Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A meta-analysis

Ilse F. de Coo, Juana C.A. Marin, Stephen D. Silberstein, Deborah I Friedman, Charly Gaul, Candace K. McClure, Alok Tyagi, Eric Liebler, Stewart J. Tepper, Michel D. Ferrari, Peter J. Goadsby

Research output: Contribution to journalArticle

Abstract

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: 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: 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 (p < 0.05). nVNS was superior to sham in episodic but not chronic cluster headache (both endpoints p < 0.01). Only four patients discontinued the studies due to adverse events. Conclusions: nVNS is a well-tolerated and effective acute treatment for episodic cluster headache. Trial registration: The studies were registered at clinicaltrials.gov (ACT1: NCT01792817; ACT2: NCT01958125).

Original languageEnglish (US)
Pages (from-to)967-977
Number of pages11
JournalCephalalgia
Volume39
Issue number8
DOIs
StatePublished - Jul 1 2019

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Vagus Nerve Stimulation
Cluster Headache
Meta-Analysis
Therapeutics
Pain
Outcome Assessment (Health Care)
Population

Keywords

  • acute treatment
  • chronic cluster headache
  • Episodic cluster headache
  • meta-analysis
  • neuromodulation
  • non-invasive vagus nerve stimulation

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache : A meta-analysis. / de Coo, Ilse F.; Marin, Juana C.A.; Silberstein, Stephen D.; Friedman, Deborah I; Gaul, Charly; McClure, Candace K.; Tyagi, Alok; Liebler, Eric; Tepper, Stewart J.; Ferrari, Michel D.; Goadsby, Peter J.

In: Cephalalgia, Vol. 39, No. 8, 01.07.2019, p. 967-977.

Research output: Contribution to journalArticle

de Coo, IF, Marin, JCA, Silberstein, SD, Friedman, DI, Gaul, C, McClure, CK, Tyagi, A, Liebler, E, Tepper, SJ, Ferrari, MD & Goadsby, PJ 2019, 'Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A meta-analysis', Cephalalgia, vol. 39, no. 8, pp. 967-977. https://doi.org/10.1177/0333102419856607
de Coo, Ilse F. ; Marin, Juana C.A. ; Silberstein, Stephen D. ; Friedman, Deborah I ; Gaul, Charly ; McClure, Candace K. ; Tyagi, Alok ; Liebler, Eric ; Tepper, Stewart J. ; Ferrari, Michel D. ; Goadsby, Peter J. / Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache : A meta-analysis. In: Cephalalgia. 2019 ; Vol. 39, No. 8. pp. 967-977.
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T1 - Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache

T2 - A meta-analysis

AU - de Coo, Ilse F.

AU - Marin, Juana C.A.

AU - Silberstein, Stephen D.

AU - Friedman, Deborah I

AU - Gaul, Charly

AU - McClure, Candace K.

AU - Tyagi, Alok

AU - Liebler, Eric

AU - Tepper, Stewart J.

AU - Ferrari, Michel D.

AU - Goadsby, Peter J.

PY - 2019/7/1

Y1 - 2019/7/1

N2 - 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: 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: 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 (p < 0.05). nVNS was superior to sham in episodic but not chronic cluster headache (both endpoints p < 0.01). Only four patients discontinued the studies due to adverse events. Conclusions: nVNS is a well-tolerated and effective acute treatment for episodic cluster headache. Trial registration: The studies were registered at clinicaltrials.gov (ACT1: NCT01792817; ACT2: NCT01958125).

AB - 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: 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: 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 (p < 0.05). nVNS was superior to sham in episodic but not chronic cluster headache (both endpoints p < 0.01). Only four patients discontinued the studies due to adverse events. Conclusions: nVNS is a well-tolerated and effective acute treatment for episodic cluster headache. Trial registration: The studies were registered at clinicaltrials.gov (ACT1: NCT01792817; ACT2: NCT01958125).

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KW - meta-analysis

KW - neuromodulation

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