{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T01:12:16Z","timestamp":1788916336843,"version":"build-2803163510"},"reference-count":64,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2022,3,15]],"date-time":"2022-03-15T00:00:00Z","timestamp":1647302400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100010618","name":"Guangzhou University of Chinese Medicine","doi-asserted-by":"publisher","award":["2021xk84"],"award-info":[{"award-number":["2021xk84"]}],"id":[{"id":"10.13039\/501100010618","id-type":"DOI","asserted-by":"publisher"}]},{"name":"China-Australia International Research Centre for Chinese Medicine"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\"><jats:title>Introduction<\/jats:title><jats:p>Migraine is a disabling, recurrent headache disorder with complex comorbidities. Conventional treatments for migraine are unsatisfactory, with side effects and limited effectiveness. Chinese herbal medicine (CHM) has been used as an alternative or complementary treatment option for migraine in China. Currently, the existing evidence of benefit of CHM for migraine has been generated from randomised clinical trials using standardised intervention with a focus on internal validity hence with limited external validity. Moreover, CHM individualised intervention design, patients\u2019 preferences and concerns, and clinicians\u2019 experience are critical to clinical decision making and therapeutic success. This real-world observational study aims to gather practice-based evidence of effects and safety of CHM for migraine in the context of integrating Chinese medicine diagnostic procedures, patients\u2019 preferences and matters relevant to clinical decision making.<\/jats:p><\/jats:sec><jats:sec id=\"sec002\"><jats:title>Methods and analysis<\/jats:title><jats:p>The study is being undertaken at the Guangdong Provincial Hospital of Chinese Medicine (GPHCM) from December 2020 to May 2022. We anticipate that approximately 400 adult migraineurs will be enrolled and observed on their migraine severity, analgesic consumption, quality of life, anxiety, depression and insomnia at baseline and then every four weeks over 12 weeks. Treatments, diagnostic information, and patient-reported most bothersome symptoms will be collected from patient clinical records. Patient\u2019s demographic data, preferences and concerns on CHM treatments will also be gathered at baseline and be analysed. Factors related to clinical outcomes will be explored with multiple correlation and multivariable regression analyses. Effects of CHM will be evaluated using generalised estimated equation, based on clinical outcome data.<\/jats:p><\/jats:sec><jats:sec id=\"sec003\"><jats:title>Discussion<\/jats:title><jats:p>This study will provide comprehensive evidence of CHM for migraine in the context of evidence-based practice.<\/jats:p><\/jats:sec><jats:sec id=\"sec004\"><jats:title>Trial registration number<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.chictr.org.cn\/searchprojen.aspx?regno=ChiCTR2000041003\" xlink:type=\"simple\">ChiCTR2000041003<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1371\/journal.pone.0265137","type":"journal-article","created":{"date-parts":[[2022,3,15]],"date-time":"2022-03-15T17:37:14Z","timestamp":1647365834000},"page":"e0265137","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":3,"title":["Migraine patients visiting Chinese medicine hospital: Protocol for a prospective, registry-based, real-world observational cohort study"],"prefix":"10.1371","volume":"17","author":[{"given":"Shaohua","family":"Lyu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire Shuiqing","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony Lin","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingbo","family":"Sun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6937-9088","authenticated-orcid":true,"given":"Charlie Changli","family":"Xue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2699-9740","authenticated-orcid":true,"given":"Xinfeng","family":"Guo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2022,3,15]]},"reference":[{"issue":"1","key":"pone.0265137.ref001","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1177\/0333102417738202","article-title":"The International Classification of Headache Disorders 3rd edition","volume":"38","author":"Headache Classification Committee of the International Headache Society (IHS)","year":"2018","journal-title":"Cephalalgia"},{"issue":"11","key":"pone.0265137.ref002","doi-asserted-by":"crossref","first-page":"954","DOI":"10.1016\/S1474-4422(18)30322-3","article-title":"Global, regional, and national burden of migraine and tension-type headache, 1990\u20132016: a systematic analysis for the Global Burden of Disease Study 2016","volume":"17","year":"2018","journal-title":"The Lancet Neurology"},{"issue":"1","key":"pone.0265137.ref003","doi-asserted-by":"crossref","first-page":"102","DOI":"10.1186\/s10194-019-1048-2","article-title":"Burden of headache disorders in China, 1990\u20132017: findings from the Global Burden of Disease Study 2017","volume":"20","author":"C Yao","year":"2019","journal-title":"J Headache Pain"},{"issue":"8","key":"pone.0265137.ref004","doi-asserted-by":"crossref","first-page":"1157","DOI":"10.1111\/j.1526-4610.2008.01217.x","article-title":"Acute Migraine Medications and Evolution From Episodic to Chronic Migraine: A Longitudinal Population-Based Study.","volume":"48","author":"ME Bigal","year":"2008","journal-title":"Headache: The Journal of Head and Face Pain"},{"issue":"7","key":"pone.0265137.ref005","doi-asserted-by":"crossref","first-page":"679","DOI":"10.1177\/0333102416638520","article-title":"Genetic epidemiology of migraine and depression","volume":"36","author":"Y Yang","year":"2016","journal-title":"Cephalalgia: an international journal of headache"},{"issue":"5","key":"pone.0265137.ref006","doi-asserted-by":"crossref","first-page":"504","DOI":"10.1080\/09540261.2017.1326882","article-title":"Depression comorbidity in migraine","volume":"29","author":"F. 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