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Establishment Of Expert Consensus And Clinical Applicability Of Integrated Traditional Chinese And Western Medicine Diagnosis And Treatment Plan For Insomnia Disorder

Posted on:2022-11-23Degree:DoctorType:Dissertation
Country:ChinaCandidate:J ZhangFull Text:PDF
GTID:1524307202497964Subject:Internal medicine of traditional Chinese medicine
Abstract/Summary:PDF Full Text Request
ObjectiveTo formulate "Expert Consensus on Insomnia Integrated Diagnosis and Treatment Plan for Insomnia" based on the Delphi method,and conduct preliminary clinical verification of the consensus plan to verify the clinical effectiveness,compliance,safety,etc.of the consensus plan,so as to form a definite curative effect.An easy-to-promote integrated Chinese and Western medicine diagnosis and treatment plan for insomnia.Methods1.Formulation of a draft of integrated traditional Chinese and Western medicine diagnosis and treatment of insomnia:organize a consensus-making expert group to determine the theme and scope of the consensus based on the principles of PICO,based on previous research foundations(systematic reviews of literature,treatises,and draft " Guidelines for the Diagnosis and Treatment of Primary Insomnia with Integrated Traditional Chinese and Western Medicine"),combined with the latest research progress,drafted the "Expert Consensus on Insomnia Disorders Integrated Chinese and Western Medicine Diagnosis and Treatment Plan".2.Delphi method expert consensus survey:It mainly adopts two forms:Delphi questionnaire survey and expert demonstration meeting.Three rounds of expert questionnaire surveys were conducted on the first draft of the consensus using the Delphi expert consultation method,and 20 questionnaires were distributed in each round.Organize and analyze the results of the questionnaire,conduct expert discussions on the controversial issues in the revised draft,and form final recommendations.3.Clinical applicability research:mainly adopts questionnaire survey method and nonrandomized controlled clinical observational research to evaluate the clinical applicability of insomnia disorder integrated traditional Chinese and western medicine diagnosis and treatment plan.Specifically,it is divided into three parts.The first is based on the "Evaluation of the Applicability of Medical Guidelines" developed by the Standards Office of Guangdong Provincial Hospital of Traditional Chinese Medicine to conduct a questionnaire survey on the users(doctors)of the consensus plan to evaluate the consensus plan in the medical service practice of the unit.The second is to investigate the subjects’ experience and satisfaction with the diagnosis and treatment plan based on the self-made questionnaire;the third is to explore the clinical applicability of the diagnosis and treatment plan in combination with nonrandomized controlled clinical observational research for further optimization Provide a basis for the revision of the consensus diagnosis and treatment plan.Results1.Research 1:The draft of integrated Chinese and Western medicine diagnosis and treatment for insomniaA total of 48 Chinese and Western medicine diagnosis and treatment guidelines,monographs,plans,and documents related to insomnia were searched,8 domestic and foreign monographs,12 articles related to insomnia diagnosis and treatment guidelines,1 specialist experience diagnosis and treatment plan,and 8 evaluation references,4 references for basic treatment,8 references for TCM decoction differentiation and administration methods,4 references for physical and psychological treatment.There are 2 literatures on efficacy evaluation.On the basis of the above-mentioned literature research,combined with the 2018 edition of the "Research on the Development of Guidelines for the Diagnosis and Treatment of Primary Insomnia Integrated Traditional Chinese and Western Medicine",and Professor Li Yan from the Department of Mental Sleep,Guangdong Provincial Hospital of Traditional Chinese Medicine,etc.Edition)compile the contents of seven sections including diagnostic criteria,evaluation and examination,Chinese and Western medicine diagnosis and treatment strategies,treatment goals,specific intervention measures,preventive health care,and curative effect evaluation of insomnia,forming a draft of the "Insomnia Integrated Chinese and Western Medicine Diagnosis and Treatment Plan".And combined with the Delphi survey technique(Delphi survey technique)to form an expert consensus plan.2.Research 2:Delphi method expert consensus surveyThe first draft of the "Expert Consensus on Integrated Chinese and Western Medicine Diagnosis and Treatment Plan for Insomnia" was used to conduct