Neuromodulation techniques for acute and preventive migraine treatment: a systematic review and meta-analysis of randomized controlled trials

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Abstract

Background

Several neuromodulation methods exists for migraine treatment. The aim of the present study was to perform a systematic review and meta-analysis of randomized controlled trials (RCTs) focusing on migraine treatment using neurostimulation methods.

Methods

We searched Medline and Embase up to July 1, 2020 for RCTs reporting acute or preventive treatment of migraine with either non-invasive or invasive neurostimulation methods. Two researchers independently assessed the eligibility of the retrieved studies and extracted data. Outcomes for the quantitative synthesis were 2 h pain free for acute treatment and headache days per month for preventive treatment. We performed subgroup analyses by treatment (stimulation method and site of application). Estimates were pooled using random-effects meta-analysis.

Results

Thirty-eight articles were included in the qualitative analysis (7 acute, 31 preventive) and 34 in the quantitative evaluation (6 acute, 28 preventive). Remote electrical neuromodulation (REN) was effective for acute treatment. Data were insufficient to draw conclusions for any other techniques (single studies). Invasive occipital nerve stimulation (ONS) was effective for migraine prevention, with a large effect size but considerable heterogeneity, whereas supra-orbital transcutaneous electrical nerve stimulation (TENS), percutaneous electrical nerve stimulation (PENS), and high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex (M1) were effective, with small to medium effect sizes. Vagus-nerve stimulation, left prefrontal cortex rTMS, and cathodal transcranial direct current stimulation (tDCS) over the M1 had no significant effect and heterogeneity was high.

Conclusion

Several neuromodulation methods are of potential interest for migraine management, but the quality of the evidence is very poor. Future large and well-conducted studies are needed and could improve on the present results.

Supplementary Information

The online version contains supplementary material available at 10.1186/s10194-020-01204-4.

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Most cited references 65

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Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement

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David Moher and colleagues introduce PRISMA, an update of the QUOROM guidelines for reporting systematic reviews and meta-analyses

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Is Open Access

Estimating the mean and variance from the median, range, and the size of a sample

Stela Pudar Hozo, Benjamin Djulbegovic, Iztok Hozo (2005)

Background Usually the researchers performing meta-analysis of continuous outcomes from clinical trials need their mean value and the variance (or standard deviation) in order to pool data. However, sometimes the published reports of clinical trials only report the median, range and the size of the trial. Methods In this article we use simple and elementary inequalities and approximations in order to estimate the mean and the variance for such trials. Our estimation is distribution-free, i.e., it makes no assumption on the distribution of the underlying data. Results We found two simple formulas that estimate the mean using the values of the median (m), low and high end of the range (a and b, respectively), and n (the sample size). Using simulations, we show that median can be used to estimate mean when the sample size is larger than 25. For smaller samples our new formula, devised in this paper, should be used. We also estimated the variance of an unknown sample using the median, low and high end of the range, and the sample size. Our estimate is performing as the best estimate in our simulations for very small samples (n ≤ 15). For moderately sized samples (15 70), the formula range/6 gives the best estimator for the standard deviation (variance). We also include an illustrative example of the potential value of our method using reports from the Cochrane review on the role of erythropoietin in anemia due to malignancy. Conclusion Using these formulas, we hope to help meta-analysts use clinical trials in their analysis even when not all of the information is available and/or reported.

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Author and article information

Contributors

Xavier Moisset:

ORCID: http://orcid.org/0000-0002-8799-0750

xavier.moisset@gmail.com

Journal

Journal ID (nlm-ta): J Headache Pain

Journal ID (iso-abbrev): J Headache Pain

Title: The Journal of Headache and Pain

Publisher: Springer Milan (Milan )

ISSN (Print): 1129-2369

ISSN (Electronic): 1129-2377

Publication date (Electronic): 10 December 2020

Publication date PMC-release: 10 December 2020

Publication date Collection: 2020

Volume: 21

Issue: 1

Electronic Location Identifier: 142

Affiliations

[1 ]GRID grid.411163.0, ISNI 0000 0004 0639 4151, Service de Neurologie, , Biostatistics unit (DRCI), Université Clermont Auvergne, CHU de Clermont-Ferrand, Inserm, Neuro-Dol, ; 58 rue Montalembert, F-63000 Clermont-Ferrand, France

[2 ]GRID grid.11899.38, ISNI 0000 0004 1937 0722, Department of Neurology, LIM 62 Pain Center, , Universidade de São Paulo, ; São Paulo, Brazil

[3 ]GRID grid.410528.a, ISNI 0000 0001 2322 4179, Department of Neurosurgery, , Université Côte Azur, FHU InovPain, CHU Nice, ; Nice, France

[4 ]GRID grid.410528.a, ISNI 0000 0001 2322 4179, Pain Department, Université Côte Azur, FHU InovPain, CHU Nice, Nice, France– Université Clermont-Auvergne, INSERM, Neuro-Dol, ; Nice, France

[5 ]GRID grid.50550.35, ISNI 0000 0001 2175 4109, Emergency Headache Center (Centre d’Urgences Céphalées), Department of Neurology, Lariboisière Hospital, , Assistance Publique des Hôpitaux de Paris, ; Paris, France

Author information

Xavier Moisset http://orcid.org/0000-0002-8799-0750

Article

Publisher ID: 1204

DOI: 10.1186/s10194-020-01204-4

PMC ID: 7726868

PubMed ID: 33302882

SO-VID: 57835ddf-781f-411a-9775-71b135eb5be7

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 30 September 2020

Date accepted : 18 November 2020

Custom metadata

ScienceOpen disciplines: Anesthesiology & Pain management

Keywords: neurostimulation,remote electrical neuromodulation,occipital nerve stimulation,transcutaneous electrical nerve stimulation,percutaneous electrical nerve stimulation (pens),repetitive transcranial magnetic stimulation,vagus-nerve stimulation ,transcranial direct current stimulation

Data availability:

ScienceOpen disciplines: Anesthesiology & Pain management

Keywords: neurostimulation, remote electrical neuromodulation, occipital nerve stimulation, transcutaneous electrical nerve stimulation, percutaneous electrical nerve stimulation (pens), repetitive transcranial magnetic stimulation, vagus-nerve stimulation , transcranial direct current stimulation

Neuromodulation techniques for acute and preventive migraine treatment: a systematic review and meta-analysis of randomized controlled trials

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Abstract

Background

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Conclusion

Supplementary Information

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Irish Journal of Paramedicine

Most cited references 65

Measuring inconsistency in meta-analyses.

Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement

Estimating the mean and variance from the median, range, and the size of a sample

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