| Objective A randomized controlled trial was conducted to evaluate the clinical efficacy of Guipi Yangxin Prescription in the treatment of insomnia with deficiency of both heart and spleen.Methods Randomized,placebo-controlled,single blind trial design was adopted.62 patients with insomnia of deficiency of heart and spleen who met the research criteria were randomly divided into experimental group and control group,with 31 cases in each group.On the basis of sleep hygiene guidance,the experimental group was treated with oral Guipi Yangxin Prescription and the control group was treated with oral placebo.The course of treatment was 4 weeks,and the patients were followed up 1 month after the treatment.Pittsburgh sleep quality index（PSQI）was used as the main evaluation standard,and and traditional Chinese medicine（TCM）syndromes score scale was used as the secondary evaluation standard.The two groups of patients were evaluated before treatment,after treatment and followed up 1 month after treatment.Meanwhile,the two groups of patients were examined for safety index before and after treatment.Finally,SPSS25.0 software was used for statistical analysis of the data,at the same time,the superiority test was used to evaluate the clinical significance of the post-treatment and follow-up efficacy of the two groups.Results1.This study included 62 patients,3 cases fell off,and a total of 59 cases completed the experiment,including 30 cases in the experimental group and 29 cases in the control group.The analysis of baseline data showed that there was no significant difference between the experimental group and the control group in gender,age,course of disease,educational level,total score and each factor score of PSQI before treatment,total score and each syndrome score of TCM syndromes before treatment（P<0.05）.The two groups were balanced and comparable.2.After 4 weeks of treatment,the total score of PSQI and the scores of various factors,the total score of TCM syndromes and the scores of various syndromes in the experimental group after treatment were lower than those before treatment,and were lower than those in the control group.There were significant differences compared with the control group（P<0.05）.The experimental group was better than the control group in improving the score of the scale.Intra-group comparison,the total score of PSQI and the various factors,the total score of TCM syndrome and the scores of various syndromes in the experimental group after treatment were significantly different from those before treatment（P<0.05）.The total scores of PSQI and TCM syndromes in the control group after treatment were significantly different from those before treatment（P<0.05）.Compared those before treatment,there were also significant differences on the scores of various factors and syndromes in the control group after treatment（P<0.05）,except for sleep disorder factor and palpitation,forgetfulness,lack of appetite,loose stool,tongue and pulse condition.After 4 weeks of treatment,in the comparison of main clinical efficacy,the total effective rate of the experimental group was 87.1%and that of the control group was 32.3%.There was significant difference between the two groups（P<0.05）.The difference of effective rate between the two groups was 54.8%,the 95%confidence interval for the difference was（34.2%-75.4%）and CL>15%.As a result,the curative effect of the experimental drug on improving sleep quality was significantly better than that of the control drug.In the comparison of secondary clinical efficacy,the total effective rate of the experimental group was 90.3%and that of the control group was 29.0%.There was significant difference in secondary clinical efficacy between the two groups（P<0.05）.The difference of effective rate between the two groups was 61.3%,the 95%confidence interval for the difference was（4.2.7%-79.9%）,and CL>15%.Therefore,the clinical efficacy of Guipi Yangxin Prescription in the treatment of insomnia with deficiency of both heart and spleen was superior to that of placebo.3.The patients were followed up for 1 month after treatment.Comparison between groups,the total scores of PSQI and TCM syndromes in the experimental group were lower than those in the control group.There was significant difference between the two groups（P<0.05）.The improvement of scale score in the experimental group was better than that in the control group.Intra-group comparison,there were significant differences in the two groups in the total scores of PSQI and TCM syndromes before treatment,after treatment and follow-up（P<0.05）.The total scores of PSQI and TCM syndromes in the experimental group were lower than those before treatment,and there was significant difference compared with those before treatment（P<0.05）.The total scores of PSQI and TCM syndromes at follow-up increased compared with that after treatment in the experimental group.There was no significant difference in the total score of PSQI at the follow-up of the experimental group compared with that after treatment,but the total score of TCM syndromes at follow-up of the experimental group was statistically different from that after treatment（P<0.05）.It shown that the improvement of TCM syndromes score in the experimental group was less than that after treatment.In the main clinical efficacy,the total effective rate of the experimental group and the control group were 77.4%and 25.8%respectively.There was significant difference in the total effective rate between the two groups（P<0.05）.The experimental group was superior to the control group.In secondary clinical efficacy,the total effective rate of the experimental group and the control group were 80.6%and 22.6%respectively.There was significant difference in the total effective rate between the two groups（P<0.05）.As a whole,the two groups still had therapeutic effect on the treatment of insomnia with deficiency of both heart and spleen and the clinical effect of the experimental group was more obvious.Compared with that after treatment,the clinical efficacy of the two groups at follow-up was weakened,but the drugs in the experiment group still has a good maintain efficacy on improving the sleep quality and TCM syndromes of insomnia patients with deficiency of both heart and spleen in short term.4.No obvious abnormalities were found in the safety tests of the two groups before treatment.Three cases fell off during the test,but it was not caused by adverse drug reactions.The 59 patients who completed the trial did not have adverse reactions during the treatment,and there were no obvious abnormalities in various safety tests after treatment.Conclusions This study preliminarily confirmed that Guipi Yangxin Prescription can effectively improve the sleep quality and TCM syndromes of insomnia with deficiency of both heart and spleen.The clinical efficacy of Guipi Yangxin Prescription is significantly better than placebo,and it has high safety.Meanwhile,Guipi Yangxin Prescription has maintain efficacy in the short time.Guipi Yangxin Prescription is worthy of further research and discussion,so as to provide more objective basis for clinical application and promotion. |
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