Evidence map›Paper›PMID 25476727›Full record

Trial reportMovement disorders : official journal of the Movement Disorder Society2015

Dysport and Botox at a ratio of 2.5:1 units in cervical dystonia: a double-blind, randomized study.

Ji Young Yun, Jae Woo Kim, Hee-Tae Kim, Sun Ju Chung, Jong-Min Kim, Jin Whan Cho, Jee-Young Lee, Ha Neul Lee, Sooyeoun You, Eungseok Oh and 5 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Movement disorders : official journal of the Movement Disorder Society, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00950664 (A Double Blind, Randomized, Multi-center, Cross-over Study to Demonstrate the Non-inferiority of Dysport® in Comparison With Botox®, Assuming a Bioequivalence Ratio of 2.5), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 9% of its field
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.

NCT00950664 phase4completednot on this map

A Double Blind, Randomized, Multi-center, Cross-over Study to Demonstrate the Non-inferiority of Dysport® in Comparison With Botox®, Assuming a Bioequivalence Ratio of 2.5:1 Units, in the Cervical Dystonia

TypeinterventionalSponsorSeoul National University HospitalRan2009 to 2011Enrolled103ConditionsCervical DystoniaArmsDysport® (abobotulinumtoxinA), Botox® (onabotulinumtoxinA)
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Pilot Single-Blind Trial of AbobotulinumtoxinA in Oromandibular Dystonia.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2018
    Trial
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Botulinum neurotoxin formulations: overcoming the confusion.Clinical, cosmetic and investigational dermatology · 2018
    Review
  16. Review
  17. Review
  18. Article
  19. Article
  20. Review
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

15 authors at 12 institutions in 1 country.

Ji Young YunDepartment of Neurology, Ewha Womans University School of Medicine and Ewha Medical Research Institute, Seoul, Republic of Korea.
Jae Woo Kim
Hee-Tae Kim
Sun Ju Chung
Jong-Min Kim
Jin Whan Cho
Jee-Young Lee
Ha Neul Lee
Sooyeoun You
Eungseok Oh
Heejeong Jeong
Young Eun Kim
Han-Joon Kim
Won Yong Lee
Beom S Jeon
Seoul National University · KRHanyang University · KRAsan Medical Center · KRChungnam National University Hospital · KRDong-A University Hospital · KREwha Womans University Medical Center · KRGyeongsang National University · KRHallym University Sacred Heart Hospital · KRKeimyung University · KRSamsung Medical Center · KRSeoul National University Bundang Hospital · KRSungkyunkwan University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We aimed to compare Dysport (abobotulinumtoxinA, Ipsen Biopharm, Slough, UK) and Botox (onabotulinumtoxinA, Allergan, Irvine, CA, USA) at a 2.5:1 ratio in the treatment of cervical dystonia (CD). A Dysport/Botox ratio of lower than 3:1 was suggested as a more appropriate conversion ratio, considering its higher efficacy and more frequent incidence of adverse effects not only in the treatment of CD but also in other focal movement disorders. A randomized, double-blind, multicenter, non-inferiority, two-period crossover study was done in CD, with a duration of at least 18 months. Patients were randomly assigned to treatment for the first period with Dysport or Botox, and they were followed up for 16 weeks after the injection. After a 4-week washout period, they were switched to the other formulation and then followed up for 16 weeks. The primary outcome was the changes in the Tsui scale between the baseline value and that at 1 month after each injection. A total of 103 patients were enrolled, and 94 completed the study. Mean changes in the Tsui scale between baseline and 4 weeks after each injection tended to favor Botox; however, this was not statistically significant (4.0 ± 3.9 points for the Dysport treatment vs. 4.8 ± 4.1 points for Botox; 95% confidence interval, -0.1-1.7; P = 0.091). The mean change of the Toronto western spasmodic torticollis rating scale score, the proportion of improvement in clinical global impression and patient global impression, and the incidences of adverse events were not significantly different between the two treatments. With regard to safety and efficacy, Dysport was not inferior to Botox in patients with CD at a conversion factor of 2.5:1. [clinicaltrial.gov: NCT00950664]

Indexed as

Acetylcholine Release InhibitorsAdultAgedBotulinum Toxins, Type ADouble-Blind MethodDrug CombinationsFemaleHumansMaleMiddle AgedPainPain MeasurementTorticollisTreatment OutcomeYoung AdultabobotulinumtoxinAAcetylcholine Release InhibitorsBotulinum Toxins, Type ADrug Combinationsbotulinum toxincervical dystoniamotor controlmovement disorderstorticollis

Identifiers

PMID25476727
PMCPMC4359015
OpenAlexW1482477937

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.