three rounds of expert questionnaire surveys using the "Delphi survey technique",an expert consensus formulation method.The research team selected 20 experts from 3 provinces and cities from the members of the "Sleep Psychology Professional Committee of the Guangdong Society of Integrated Traditional Chinese and Western Medicine" to participate in the Delphi questionnaire survey.The expert fields involve Chinese and Western medicine psychology,sleep medicine,and Chinese and Western medicine clinical.Medicine etc.The results of the three rounds of survey questionnaires show that the participation of experts is relatively high(both positive coefficients are 100%),the content of the survey questionnaire is highly reliable and authoritative(the expert authority coefficient Q is between 0.62 and 0.79).and the expert opinions of each item in the questionnaire Harmony,small differences(coefficient of variation CV ≤30%).Based on the results of three rounds of Delphi questionnaires,the recommended draft of "Expert Consensus on Insomnia Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment Plan" was written.3.Research 3:Clinical Applicability Investigation and Observational Research3.1 Research on evaluation of clinical applicability of doctor version3.1.1 Research obj ectsThe subjects of the study were 12 doctors who used the"Insomnia Disorder Integrated Chinese and Western Medicine Diagnosis and Treatment Program" in the Department of Mental Sleep,Guangdong Provincial Hospital of Traditional Chinese Medicine from September 2020 to December 2020 to carry out clinical diagnosis and treatment practices.3.1.2 Response rateA total of 12 questionnaires on suitability of doctors were sent,with a response rate of 100.00%.3.1.3 Basic information of subjectsThe average age of the participants was 34.08±5.47,and the working years was 7.83±6.13.Master degree and above account for 75%.Professional titles of attending and above accounted for 41.6%.The subject of Chinese and Western medicine psychology sleep accounted for 75%.Doctors with provincial and ministerial scientific research subject experience accounted for 25%.Doctors holding positions in international societies accounted for 16.7%.3.1.4 Survey results100.00%of the doctors who participated in the survey questionnaire believed that the insomnia disorder integrated traditional Chinese and western medicine diagnosis and treatment plan was more applicable than the level of health care in our country and the unit,and the level of other related diagnosis and treatment plans.100.00%of people think that the consensus plan is more than good in coordination with related standard content and related medical resources.100.00%believe that the clarity of the scope of application of the consensus,the accuracy of diagnostic points,the rationality of auxiliary examinations,the completeness and rationality of the content and structure,the understandability of the content,and the compatibility of the content are all relatively good.it is good.100.00%of people think that there is no contradiction between the consensus content,and the clinical application is simple.The consensus is good for the rationality of medical resource utilization,the importance of medical management standards and medical service quality assurance,the importance of improving the level of medical technology,and the applicability of the medical service practice in the region and the unit.91.67%of the people think that the consensus plan is better than the medical level in the region,and 8.30%think it is inferior.83.33%of people think that the consensus is relatively scalable.16.6%think that the consensus is poor in scalability.3.2 Clinical applicability evaluation survey of patient version3.2.1 Research objectsThe subjects of the study were insomnia patients who participated in and completed the non-randomized controlled clinical applicability study of the insomnia disorder integrated traditional Chinese and western medicine diagnosis and treatment program in the Department of Mental Sleep,Guangdong Provincial Hospital of Traditional Chinese Medicine from September 2020 to December 2020.3.2.2 Response rateA total of 70 patient suitability questionnaires were sent,55 questionnaires were returned,and the response rate was 78.57%.3.2.3 Basic information of subjectsThe average age of the subjects participating in the survey was 43.26±11.61 in the control group,41.69±12.90 in the treatment group,26.32%males in the control group and 73.68%females;25.00%males and 75.00%females in the treatment group.There was no statistical difference in gender and age between the two groups(P>0.05).3.2.4 Survey resultsIn the control group,those who participated