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口服中药治疗偏头痛的疗效与安全性:一项使用稳健方差估计模型的系统评价与荟萃分析

Efficacy and Safety of Oral Chinese Herbal Medicine for Migraine: A Systematic Review and Meta-Analyses Using Robust Variance Estimation Model.

作者信息

Lyu Shaohua, Zhang Claire Shuiqing, Guo Xinfeng, Zhang Anthony Lin, Sun Jingbo, Chen Genghang, Xue Charlie Changli, Luo Xiaodong

机构信息

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.

The China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Melbourne, VIC, Australia.

出版信息

Front Neurol. 2022 Jul 6;13:889336. doi: 10.3389/fneur.2022.889336. eCollection 2022.

DOI:10.3389/fneur.2022.889336
PMID:35873759
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9296769/
Abstract

BACKGROUND

Migraine is a prevalent headache disorder with significant impacts on patients' quality of life and economic burden. Chinese herbal medicine (CHM) is commonly prescribed for migraine in China. This review aimed to provide a rigorous evaluation of evidence on the efficacy of oral CHM for migraine and explore the correlation between its effect size and treatment duration.

METHODS

We searched nine digital databases (PubMed, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, AMED, BioMedical Literature, CNKI, CQVIP, and Wanfang Data) from their inceptions to May 2021, with the language being restricted to Chinese and English. Randomized, placebo-controlled trials using oral CHM to treat adult migraine were included. Data screening and extraction were conducted by two independent reviewers. The methodological quality of randomized controlled trials (RCTs) was assessed using the Cochrane Risk of Bias tool. Meta-analyses were conducted to estimate the effect size using a random effect model, and a robust variance estimation (RVE) model was constructed to explore the correlation between treatment effects and treatment duration. The certainty of the evidence was assessed with the Grading of Recommendations Assessment, Development, and Evaluation. Publication bias was tested using a funnel plot and Egger's test.

RESULTS

A total of 18 RCTs involving 3,015 participants were included. Results of the meta-analyses showed that, at the end of the treatment phase, CHM was more efficacious than placebo in reducing migraine frequency, migraine days, and pain severity, and increasing response rate. Additionally, CHM showed superior effects to placebo in lowering migraine frequency and pain severity at the end of the 4-week follow-up. The RVE model suggested that the benefits of CHM for migraine frequency and pain intensity increased as treatment duration extended. The number of adverse events reported by the CHM and placebo groups was comparable. The certainty of the evidence was graded as "moderate." No publication bias was detected.

CONCLUSION

Oral CHM appeared to be more efficacious than placebo for reducing migraine frequency and pain severity. Greater treatment effects were associated with longer treatment duration. The oral CHM was well tolerated.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/prospero/#recordDetails, identifier: CRD42021270719.

摘要

背景

偏头痛是一种常见的头痛疾病,对患者的生活质量和经济负担有重大影响。在中国,中药常用于治疗偏头痛。本综述旨在对口服中药治疗偏头痛的疗效证据进行严格评估,并探讨其效应大小与治疗持续时间之间的相关性。

方法

我们检索了九个数字数据库(PubMed、EMBASE、CINAHL、Cochrane对照试验中心注册库、AMED、生物医学文献数据库、中国知网、维普资讯和万方数据),检索时间从建库至2021年5月,语言限制为中文和英文。纳入使用口服中药治疗成人偏头痛的随机、安慰剂对照试验。由两名独立的评审员进行数据筛选和提取。使用Cochrane偏倚风险工具评估随机对照试验(RCT)的方法学质量。采用随机效应模型进行荟萃分析以估计效应大小,并构建稳健方差估计(RVE)模型以探讨治疗效果与治疗持续时间之间的相关性。使用推荐分级评估、制定和评价方法评估证据的确定性。使用漏斗图和Egger检验检测发表偏倚。

结果

共纳入18项RCT,涉及3015名参与者。荟萃分析结果显示,在治疗阶段结束时,中药在降低偏头痛发作频率、偏头痛天数和疼痛严重程度以及提高缓解率方面比安慰剂更有效。此外,在4周随访结束时,中药在降低偏头痛发作频率和疼痛严重程度方面显示出比安慰剂更好的效果。RVE模型表明,中药对偏头痛发作频率和疼痛强度的益处随着治疗持续时间的延长而增加。中药组和安慰剂组报告的不良事件数量相当。证据的确定性等级为“中等”。未检测到发表偏倚。

结论

口服中药在降低偏头痛发作频率和疼痛严重程度方面似乎比安慰剂更有效。治疗效果越好与治疗持续时间越长相关。口服中药耐受性良好。

系统评价注册

https://www.crd.york.ac.uk/prospero/#recordDetails,标识符:CRD42021270719。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24ed/9296769/56a6ac1d5a48/fneur-13-889336-g0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24ed/9296769/1a6cae3739a5/fneur-13-889336-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24ed/9296769/2f1257623fdf/fneur-13-889336-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24ed/9296769/b864ce4ffa38/fneur-13-889336-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24ed/9296769/deca32434dcf/fneur-13-889336-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24ed/9296769/56a6ac1d5a48/fneur-13-889336-g0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24ed/9296769/1a6cae3739a5/fneur-13-889336-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24ed/9296769/2f1257623fdf/fneur-13-889336-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24ed/9296769/b864ce4ffa38/fneur-13-889336-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24ed/9296769/deca32434dcf/fneur-13-889336-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24ed/9296769/56a6ac1d5a48/fneur-13-889336-g0005.jpg

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