| [Background]Insomnia is mainly manifested by the long time needed to fall asleep or easy to wake up in the middle of sleep,or no longer fall asleep after waking up,and unsatisfied with sleep,affecting daytime activities,reducing work and study efficiency,and even causing more serious accidents.The name of the disease in Chinese medicine is "sleeplessness","not to close eyes",etc.Since the "Yellow Emperor’s Classic of Internal Medicine",there is a certain understanding of the formation of sleep and the pathogenesis of insomnia.Later medical practitioners also inherited and developed the mechanism of Yang not entering Yin from Huangdi Neijing.Modern medical practitioners have identified insomnia on the basis of the eight principles of identification of the internal organs,i.e.,all.the five internal organs and six internal organs cause insomnia;according to the influence of pathological factors,the identification of deficiency of qi,blood,phlegm and stasis is more flexible in clinical application.Based on the current understanding,the influence of emotion on sleep is particularly important.With the increased pace and stress of modern life,the number of insomnia has increased.Insomnia causes a great medical burden,and the annual loss of quality of life adjustment due to insomnia is greater than that caused by other medical and psychiatric disorders.Insomnia is mostly co-morbid with depression and anxiety,and 80%of the increase in health care costs after insomnia diagnosis is attributed to the management of insomnia and coexisting disorders.Patients with chronic diseases have increased rates of insomnia due to illness and psychological factors,which are also detrimental to recovery from illness,resulting in a vicious cycle.In a community survey in China,it was shown that the prevalence of chronic insomnia in the community was 23.26%.At present,the modern medical system is dominated by medication,such as benzodiazepines and non-benzodiazepines,atypical antidepressants and atypical antipsychotics,with problems of drug abuse,as well as damage to life and property,and patients have certain concerns about the use of sedative sleeping drugs,fearing addiction,whether there is a withdrawal reaction and other side effects.Cognitive-behavioral therapy for insomnia is recommended as the first-line treatment for insomnia;cognitive-behavioral therapy is mainly used to improve insomnia by changing patients’ wrong attitudes toward sleep,bad behaviors,catastrophizing cognition,and establishing good sleep habits.Psychotherapy also has certain problems,such as the disadvantages of uneven therapists,large costs and long treatment courses.Other non-pharmacological treatments for insomnia include transcranial magnetic stimulation.The available clinical data are still relatively small,and more objective data and multicenter double-blind controlled studies are needed to further confirm the clinical efficacy of rTMS for primary insomnia.Traditional medicine has its own advantages in the treatment of insomnia,and the Yangxin Dawayimixike MiGao is derived from classical Vedic medical texts and has been used for a long time for the treatment of insomnia,but the lack of scientific and rigorous clinical research has limited the use and promotion of this Vedic medicine to a certain extent.Yangxin Dawayimixike MiGao has the effect of calming and tranquilizing the mind,invigorating blood circulation,tonifying the brain and strengthening the heart,strengthening the stomach and toning the body,applied in the treatment and prevention of cardiovascular diseases.The application of Yangxin Dawayimixike MiGao in cardiovascular diseases has been studied to confirm the superior effectiveness in shortening patients’ hospitalization and improving their quality of life.The long-term development of insomnia not only has a negative impact on mood,but also causes a decrease in immune resistance,affects blood pressure,and increases the risk of cardiovascular diseases.There are few clinical trial studies on the application of Nourishing Heart Honey Paste in insomnia,but there have been clinical reports of its application in insomnia.Based on the understanding of double heart disease,the efficacy of nourishing heart honey paste in insomnia was further explored.Firstly,there is no need to worry about drug abuse and withdrawal reactions,so patients will not have too many concerns and have good acceptability;secondly,the drug has a good taste and patients will have good compliance when taking it for a long period of time;furthermore,Yangxin Dawayimixike MiGao is derived from the classical medical books and has been applied for a long time,so it is safe and effective for patients.Randomized,controlled,double-blind,multicenter is of high quality trials for the detection of the effectiveness of drug therapy,and there is no strict clinical design study for the application of this drug in insomnia at present.Therefore,based on the previous study,we designed a multicenter,randomized,double-blind,double-simulation,parallel-controlled clinical study on patients with qi stagnation and blood stasis insomnia to investigate the efficacy and safety of nourishing heart Yangxin Dawayimixike MiGao in the treatment of patients with qi stagnation and blood stasis insomnia,and to observe the performance of Yangxin Dawayimixike MiGao in depression,anxiety and somatization,to confirm that Yangxin Dawayimixike MiGao is It is worth to promote a method of treating insomnia in Chinese medicine,and provide evidence-based medical evidence for the treatment of insomnia in Chinese medicine.[Objective]To study the efficacy and safety of Yangxin Dawayimixike MiGao in the treatment of insomnia in patients with Qi stagnation and blood stasis,and to provide evidence-based medical evidence for the treatment of insomnia in Chinese medicine.Methods1 Study design:multicenter,randomized,double-blind,double-simulation,parallel-controlled clinical trial.2 study subjects:96 patients diagnosed with qi stagnation and blood stasis type insomnia who attended the outpatient clinics of Guang’anmen Hospital of the Chinese Academy of Traditional Chinese Medicine,Xiangyang Hospital of Traditional Chinese Medicine,the Third Hospital of Henan University of Traditional Chinese Medicine,and the Affiliated Hospital of Henan Provincial Academy of Traditional Chinese Medicine from December 2019 to April 2021 were divided into observation and control groups in a 3:1 ratio,with 72 cases in the observation group and 24 cases in the control group.3 Treatment method:The observation group was given Yangxin Dawayimixike MiGao(3g/time,2 times a day,p.o.)