| BackgroudInsomnia is serious, duration of symptoms, the high recurrence rate physical, psychological, social function significantly impaired and seriously influencing the quality of life of patients of a kind of disease. Traditional Chinese medicine(TCM) treatment of this disease has a unique effect and advantages. For a long time, TCM scholars have generally agreed that the pathogenesis of insomnia is always over-abundant yin with deficient yang, yang does not enter the yin. Treatment on this disease often give priority to nourishing yin and clear heat,tranquilizing the mind, herbal prescription more of the goods with cold, few of according to the ruler from deficient yang. However, Because the differences of human endowments, long or temporary course of disease and misconduct, yin and yang of partial flourishing and failure often easily convert to one another, so there are a substantial part of patients suffering insomnia whose disorders treatment often got good effect by herbal prescription of the goods of warming supplement when poor treatment effect of their disorders by prescription of much the goods of nourish yin and tranquilizing the mind in clinical practice. Why?It is the reason for neglect-ing yang deficiency?It is worthy of deep research and exploration.TCM experts in TCM theory has a solid foundation, essence of TCM theory to grasp are unique, In clinical practice has a wealth of experience, the treatment effect is more prominent.So to speak, Chinese medicine experts to some extent represents the essence of theory and practice of medicine, diagnosis and treatment of their experience and theoretical understanding are worthy of being concerned.The present study of TCM experts experience of diagnosis and treatment is mainly limited to the description of the TCM experts experiential theory and a lot of medical case reports and clinical resear-ch. these have played certain role in the inheritance and promotion of TCM experts experience of diagnosis and treatment, However, Because of absence of its structural integrity, the clinical diagnosis and treatment elements, repeat for all clinical validation and optimization of standarded diagnosis and treatment programs, In particular, absence of potential information and rules, such as accurate and comprehensive statement of indication, determine the basis and method, grasp the relation between the principal contradicton and so on, it was largely restricted to implement continuous optimization, large-scale applications of specification clinic experience. Therefore, exploring the effective research methods sorting, inherited Chinese Medicine Clinic experience, converting intangible experience to become the standarded opera-tional diagnosis and treatment program, is worthy of our research direction.Guangdong Provincial Hospital of TCM has its own TCM experts, while a lot of the middle-aged of TCM doctors who learn from national noted old TCM doctors, therefore by summarizing and analyzing the experience of insomnia diognosis and treatment,it has good basis and feasiability to determine the optimization of Traditional Chinese medical diognosis and treatment.ObjectivesThe background of the above to be considered, this study plan to take the TCM experts'experience of diagnosis and treatment in our hospital as a starting point,will chose yang deficiency insomnia as the object of study, exploratorily applicate qualitative research methods(including content analysis, literature review, individual interviews) to construct the TCM diagnosis and treatment program of yang deficiency insomnia; Reference to the international "non-randomized study" design principle, to be two-way analysis of prospective non-randomized clinical trial, initial verification and optimization of the diagnosis and treatment is designed to show the potential effectiveness of the program and the prospects for further research to provide an objective test evidence, while to provide some ideas and inspiration for TCM experts'experience of standardization and large-scale application.MethodsThe study is exploratory research, which adopt Qualitative research and quantitative research combination of research methods. The concrete content includes:1. According to objectives of the study, combined the existing insomnia (BuMei) related theoretical basis of researchers,《Related literature of treatment on insomnia from yang deficiency characteristics of TCM profession information collection form》was formatted, adopting bibliometrics,content analysis and other methods, systematic collecting and analyzing profession congnition with diagnosis and treatment on insomnia from yang deficiency in TCM periodical literature, summarized the law on diagnosis and treatment on yang deficiency insomnia, in order to make theoretical preparation for the initial construction of TCM diagnosis and treatment program of yang deficiency insomnia.2. Based on previous studies in the literature, closely around the research topic, using qualitative interviews to execute semistructured interviews with expert with relevant profession background (who mainly have a deep theoretical congnition and rich practical experience in diagnosis and treatment on yang deficiency insomnia),to understand and get the expert in personal effective experience of diagnosis and treatment yang deficiency insomnia, initially construct expert individual TCM program of diagnosis and treatment insomnia, for the next step of laying the foundation for further verification and optimization of the diagnosis and treatment.3. In accordance with the requirements of "clinical trial" treatment evaluation, under the premise of objects,inervention,effects of three aspects of the "features","elements" in full attention and refining, taking prospective case strict set of observations, recording