for the treatment of the two most frequent forms of CD, predominantly torticollis and laterocollis. DESIGN: A prospective, open-label study of Dysport (500 U; Ipsen Biopharm Ltd) administered according to a defined intramuscular injection algorithm. SETTING: German and Austrian outpatient clinics. PARTICIPANTS: 516 male and female patients (aged ≥18 years) with de novo CD. The majority of patients had torticollis (78.1%). 35 patients had concomitant depression (MedDRA-defined). MAIN OUTCOME MEASURES: Change from baseline to weeks 4 and 12 in Craniocervical Dystonia Questionnaire (CDQ-24) total and subscale scores, patient diary items (‘day-to-day capacities and activities’, ‘pain’ and ‘duration of pain’) and global assessment of pain. RESULTS: Significant improvements were observed in CDQ-24 total and subscale scores at week 4 and were sustained up to week 12 (p<0.001). Changes in CDQ-24 scores did not significantly differ between the torticollis and laterocollis groups or between patients with or without depression. There were also significant reductions in patient diary item scores for activities of daily living, pain and pain duration at weeks 4 and 12 (p<0.001). Pain relief (less or no pain) was reported by 66% and 74.1% of patients at weeks 4 and 12, respectively. Changes in pain parameters demonstrated a positive relationship with change in Tsui score. CONCLUSIONS: After standardised open-label treatment with Dysport 500 U, improvements in QoL and pain intensity up to 12 weeks in patients with CD were observed. |
format | Online Article Text |
id | pubmed-3641454 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-36414542013-05-07 An open-label cohort study of the improvement of quality of life and pain in de novo cervical dystonia patients after injections with 500 U botulinum toxin A (Dysport) Hefter, H Benecke, R Erbguth, F Jost, W Reichel, G Wissel, J BMJ Open Neurology OBJECTIVES: It remains to be determined whether the benefits of botulinum toxin type A (BoNT-A) on cervical dystonia (CD) motor symptoms extend to improvements in patient's quality of life (QoL). This analysis of a large, multicentre study was conducted with the aim of investigating changes in QoL and functioning among de novo patients receiving 500 U BoNT-A (abobotulinumtoxinA; Dysport) for the treatment of the two most frequent forms of CD, predominantly torticollis and laterocollis. DESIGN: A prospective, open-label study of Dysport (500 U; Ipsen Biopharm Ltd) administered according to a defined intramuscular injection algorithm. SETTING: German and Austrian outpatient clinics. PARTICIPANTS: 516 male and female patients (aged ≥18 years) with de novo CD. The majority of patients had torticollis (78.1%). 35 patients had concomitant depression (MedDRA-defined). MAIN OUTCOME MEASURES: Change from baseline to weeks 4 and 12 in Craniocervical Dystonia Questionnaire (CDQ-24) total and subscale scores, patient diary items (‘day-to-day capacities and activities’, ‘pain’ and ‘duration of pain’) and global assessment of pain. RESULTS: Significant improvements were observed in CDQ-24 total and subscale scores at week 4 and were sustained up to week 12 (p<0.001). Changes in CDQ-24 scores did not significantly differ between the torticollis and laterocollis groups or between patients with or without depression. There were also significant reductions in patient diary item scores for activities of daily living, pain and pain duration at weeks 4 and 12 (p<0.001). Pain relief (less or no pain) was reported by 66% and 74.1% of patients at weeks 4 and 12, respectively. Changes in pain parameters demonstrated a positive relationship with change in Tsui score. CONCLUSIONS: After standardised open-label treatment with Dysport 500 U, improvements in QoL and pain intensity up to 12 weeks in patients with CD were observed. BMJ Publishing Group 2013-04-26 /pmc/articles/PMC3641454/ /pubmed/23604344 http://dx.doi.org/10.1136/bmjopen-2012-001853 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/ and http://creativecommons.org/licenses/by-nc/3.0/legalcode |
spellingShingle | Neurology Hefter, H Benecke, R Erbguth, F Jost, W Reichel, G Wissel, J An open-label cohort study of the improvement of quality of life and pain in de novo cervical dystonia patients after injections with 500 U botulinum toxin A (Dysport) |
title | An open-label cohort study of the improvement of quality of life and pain in de novo cervical dystonia patients after injections with 500 U botulinum toxin A (Dysport) |
title_full | An open-label cohort study of the improvement of quality of life and pain in de novo cervical dystonia patients after injections with 500 U botulinum toxin A (Dysport) |
title_fullStr | An open-label cohort study of the improvement of quality of life and pain in de novo cervical dystonia patients after injections with 500 U botulinum toxin A (Dysport) |
title_full_unstemmed | An open-label cohort study of the improvement of quality of life and pain in de novo cervical dystonia patients after injections with 500 U botulinum toxin A (Dysport) |
title_short | An open-label cohort study of the improvement of quality of life and pain in de novo cervical dystonia patients after injections with 500 U botulinum toxin A (Dysport) |
title_sort | open-label cohort study of the improvement of quality of life and pain in de novo cervical dystonia patients after injections with 500 u botulinum toxin a (dysport) |
topic | Neurology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3641454/ https://www.ncbi.nlm.nih.gov/pubmed/23604344 http://dx.doi.org/10.1136/bmjopen-2012-001853 |
work_keys_str_mv | AT hefterh anopenlabelcohortstudyoftheimprovementofqualityoflifeandpainindenovocervicaldystoniapatientsafterinjectionswith500ubotulinumtoxinadysport AT benecker anopenlabelcohortstudyoftheimprovementofqualityoflifeandpainindenovocervicaldystoniapatientsafterinjectionswith500ubotulinumtoxinadysport AT erbguthf anopenlabelcohortstudyoftheimprovementofqualityoflifeandpainindenovocervicaldystoniapatientsafterinjectionswith500ubotulinumtoxinadysport AT jostw anopenlabelcohortstudyoftheimprovementofqualityoflifeandpainindenovocervicaldystoniapatientsafterinjectionswith500ubotulinumtoxinadysport AT reichelg anopenlabelcohortstudyoftheimprovementofqualityoflifeandpainindenovocervicaldystoniapatientsafterinjectionswith500ubotulinumtoxinadysport AT wisselj anopenlabelcohortstudyoftheimprovementofqualityoflifeandpainindenovocervicaldystoniapatientsafterinjectionswith500ubotulinumtoxinadysport AT hefterh openlabelcohortstudyoftheimprovementofqualityoflifeandpainindenovocervicaldystoniapatientsafterinjectionswith500ubotulinumtoxinadysport AT benecker openlabelcohortstudyoftheimprovementofqualityoflifeandpainindenovocervicaldystoniapatientsafterinjectionswith500ubotulinumtoxinadysport AT erbguthf openlabelcohortstudyoftheimprovementofqualityoflifeandpainindenovocervicaldystoniapatientsafterinjectionswith500ubotulinumtoxinadysport AT jostw openlabelcohortstudyoftheimprovementofqualityoflifeandpainindenovocervicaldystoniapatientsafterinjectionswith500ubotulinumtoxinadysport AT reichelg openlabelcohortstudyoftheimprovementofqualityoflifeandpainindenovocervicaldystoniapatientsafterinjectionswith500ubotulinumtoxinadysport AT wisselj openlabelcohortstudyoftheimprovementofqualityoflifeandpainindenovocervicaldystoniapatientsafterinjectionswith500ubotulinumtoxinadysport |