ObjectiveThis study interprets the content of insomnia,the theory of ’opening-closing-pivoting of three-yin and three-yang,’ and the theory of Yunqi.It explores the Circadian rhythm,pathogenesis,and treatment of insomnia.In addition,we have construct the ’syndrome differentiation and treatment system of insomnia with three-yin and three-yang.’ The study explains the correlation between insomnia,the ’syndrome differentiation and treatment system of insomnia with three-yin and three-yang,’ and the factors of Yunqi.Besides,the clinical efficacy of the system was evaluated.The purpose of this study is to provide a theoretical and clinical basis for the diagnosis and treatment of insomnia with the theory of’opening-closing-pivoting of three-yin and three-yang’ and to promote the application of the theory of Yunqi and the theory of ’opening-closing-pivoting of three-yin and three-yang’ in clinical practice.Method1.The study to sort out and interpret the research progress of insomnia in Traditional Chinese medicine(TCM)and Western medicine through literature research.Furthermore,it systematically discusses the origin,connotation,content,and application of the theory of’opening-closing-pivoting of three-yin and three-yang’ and the theory of Yunqi,besides,holds its application ideas.2.Through theoretical research and early clinical trial,this study is guided by the theory of Yunqi,based on the theory of ’opening-closing-pivoting of three-yin and three-yang,’combined with Syndrome differentiation of six meridians,to explain the Circadian rhythm,enrich and innovate the pathogenesis of insomnia and the treatment of TCM,and build the’syndrome differentiation and treatment system of insomnia with three-yin and three-yang.’3.Referring to the design of the case-control study,the patients with insomnia who were treated in the Department of Neurology of the Affiliated Hospital of the Shandong University of TCM and the Longsha Medical Characteristic Clinic were the case group,and the non-insomnia patients at the same time and in the same location were the control group.We collected two groups of relevant data and analyzed the correlation between a single Yunqi factor,multiple Yunqi factors,and other factors with insomnia and the relationship between the ’syndrome differentiation and treatment system of insomnia with three-yin and threeyang’ by using single factor and multiple factor logistic regression and other statistical methods.Explain the inner connection between insomnia.4.Referring to the pragmatic randomized controlled trial(PRCT),181 patients who met the criteria were randomly divided into the intervention group and control group according to 1:2.The intervention group was treated according to the ’syndrome differentiation and treatment system of insomnia with three-yin and three-yang.’ In contrast,the control group was treated with western medicine.The treatment period is four weeks.The Pittsburgh Sleep Quality Index(PSQI),Insomnia Severity Index(ISI),TCM Syndrome Observation Table,and Sleep Breathing Monitor were used to compare the two groups before treatment,at the end of treatment two weeks,and at the end of therapy four weeks.To evaluate the clinical efficacy of the ’syndrome differentiation and treatment system of insomnia with three-yin and three-yang.’Results1.The first chapter sorts out the name,pathogenesis,and treatment of insomnia in ’Inner Canon of Huangdi’ and ’Treatise on Febrile Diseases’,summarizes the pathogenesis model,evaluation method,diagnosis,and treatment of insomnia in Western medicine.we hold the origin,connotation and significance of the theory of ’opening-closing-pivoting of three-yin and three-yang,’ and discuss the connotation,content,and application of the theory of Yunqi.2.The second chapter summarizes the main points of clinical application of the theory of opening-closing-pivoting.It discusses the influence of the function of opening-closingpivoting on the Circadian rhythm from many aspects,such as the yin and yang in nature,the yin and yang in the human body,and the Yingqi and Weiqi.It discusses the pathogenesis,the critical points of syndrome differentiation,and the representative insomnia prescriptions from the perspectives of Shaoyang,Shaoyin,Yangming,Taiyin,Jueyin,Shaoyin-Shaoyang,Shaoyang-Yangming,and Shaoyin-Yangming.3.In the third chapter,1237 cases were included in the case group and 2739 cases in the control group.The specific results are as follows.(1)There is a correlation between Keqi,Yunqi-Yihua,and insomnia(P<0.05),and people who were born with Shaoyin-Junhuo of Keqi,Taiyin-Shitu of Keqi,Taiyang-Hanshui of Keqi and Buhe of Yunqi-Yi Hua are at high risk of disease(OR>1).(2)There is a correlation between Sitian,Zaiquan,Yunqi-Tonghua,and insomnia of Shaoyin disease(P<0.05),and people who were born with Shaoyin-Junhuo of Sitian,Yangming-Zaojin of Zaiquan,Yangming-Zaojin of Sitian,Shaoyin-Junhuo of Zaiquan and Suihui of Yunqi-Tonghua are at high risk of disease(OR>1).Corrected multivariate logistic regression analysis retains the factors Sitian and Zaiquan(P<0.05).(3)There is a correlation between Sitian,Zaiquan,Kezhu-Jialin,and insomnia of ShaoyinShaoyang disease(P<0.05),and people who were born with Jueyin-Fengmu of Sitian,Shaoyang-Xianghuo of Zaiquan,Yangming-Zaojin of Sitian,Shaoyin-Junhuo of Zaiquan and non-Xiangde of Kezhu-Jialin are at high risk of disease(OR>1).Corrected multivariate logistic regression analysis retains only the factor Kezhu-Jialin(P<0.05).(4)There is a correlation between Sitian,Zaiquan,and insomnia of Shaoyang disease(P<0.05),and people who were born with Shaoyang-Xianghuo of Sitian,Jueyin-Fengmu of Zaiquan are at high risk of disease(OR>1),besides,people who were born with Taiyang-Hanshui of Sitian,Taiyin-Shitu of Zaiquan are at low risk of disease(OR<1).