+ XueFuZhuYu capsule Simulants(6 capsules once,2 times a day,p.o.),and the control group was given Yangxin Dawayimixike MiGao Simulants(3g/time,2 times/day,p.o.)+XueFuZhuYu capsule(6 capsules once,2 times a day,p.o.).Duration of treatment 8w.4.Observation indexes and observation time points:general demographic data were surveyed before treatment,Insomnia Severity Index Scale(ISI),Pittsburgh Sleepiness Index Scale(PSQI),Chinese Medicine Evidence Score Scale,Hamilton Depression Scale(HAMD),Hamilton Anxiety Inventory(HAMA),Patient Health Questionnaire-9(PHQ-9),Patient Health Questionnaire-15(PHQ-15),Generalized Anxiety Scale(GAD)was assessed once at week 0,4 weeks and 8 weeks;efficacy assessment was observed once at 4 weeks and 8 weeks after treatment;adverse effect scale was completed at week 4 and 8 after treatment;blood and urine routine,liver and kidney function and electrocardiogram were tested once before and once at the end of treatment;post-treatment adverse events were recorded in both groups.[Results]1 Baseline informationIn this study,96 cases were actually enrolled,including 72 cases in the test group and 24 cases in the control group,32(33.3%)men and 64(66.7%)women,with no significant differences between the two groups in terms of gender,age and other demographic data(P>0.05),which were comparable.unbalanced baseline ISI total score needed to be considered for inclusion of covariate analysis to correct for unbalanced baseline.2 Comparison of total scores and efficacy ratings of insomnia severity indexBy paired t-test,there was a statistically significant difference between the ISI severity index scale scores of the test group at each visit point and the baseline(P<0.001),and the test group had good treatment effect.There was a statistically significant difference between the two groups in the test group and the observation group(P<0.01),and the difference between the two groups was statistically significant when included in the analysis of covariance model,and the test group was superior to the control group.In the test group,83.33%(60 cases)were cured after 8 w of treatment,13.89%(10 cases)for mild insomnia and 2.78%(2 cases)for moderate insomnia,while in the control group,12.50%(3 cases)were cured after 8 w of treatment,41.67%(10 cases)for mild insomnia,41.67%(10 cases)for moderate insomnia and 4.17%(1 case)for severe insomnia,and the difference between the two groups There was a statistically significant difference between the two groups(CMH-Chisq=42.97,P<0.01).3 The efficacy of the total evidence score of the Chinese medicine evidence score scaleAfter 8 w of treatment,the decrease in the total score of CMH was 7.03±3.03,compared with 1.75±2.95 in the control group,with a statistically significant difference between the two groups(t=7.43,P<0.01).After 8 weeks of treatment,20.83%(15 cases)were cured,36.11%(26 cases)were effective,37.50%(27 cases)were effective,and 5.56%(4 cases)were ineffective in the test group,while 0%(0 cases)were cured,4.17%(1 case)were effective,37.50%(9 cases)were effective,and 58.33%(14 cases)were ineffective in the control group after 8 w of treatment.),the difference between the two groups was statistically significant(CMH-Chisq=32.34,p<0.01).4 Total score and efficacy of Pittsburgh Sleepiness Index scaleThe decrease value of PSQI total score after 8w of treatment was 8.33±3.18 in the test group and 1.46±3.23 in the control group,and the difference between the two groups was statistically significant(t=9.1465,P<0.01).The test group was superior to the control group.After 8 weeks of treatment,the clinical recovery was 87.50%(63 cases),effective 11.11%(8 cases)and ineffective 1.39%(1 case)in the test group,while the clinical recovery was 16.67%(4 cases),effective 37.50%(9 cases)and ineffective 45.83%(11 cases)in the control group,and the difference between the two groups was statistically significant(CMH-Chisq=46.94,P<0.01).5 Comparison of total scores of PHQ-4,PHQ-9,GAD-7 and PHQ-15 scalesThe decrease value of PHQ-4 total score after 8w of treatment was 1.44±1.92 in the test group and-0.13±1.15 in the control group,and the difference between the two groups was statistically significant(corrected t=4.80,P<0.01).The decrease in PHQ-9 total score after 8w of treatment was 3.61 ±3.40 in the test group and 0.38±2.26 in the control group,with a statistically significant difference between the two groups(corrected t=5.30,P<0.01).After 8 w of treatment,the decrease in GAD-7 total score was 2.56±3.44 in the test group and-0.04±1.65 in the control group,and the difference between the two groups was statistically significant(corrected t=4.92,P<0.01).After 8 w of treatment,the decrease of PHQ-15 total score was 3.25±3.05 in the test group and-0.13±2.25 in the control group,and the difference between the two groups was statistically significant(corrected t=4.98,P<0.01).6 Treatment safetyThere was no statistically significant difference in the clinical significance of each vital sign,laboratory and electrocardiogram examination between the groups before and after treatment(p>0.05).During the treatment process,drug-related adverse events occurred 2 times in 2 subjects in the observation group,with an incidence rate of 2.78%;5 times in 5 subjects in the control group,with an incidence rate of 20.83%,and the difference between the two groups was statistically significant by Fisher’s exact probability method(p=0.01).There were no serious adverse events in either group.[Conclusion].1 For the treatment of patients with qi stagnation and blood stasis type insomnia,Yangxin Dawayimixike MiGao is superior to XueFuZhuYu capsule.2 For the treatment of insomnia patients with Qi stagnation and Blood stasis,Yangxin Dawayimixike MiGao can improve the Chinese medical evidence of the patients.3 Yangxin Dawayimixike MiGao was able to reduce Hamilton Depression Scale,Hamilton Anxiety Scale,and Somatic Symptom Scale scores while treating insomnia in patients with Qi stagnation and Blood stasis type. |
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