机构:[1]The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine and Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China,广东省中医院[2]The China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia
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' preferences and concerns, and clinicians' 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' preferences and matters relevant to clinical decision making.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's 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.This study will provide comprehensive evidence of CHM for migraine in the context of evidence-based practice.ChiCTR2000041003.
基金:
This study was funded by Guangzhou
University of Chinese Medicine “Double First-
Class” and High-level University Discipline Collaborative Innovation Team in the form of a
grant to JBS (No.2021xk84). The study was also
funded by China-Australia International Research
Centre for Chinese Medicine (CAIRCCM)-a joint
initiative of RMIT University, Australia and the
Guangdong Provincial Academy of Chinese
Medical Sciences, China in the form of a grant to
XFG.
第一作者机构:[1]The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine and Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China,[2]The China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia
共同第一作者:
通讯作者:
通讯机构:[1]The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine and Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China,[2]The China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia
推荐引用方式(GB/T 7714):
Lyu Shaohua,Zhang Claire Shuiqing,Zhang Anthony Lin,et al.Migraine patients visiting Chinese medicine hospital: Protocol for a prospective, registry-based, real-world observational cohort study.[J].PLOS ONE.2022,17(3):doi:10.1371/journal.pone.0265137.
APA:
Lyu Shaohua,Zhang Claire Shuiqing,Zhang Anthony Lin,Sun Jingbo,Xue Charlie Changli&Guo Xinfeng.(2022).Migraine patients visiting Chinese medicine hospital: Protocol for a prospective, registry-based, real-world observational cohort study..PLOS ONE,17,(3)
MLA:
Lyu Shaohua,et al."Migraine patients visiting Chinese medicine hospital: Protocol for a prospective, registry-based, real-world observational cohort study.".PLOS ONE 17..3(2022)