in the groups of traditional Chinese medicine decoction,interest regulation,sleep cognitive management,western medicine,anxiety management,and depression management,the proportion of people who believed that each of the above treatments was most helpful was 57.89%and 57.89%,respectively,47.37%,31.58%,26.32%,15.79%.The corresponding populations in the treatment group were 69.44%,50.00%,30.56%,25.00%,16.67%,8.33%,respectively.There was no statistical difference between the two groups in the experience of the above treatment methods(P>0.05).The two groups were not satisfied with the treatment of insomnia in terms of the satisfaction of the two groups on the treatment of insomnia with "simple traditional Chinese medicine,traditional Chinese medicine combined with western medicine,traditional Chinese medicine combined with interest adjustment group and sleep awareness group,anxiety management group,interest adjustment group,sleep awareness group" See statistical difference(P>0.05).There was a statistically significant difference in satisfaction with the treatment of insomnia by Western medicine alone(P<0.05).The satisfaction rate of the two groups was statistically different in the satisfaction rate of depression management group treatment of insomnia accompanied by depression(P<0.05).There was no statistical difference between the two groups in terms of satisfaction with the outpatient treatment process,process arrangement,outpatient doctor’s service attitude,and ease of program implementation(P>0.05).The reasons for the treatment group’s satisfaction with the plan were related to the efficacy(13.89%)and the doctor’s attitude(11.11%).13.89%of people are satisfied with the curative effect of Chinese medicine,Chinese medicine+breath adjustment.8.33%of the people were satisfied with the curative effect of breathing,breathing+sleep cognition,Chinese medicine+breathing±sleep cognition.The reason why the control group was satisfied with the curative effect was related to the curative effect(15.79%).15.79%were satisfied with the effect of pranayama.10.54%of the people were satisfied with the curative effect of traditional Chinese medicine,breath adjustment+sleep cognition,and sleep cognition.Regarding the recommendations on the treatment plan,5.56%of the people in the treatment group each hope to increase Chinese patent medicines,physical therapy,and treatment courses.2.78%of the people think that "Western medicine,sleep cognition,warm feet before going to bed" are effective for insomnia.2.78%of the people hope to "increase hormone inspections,clarify the treatment process,change the plan in time when the plan is invalid,give specific explanations and suggestions for patients’ questions,and be able to regularly treat outpatients and improve the diagnosis and treatment environment." 2.78%of people think that the treatment is "too expensive".52.78%of the people did not put forward specific opinions.In the control group,10.53%of the people suggested "integrated traditional Chinese and western medicine for insomnia",and 5.26%of each suggested "improving the diagnosis of disease and increasing the course of treatment";5.26%of the people thought that "sleep is related to psychology,and solving psychological problems can improve sleep".5.26%of people think that "sleep cognition is effective,and it is recommended to increase sleep-related science popularization".5.26%of people "hope to make it easy to register,get treatment on weekends,and free treatment."For the desired treatment,13.89%of the people in the treatment group hope to "cure or improve insomnia",and 13.89%want to "get acupuncture treatment." 11.11%of people each hope to obtain "integrated Chinese and Western medicine treatment,combined Chinese and western medicine psychotherapy and sleep cognitive therapy".2.78%of people each hope to obtain "Chinese medicine+breath adjustment,Chinese medicine,psychotherapy,dietary guidance,anxiety management,psychological and sleep assessment,follow-up,and more detailed treatment plans." 