Wu Qianyan, Chen Xuan, Gan Guoqing, Zhang Qingyuan, Yu Letian, Li Chunxiao, Zhang Ying, Ao Meiying
Discipline of Chinese and Western Integrative Medicine, College of Traditional Chinese Medicine, Jiangxi University of Chinese Medicine, Nanchang, Jiangxi, 330004, China.
Committee of Communist Youth League, Jiangxi University of Chinese Medicine, Nanchang, Jiangxi, 330004, China.
J Ethnopharmacol. 2022 Nov 15;298:115669. doi: 10.1016/j.jep.2022.115669. Epub 2022 Aug 27.
Insomnia is a common form of sleep disorder. Traditional Chinese medicine (TCM) compounds have definite curative effects and a low incidence of adverse reactions, which is recognized to be an effective intervention means for the treatment of insomnia.
Based on mining the clinical research data of treating insomnia of yin deficiency syndrome (IYDS) with TCM compounds systematically, the study is to analyze the research hotspots and development trends in this field, explore the medication rule, evaluate the quality of research, so as to provide reference and direction for clinical application and scientific research in this field.
The relevant literature was retrieved and managed by evidence-based medicine strategy and EndNote software respectively. The bibliometric method was used to mine and analyze data characteristics. The VOSviewer software was used to make visual knowledge maps, the IBM SPSS Modeler software was used for association rule analysis of herbs, and the Cochrane tool and MINORS scale were used for quality analysis of literature.
(1) A total of 184 related studies were included according to the inclusion and exclusion criteria. (2) The research popularity showed a dynamic upward trend and the research hotspot showed a trend of migration and refinement, etc. (3) The commonly used herbs in this field were Ziziphus jujuba var. spinosa (Bunge) Hu ex H.F.Chow, etc; the commonly used TCM prescriptions were Huanglian Ejiao Decoction, etc; the commonly used dosage forms were traditional decoction, etc; the commonly used combinations of herbs included Ziziphus jujuba var. spinosa (Bunge) Hu ex H.F.Chow-Poria cocos（Schw.）Wolf, etc. (4) The rate of the studies containing ethical review numbers and clear inclusion standards did not reach 50%, and the risk bias of methodological was high. However, a separate analysis of data showed that the specification of study design was on the rise obviously in recent years, and Meta-analysis and sensitivity analysis could confirm the effectiveness and stability of clinical efficacy which was the key indicator in treating IYDS with TCM prescriptions. There were significant differences among administration protocols of different clinical studies of the same name TCM compounds. However, the scientific significance of each unique dosing regimen were expected to be elaborated or discussed.
The clinical research number of TCM compounds treating IYDS was in a dynamic upward trend, and the outcome indicators tended to be diversified and detailed. The dosage forms mainly included decoction, supplemented by Chinese patent medicine. The design of clinical studies in this field was not standardized enough, but the key indicators were scientific and stable. We expected that later studies could pay more attention to improving the standardization of trial design, reducing the risk bias in the process of methodological design, conducting high-quality standardized multicenter, large-sample randomized controlled clinical trials to provide scientific evidence with high evidentiary strength, establishing the recognized administration protocols for the same name TCM prescriptions or clarifying the targeting of different protocols, and promoting the application and popularity of TCM compounds in treating IYDS.
失眠是一种常见的睡眠障碍形式。中药复方具有确切的疗效且不良反应发生率低，被公认为是治疗失眠的有效干预手段。
本研究基于系统挖掘中药复方治疗阴虚型失眠（IYDS）的临床研究数据，分析该领域的研究热点和发展趋势，探索用药规律，评估研究质量，为该领域的临床应用和科研提供参考与方向。
分别采用循证医学策略和EndNote软件检索及管理相关文献。运用文献计量学方法挖掘和分析数据特征。使用VOSviewer软件制作可视化知识图谱，IBM SPSS Modeler软件进行中药关联规则分析，Cochrane工具和MINORS量表进行文献质量分析。
（1）根据纳入和排除标准，共纳入184项相关研究。（2）研究热度呈动态上升趋势，研究热点呈现迁移和细化等趋势。（3）该领域常用中药有酸枣仁等；常用中药方剂有黄连阿胶汤等；常用剂型为传统汤剂等；常用中药配伍有酸枣仁 - 茯苓等。（4）包含伦理审查编号和明确纳入标准的研究比例未达50%，方法学风险偏倚较高。但单独分析数据显示，近年来研究设计的规范性明显上升，Meta分析和敏感性分析可证实临床疗效的有效性和稳定性，这是中药方剂治疗IYDS的关键指标。同名中药复方不同临床研究的给药方案存在显著差异。然而，每种独特给药方案的科学意义有待阐述或讨论。
中药复方治疗IYDS的临床研究数量呈动态上升趋势，结局指标趋于多样化和细化。剂型主要为汤剂，辅以中成药。该领域临床研究设计规范性不足，但关键指标科学稳定。期望后续研究能更加注重提高试验设计的规范性，降低方法学设计过程中的风险偏倚，开展高质量标准化的多中心、大样本随机对照临床试验，提供具有高证据强度的科学证据，建立同名中药方剂公认的给药方案或明确不同方案的针对性，促进中药复方在治疗IYDS中的应用和推广。
