Botulinum toxin type A therapy for hemifacial spasm.


Journal

The Cochrane database of systematic reviews
ISSN: 1469-493X
Titre abrégé: Cochrane Database Syst Rev
Pays: England
ID NLM: 100909747

Informations de publication

Date de publication:
19 11 2020
Historique:
entrez: 19 11 2020
pubmed: 20 11 2020
medline: 22 12 2020
Statut: epublish

Résumé

This is an update of a Cochrane Review, first published in 2005. Hemifacial spasm (HFS) is characterised by unilateral, involuntary contractions of the muscles innervated by the facial nerve. It is a chronic disorder, and spontaneous recovery is very rare. The two treatments routinely available are microvascular decompression and intramuscular injections with botulinum toxin type A (BtA). To compare the efficacy, safety, and tolerability of BtA versus placebo in people with HFS. We searched CENTRAL, MEDLINE, Embase, reference lists of articles, and conference proceedings in July 2020. We ran the electronic database search, with no language restrictions, in July 2020. Double-blind, parallel, randomised, placebo-controlled trials (RCTs) of BtA versus placebo in adults with HFS. Two review authors independently assessed records. We planned to select included studies, extract data using a paper pro forma, and evaluate the risk of bias. We resolved disagreements by consensus, or by consulting a third review author. We planned to perform meta-analyses. The primary efficacy outcome was HFS-specific improvement. The primary safety outcome was the proportion of participants with any adverse event. We found no parallel-group randomised controlled trials comparing BtA and placebo in HFS. We did not find any randomised trials that evaluated the efficacy and safety of botulinum toxin type A in people with hemifacial spasm, so we are unable to draw any conclusions. Observational data show a strong association between BtA treatment and symptom improvement, and a favourable safety profile. While it is unlikely that future placebo-controlled RCTs will evaluate absolute efficacy and safety, they should address relevant questions for both people with HFS (such as long-term effects, quality of life, and other patient-reported outcomes), and clinicians (such as relative effectiveness of different BtA formulations and schemes of treatment) to better guide clinical practice.).

Sections du résumé

BACKGROUND
This is an update of a Cochrane Review, first published in 2005. Hemifacial spasm (HFS) is characterised by unilateral, involuntary contractions of the muscles innervated by the facial nerve. It is a chronic disorder, and spontaneous recovery is very rare. The two treatments routinely available are microvascular decompression and intramuscular injections with botulinum toxin type A (BtA).
OBJECTIVES
To compare the efficacy, safety, and tolerability of BtA versus placebo in people with HFS.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, reference lists of articles, and conference proceedings in July 2020. We ran the electronic database search, with no language restrictions, in July 2020.
SELECTION CRITERIA
Double-blind, parallel, randomised, placebo-controlled trials (RCTs) of BtA versus placebo in adults with HFS.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed records. We planned to select included studies, extract data using a paper pro forma, and evaluate the risk of bias. We resolved disagreements by consensus, or by consulting a third review author. We planned to perform meta-analyses. The primary efficacy outcome was HFS-specific improvement. The primary safety outcome was the proportion of participants with any adverse event.
MAIN RESULTS
We found no parallel-group randomised controlled trials comparing BtA and placebo in HFS.
AUTHORS' CONCLUSIONS
We did not find any randomised trials that evaluated the efficacy and safety of botulinum toxin type A in people with hemifacial spasm, so we are unable to draw any conclusions. Observational data show a strong association between BtA treatment and symptom improvement, and a favourable safety profile. While it is unlikely that future placebo-controlled RCTs will evaluate absolute efficacy and safety, they should address relevant questions for both people with HFS (such as long-term effects, quality of life, and other patient-reported outcomes), and clinicians (such as relative effectiveness of different BtA formulations and schemes of treatment) to better guide clinical practice.).

Identifiants

pubmed: 33211908
doi: 10.1002/14651858.CD004899.pub3
pmc: PMC8078498
doi:

Substances chimiques

Neuromuscular Agents 0
Placebos 0
Botulinum Toxins, Type A EC 3.4.24.69

Types de publication

Journal Article Research Support, Non-U.S. Gov't Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

CD004899

Subventions

Organisme : Department of Health
ID : 16/114/26
Pays : United Kingdom

Commentaires et corrections

Type : UpdateOf

Informations de copyright

Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Auteurs

Gonçalo S Duarte (GS)

Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.
Instituto de Medicina Molecular João Lobo Antunes, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.

Filipe B Rodrigues (FB)

Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.
Instituto de Medicina Molecular João Lobo Antunes, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.

Mafalda Castelão (M)

Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.
Instituto de Medicina Molecular João Lobo Antunes, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.

Raquel E Marques (RE)

Instituto de Medicina Molecular João Lobo Antunes, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.
Ophthalmology University Clinic, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.

Joaquim Ferreira (J)

Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.
Instituto de Medicina Molecular João Lobo Antunes, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.

Cristina Sampaio (C)

CHDI Foundation, Princeton, NJ, USA.

Austen P Moore (AP)

The Walton Centre NHS Foundation Trust, Liverpool, UK.

João Costa (J)

Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.
Instituto de Medicina Molecular João Lobo Antunes, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.

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Classifications MeSH