Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A meta-analysis.
Episodic cluster headache
acute treatment
chronic cluster headache
meta-analysis
neuromodulation
non-invasive vagus nerve stimulation
Journal
Cephalalgia : an international journal of headache
ISSN: 1468-2982
Titre abrégé: Cephalalgia
Pays: England
ID NLM: 8200710
Informations de publication
Date de publication:
Jul 2019
Jul 2019
Historique:
entrez:
28
6
2019
pubmed:
28
6
2019
medline:
24
10
2020
Statut:
ppublish
Résumé
Two randomized, double-blind, sham-controlled trials (ACT1, ACT2) evaluated non-invasive vagus nerve stimulation (nVNS) as acute treatment for cluster headache. We analyzed pooled ACT1/ACT2 data to increase statistical power and gain insight into the differential efficacy of nVNS in episodic and chronic cluster headache. Data extracted from ACT1 and ACT2 were pooled using a fixed-effects model. Main outcome measures were the primary endpoints of each study. This was the proportion of participants whose first treated attack improved from moderate (2), severe (3), or very severe (4) pain intensity to mild (1) or nil (0) for ACT1 and the proportion of treated attacks whose pain intensity improved from 2-4 to 0 for ACT2. The pooled population included 225 participants (episodic: n = 112; chronic: n = 113) from ACT1 (n = 133) and ACT2 (n = 92) in the nVNS (n = 108) and sham (n = 117) groups. Interaction was shown between treatment group and cluster headache subtype ( nVNS is a well-tolerated and effective acute treatment for episodic cluster headache. The studies were registered at clinicaltrials.gov (ACT1: NCT01792817; ACT2: NCT01958125).
Sections du résumé
BACKGROUND
BACKGROUND
Two randomized, double-blind, sham-controlled trials (ACT1, ACT2) evaluated non-invasive vagus nerve stimulation (nVNS) as acute treatment for cluster headache. We analyzed pooled ACT1/ACT2 data to increase statistical power and gain insight into the differential efficacy of nVNS in episodic and chronic cluster headache.
METHODS
METHODS
Data extracted from ACT1 and ACT2 were pooled using a fixed-effects model. Main outcome measures were the primary endpoints of each study. This was the proportion of participants whose first treated attack improved from moderate (2), severe (3), or very severe (4) pain intensity to mild (1) or nil (0) for ACT1 and the proportion of treated attacks whose pain intensity improved from 2-4 to 0 for ACT2.
RESULTS
RESULTS
The pooled population included 225 participants (episodic: n = 112; chronic: n = 113) from ACT1 (n = 133) and ACT2 (n = 92) in the nVNS (n = 108) and sham (n = 117) groups. Interaction was shown between treatment group and cluster headache subtype (
CONCLUSIONS
CONCLUSIONS
nVNS is a well-tolerated and effective acute treatment for episodic cluster headache.
TRIAL REGISTRATION
BACKGROUND
The studies were registered at clinicaltrials.gov (ACT1: NCT01792817; ACT2: NCT01958125).
Identifiants
pubmed: 31246132
doi: 10.1177/0333102419856607
pmc: PMC6637721
doi:
Banques de données
ClinicalTrials.gov
['NCT01792817', 'NCT01958125']
Types de publication
Journal Article
Meta-Analysis
Langues
eng
Sous-ensembles de citation
IM
Pagination
967-977Commentaires et corrections
Type : CommentIn
Références
Neurology. 2000 May 9;54(9):1832-9
pubmed: 10802793
Cephalalgia. 2000 Nov;20(9):826-9
pubmed: 11167912
Neurology. 2003 Feb 25;60(4):630-3
pubmed: 12601104
Neurosci Lett. 2003 Nov 13;351(2):79-82
pubmed: 14583386
Headache. 2004 May;44(5):414-25
pubmed: 15147249
Lancet. 2005 Sep 3-9;366(9488):843-55
pubmed: 16139660
Neurology. 2006 Jul 11;67(1):109-13
pubmed: 16832088
Arch Neurol. 2006 Nov;63(11):1537-42
pubmed: 16966497
Neurology. 2007 Aug 28;69(9):821-6
pubmed: 17724283
JAMA. 2009 Dec 9;302(22):2451-7
pubmed: 19996400
Cephalalgia. 2010 Dec;30(12):1531-4
pubmed: 20974600
BMJ. 2012 Apr 11;344:e2407
pubmed: 22496300
Cephalalgia. 2013 Jul;33(9):629-808
pubmed: 23771276
Nat Rev Neurol. 2014 Mar;10(3):144-55
pubmed: 24535465
Curr Pain Headache Rep. 2014 May;18(5):415
pubmed: 24671392
Neuroimage Clin. 2014 Oct 18;6:415-23
pubmed: 25379455
J Headache Pain. 2014 Nov 27;15:79
pubmed: 25430992
Cephalalgia. 2016 May;36(6):534-46
pubmed: 26391457
Cephalalgia. 2017 Feb;37(2):148-153
pubmed: 27009563
J Headache Pain. 2016;17:44
pubmed: 27102121
Cephalalgia. 2017 Aug;37(9):873-880
pubmed: 27313215
Headache. 2016 Sep;56(8):1317-32
pubmed: 27593728
Brain Stimul. 2017 Jan - Feb;10(1):19-27
pubmed: 28104084
Neurobiol Dis. 2017 Jun;102:96-104
pubmed: 28286178
Cephalalgia. 2018 Apr;38(5):959-969
pubmed: 29231763
Ann Neurol. 2018 Dec;84(6):886-892
pubmed: 30362165
Neurology. 2019 Jul 30;93(5):e518-e521
pubmed: 31243069
Acta Neurol Scand. 1993 Jul;88(1):63-9
pubmed: 8396833