| BackgroundThis study adopts cluster-randomized controlled clinical study design to evaluate the clinical effect and safety of Traditional Chinese Medicine Integrated Intervention(TCM)which combined Tiaogan-jianpi cream formula or Shuxin-anshen cream formula with herbal acupoint application and foot-bath with herbal for mild chronic insomnia.Study aimed at forming a set of traditional Chinese medicine integrated intervention technical scheme and operation specification directed against mild chronic insomnia,exploring its application,indications,techniques scheme,operation specification,the evaluation index system,and so on,formatting generic technology for the characteristics of traditional Chinese medicine diagnosis and treatment of mild chronic insomnia.MethodsIn this study,cluster-randomized trials were used to divide the cluster units that met the inclusion criteria into the Traditional Chinese Medicine Integrated Intervention group(TCM group)and the controlled group(placebo group)through a simple randomized method.By the staff who did not know the results of the cluster group,the qualified individual subjects were included in the study according to the inclusion and exclusion criteria.Both groups of mild chronic insomnia were given sleep hygiene guidelines,on this basis,the experimental group accepted Traditional Chinese Medicine Integrated Intervention(cream formula,herbal acupoint application,foot-bath with herbal),control group accepted placebo intervention(placebo cream,placebo acupoint application,foot-bath with clear water).Two groups both continued intervention for two period of treatment with 4 weeks one course,and follow-up to the end of 3 months.Pittsburgh sleep quality index(PSQI),patient self-assessment tool for depression(PHQ-9),generalized anxiety scale(GAD-7),Traditional Chinese medicine quality of life scale for insomnia(TCMQLI-21)and adverse events were evaluated before and after the intervention and follow-up of patients with insomnia at each node.SPSS17.0 was used for statistical analysis of the data and conclusions were drawn.ResultsA total of 158 patients,82 in the experimental group and 76 in the control group were included in this study.151 cases of researchers were actually completed,including 80 cases in the experimental group and 71 cases in the control group.Two groups of patients before treatment on the distribution of the gender,age,occupation,education level,marital status,religious beliefs,the length of the course of the disease,allergy,alcohol and tobacco dependence may,merge disease situation,the virtual empirical type structure,PSQI each factor and total score,insomnia in traditional Chinese medicine quality of life scale(TCMQLI-21),depression self rating scale(PHQ-9),generalized anxiety scale(GAD-7)group,there were no statistically significant difference between good comparability between the two groups(P>0.05).Patients before treatment PSQI score of 10.10±1.91,the control group PSQI score 10.24±1.81,there was no statistically significant difference in the two groups,the observation of two groups of four repetitive measure analysis of variance comparison of PSQI scores point,the results show that the two groups in different observation point of PSQI score difference was statistically significant(F=11.334,P=0.001),two groups with time effect(F=247.07,P<0.001),the interaction of the group and time effect was statistically significant(F=18.498,P<0.001).The results of multivariate test showed that after one course of treatment,the total PSQI score of the experimental group was 6.94±2.38,and that of the control group was 7.62±2.33.There was no statistically significant difference between the two groups(P>0.05).After two courses of treatment(6.07±2.58 of the experimental group,7.77±2.21 of the control group)and one month of follow-up(6.07±2.70 of the experimental group,8.01±2.13 of the control group),the differences between the two groups were statistically significant(P<0.05).The improvement of sleep quality factor and daytime functional factor was particularly prominent(P<0.05),and the efficacy advantage of TCM comprehensive intervention group was still significant 1 month after drug withdrawal(P<0.05).2.The total effective rate after 2 courses of treatment and 1 month follow-up were taken as evaluation indexes respectively.The total effective rate of the experimental group after 2 courses of treatment was 78.75%,significantly higher than that of the control group(56.33%).After 1 month follow-up,the total effective rate of the experimental group was 3.75%,and that of the control group was 43.66%(12.67%).The difference between the two groups was still statistically significant(P<0.05).3.Repeated measurement anova was used to compare the scores of PSQI factors at 4 observation points in the two groups.There were statistically significant differences in sleep quality and daytime dysfunction factors between the two groups at different observation points(P<0.05),while there were no statistically significant differences in other 5 factors between the two groups at different observation points(P>0.05).Seven factors in addition to the hypnotic drug use factor has time effect(P<0.05),the sleep quality factor,sleep time factor,efficiency factor,sleep disturbance factor,time factor groups with the daytime dysfunction interaction effect was statistically significant(P<0.05),the sleep time factor and hypnotic drug use factor groups with the interaction effect of no statistical significance(P>0.05).The results of multivariate test showed that there were statistically significant differences between the two groups of sleep quality factors after 1 course of intervention(P<0.05),and that there were statistically significant differences between