comprehensive influen-tial factors on the efficacy when trial was designed, initially evaluate the treatment program's efficacy and safety, meanwhile compare first diagnostic fators dfferences with effective and ineffective cases, in order to guide the individual medication, and provide the evidence for further optimization of diagnosis and treatment programs. Result1."The treatment of insomnia from yang deficiency" Content Analysis of Chinese Periodical Literature1.1 The TCM ideas about diagnosis and treatment on insomnia:literature about TCM differentiation of disease accounted for a larger proportion (45%,27/60), including differentiation of etiology and pathogenesis (25%,15/60), disting-uishing the pathogenesis (13%,8/60), distinguishing the cause (7%,4/60), and the followed is about differentiation of diseases and TCM syndrome (42%,25/60), mainly is how to distinguish the pathogenesis with syndrome differentiation of viscera(30%,18/60), and purely ideas of differentiation of syndrome are in a very small share of cases (7%,4/60). It shows that the treatment of insomnia from the yang deficiency emphasizes more on disease differentiation.1.2 The results of differentiation diseases of treatment insomnia from yang deficiency shows that " Yang can not insert into yin, yin and yang are failure to connect" (48%,13/27) and "Deficiency of Yang Qi, lost the support of spirit" (33%,9/27) which accounted for a high proportion; while the results of differentiation of diseases and TCM syndrome showed that "disharmony between heart and kidney, disturbance of the regulation between water and fire" (48%,12/25) and "Deficiency of Yang and excess of Yin, upward floating of asthenia-yang, or the disturbance of spirit, or spirit dystrophy" (24%,6/25) is in a high proportion;from these 4 literature about differentiation and treatment, we cold see Syndrome Differentiation of Visceral and Qi, blood, fluid and water are main classification. After classification, Qi deficiency of stomach and spleen, spleen yang deficiency failure, deficiency of kidney yang, deficiency of spleen and kidney, deficiency of heart and spleen, stomach and spleen deficiency, damp accumulated, disharmony between heart and kidney.1.3 Most of literature refers the evidences of TCM diagnosis and treatment on insomnia from yang deficiency. Based on the specific point of view, we can see the frequency of literature in descending order are symptoms and tongue and pulse of yang deficiency, yang (Qi) wounded factors, course long (long treatment), past medication history and the removal factors.1.4 More than half of the researchers choose the insomnia treatment prin ciple of warming yang and tranquilizing mind from the yang deficiency. Th e followed is warming yang and invigorating principle and warming yang an d expelling yin principle. However, less application of warming yang and e xpelling damp (phlegm) principle, warming yang and relieving the exterior sydrome principle, warming yang and regulating the blood principle relat ively.1.5 On the treatment of insomnia from the yang deficiency, the prescription which used most is Gui Zhi Tangs accounted for 35.4%(17/48); and the followed by 22.9% from the intended prescription (11/48), Si Ni Tangs accounted for 18.8%(9/48) and Shen Qi pills which accounting for 14.6%(7/48).Over 50% reported in the literature on the treatment of insomnia from yang deficiency shows that commonly used drugs were Fu Zhi, Gan Cao, Gui Zhi, Long Gu, Mu Li, FU Ling, Ren Sheng, Bai shu.2.Construction of individual diagnosis and treatment program based on qualitative interviews on expert2.1 Diagnosis of differentiationDifferentiation Category:yang can not insert into yin, disharmony between heart and kidney:(1)relative imbalance of yin and yang:①biochemical lack of sources (deficiency);②excessive yin hinders yang; (2)movements disorders:①liver and gall bladder loss sparse;②disturbances of pulmonary Qi;③turn negative in the middle heater;(3)Meridian barrier:①phlegm and dampness obstruct;②blood stasis 2.2 intervention programsTherapeutic Governing principle:support yang and inhibit yin, regulate the pivot and guide the Qi to ascend and descend. Prescription drugs:the main prescription is:Si Ni Tang and Gui Zhi Gan Cao Long Gu Mu Li Tang; Recipe: Shou Fu ZHi(cook first) 15-30g, Gan Jiangl5-30g, Gan Cao30-60g, Long Gu30g, Mu Li30g;decoction method:first cooked Shou Fu Zhi,Long Gu and Mu Li 30-40 minutes, then add other drugs to cook together for 1 hour. Take the warm soup in 9-10 am and 4-5 pm.3. Study on initial verification and optimization for TCM diagnosis and treatment program of Yang deficiency insomnia3.1 The efficacy and safety initial evaluation of the diagnosis and treatment program(forward analysis)3.1.1 Comprehensive efficacy evaluation before and after InterventionTotal effective rate was 37.5% after one month treatment, while total effective rate was 70% after two months treatment. The total effective rate was still 70% after stopping treatment. The research showed some patients felt better after the first month treatment, but total effective rate was not high, which was increasing after two months treatment and reached the highest. Follow-up found that the total effective rate did not decline due to withdrawal.3.1.2 PSQI and ISI sores before and after interventionComparing with the pre-intervention total score of PSQI and scores of seven factors, the scores of post-intervention was lower and there was a significance difference (P<0.05). Sleep disorders scores decreased during the first two months intervention, but did not reach statistical significance (P> 0.05), while the scores decline reach significance difference during after stopping treatment(P<0.05). It maybe relate to the accumulation effect of Chinese herbs. Hypnotic drugs factor scores decreased as