eprintid: 1530007
rev_number: 28
eprint_status: archive
userid: 608
dir: disk0/01/53/00/07
datestamp: 2016-12-01 10:22:11
lastmod: 2021-12-02 23:10:10
status_changed: 2016-12-01 10:22:11
type: article
metadata_visibility: show
creators_name: Duarte, GS
creators_name: Castelão, M
creators_name: Rodrigues, FB
creators_name: Marques, RE
creators_name: Ferreira, J
creators_name: Sampaio, C
creators_name: Moore, AP
creators_name: Costa, J
title: Botulinum toxin type A versus botulinum toxin type B for cervical dystonia
ispublished: pub
divisions: UCL
divisions: B02
divisions: C07
divisions: D07
divisions: F86
note: Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
abstract: BACKGROUND: This is an update of a Cochrane review first published in 2003. Cervical dystonia is the most common form of focal dystonia and is a disabling disorder characterised by painful involuntary head posturing. There are two available formulations of botulinum toxin, with botulinum toxin type A (BtA) usually considered the first line therapy for this condition. Botulinum toxin type B (BtB) is an alternative option, with no compelling theoretical reason why it might not be as- or even more effective - than BtA. OBJECTIVES: To compare the efficacy, safety and tolerability of botulinum toxin type A (BtA) versus botulinum toxin type B (BtB) in people with cervical dystonia. SEARCH METHODS: To identify studies for this review we searched the Cochrane Movement Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, reference lists of articles and conference proceedings. All elements of the search, with no language restrictions, were last run in October 2016. SELECTION CRITERIA: Double-blind, parallel, randomised, placebo-controlled trials (RCTs) comparing BtA versus BtB in adults with cervical dystonia. DATA COLLECTION AND ANALYSIS: Two independent authors assessed records, selected included studies, extracted data using a paper pro forma, and evaluated the risk of bias. We resolved disagreements by consensus or by consulting a third author. We performed meta-analyses using the random-effects model, for the comparison BtA versus BtB to estimate pooled effects and corresponding 95% confidence intervals (95% CI). No prespecified subgroup analyses were carried out. The primary efficacy outcome was improvement on any validated symptomatic rating scale, and the primary safety outcome was the proportion of participants with adverse events. MAIN RESULTS: We included three RCTs, all new to this update, of very low to low methodological quality, with a total of 270 participants.Two studies exclusively enrolled participants with a known positive response to BtA treatment. This raises concerns of population enrichment, with a higher probability of benefit from BtA treatment. None of the trials were free of for-profit bias, nor did they provide information regarding registered study protocols. All trials evaluated the effect of a single Bt treatment session, and not repeated treatment sessions, using doses from 100 U to 250 U of BtA (all onabotulinumtoxinA, or Botox, formulations) and 5000 U to 10,000 U of BtB (rimabotulinumtoxinB, or Myobloc/Neurobloc).We found no difference between the two types of botulinum toxin in terms of overall efficacy, with a mean difference of -1.44 (95% CI -3.58 to 0.70) points lower on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) for BtB-treated participants, measured at two to four weeks after injection. The proportion of participants with adverse events was also not different between BtA and BtB (BtB versus BtA risk ratio (RR) 1.40; 95% CI 1.00 to 1.96). However, when compared to BtA, treatment with BtB was associated with an increased risk of one adverse events of special interest, namely treatment-related sore throat/dry mouth (BtB versus BtA RR of 4.39; 95% CI 2.43 to 7.91). Treatment-related dysphagia (swallowing difficulties) was not different between BtA and BtB (RR 2.89; 95% CI 0.80 to 10.41). The two types of botulinum toxin were otherwise clinically non-distinguishable in all the remaining outcomes. AUTHORS' CONCLUSIONS: The previous version of this review did not include any trials, since these were still ongoing at the time. Therefore, with this update we are able to change the conclusions of this review. There is low quality evidence that a single treatment session of BtA (specifically onabotulinumtoxinA) and a single treatment session of BtB (rimabotulinumtoxinB) are equally effective and safe in the treatment of adults with certain types of cervical dystonia. Treatment with BtB appears to present an increased risk of sore throat/dry mouth, compared to BtA. Overall, there is no clinical evidence from these single-treatment trials to support or contest the preferential use of one form of botulinum toxin over the other.
date: 2016-10-26
date_type: published
official_url: http://dx.doi.org/10.1002/14651858.CD004314.pub3
oa_status: green
full_text_type: pub
language: eng
primo: open
primo_central: open_green
verified: verified_manual
elements_id: 1193642
doi: 10.1002/14651858.CD004314.pub3
lyricists_name: Brogueira Rodrigues, Filipe
lyricists_id: FBROG17
actors_name: Brogueira Rodrigues, Filipe
actors_id: FBROG17
actors_role: owner
full_text_status: public
publication: Cochrane Database of Systematic Reviews
volume: 10
article_number: CD004314
event_location: England
citation:        Duarte, GS;    Castelão, M;    Rodrigues, FB;    Marques, RE;    Ferreira, J;    Sampaio, C;    Moore, AP;           Duarte, GS;  Castelão, M;  Rodrigues, FB;  Marques, RE;  Ferreira, J;  Sampaio, C;  Moore, AP;  Costa, J;   - view fewer <#>    (2016)    Botulinum toxin type A versus botulinum toxin type B for cervical dystonia.                   Cochrane Database of Systematic Reviews , 10     , Article CD004314.  10.1002/14651858.CD004314.pub3 <https://doi.org/10.1002/14651858.CD004314.pub3>.       Green open access   
 
document_url: https://discovery.ucl.ac.uk/id/eprint/1530007/1/2016%2010%20Botulinum%20toxin%20type%20A%20versus%20botulinum%20toxin%20type%20B%20for%20cervical%20dystonia.pdf