| Objective:1.Look up and sort out the literature related to the research of insomnia in Chinese medicine,and dig out the main body,research hotspot and evolution trend of this area.2.By observing the improvement of various observation indicators before and after the treatment of insomnia(phlegm-heat disturbing the spirit),the effectiveness and safety of the empirical formula summed up based on the Qingtan Ningshen Method in the treatment of insomnia(phlegm-heat disturbing the spirit)Conduct relevant clinical evaluations to provide reference for alleviating patients’ symptoms,promoting clinical applications and mechanism research.Method:1.Based on Gephi and Cite Space software,mining the Chinese medicine literature of insomnia in the past 10 years,extract the literature data to construct and analyze the knowledge map.2.A multi-center,randomized controlled trial design was used to observe patients aged 18-65 who were admitted to the Department of Brain Diseases,Hubei Provincial Hospital of Traditional Chinese Medicine and Hubei University of Traditional Chinese Medicine from May 2019 to December 2020.The trial was enrolled as follows:Subjects who met the diagnostic criteria for insomnia(phlegm-heat disturbing type)were randomly divided into control(Huanglian Wendan Decoction)group and treatment group 1(Qingtan Ningshen Decoction),treatment group 2(Xiangfu Wendan Decoction),12 cases in each of the three groups,36 cases in total.The three groups of patients all took the medicine for 4 consecutive weeks,and followed up once in the first week,second week,third week,and fourth week.Observe the three groups of patients before and after treatment Spiegel Sleep Questionnaire,Pittsburgh Sleep Quality Index(PSQI),Insomnia Severity Index(ISI),Dialectical Treatment Information Observation Form,Anxiety Self-Rating Scale(SAS),Beck Depression Self-Rating Scale(BDI)),evaluate the clinical efficacy of Qingtan Ningshen method in the treatment of insomnia(phlegm-heat disturbing spirit),and evaluate its safety by observing the vital signs and adverse reactions of the subjects before and after the medication,and asking about the specific medication experience.Result:1.In the past ten years,the number of documents in the field of Chinese medicine research on insomnia has generally fluctuated and increased.Huang Junshan,Wang Weidong,and Wang Ping are high-volume researchers.Research institutions are mainly concentrated in Beijing University of Chinese Medicine,Guang’anmen Hospital of China Academy of Chinese Medical Sciences,and Shandong Traditional Chinese Medicine.Universities,etc.have relatively dense cooperation networks.The keyword "phlegm-heat internal disturbance" has emerged since 2015.Cluster keywords such as anxiety insomnia and Guipi Decoction have been studied frequently.2.The study actually enrolled 36 cases,dropped 1 case,and actually completed 35 cases,including 12 cases in the control group and 24 cases in the treatment group.Main efficacy indicators: The efficacy of TCM syndromes showed that the clinical cure rate of the control group was 0%,the marked rate was 8.3%,the effective rate was 75%,the ineffective rate was 16.7%,and the total effective rate was 83.3%.The cure rate in the treatment group was 4.2%,and the significant rate was 41.7%,the effective rate is 45.8%,the inefficiency is 8.3%,and the total effective rate is 91.6%.The cure rate,apparent rate and effective rate between groups are slightly different,and the difference in total effective rate is statistically significant(P = 0.045 <0.05).The clinical curative effect of sleep state was 32 cases,and 4 cases were ineffective.The recovery rate of the control group was 16.7%,the marked rate was 16.7%,the effective rate was 58.3%,and the ineffective rate was 8.3%.The cure rate of the treatment group was 16.7%,a marked rate of 4.2%,effective rate was 70.8%,inefficiency rate was 8.3%;the effective rate of groups is slightly different,but the difference is not statistically significant(P> 0.05).Secondary efficacy indicators: PSQI score and ISI score both showed that the PSQI score and ISI score of each group were significantly reduced after treatment.Other indicators: There was no statistical difference in the baseline and final results between the SAS and BDI groups.Safety indicators: A total of 4 cases of adverse reactions occurred in this study,including 1 case in the control group and 3 cases in the treatment group.There were no abnormalities in the vital signs and 12-lead electrocardiogram of the two groups before and after treatment.Conclusion:1.Research on insomnia in traditional Chinese medicine has attracted more from researchers.The cooperation and exchanges between researchers in different regions should be further strengthened in the future;and the integration of regional resources should to be further improved to jointly promote the development and progress of the subject and cross-integration with other disciplines.2.This study preliminarily verified the effectiveness and safety of the Qingtan Ningshen Method in the treatment of insomnia(phlegm heat disturbing the mind),and provided a scientific basis for the clinical application of the empirical prescriptions summarized by the research team based on the Qingtan Ningshen Method,provide preliminary evidence for further large-sample clinical trials,which is of great significance to the inheritance and innovation of traditional Chinese medicine prescriptions. |
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