Table 2_Determining the efficacy and safety of acupuncture for the treatment of menstrual migraine: an updated systematic review and meta-analysis.docx

BackgroundMenstrual migraine (MM) is a common type of headache linked to hormonal fluctuations during the menstrual cycle, remains challenging to treat due to the limited efficacy of current therapies. While acupuncture shows potential as a therapeutic option for MM, the existing evidence does not clearly support its routine clinical use. This protocol for a systematic review (SR) and meta-analysis seeks to gather and evaluate recent clinical evidence regarding the effectiveness and safety of acupuncture in treating MM.
MethodsA comprehensive search was conducted across multiple databases from their inception to April 2025, including PubMed, Medline, Ovid, Embase, ScienceDirect, the Chinese National Knowledge Infrastructure (CNKI), Wanfang, the Chinese Biomedical Literature (CBM) database, and the VIP Database. This was complemented by regular updates from trial registries such as the Cochrane Central Register of Controlled Trials (CENTRAL) and the WHO International Clinical Trials Registry Platform (ICTRP), which target unpublished and ongoing randomized controlled trials (RCTs). Eligible studies were RCTs comparing acupuncture with Western medicine, herbal remedies, sham acupuncture, or no intervention for the management of MM. Primary outcomes included the pain intensity [Visual Analog Scale (VAS)], the frequency of migraine attacks (FM), and duration of migraine (DM). Secondary outcomes encompassed response rate, Headache Impact Test-6 (HIT-6), the Menstrual Headache Index (MHI), the serum levels of 5-hydroxytryptamine (5-HT), and adverse events. Analyses involved meta-analysis, subgroup comparisons, publication bias detection, sensitivity testing, risk-of-bias evaluations, and profiling of adverse events. The quality of evidence was judged according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria.
ResultsA total of 39 RCTs comprising 2,584 participants were included. Compared with control interventions, acupuncture significantly reduced VAS scores, decreased the frequency and duration of migraine attacks, and improved response rates, as well as HIT-6 and MHI scores. Additionally, acupuncture was associated with increased serum 5-HT levels. Meta-analytic findings indicated that acupuncture demonstrated a favorable safety profile in the treatment of MM.
ConclusionFindings suggest that acupuncture for MM produced the most notable reductions in migraine severity. Nevertheless, the GRADE assessment indicated low overall certainty of the evidence, with considerable heterogeneity present in multiple pooled analyses. Therefore, well-designed, large-scale RCTs are urgently required to strengthen the evidence base.
Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD42022367446.

背景
月经性偏头痛（Menstrual Migraine, MM）是一类与月经周期激素波动相关的常见头痛类型，当前疗法疗效有限，治疗仍具挑战。尽管针灸作为MM的治疗方案展现出潜力，但现有证据尚未明确支持其在临床中的常规应用。本系统评价（Systematic Review, SR）与荟萃分析方案旨在收集并评估近期关于针灸治疗MM的有效性与安全性的临床证据。

方法
研究团队于建库至2025年4月期间，对多个数据库开展全面检索，涵盖PubMed、Medline、Ovid、Embase、ScienceDirect，以及中国知网（Chinese National Knowledge Infrastructure, CNKI）、万方数据知识服务平台、中国生物医学文献数据库（Chinese Biomedical Literature, CBM）与维普资讯数据库。此外，通过Cochrane对照试验中心注册库（Cochrane Central Register of Controlled Trials, CENTRAL）及世界卫生组织国际临床试验注册平台（WHO International Clinical Trials Registry Platform, ICTRP）等试验注册渠道进行定期补充检索，以覆盖未发表及正在进行的随机对照试验（Randomized Controlled Trial, RCT）。
纳入的合格研究为对比针灸与西药、中草药、假针灸或无干预措施治疗MM的随机对照试验。主要结局指标包括疼痛强度[视觉模拟评分法（Visual Analog Scale, VAS）]、偏头痛发作频率（Frequency of Migraine Attacks, FM）与偏头痛持续时长（Duration of Migraine, DM）。次要结局指标涵盖应答率、头痛影响测定-6量表（Headache Impact Test-6, HIT-6）、月经性头痛指数（Menstrual Headache Index, MHI）、血清5-羟色胺（5-hydroxytryptamine, 5-HT）水平及不良事件。
分析方法包括荟萃分析、亚组比较、发表偏倚检测、敏感性分析、偏倚风险评估及不良事件特征分析。证据质量采用推荐分级、评估、制定与评价（Grading of Recommendations Assessment, Development and Evaluation, GRADE）标准进行判定。

结果
最终共纳入39项随机对照试验，涉及2584名受试者。与对照干预措施相比，针灸可显著降低VAS评分，减少偏头痛发作频率与持续时长，提升应答率及HIT-6、MHI评分。此外，针灸可升高血清5-HT水平。荟萃分析结果显示，针灸治疗MM具有良好的安全性。

结论
研究结果表明，针灸治疗MM可显著降低偏头痛严重程度。但GRADE评估显示证据整体质量较低，多项合并分析存在显著异质性。因此，亟需开展设计严谨的大规模随机对照试验以强化相关证据基础。

系统评价注册：https://www.crd.york.ac.uk/PROSPERO/view/CRD42022367446.