| ObjectiveBased on the academic thought of "heart-kidney ascending and descending ",the research observes the clinical efficacy and safety of Jiaotai Shenzhi Decoction in the treatment of chronic insomnia with Cardionephric Disharmony,provides a clinically feasible solution for the treatment of chronic insomnia by traditional Chinese medicine,and provides scientific evidence for the theoretical study of the viscera-qi mechanism of traditional Chinese medicine.MethodsIn this study,120 patients with chronic insomnia who met the diagnostic criteria from May 2020 to May 2021 in neurology department of Wuhan Hospital of Traditional Chinese Medicine were selected as the research subjects.Using random number table method,the patients were divided into the traditional Chinese medicine test group（Jiaotai Shenzhi Decoction group）,the Chinese patent medicine control group（Wuling Capsule group）and the Western medicine control group（Ezopiclone group）,with 40 cases in each group.All three groups were intervened on the basis of the same basic sleep knowledge education.The the traditional Chinese medicine test group was treated with Jiaotai Shenzhi decoction,a self-made traditional Chinese medicine decoction.The Chinese patent medicine group took Wuling Capsules,and the control group was observed by taking eszopiclone tablets as a positive drug control group.The duration of treatment was 4 weeks（28 days）,and the Pittsburgh Sleep Quality Index（PSQI）,TCM syndromes,SAS score and SDS score were collected before treatment（day 1）,and after treatment（day 28）.One month after the end of treatment,three groups were followed up respectively to observe the recurrence of insomnia and the changes of various scores,in order to make a scientific and objective evaluation on the short-term and long-term efficacy and safety of Jiaotai Shenzhi Decoction in the treatment of chronic insomnia.Results1.A total of 114 qualified cases were finally completed.By comparing the course of disease,age and gender of the three groups of cases,there was no significant difference between the three groups（P>0.05）,which was comparable.2.Comparison of the overall clinical efficacy of the three groupsComparison within the group:the three groups were compared before and after the medication,and there were obvious effects（P<0.05）.The total clinical effective rate was 76.92%in the Chinese medicine test group,84.21%in the western medicine control group,and 70.27%in the Chinese patent medicine group.Comparison between groups:There was a statistical difference in the total effective rate among the three groups（P<0.05）.The clinical effective rate of the group was higher than that of the Chinese patent medicine group,and the difference was statistically significant（P<0.05）.There was no significant difference in the effective rate with the western medicine group（P>0.05）.3.Comparison of the efficacy of TCM syndromes.Comparison within groups:The scores of TCM syndromes in the three groups before and after treatment were decreased,but only the difference between the TCM group and the Chinese patent medicine control group was statistically significant（P<0.05）,and the scores before and after the western medicine control group were not statistically significant.difference（P>0.05）.Comparison between groups:After the treatment of Chinese medicine group,the total effective rate of the syndrome was the highest,which was 87.18%,the Chinese patent medicine group was 78.37%,and the western medicine group was 55.26%.There were differences among the three groups（P<0.05）.After comparing the three groups,the TCM experimental group had significant advantages in improving TCM syndrome scores and total effective rate,which was superior to the TCM group and the Western medicine group（P<0.05）.4.PSQI scale score calculationComparison within groups:The total score of PQSI decreased in the three groups before and after treatment（P<0.05）.Among them,the total PSQI score and the individual factor scores of the traditional Chinese medicine experimental group were significantly decreased（P<0.01）.Comparison between groups:Compared with the traditional Chinese medicine experimental group and the Chinese patent medicine control group,the PSQI total score was significantly improved（P<0.05）,and it had advantages in sleep quality,sleep time,sleep onset time,and improvement of various sleep factors of daytime dysfunction（P<0.05）.Compared with the western medicine control group,there was no significant difference in improving PSQI total score,sleep quality,sleep time and various sleep factors（P>0.05）,and it was inferior to the western medicine group in shortening the time to fall asleep,but it improved daytime dysfunction.There is a significant advantage in terms of（P<0.01）.5.Comparison of emotional state improvementComparison within groups:There was no significant difference in the scores of SAS and SDS scales before treatment among the three groups,and they were comparable（P>0.05）.And after the treatment of the three groups before and after the self-comparison,the scale scores were all decreased,and the difference was statistically significant（P<0.05）.Comparison between groups:Compared with the three groups after treatment,the improvement of SAS and SDS scores in the Chinese medicine experimental group was better than that in the Chinese patent medicine group and the western medicine group,with statistical significance（P<0.05）;There was no statistical difference in SDS score（P>0.05）.6.Comparison of recurrence ratesThrough follow-up,the recurrence rate of the traditional Chinese medicine group was the lowest,which was 12.82%,and the recurrence rate of the western medicine group was the highest,which was 12.82%.The recurrence rate was 36.84%among the three groups（P<0.05）.Compared among the three groups,the recurrence rate of the traditional Chinese medicine group was significantly lower than that of the western medicine group,and the difference was statistically significant（P<0.05）.However,there was no significant difference in the recurrence rate between the Chinese medicine group and the Chinese patent medicine group（P>0.05）.7.Safety comparisonThere were no obvious abnormalities in laboratory test indexes before and after treatment in 114 patients.During the study period,a total of 4 adverse reactions occurred,manifested as mild diarrhea,dizziness,fatigue and discomfort.Among them,there was 1 case in the Chinese medicine group,3 cases in the western medicine group,and none in the Chinese patent medicine group.The incidence of adverse reactions in the traditional Chinese medicine group was lower than that in the western medicine group,but the difference was not statistically significant（P>0.05）.Conclusion1.Jiaotai Shenzhi Decoction has a significant curative effect on chronic insomnia with Cardionephric Disharmony.It has significant advantages in improving insomnia accompanying symptoms,improving daytime function,and improving quality of life,and has certain anti-anxiety and depression effects.And high safety,low recurrence rate,has advantages in long-term efficacy.2.Jiaotai Shenzhi Decoction provides a feasible solution for the treatment of chronic insomnia in traditional Chinese medicine,demonstrates the scientificity of the theory of "heart and kidney ascending and descending",and enriches the connotation of the theory of qi machine ascending and descending. |
PDF Full Text Request