Document Detail


DYSBOT: a single-blind, randomized parallel study to determine whether any differences can be detected in the efficacy and tolerability of two formulations of botulinum toxin type A--Dysport and Botox--assuming a ratio of 4:1.
MedLine Citation:
PMID:  9399229     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Elston and Russell discovered a difference in the biological potency of the English formulation of botulinum toxin type A or BTX-A (Dysport) and the American formulation (Botox). Potency of both is expressed in LD50 mouse units, but because of assay differences, these units are not equivalent. Since the first warning by Quinn and Hallet on the clinical importance of this issue, it has been impossible to reach a consensus on the conversion factor for the potency of these formulations.
OBJECTIVE: To test the hypothesis that the conversion factor for the clinical potency of Dysport to Botox is approximately 4:1. DYSBOT is an acronym that results from adding "DYS" from Dysport with "BOT" from Botox.
PATIENTS AND METHODS:
DESIGN: A single-blind, randomized, parallel comparison. A total of 91 patients with blepharospasm or hemifacial spasm were randomized to treatment with Dysport or Botox using a fixed potency ratio of 4:1. Clinical evaluations: The patients were evaluated at baseline (day of the treatment). 1 month after treatment, and whenever the effect was judged to be fading. Objective and functional rating scales were used as quantitative measures of the change in clinical status. Adverse reactions were collected using a systematic questionnaire.
RESULTS: Using this ratio between products, both Dysport and Botox groups produced similar clinical efficacy and tolerability. For patients showing a positive response without the need of a booster, the duration of effect was 13.3 +/- 5.9 weeks for the Dysport group and 11.2 +/- 5.8 weeks for the Botox group. Of 48 patients, 11 (23%) needed booster treatment in the Dysport group compared with five (12%) of 43 in Botox group. Adverse events were noted in 24 (50%) of 48 patients in the Dysport group and 20 (47%) of 43 of the Botox-treated group.
CONCLUSIONS: Using a 4:1 conversion ratio for Dysport and Botox, similar results were obtained for the two treatments in an appropriately powered study, suggesting that this conversion factor is a good estimate of their comparative clinical potencies.
Authors:
C Sampaio; J J Ferreira; F Simões; M J Rosas; M Magalhães; A P Correia; A Bastos-Lima; R Martins; A Castro-Caldas
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Movement disorders : official journal of the Movement Disorder Society     Volume:  12     ISSN:  0885-3185     ISO Abbreviation:  Mov. Disord.     Publication Date:  1997 Nov 
Date Detail:
Created Date:  1998-02-10     Completed Date:  1998-02-10     Revised Date:  2014-07-29    
Medline Journal Info:
Nlm Unique ID:  8610688     Medline TA:  Mov Disord     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1013-8     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Aged
Blepharospasm / drug therapy*
Botulinum Toxins, Type A / therapeutic use*
Drug Tolerance
Female
Hemifacial Spasm / drug therapy*
Humans
Male
Middle Aged
Neuromuscular Agents / therapeutic use*
Single-Blind Method
Time Factors
Chemical
Reg. No./Substance:
0/Neuromuscular Agents; EC 3.4.24.69/Botulinum Toxins, Type A

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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