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针灸联合药物治疗围绝经期失眠:一项系统评价与Meta分析

Integrated acupuncture-pharmacotherapy for perimenopausal insomnia: a systematic review and meta-analysis.

作者信息

Yang Boxiang, Jiang Shengwen, Teng Yubo, Wang Yiming, Zhang Jingyi, Gao Chang, Song Chunhua

机构信息

School of Graduate, Heilongjiang University of Chinese Medicine, Harbin, China.

School of Basic Medical Science, Shenyang Medical College, Shenyang, China.

出版信息

Front Neurol. 2025 Aug 20;16:1633794. doi: 10.3389/fneur.2025.1633794. eCollection 2025.

Abstract

OBJECTIVE

Insomnia is a prevalent symptom among perimenopausal women, mainly attributed to estrogen-progesterone imbalance and neuropsychiatric factors, significantly impacting their quality of life. This article seeks to systematically evaluate the efficacy of integrated acupuncture-pharmacotherapy (AP) in treating perimenopausal insomnia (PMI), offering new insights for the management of insomnia in women.

METHODS

Searches were conducted in 8 databases: PubMed, Web of Science (WOS), Cochrane Library, Embase, China National Knowledge Infrastructure (CNKI), China Biology Medicine Disc (CBM), Wanfang Academic Journal Full-text Database (Wanfang), and Chongqing VIP Database (CQVIP). Database searches extended through August 1, 2024. Endnote 20 was used to build the database and screen for eligible randomized controlled trials (RCTs). The efficacy of AP for PMI were demonstrated by assessing 3 primary outcome measures (Effective rate, Hamilton Anxiety Scale [HAMA], Traditional Chinese Medicine Syndromes [TCMS]) and 5 secondary outcome measures (Pittsburgh Sleep Quality Index [PSQI], Modified Kupperman Index [KMI], Luteinizing Hormone [LH], Follicle-Stimulating Hormone [FSH], Estradiol [E]). The risk of bias was assessed according to the . Data analysis was performed using RevMan 5.4 and StataMP 15.0. Subgroup or sensitivity analysis was applied as necessary to address issues of heterogeneity. Regression analysis was used to determine whether the division of potential subgroups is reasonable. The evidence quality level was evaluated using the GRADEprofiler following the GRADE approach.

RESULTS

A total of 12 eligible studies comprising 969 PMI cases were ultimately included in this meta-analysis. Pooled results indicated AP had statistically significant benefits for PMI: Efficacy (Effective rate [RR = 1.22, 95% CI (1.13, 1.30),  = 3.88,  < 0.00001]), Scores (HAMA [MD = -3.26, 95% CI (-3.79, -2.73),  = 12.06,  < 0.00001]), TCMS [MD = -0.98, 95% CI (-1.21, -0.74),  = 7.99,  < 0.00001], PSQI [MD = -3.12, 95% CI (-4.21, -2.03),  = 5.63,  < 0.00001], KMI [MD = -3.96, 95% CI (-5.78, -2.15),  = 4.28,  < 0.0001], and Hormone levels LH [MD = -10.16, 95% CI (-16.41, -3.91),  = 3.18,  = 0.001 < 0.05], FSH [MD = -8.65, 95% CI (-13.67, -3.64),  = 3.39,  = 0.0007 < 0.05], E [MD = 15.87, 95% CI (10.16, 21.58),  = 5.45,  < 0.00001].

CONCLUSION

AP demonstrates significant efficacy in treating PMI patients, offering an innovative integrative therapy with substantial clinical value. Future studies should involve more large-scale, multicenter RCTs with long-term follow-up.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/PROSPERO/view/CRD42024579691.

摘要

目的

失眠是围绝经期女性中普遍存在的症状,主要归因于雌激素 - 孕激素失衡和神经精神因素,严重影响她们的生活质量。本文旨在系统评价针灸 - 药物综合疗法(AP)治疗围绝经期失眠(PMI)的疗效,为女性失眠的管理提供新见解。

方法

在8个数据库中进行检索:PubMed、科学网(WOS)、考克兰图书馆、Embase、中国知网(CNKI)、中国生物医学文献数据库(CBM)、万方学术期刊全文数据库(万方)和重庆维普数据库(CQVIP)。数据库检索截至2024年8月1日。使用Endnote 20建立数据库并筛选符合条件的随机对照试验(RCT)。通过评估3项主要结局指标(有效率、汉密尔顿焦虑量表 [HAMA]、中医证候 [TCMS])和5项次要结局指标(匹兹堡睡眠质量指数 [PSQI]、改良Kupperman指数 [KMI]、促黄体生成素 [LH]、促卵泡生成素 [FSH]、雌二醇 [E])来证明AP对PMI的疗效。根据……评估偏倚风险。使用RevMan 5.4和StataMP 15.0进行数据分析。必要时应用亚组或敏感性分析来解决异质性问题。使用回归分析确定潜在亚组的划分是否合理。采用GRADE方法,使用GRADEprofiler评估证据质量水平。

结果

本荟萃分析最终纳入了12项符合条件的研究,共969例PMI病例。汇总结果表明,AP对PMI具有统计学显著益处:疗效(有效率 [RR = 1.22,95% CI (1.13, 1.30),χ² = 3.88,P < 0.00001])、评分(HAMA [MD =  -3.26,95% CI (-3.79, -2.73),χ² = 12.06,P < 0.00001])、TCMS [MD =  -0.98,95% CI (-1.21, -0.74),χ² = 7.99,P < 0.00001]、PSQI [MD =  -3.12,95% CI (-4.21, -2.03),χ² = 5.63,P < 0.00001]、KMI [MD =  -3.96,95% CI (-5.78, -2.15),χ² = 4.28,P < 0.0001],以及激素水平LH [MD =  -10.16,95% CI (-16.41, -3.91),χ² = 3.18,P = 0.001 < 0.05]、FSH [MD =  -8.65,95% CI (-13.67, -3.64),χ² = 3.39,P = 0.0007 < 0.05]、E [MD =  15.87,95% CI (10.16, 21.58),χ² = 5.45,P < 0.00001]。

结论

AP在治疗PMI患者方面显示出显著疗效,提供了一种具有重要临床价值的创新综合疗法。未来的研究应纳入更多大规模、多中心且具有长期随访的RCT。

系统评价注册

https://www.crd.york.ac.uk/PROSPERO/view/CRD42024579691

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e0dd/12406132/51ed531f7bcf/fneur-16-1633794-g001.jpg

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