(5)There is a correlation between Sitian,Zaiquan,and insomnia of Yueyin disease(P<0.05),and people who were born with Jueyin-Fengmu of Sitian,Shaoyang-Xianghuo of Zaiquan are at high risk of disease(OR>1).(6)There is a correlation between Suiyun,Sitian,Zaiquan,Kezhu-Jialin and insomnia of Yangming disease(P<0.05),and people who were born with Huoyun-Taiguo of Suiyun,Yangming-Zaojin of Sitian,Shaoyin-Junhuo of Zaiquan,non-Xiangde of Kezhu-Jialin are at high risk of disease(OR>1).Corrected multivariate logistic regression analysis retains only the factor Suiyun(P<0.05).(7)There is a correlation between Suiyun,Sitian,Zaiquan,YunqiYihua and insomnia of Taiyin disease(P<0.05),and people who were born with Tuyun-Buji of Suiyun,Muyun-Taiguo of Suiyun,Taiyin-Shitu of Sitian,Taiyang-Hanshui of Zaiquan,Shunhua of Yunqi-Yihua are at high risk of disease(OR>1).Corrected multivariate logistic regression analysis retains the factors Suiyun,Sitian,and Zaiquan(P<0.05).(8)There is a correlation between gender and insomnia of Shaoyin-Shaoyang disease and Taiyin Disease(P<0.05),and women have a high risk of insomnia due to Shaoyin-Shaoyang disease(OR>1).In contrast,men have a high risk of insomnia due to Taiyin disease(OR>1).There is a correlation between age and insomnia of Shaoyin disease,Shaoyin-Shaoyang disease,and Jueyin Disease(P<0.05),and the young have a high risk of insomnia due to Shaoyin disease,while the old have a high risk of insomnia due to Shaoyin-Shaoyang disease and Jueyin disease.(9)Suiyun,Sitian-Zaiquan,Kezhu-Jialin,Yunqi-Tonghua,Yunqi-Yihua and insomnia are related to the ’syndrome differentiation and treatment system of insomnia with three-yin and three-yang’,of which the Sitian-Zaiquan is the most closely related.4.In the fourth chapter,Full-analysis-set(FAS)included 120 patients in the intervention group and 61 in the control group.Per-protocol-set(PPS)included 112 patients in the intervention group and 56 in the control group.The FAS analysis results are the same as the PPS analysis results,as follows.(1)Baseline analysis: there was no statistical difference between the two groups in gender,age,course of the disease,distribution of TCM syndrome types,and observation index data,indicating that the baseline is consistent and comparable(P>0.05).(2)Analysis of observation indicators: The points and total scores of PSQI were reduced in the two groups at the end of 2 and 4 weeks of treatment(P<0.05),and the intervention group was better than the control group in improving sleep quality,daytime dysfunction,and total scores at the end of 2 weeks of treatment(P<0.05),Moreover,the intervention group was better than the control group in improving sleep quality,sleep disorder,daytime dysfunction,and total scores at the end of 4weeks of treatment(P<0.05).The ISl scores were reduced in the two groups at the end of 2 and 4 weeks of treatment(P<0.05),and the intervention group was better than the control group(P<0.05).The scores of the TCM syndrome observation table were reduced in the two groups at the end of 2 and 4 weeks of treatment(P<0.05),and the intervention group was better than the control group(P<0.05).The time to fall asleep,total sleep time,the number of awakenings,sleep efficiency,proportion of Stable,proportion of Unstable,and proportion of REM in the two groups was improved compared at the end of 2 and 4 weeks of treatment(P<0.05).Furthermore,the intervention group was better than the control group in improving proportion of Stable and proportion of Unstable at the end of 2 weeks of treatment(P<0.05).Moreover,the intervention group was better than the control group in improving sleep efficiency,proportion of Stable,and proportion of Unstable at the end of 4 weeks of treatment(P<0.05).(3)Efficacy evaluation: FAS and PPS showed that the efficacy of insomnia and TCM syndrome in the intervention group was better than in the control group.Conclusion1.Based on the theory of ’opening-closing-pivoting of three-yin and three-yang,’ this study explores the Circadian rhythm,the pathogenesis of insomnia,and the diagnosis and treatment of insomnia in TCM.At the same time,combines with previous trials,the system of ’pathogenesis-syndrome types-key points of syndrome differentiation-representative prescriptions’ based on this theory was initially established.2.This study explores the correlation between insomnia,the ’syndrome differentiation and treatment system of insomnia with three-yin and three-yang,’ and the factors of Yunqi.It assists the clinical syndrome differentiation of insomnia,explains the internal relationship between the theory of ’opening-closing-pivoting of three-yin and three-yang’ and the theory of Yunqi from a clinical perspective,and promotes the combination of the two in clinical practice.3.the ’syndrome differentiation and treatment system of insomnia with three-yin and three-yang’ can effectively reduce PSQI score,ISI score,TCM syndrome score,and Sleep Breathing Monitor-related factors,comprehensively improving sleep and daytime functional status.It is superior to western medicine in improving sleep efficiency,daytime function,sleep disorder,sleep structure,sleep quality,and its effect on insomnia.In addition,The impact of insomnia and TCM syndrome is better than that of Western medicine.4.This study provides the theoretical and clinical basis for the diagnosis and treatment of insomnia by using the theory of ’opening-closing-pivoting of three-yin and three-yang’and the ’syndrome differentiation and treatment system of insomnia with three-yin and threeyang’ has the advantages of clear pathogenesis,simple syndrome differentiation,and accurate curative effect.Treating disease based on this theory has crucial clinical application value and is worthy of research and promotion. |