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A botulinum toxin A treatment algorithm for de novo management of torticollis and laterocollis
  1. Harald Hefter1,
  2. Andreas Kupsch2,
  3. Martina Müngersdorf3,
  4. Sebastian Paus4,
  5. Andrea Stenner5,
  6. Wolfgang Jost6
  7. on behalf of the Dysport Cervical Dystonia Study Group*
  1. 1Department of Neurology, University of Düsseldorf, Moorenstrasse, Düsseldorf, Germany
  2. 2Department of Neurology, University Hospital Charité, Campus Virchow-Klinkum, Augustenburger Platz, Berlin, Germany
  3. 3Neurologie am Hackeschen Markt, Dircksenstr, Berlin, Germany
  4. 4Department of Neurology, University of Bonn, Sigmund-Freud-Strasse, Bonn, Germany
  5. 5Out-Patient Department of Neurology, Paracelsus Klinik, Werdauer Strasse, Zwickau, Germany
  6. 6Department of Neurology, Deutsche Klinik für Diagnostik Wiesbaden, Aukammallee, Wiesbaden, Germany
  1. Correspondence to Harald Hefter; harald.hefter{at}online.de

Abstract

Objectives Few studies have investigated the injection patterns for botulinum toxin type A for the treatment of heterogeneous forms of cervical dystonia (CD). This large, prospective, open-label, multicentre study aimed to evaluate the effectiveness and safety of 500 U botulinum toxin A for the initial treatment according to a standardised algorithm of the two most frequent forms of CD, predominantly torticollis and laterocollis.

Design Patients (aged ≥18 years) with CD not previously treated with botulinum neurotoxin therapy were given one treatment with 500 U Dysport, according to a defined intramuscular injection algorithm based on clinical assessment of direction of head deviation, occurrence of shoulder elevation, occurrence of tremor (all evaluated using the Tsui rating scale) and hypertrophy of the sternocleidomastoid muscle.

Results In this study, 516 patients were enrolled, the majority of whom (95.0%) completed treatment. Most patients had torticollis (78.1%). At week 4, mean Tsui scores had significantly decreased by −4.01, −3.76 and −4.09 points in the total, torticollis and laterocollis populations, respectively. Symptom improvement was equally effective between groups. Tsui scores remained significantly below baseline at week 12 in both groups. Treatment was well tolerated; the most frequent adverse events were muscular weakness (13.8%), dysphagia (9.9%) and neck pain (6.6%).

Conclusions Dysport 500 U is effective and well tolerated for the de novo management of a range of heterogeneous forms of CD, when using a standardised regimen that allows tailored dosing based on individual symptom assessment.

Clinical trials information (NCT00447772; clinicaltrials.gov)

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Footnotes

  • * The members of the Dysport Cervical Dystonia Study Group are listed in appendix 1.

  • Correction notice The “To cite: …” information and running footer in this article have been updated with the correct volume number (volume 1).

  • To cite: Hefter H, Kupsch A, Müngersdorf M, et al; on behalf of the Dysport Cervical Dystonia Study Group. A botulinum toxin A treatment algorithm for de novo management of torticollis and laterocollis. BMJ Open 2011;1:e000196. doi:10.1136/bmjopen-2011-000196

  • Funding Funding was provided by Ipsen Pharma, Germany.

  • Competing interests HH: consultant and speaker for Ipsen; AK: speaker honoria from Ipsen; MM: speaker for Ipsen; SP: consultant and speaker for Ipsen; AS: speaker for Ipsen; WJ: consultant and speaker for Ipsen.

  • Patient consent Obtained.

  • Ethics approval Ethics approval was provided by Ethics Committee of the Medical Faculty of the Heinrich-Heine University of D¨sseldorf, Moorenstrasse, D¨sseldorf, Germany (Lead EC) and local Ethics Committees.

  • Contributors HH and WJ were involved in the concept and study design, study conduct, data collection, analysis and interpretation, manuscript writing, review and critique. All other authors were involved in conducting the study, data collection, manuscript review and critique. All authors approved the final manuscript.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Data management and statistical analyses were performed by GKM Gesellschaft für Therapieforschung in Munich, Germany.

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