27.78%of the people did not give specific opinions.26.32%of the people in the control group hope to obtain "integrated Chinese and Western medicine physical therapy,acupuncture treatment";21.05%want to obtain"psychological consultation,integrated traditional Chinese and Western medicine psychological treatment";10.53%of people each want to obtain "Chinese medicine,systemic and personalized medicine" treatment".10.53%of people hope to "get free treatment,cure insomnia,and gain popular science knowledge related to insomnia".10.53%did not give specific opinions.3.3 Results of clinical observational research3.3.1 Research objectThe subjects were patients with insomnia who were admitted to the Department of Mental Sleep,Guangdong Provincial Hospital of Traditional Chinese Medicine from September 2020 to December 2020.They met the criteria for the research plan and signed the informed consent form.A total of 80 subjects were included in the study,including 47 cases in the consensus protocol group(referred to as the treatment group)and 33 cases in the non-consensus protocol group(referred to as the control group).During the study,5 people in the control group dropped out,with a drop-out rate of 15.15%,and 28 cases completed treatment;in the consensus protocol treatment group,5 cases fell out with a drop-out rate of 10.64%,and 42 cases completed treatment.There was no statistical difference between the treatment group and the control group in the dropout rate(P>0.05).Finally,70 subjects were included in the analysis set,including 28 in the control group and 42 in the treatment group.3.3.2 Baseline analysis of demographic characteristics of subjectsThe 70 subjects had an average age of 42.3 years;17 were males and 53 were females,with a male to female ratio of 1:3.12.Married patients accounted for 65.71%;bachelor degree or above accounted for 54.29%;retired or unemployed persons accounted for 42.86%.The median duration of the disease was 3(1,10)years;61.43%of patients had no stressful life events;95.86%of patients had no previous medical history;55.71 patients had no history of sedative hypnotic drugs 2 weeks before treatment%;87.14%of patients have no history of using anti-anxiety and depressive drugs.The two groups have consistent baselines in demographic information,culture,occupation,course of disease,history of drug use,stressful life events,laboratory indicators,etc.,and there is no statistical difference,and they are comparable.3.3.3 Clinical research results3.3.3.1 Baseline analysis of efficacy indicatorsBefore treatment,the control group had a total average score of 19.86±5.64 on the Insomnia Severity Index(ISI),a total average score of 15.04±2.96 on the Pittsburgh Sleep Severity Index(PSQI),and a total score of Cornell Health Inventory(CMI)(AR)The MR(psychological symptoms)score and the median and interquartile range in the scale were 43(22.5,57)and 15.5(6.5,19)respectively;the total mean sleep belief and attitude(DBAS)score was 86.75± 12.84 The scores of the Self-rating Anxiety Scale(SAS)and the median and interquartile range of each factor score were 44.38(41.25,57.50);the total mean score of the Self-rating Depression Scale(SDS)was 53.17± 10.76.The average ISI score of the treatment group was 19.86±5.64,and the average PSQI score was 15.04±2.96.The total CMI score,MR score,median,and interquartile range were 35(20,51)and 11(7,18),respectively;DBAS total average The score is 81.90±10.21;the SAS score and the median score of each factor and the interquartile range are 44.38(41.25,57.50);the total average SDS score is 56.79± 12.66.Before treatment,the two groups had no statistical differences in ISI,PSQI,CMI,DBAS,SAS,and SDS scale scores,and the baselines were consistent and comparable.3.3.3.2 Analysis of curative effect indicators(not stratified)A:The main efficacy indicators(ISI,PSQI,CMI),after 4 weeks of treatment:①ISI:The total mean score of ISI in the control group was 13.86±5.81,and the total effective rate was 47.62%;the total mean score of ISI in the treatment group was 11.31 ± 5.59,and the total effective rate was 74.29%.②PSQI:The total mean score of PSQI in the control group was 10.88±4.12,and the total effective rate was 38.46%;the total mean score of PSQI in the treatment group was 1 1.92±4.68,and the total effective rate was 56.10%.③CMI:The total score of CMI,the total score and median of M-R of the control group,and the interquartile range were 26(21,56)and 7(2,23).The abnormal rates of CMI total score and M-R total score were 40.74%and 33.33%,respectively,and the total effective rate of CMI was 44.44%.In the treatment group,the total score of CMI,the total score of M-R and the median,interquartile range were 25(13,39)and 7(3,13).The abnormal rate of CMI total score and M-R total score were 29.27%and 14.63%,respectively,and the total effective rate of CMI was 58.54%.B:Secondary efficacy indicators(DBAS,SAS,SDS),after 4 weeks of treatment:④DBAS:The total mean DBAS score of the control group was 88.17±9.58,and the total mean DBAS score of the treatment group was 91.25±11.18.⑤SAS:The total SAS score,median,and interquartile range of the control group were 45(36.25,51.25);the SAS total score,median,and interquartile range of the treatment group were 37.50(36.25,47.50).The number of people with mild,moderate,and severe anxiety in the control group were 35.71%,7.14%,and 0.00%,respectively,and the number of people in the treatment group with mild,moderate,and severe anxiety were 17.39%,0.00%,and 0.00%,respectively.The total effective rate of the control group was 7.14%;the total effective rate of the treatment group was 34.78%.