Evidence map›Paper›PMID 25324317›Full record

Trial reportBMJ open2014

Factors affecting the health-related quality of life of patients with cervical dystonia and impact of treatment with abobotulinumtoxinA (Dysport): results from a randomised, double-blind, placebo-controlled study.

Margaret Mordin, Catherine Masaquel, Chandra Abbott, Catherine Copley-Merriman

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 23 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00257660 phase3completednot on this map

A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia

TypeinterventionalSponsorIpsenRan2005 to 2006Enrolled116ConditionsCervical DystoniaArmsBotulinum toxin type A, Placebo
NCT00288509 phase3completednot on this map

A Phase III, Prospective, Multicenter, Open-label Extension Study to Assess the Longer Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Cervical Dystonia

TypeinterventionalSponsorIpsenRan2006 to 2008Enrolled108ConditionsCervical DystoniaArmsBotulinum toxin type A
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Botulinum toxin type A therapy for cervical dystonia.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Botulinum toxin type A therapy for cervical dystonia.The Cochrane database of systematic reviews · 2017
    Pooled it
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Observational
  16. Botulinum Toxin Treatment of Movement Disorders.Current treatment options in neurology · 2018
    Review
  17. Article
  18. Article
  19. Review
  20. Impact of Neu-botulinumtoxinA on the Severity and Quality of Life of Cervical Dystonia Patients.Tremor and other hyperkinetic movements (New York, N.Y.) · 2016
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Margaret MordinMarket Access and Outcomes Strategy, RTI Health Solutions, Ann Arbor, Michigan, USA.
Catherine MasaquelMarket Access and Outcomes Strategy, RTI Health Solutions, Ann Arbor, Michigan, USA.ORCID http://orcid.org/0000-0002-5983-7863
Chandra AbbottNeurology Medical Affairs, Ipsen Biopharmaceuticals Inc, Basking Ridge, New Jersey, USA.
Catherine Copley-MerrimanMarket Access and Outcomes Strategy, RTI Health Solutions, Ann Arbor, Michigan, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo describe the health-related quality of life (HRQOL) burden of cervical dystonia (CD) and report on the HRQOL and patient perception of treatment benefits of abobotulinumtoxinA (Dysport).

designThe safety and efficacy of a single injection of abobotulinumtoxinA for CD treatment were evaluated in a previously reported international, multicenter, double-blind, randomised trial. HRQOL measures were assessed in the trial and have not been previously reported.

settingMovement disorder clinics in the USA and Russia.

participantsPatients had to have a diagnosis of CD with symptoms for at least 18 months, as well as a total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score of at least 30; a Severity domain score of at least 15; and a Disability domain score of at least 3. Key exclusion criteria included treatment with botulinum toxin type A (BoNT-A) or botulinum toxin type B (BoNT-B) within 16 weeks of enrolment.

interventionsPatients were randomised to receive either 500 U abobotulinumtoxinA (n=55) or placebo (n=61). PRIMARY AND SECONDARY OUTCOME MEASURES: Efficacy assessments included TWSTRS total (primary end point) and subscale scores at weeks 0, 4, 8, 12; a pain visual analogue scale at weeks 0 and 4; and HRQOL assessed by the SF-36 Health Survey (SF-36; secondary end point) at weeks 0 and 8.

resultsPatients with CD reported significantly greater impairment for all SF-36 domains relative to US norms. Patients treated with abobotulinumtoxinA reported significantly greater improvements in Physical Functioning, Role Physical, Bodily Pain, General Health and Role Emotional domains than placebo patients (p≤0.03 for all). The TWSTRS was significantly correlated with Physical Functioning, Role Physical and Bodily Pain scores, for those on active treatment.

conclusionsCD has a marked impact on HRQOL. Treatment with a single abobotulinumtoxinA injection results in significant improvement in patients' HRQOL. TRIAL REGISTRATION NUMBER: The trial is registered at ClinicalTrials.gov, numbers NCT00257660 and NCT00288509.

Indexed as

Neck MusclesPatient SatisfactionQuality of LifeAcetylcholine Release InhibitorsAdultAgedBotulinum Toxins, Type ADouble-Blind MethodDystoniaFemaleHealth StatusHumansInjections, IntramuscularMaleMiddle AgedNeck PainabobotulinumtoxinAAcetylcholine Release InhibitorsBotulinum Toxins, Type AQUALITATIVE RESEARCH

Identifiers

PMID25324317
PMCPMC4201999

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.