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Comparison of Effects and Brain-Gut Regulatory Mechanisms of Acupuncture and Flunarizine for Migraine: Study Protocol for a Randomized Controlled Trial

BACKGROUND: As a central nervous system disease, migraine often coexists with gastrointestinal disorders, which suggests a disruption of brain-gut regulation. Clinical studies have confirmed that acupuncture and flunarizine not only alleviate migraine attacks but also substantially inhibit accompany...

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Autores principales: Wang, Ya-Nan, Sun, Ming-Sheng, Ni, Xi-Xiu, Tian, Tian, Liu, Lu, Li, Xiao, Xu, Tao, Zhou, Si-Yuan, Chen, Jiao, Liang, Fan-Rong, Liu, Ji-Xin, Zhao, Ling
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7810526/
https://www.ncbi.nlm.nih.gov/pubmed/33505495
http://dx.doi.org/10.1155/2021/5676718
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author Wang, Ya-Nan
Sun, Ming-Sheng
Ni, Xi-Xiu
Tian, Tian
Liu, Lu
Li, Xiao
Xu, Tao
Zhou, Si-Yuan
Chen, Jiao
Liang, Fan-Rong
Liu, Ji-Xin
Zhao, Ling
author_facet Wang, Ya-Nan
Sun, Ming-Sheng
Ni, Xi-Xiu
Tian, Tian
Liu, Lu
Li, Xiao
Xu, Tao
Zhou, Si-Yuan
Chen, Jiao
Liang, Fan-Rong
Liu, Ji-Xin
Zhao, Ling
author_sort Wang, Ya-Nan
collection PubMed
description BACKGROUND: As a central nervous system disease, migraine often coexists with gastrointestinal disorders, which suggests a disruption of brain-gut regulation. Clinical studies have confirmed that acupuncture and flunarizine not only alleviate migraine attacks but also substantially inhibit accompanying gastrointestinal symptoms. However, it is still not clear how acupuncture and flunarizine regulate the interactions of brain, gut, and microbiome. Therefore, this study will combine neuroimaging technology and gut microbiota detection technology to explore and compare the effects and brain-gut modulating mechanisms of acupuncture and flunarizine for migraine. METHODS: This randomized clinical trial will recruit 66 patients with migraine without aura. Participants will be randomly assigned in a 1 : 1 ratio to an acupuncture group or a control group. The acupuncture treatment strategy is based on experience from our previous study and consensus meetings with clinical experts. Patients will receive 12 sessions of manual acupuncture treatment (once every other day to a total of three times per week, followed by a 2-day break). Flunarizine will be administered at a dose of 5 mg daily in the control group. Participants in both groups will receive treatment for a period of 4 weeks. The primary outcome is the change in frequency of migraine attacks, and the secondary outcomes include the changes in migraine days (days on which migraine attacks occurred), average migraine severity, gastrointestinal symptoms, psychiatric symptoms, and quality of life. Fresh stool samples will be collected, and 16S ribosomal RNA gene sequencing analysis will be used for gut microbiota. Magnetic resonance imaging will be applied to detect between-group changes in brain function. The abovementioned indicators will be collected at baseline, after a 4-week intervention, and at the 12-week follow-up. Discussions. From the perspective of brain-gut regulatory mechanisms, we will combine brain neuroimaging and gut microbiological data to partially reveal the similarities and differences of acupuncture and flunarizine on the treatment of migraine. The trial is registered with ChiCTR2000034417.
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spelling pubmed-78105262021-01-26 Comparison of Effects and Brain-Gut Regulatory Mechanisms of Acupuncture and Flunarizine for Migraine: Study Protocol for a Randomized Controlled Trial Wang, Ya-Nan Sun, Ming-Sheng Ni, Xi-Xiu Tian, Tian Liu, Lu Li, Xiao Xu, Tao Zhou, Si-Yuan Chen, Jiao Liang, Fan-Rong Liu, Ji-Xin Zhao, Ling Evid Based Complement Alternat Med Research Article BACKGROUND: As a central nervous system disease, migraine often coexists with gastrointestinal disorders, which suggests a disruption of brain-gut regulation. Clinical studies have confirmed that acupuncture and flunarizine not only alleviate migraine attacks but also substantially inhibit accompanying gastrointestinal symptoms. However, it is still not clear how acupuncture and flunarizine regulate the interactions of brain, gut, and microbiome. Therefore, this study will combine neuroimaging technology and gut microbiota detection technology to explore and compare the effects and brain-gut modulating mechanisms of acupuncture and flunarizine for migraine. METHODS: This randomized clinical trial will recruit 66 patients with migraine without aura. Participants will be randomly assigned in a 1 : 1 ratio to an acupuncture group or a control group. The acupuncture treatment strategy is based on experience from our previous study and consensus meetings with clinical experts. Patients will receive 12 sessions of manual acupuncture treatment (once every other day to a total of three times per week, followed by a 2-day break). Flunarizine will be administered at a dose of 5 mg daily in the control group. Participants in both groups will receive treatment for a period of 4 weeks. The primary outcome is the change in frequency of migraine attacks, and the secondary outcomes include the changes in migraine days (days on which migraine attacks occurred), average migraine severity, gastrointestinal symptoms, psychiatric symptoms, and quality of life. Fresh stool samples will be collected, and 16S ribosomal RNA gene sequencing analysis will be used for gut microbiota. Magnetic resonance imaging will be applied to detect between-group changes in brain function. The abovementioned indicators will be collected at baseline, after a 4-week intervention, and at the 12-week follow-up. Discussions. From the perspective of brain-gut regulatory mechanisms, we will combine brain neuroimaging and gut microbiological data to partially reveal the similarities and differences of acupuncture and flunarizine on the treatment of migraine. The trial is registered with ChiCTR2000034417. Hindawi 2021-01-07 /pmc/articles/PMC7810526/ /pubmed/33505495 http://dx.doi.org/10.1155/2021/5676718 Text en Copyright © 2021 Ya-Nan Wang et al. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Wang, Ya-Nan
Sun, Ming-Sheng
Ni, Xi-Xiu
Tian, Tian
Liu, Lu
Li, Xiao
Xu, Tao
Zhou, Si-Yuan
Chen, Jiao
Liang, Fan-Rong
Liu, Ji-Xin
Zhao, Ling
Comparison of Effects and Brain-Gut Regulatory Mechanisms of Acupuncture and Flunarizine for Migraine: Study Protocol for a Randomized Controlled Trial
title Comparison of Effects and Brain-Gut Regulatory Mechanisms of Acupuncture and Flunarizine for Migraine: Study Protocol for a Randomized Controlled Trial
title_full Comparison of Effects and Brain-Gut Regulatory Mechanisms of Acupuncture and Flunarizine for Migraine: Study Protocol for a Randomized Controlled Trial
title_fullStr Comparison of Effects and Brain-Gut Regulatory Mechanisms of Acupuncture and Flunarizine for Migraine: Study Protocol for a Randomized Controlled Trial
title_full_unstemmed Comparison of Effects and Brain-Gut Regulatory Mechanisms of Acupuncture and Flunarizine for Migraine: Study Protocol for a Randomized Controlled Trial
title_short Comparison of Effects and Brain-Gut Regulatory Mechanisms of Acupuncture and Flunarizine for Migraine: Study Protocol for a Randomized Controlled Trial
title_sort comparison of effects and brain-gut regulatory mechanisms of acupuncture and flunarizine for migraine: study protocol for a randomized controlled trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7810526/
https://www.ncbi.nlm.nih.gov/pubmed/33505495
http://dx.doi.org/10.1155/2021/5676718
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