⑥SDS:The total mean SDS score of the control group was 45.44±12.5;the total mean SDS score of the treatment group was 48.17±12.12.The number of people without depression,mild,moderate,and severe depression in the control group were 69.23%,23.08%,7.69%,and 0.00%,respectively;the number of people without depression,mild,moderate,and severe depression in the treatment group were 72.43%,13.64%,and 13.64%,respectively.9.09%,4.55%.The total effective rate of the control group was 30.77%;the total effective rate of the treatment group was 31.82%.A:The main efficacy indicators(ISI,PSQI,CMI),after 4 weeks of treatment:Comparing the two groups before and after the group,the total average scores of ISI and PSQI of the two groups were lower than before treatment,there was a statistical difference(P<0.05).Only the average CMI and M-R total scores of the treatment group decreased compared with before treatment,with statistical difference(P<0.05).In comparison between the two groups,the total effective rate of ISI in the treatment group was higher than that in the control group,showing statistical differences(P<0.05).There was no statistical difference between the two groups in the total average scores of ISI,PSQI,CMI and M-R,the total effective rate of PSQI,CMI,and the abnormal rate of CMI and M-R(P>0.05).B:Secondary efficacy indicators(DBAS,SAS,SDS),after 4 weeks of treatment:Before and after comparison between the two groups,only the treatment group had statistical differences in the improvement of DBAS,SAS total average score,SAS and SDS severity(P<0.05).The mean SDS scores of the two groups showed a decreasing level,and the mean SDS values of the two groups were statistically different before and after treatment(P<0.05).There was no significant difference in the total score of DBAS,the total score of SAS and SDS,and the total effective rate of SAS and SDS between the two groups(P>0.05).3.3.3.3 Stratified analysis of curative effect indicators(stratified treatment based on PSQI score(PSQI≥/<15 points))A:Insomnia patients with PSQI<15,after 4 weeks of treatment:①ISI:The total mean ISI score of the control group(n=8)was 13.88±2.035 and the total mean ISI score of the treatment group(n=18)was 11.67± 5.88.The total effective rate of the control group was 25.00%,and the total effective rate of the treatment group was 66.67%.②PSQI:The total mean PSQI score of the control group(n=11)was 11.27± 3.2,and the total mean PSQI score of the treatment group(n=19)was 9.63 ± 3.86.The total effective rate in the control group was 18.18%,and the total effective rate in the treatment group was 52.63%.③CMI:Control group(n=13)CMI total score median and interquartile range 24(21,56),MR median and interquartile range 7(4,21);treatment group(n=19)The median and interquartile range of CMI total score is 7(3,16),and the median and interquartile range of MR is 7(3,16).The total effective rate of the control group was 46.15%,and the total effective rate of the treatment group was 57.89%.The abnormal rates of CMI and M-R at stage 3 in the control group were 38.46%and 30.77%,respectively,and the abnormal rates of CMI and M-R at stage 3 in the treatment group were 36.84%and 15.79%,respectively.④SAS:The median and interquartile range of SAS in the control group(n=9)and treatment group(n=12)were 41.25(36.25,51.25)and 41.25(36.25,47.50),respectively.The number of insomnia patients in the control group without anxiety,mild,moderate,and severe anxiety were 55.56%,33.33%,11.11%,and 0.00%,respectively;the number of insomnia patients in the treatment group without anxiety,mild,moderate,and severe anxiety were 83.33%,respectively,16.67%,0.00%,0.00%.The total effective rate of the control group was 0.00%,and the total effective rate of the treatment group was 8.33%.⑤SDS:The total mean SDS scores of the control group(n=9)and the treatment group(n=12)were 42.72±10.26 and 51.48± 11.06,respectively.The number of insomnia patients without depression,mild,moderate,and severe depression in the control group were 77.78%,22.22%,0.00%,and 0.00%,respectively;the number of insomnia patients in the treatment group without depression,mild,moderate,and severe depression were 66.67%,respectively,16.67%,16.67%,0.00%.The total effective rate of the control group was 22.22%,and the total effective rate of the treatment group was 25.00%.B:Insomnia patients with PSQI≥15 points,after 4 weeks of treatment:①ISI:the control group(n=13)the total average ISI score is 13.85±7.34,the treatment group(n=17)the total average ISI score is 10.94±5.41;the total effective rate of the control group is 61.54%,and the total effective rate of the treatment group is 82.35%.