dynamic fluctuations, the scores of after one month treatment and one month follow-ups did not reach statistical significance(P> 0.05). However, there was a significant difference after two months treatment (P<0.05). It indicated that some patients decreased the dose of hypnotic drugs after two months intervention, but the dose of hypnotic drugs were given again. Comparing with the pre-intervention, ISI scores of first,second month treatment and after stopping intervention decreased, and it reached the statistical difference (P<0.01) 3.1.3 Comparison of objective assessment of sleep before and after inter-vention (sleep monitoring)Compared with pre-intervention, the objective sleep efficiency and arousal times are statistically different (P<0.05). Objective differences in sleep latency and waking time were close to the edge of statistical significance (P=0.07, P=0.06).And objective sleep time and sleep structure was no significant difference(P>0.05). It indicated that the therapy greatly improved objective sleep efficiency and reduced the arousal, partially improved objective falling-sleep time and awake time(considering inadequate sample size), but no effect on objective sleeping time and the sleep structure. 3.1.4 Comparisons of SAS, SDS and Life Quality Assessment before and after interventionCompared with pre-intervention, SAS and SDS scores of post-intervention were obviously decreased and there was a significant difference (P< 0.01). Compared with pre-intervention, results of Life Quality Assessment were improved during the first and second months intervention and after stopping intervention and there was a significant difference (P<0.05) 3.1.5 Reduction and stop of sedative hypnotics and adverse effects13 patients take western medicine at the initial session,3 of them stopped using western medicine after the TCM treatment,2 of them reduced to the dose to 1 pill per week from 1 pill per night, and 3 of them reduced the dose to 1 pill per night from 2 pill per night,5 of them kept the same dose. During the treatment, patients insist seeing the doctor once one or two week,2 patients had transient body itching, rash, peeling at the right hand thenar, blisters phenomenon, but all the symptoms disappeared when continuing receiving the treatment. 3.2 Correlation analysis of efficacy of diagnosis and treatment programs and diseases information. (Backward analysis) 3.2.1 Effective and ineffective cases of groupingIn this study, groupings were made since the first month follow-ups after the treatment. There were two groups, one is the efficacy group the other is none efficacy group. And the efficacy group included 28 cases of cured patients, markedly efficacy and efficacy. None efficacy group had 12 cases. 3.2.2 Comparisons of the disease information difference of efficacy group and none efficacy groupThrough the single factor analysis, this study compared the information difference of initial treatment between the two groups. The information included four TCM diagnostic informations, previous history and all the assessment surveys.11 variables were brought into equation by Pearsonx2 test or Fisher test P<0.05. The results presented that symptoms of cold, mental fatigue, irritability, palpitations, chills, cold extremities, thirst hot drink and sweating were positive related to the efficacy, while the symptoms of anxiety, constipation and red tip tongue were negative related to the efficacy. It indicated that the efficacy would be better treating yang deficency insomnia using the diagnosis and treatment program when symptoms of cold, mental fatigue, irritability dryness, palpitations, chills, cold extremities, thirst hot drink and sweating appeared and no symptoms of anxiety, constipation and red tip tongue. After the logistic regression analysis of containing single factor, efficacy variable and none efficacy variable were set as the dependent variable, above 11 disease information setting as the independent variable. The variable selection method is stepwise (Inclusion criteria P<0.05, exclusion criteria P>0.1). The variable of irritability and chills was included in the final formula, and it indicated a significant difference (P<0.05). It showed the core evidence of differentiation for treatment program was irritability and chills.Conclusions:1. In this study, the systematic collection, analysis of the treatment of insomnia from the yang deficiency treatment relating Chinese medicine journal articles, found that Traditional Chinese medicine on the treatment of yang deficiency insomnia and the accumulation of a theoretical knowledge and practical experience. It expanded to some extent the diagnosis and treatments for insomnia. However, the number of the relating articles were not high, Its overall cognition is insufficiency.2. This study explored the opinion of experts for more in-depth individual semi-structured interviews were the first time of Qualitative Research in clinical TCM fields. It indicated the advantages of using qualitative research of TCM specialty and provides some ideas and references for future standardization and large-scale application of TCM experts'clinical experience.3. This study initially obtained complete structre, the clinical diagnosis and treatment elements, suitable for clinical repetitive validation and optimi-zation of TCM diagnois and treatment program of yang deficiency insomnia. The results showed that the circular movement theory, suppression ying while strengthening yang, cardinal running and guide air-lift method for the treatment of Chinese medicine clinics in the treatment of yang deficency insomnia are more significant effect. It had the clinical application value, worthy of further exploration and confirmation, and clinically promoting the use.
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