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

Abstract

BackgroundMigraine 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.MethodsWe 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.ResultsA 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.ConclusionOral 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 Registrationhttps://www.crd.york.ac.uk/prospero/#recordDetails, identifier: CRD42021270719.

Real-world observations and impacts of Chinese herbal medicine for migraine: results of a registry-based cohort study

“…Furthermore, when administered for 28 days or more, CHM might lead to a more sustained effects in reducing peak pain NRS, compared to that when administered for less than 28 days. In summary, a longer CHM treatment duration is associated with a better treatment response, this is consistent with the conclusions from our previous systematic review ( Lyu et al, 2022a ).…”

“…Moreover, no severe AEs were reported in the current study. The safety profile of CHM for migraine, including the low rate of AEs and the prevailing occurrence of gastrointestinal discomforts, was consistent with our previous findings ( Lyu et al, 2020 ; Lyu et al, 2022a ).…”

“…The frequency analysis indicated that herbs gan cao , gui zhi , chuan xiong , fu ling , bai zhu , yan hu suo , ban xia , chen pi , bai shao and xiang fu , were widely utilised for migraine, which is similar to the findings of our previous research ( Lyu et al, 2020 ; Lyu et al, 2022a ; Lyu et al, 2022b ; Zhang et al, 2022 ). These herbs were reported to exhibit anti-migraine, anti-depression, neuroprotective, sedative-hypnotic and/or antiemetic actions, as summarised in Table 8 .…”

“…Moreover, CHM may effectively improve specific quality of life for the migraine patients, regardless of the treatment duration. The beneficial effects of CHM in improving patients' quality of life were also reported in our previous systematic reviews for migraines (Lyu et al, 2020;Lyu et al, 2022a), and for other conditions, such as atopic dermatitis, cancer, perimenopausal women, etc. (Hon et al, 2007;Chan et al, 2011;Xia et al, 2012).…”

“…In China, CHM is prescribed to over 60% of outpatient migraine cases according to a retrospective analysis of the China Health Insurance Research Association medical insurance claims database ( Yu et al, 2020 ). Meta-analyses of randomised controlled trials (RCTs) have demonstrated the effectiveness of CHM for migraine in controlled settings ( Zhou et al, 2013 ; Li et al, 2015 ; Lyu et al, 2020 ; Lyu et al, 2022a ). However, this existing evidence has limitations in terms of generalisability because of the highly selective eligibility criteria, unified interventions, and predefined treatment duration in RCT designs.…”