②PSQI:the control group(n=15)has a total PSQI score of 12.40±5.59,the treatment group(n=18)has a total PSQI score of 11.96±4.11;the control group has a total effective rate of 53.33%,and the treatment group has a total effective rate of 59.09%.③CMI:Control group(n=14)CMI total score median and interquartile range 33(23,55),MR median and interquartile range 8(2,25),treatment group(n=22)The median and interquartile range of CMI total score is 23.5(11,35),and the median and interquartile range of MR is 7(0,9).The total effective rate in the control group was 42.86%,and the total effective rate in the treatment group was 59.09%.The abnormal rates of CMI and M-R at stage 3 of the control group were 42.86%and 35.71%,respectively.The abnormal rates of CMI and M-R at stage 3 of the treatment group were 22.73%and 13.64%,respectively.④SAS:The median and interquartile range of SAS in the control group(n=5)and treatment group(n=11)were 48.75(33.75,50.00)and 35.25(35.00,47.50),respectively.The number of insomnia patients in the control group without anxiety,mild,moderate,and severe anxiety were 60.00%,40.00%,0.00%,and 0.00%,respectively;the number of insomnia patients in the treatment group without anxiety,mild,moderate,and severe anxiety were 81.82%,respectively,18.18%,0.00%,0.00%.The total effective rate of the control group was 20.00%,and the total effective rate of the treatment group was 63.64%.⑤SDS:The total mean SDS scores of the control group(n=4)and the treatment group(n=10)were 51.56± 16.50 and 44.20± 12.69,respectively.The number of insomnia patients in the control group without depression,mild,moderate,and severe depression were 50.00%,25.00%,25.00%,and 0.00%;the number of insomnia patients in the treatment group without depression,mild,moderate,and severe depression was 80.00%,respectively,10.00%,0.00%,9.09%.The total effective rate of the control group and the treatment group was 50.00%.A:Insomnia patients with PSQI<15,after 4 weeks of treatment:(1)Before and after comparison between the two groups:①Main efficacy indicators:The total average scores of ISI,PSQI,CMI,and M-R in the two groups were reduced compared to before treatment.Only the total scores of ISI,PSQI,CMI and M-R in the treatment group were statistically different before and after treatment(P<0.05).②Secondary efficacy indicators:There were statistical differences in the improvement of the severity of SDS between the two groups before and after treatment(P<0.05).There was no statistical difference in the total scores of SAS and SDS,and the severity of SAS(P>0.05).(2)Comparison between the two groups:①Main efficacy indicators:There was no significant difference between the two groups in the total average score of ISI,PSQI,CMI and M-R,total effective rate,CMI,and M-R abnormal rate(P>0.05).②Secondary efficacy indicators:There was no statistical difference in the total scores and severity of SAS and SDS,and the total effective rate(P>0.05).(3)Analysis of deduction:①Treatment period(period 2-1,period 3-2,period 3-1):In the treatment group,the improvement of "PSQI total score,PSQI factors,such as "subjective sleep quality,time to fall asleep,sleep time,sleep disturbance" was statistically different from the control group during 0-14 days of treatment(P<0.05).The"hypnotic drugs" factor of PSQI and the"cardiovascular" system symptoms of CMI were statistically different from those of the control group during 14-28 days of treatment(P<0.05).In the improvement of CMI "fatigue" symptoms,there was a statistical difference between 0-28 days of the treatment period compared with the control group(P<0.05).②Follow-up period(Phase 4-3):The treatment group has statistically significant differences in the improvement of "PSQI total score,ISI total score,subjective sleep quality,time to fall asleep,and sleep efficiency" for insomnia patients with PSQI<15 points compared with the control group(P<0.05).B:Insomnia patients with PSQI≥15 points,after 4 weeks of treatment:(1)Before and after comparison between the two groups:①Main efficacy indicators:The total average scores of ISI,PSQI,CMI and M-R in the two groups were all lower than before treatment,and the efficacy was statistically different(P<0.05).②Secondary efficacy indicators:only the treatment group showed statistical differences in the total scores of SAS and SDS and the severity of SAS and SDS(P<0.05).(2)Comparison between the two groups:①Main efficacy indicators:There was no significant difference between the two groups in the total average score of ISI,PSQI,CMI and M-R,total effective rate,CMI and M-R abnormal rate(P>0.05).