Ethnopharmacological relevance: 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.
Aim of the study: 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.
Materials and methods: 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.
Results: (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.
Conclusion: 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.
Keywords: Evaluation of research quality; Insomnia of yin deficiency syndrome; Medication rule; Research hotspots; TCM compounds.
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