the two groups of sleep quality factors and daytime dysfunction factors after 2 courses of intervention and 1 month of follow-up(P<0.05).There was no statistically significant difference between the two groups at the observation time points of sleep time factor,sleep time factor,sleep efficiency factor,sleep disorder factor and hypnotic drug use factor(P>0.05).4.On two groups of four observation point TCLQLI-21 total score and the comparison of each dimension points using repetitive measure analysis of variance,the results show that the two groups in different observation point TCLQL1-21 total score,physiological function of the dimensions,the psychological function dimension,cognitive function,dimension,the environment affect the dimension difference was statistically significant(P<0.05),two groups of social function dimension is no statistical difference(P>0.05).TCLQLI-21 total score and each dimension score had time effect(P<0.05),and the interaction effect between groups and time was statistically significant(P<0.05).The results of multivariate test showed that there were statistically significant differences in the cognitive function dimension between the two groups after one course of intervention(P=0.038<0.05),and TCLQLI-21 total score,physiological function dimension,psychological function dimension,cognitive function dimension,social function dimension and environmental impact dimension between the two groups after two courses of intervention(P=0.038<0.05).The total score of TCLQLI-21 and the scores of each dimension between the two groups were still statistically different after 1 month of follow-up(P<0.05).5.Repeated measurement anova was used to compare the phq-9 and GAD-7 scores at 4 observation points in the two groups,and the results showed that there was statistically significant difference between the two groups in PHQ-9 and GAD-7 scores at different observation points(P<0.05),while no statistically significant difference was found between the two groups(P>0.05).Both PHQ-9 and GAD-7 scores had time effect(P<0.05),and the interaction effect between groups and time was statistically significant(P<0.05).Multivariate test results showed that there was no statistically significant difference in PHQ-9 and GAD-7 scores between the two groups after one course of intervention(P=0.038<0.05),and that there was statistically significant difference in PHQ-9 and GAD-7 scores between the two groups after two courses of intervention(P<0.05).After 1 month of follow-up,the scores of PHQ-9 and GAD-7 were still statistically different(P<0.05).6.Auxiliary analysisThe total effective rate differences of 9 units were compared at 1 month follow-up after the end of treatment.Krukal-wallis H rank sum test was carried out by analyzing data of multiple groups of grades,and groups were divided into "1-5","6-9" comparison test group and control group.The results showed that there was no statistically significant difference between 5 units in the experimental group(P>0.05)and 4 units in the control group(P>0.05).The total PSQI scores of 5 units in the experimental group and 4 units in the control group were tested respectively after 1 month follow-up after treatment.The results showed that there was no statistically significant difference between 5 units in the experimental group(P>0.05)and 4 units in the control group(P>0.05).To compare the therapeutic effect difference between virtual and real.The efficacy of 1 month follow-up(T3 time point)was taken as the final evaluation index,and the rank sum test of grade data was used.The comparison results between the two groups of the same syndrome showed that there was a statistical difference between the two groups of the deficiency syndrome(P=0.018),and there was a statistical difference between the two groups of the empirical evidence(P<0.001).Compared between the two groups of different syndromes,there was no statistical difference in the efficacy between the two groups of the experimental group(P>0.05)and the control group(P>0.05),suggesting that the efficacy of different intervention schemes for different syndromes was consistent.The total scores of PSQI of different syndromes in the two groups were compared before and after treatment for 1 month,and the results showed that there was no statistically significant difference between the two groups before and after treatment for 1 month(P>0.05).7.In terms of safety indicators,a total of 158 patients were included in 9 units.There were 82 cases in the experimental group and 76 cases in the control group.Heart rate,blood pressure,blood routine,urine routine,liver function(ALT,AST),renal function(Cr,BUN),and electrocardiogram all showed no abnormal changes before and after treatment.In the treatment group of TCM comprehensive intervention technology,adverse reactions occurred in the first half of the first course of treatment in 16 cases,87.5%of which were related to the paste prescription,all of which occurred in the first half of the first course of treatment(within 15 days),and were not combined with the use of traditional Chinese medicine foot massage and/or acupoint sticking therapy.After treatment,the adverse reactions in the second course of treatment were reduced to 2.5%.Adverse reactions were observed in 3 cases in the control group.ConclusionThe Traditional Chinese Medicine Integrated Intervention has obvious improvement effect on the sleep condition of mild chronic insomnia,especially on the improvement of sleep quality and daytime function,and the curative effect is significantly different from that of placebo group.It can significantly improve anxiety,depression and quality of life and has clinical significance. |
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