②Secondary curative effect index:The treatment group has a statistically significant difference in improving the total SAS score of patients with insomnia compared with the control group(P<0.05).There was no statistical difference between the two groups in the total score of SDS,the severity of SAS and SDS,and the total effective rate(P>0.05).(3)Analysis of deduction:①Treatment period(Phase 2-1,Phase 3-1,Phase 3-2):The treatment group has statistically significant differences in the symptoms of CMI "previous health status" in the early and mid-treatment period(0-14 days)compared with the control group(P<0.05).In the improvement of ISI total score and PSQI factors such as "subjective sleep quality,sleep efficiency" there was a statistical difference(P<0.05)in the late treatment period(14-28 days)compared with the control group.In the improvement of CMI "nervous system"symptoms,there was a statistically significant difference(P<0.05)during the treatment period(days 0-28)compared with the control group.②Follow-up period(phase 4-3):The improvement of PSQI factor "subjective sleep quality" in the treatment group was statistically different than that in the control group(P<0.05).3.3.4 Analysis of the correlation between PSQI and SAS,SDS and CMI(1)In insomnia patients with PSQI<15 points,the PSQI factor "day dysfunction" was positively correlated with the total scores of CMI and SDS(correlation coefficients were(r=0.433,P=0.013);(r=0.517,P=0.016)),the hypnotic drugs were negatively correlated with the total SAS score(r=-0.436,P=0.049).(2)In patients with PSQI≥ 15 points,"sleep disturbance","day dysfunction",PSQI total score and CMI score were positively correlated(correlation coefficients were(r=0.491,P=0.002),respectively);(r=0.331,P=0.043);(r=0.397,P=0.014),the time to fall asleep was negatively correlated with the total scores of SAS and SDS(the correlation coefficients were(r=-0.614,P=0.009);(r=-0.519,P=0.048)).(3)Without stratification,PSQI factors "sleep disturbance" and "day dysfunction" are positively correlated with CMI scores(correlation coefficients are(r=0.395,P=0.001),respectively);(r=0.350,P=0.003),the,day dysfunction" was positively correlated with the total SAS score(the correlation coefficients were(r=-0.333,P=0.041).3.3.5 Analysis of personality psychological characteristics(MMPI,EMBU,ENRICH)(1)Minnesota Multiple Personality Test(MMPI)The scores of the MMPI scale of male patients with insomnia and female patients with insomnia compared with the Chinese norm were significantly higher than the norm,showing statistical differences(P<0.05).In the baseline period,the top three abnormal rates of clinical factors in the control group were ranked from high to low:Hy(61.54%),Pd(38.46%),Hs(30.77%),and D(30.77%).The treatment group ranked the top three in descending order:Hy(77.42%),Hs(61.29%),D(58.06%),Pd(58.06%).The higher abnormal rates in the two groups were Hy,Hs,D,and Pd.There was no statistical difference in the abnormal rate between the two groups(P>0.05).(2)Defense method(DSQ)The defense mechanism of patients with insomnia is more prominent in the intermediate defense mechanism(44.12%).The defense mechanism of the control group is mainly immature(50.00%)and intermediate(50.00%);the treatment group is mainly mature(45.83%)and intermediate(41.67%).There is no statistical difference between the two groups(P>0.05).(3)Parental rearing method(EMBU)During the baseline period,the comparison results of the Chinese norms of parental parenting of insomnia patients showed that parental parenting methods of insomnia patients were higher in father factor Ⅱ(punishment,severe),father factor Ⅴ(refusal to deny),and mother factor Ⅳ(severe punishment).Norm,and statistically different(P<0.05).Among them,father factor Ⅰ and mother factor Ⅰ(warmth,understanding),father factorⅢ and mother factor Ⅱ(excessive interference),father factor Ⅳ(preference for subjects),father factor Ⅵ(overprotection)are all lower than the norm.And there are statistical differences(P<0.05).Among them,the maternal factor Ⅲ(rejection,denial)factor score was higher than the norm;the maternal factor Ⅴ(participant preference)factor score was lower than the norm,but there was no statistical difference(P>0.05).In the baseline period,the parental rearing style questionnaire EMBU scores of the treatment group and the control group were not significantly different between the cofactor groups except for maternal factors Ⅰ,Ⅲ,and Ⅴ(P>0...
Keywords/Search Tags:Insomnia, Integrated Traditional Chinese and Western Medicine, Diagnosis and treatment plan, Consensus, Applicability
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