Cochrane systematic review and meta-analysis of botulinum toxin for the prevention of migraine

Objectives To assess the effects of botulinum toxin for prevention of migraine in adults.Design Systematic review and meta-analysis.Data sources CENTRAL, MEDLINE, Embase and trial registries.Eligibility criteria We included randomised controlled trials (RCTs) of botulinum toxin compared with placebo...

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Main Authors: Clare P Herd, Julie Edwards, Natalie J Ives, AJ Sinclair, Claire L Tomlinson, Caroline Rick, William J Scotton, Carl E Clarke
Format: Article
Language:English
Published: BMJ Publishing Group 2019-07-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/7/e027953.full
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author Clare P Herd
Julie Edwards
Natalie J Ives
AJ Sinclair
Claire L Tomlinson
Caroline Rick
William J Scotton
Carl E Clarke
author_facet Clare P Herd
Julie Edwards
Natalie J Ives
AJ Sinclair
Claire L Tomlinson
Caroline Rick
William J Scotton
Carl E Clarke
author_sort Clare P Herd
collection DOAJ
description Objectives To assess the effects of botulinum toxin for prevention of migraine in adults.Design Systematic review and meta-analysis.Data sources CENTRAL, MEDLINE, Embase and trial registries.Eligibility criteria We included randomised controlled trials (RCTs) of botulinum toxin compared with placebo, active treatment or clinically relevant different dose for adults with chronic or episodic migraine, with or without the additional diagnosis of medication overuse headache.Data extraction and synthesis Cochrane methods were used to review double-blind RCTs. Twelve week post-treatment time-point data was analysed.Results Twenty-eight trials (n=4190) were included. Trial quality was mixed. Botulinum toxin treatment resulted in reduced frequency of −2.0 migraine days/month (95% CI −2.8 to −1.1, n=1384) in chronic migraineurs compared with placebo. An improvement was seen in migraine severity, measured on a numerical rating scale 0 to 10 with 10 being maximal pain, of −2.70 cm (95% CI −3.31 to −2.09, n=75) and −4.9 cm (95% CI −6.56 to −3.24, n=32) for chronic and episodic migraine respectively. Botulinum toxin had a relative risk of treatment related adverse events twice that of placebo, but a reduced risk compared with active comparators (relative risk 0.76, 95% CI 0.59 to 0.98) and a low withdrawal rate (3%). Although individual trials reported non-inferiority to oral treatments, insufficient data were available for meta-analysis of effectiveness outcomes.Conclusions In chronic migraine, botulinum toxin reduces migraine frequency by 2 days/month and has a favourable safety profile. Inclusion of medication overuse headache does not preclude its effectiveness. Evidence to support or refute efficacy in episodic migraine was not identified.
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spelling doaj-art-4cafcd1cddbc4aae839555b1da374dfb2025-08-20T02:28:01ZengBMJ Publishing GroupBMJ Open2044-60552019-07-019710.1136/bmjopen-2018-027953Cochrane systematic review and meta-analysis of botulinum toxin for the prevention of migraineClare P Herd0Julie Edwards1Natalie J Ives2AJ Sinclair3Claire L Tomlinson4Caroline Rick5William J Scotton6Carl E Clarke71 Institute of Applied Health Research, University of Birmingham, Birmingham, UK5 Sandwell and West Birmingham Hospitals NHS Trust, Department of Neurology, Birmingham, Birmingham, UKBirmingham Clinical Trials Unit (BCTU), Institute of Applied Health Research, University of Birmingham, Birmingham, UK4 University of Birmingham, Institute of Metabolism and Systems Research, Birmingham, UK2 BCTU, University of Birmingham, Birmingham, UKBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK4 University of Birmingham, Institute of Metabolism and Systems Research, Birmingham, UKprofessor of clinical neurology and honorary consultant neurologistObjectives To assess the effects of botulinum toxin for prevention of migraine in adults.Design Systematic review and meta-analysis.Data sources CENTRAL, MEDLINE, Embase and trial registries.Eligibility criteria We included randomised controlled trials (RCTs) of botulinum toxin compared with placebo, active treatment or clinically relevant different dose for adults with chronic or episodic migraine, with or without the additional diagnosis of medication overuse headache.Data extraction and synthesis Cochrane methods were used to review double-blind RCTs. Twelve week post-treatment time-point data was analysed.Results Twenty-eight trials (n=4190) were included. Trial quality was mixed. Botulinum toxin treatment resulted in reduced frequency of −2.0 migraine days/month (95% CI −2.8 to −1.1, n=1384) in chronic migraineurs compared with placebo. An improvement was seen in migraine severity, measured on a numerical rating scale 0 to 10 with 10 being maximal pain, of −2.70 cm (95% CI −3.31 to −2.09, n=75) and −4.9 cm (95% CI −6.56 to −3.24, n=32) for chronic and episodic migraine respectively. Botulinum toxin had a relative risk of treatment related adverse events twice that of placebo, but a reduced risk compared with active comparators (relative risk 0.76, 95% CI 0.59 to 0.98) and a low withdrawal rate (3%). Although individual trials reported non-inferiority to oral treatments, insufficient data were available for meta-analysis of effectiveness outcomes.Conclusions In chronic migraine, botulinum toxin reduces migraine frequency by 2 days/month and has a favourable safety profile. Inclusion of medication overuse headache does not preclude its effectiveness. Evidence to support or refute efficacy in episodic migraine was not identified.https://bmjopen.bmj.com/content/9/7/e027953.full
spellingShingle Clare P Herd
Julie Edwards
Natalie J Ives
AJ Sinclair
Claire L Tomlinson
Caroline Rick
William J Scotton
Carl E Clarke
Cochrane systematic review and meta-analysis of botulinum toxin for the prevention of migraine
BMJ Open
title Cochrane systematic review and meta-analysis of botulinum toxin for the prevention of migraine
title_full Cochrane systematic review and meta-analysis of botulinum toxin for the prevention of migraine
title_fullStr Cochrane systematic review and meta-analysis of botulinum toxin for the prevention of migraine
title_full_unstemmed Cochrane systematic review and meta-analysis of botulinum toxin for the prevention of migraine
title_short Cochrane systematic review and meta-analysis of botulinum toxin for the prevention of migraine
title_sort cochrane systematic review and meta analysis of botulinum toxin for the prevention of migraine
url https://bmjopen.bmj.com/content/9/7/e027953.full
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