Study On The Efficacy And Mechanism Of Tianwang Buxin Granules On Perimenopausal Insomnia Based On Intestinal Flora

Objective To study the relationship between perimenopausal insomnia and intestinal flora,and whether Tianwang Buxin granules and Tianwang Buxin slices are equivalent,and to explore the potential mechanism of Tianwang Buxin granules in exerting its clinical efficacy by regulating the intestinal flora composition in perimenopausal insomnia patients.Methods1.Theoretical study:A systematic summary reviewed the ancient Chinese books and modern scholars’ understanding of the disease name,etiology,pathogenesis and treatment methods of insomnia,and expounded the possible mechanism of Chinese medicine for insomnia.The etiology and pathogenesis of TCM in perimenopausal insomnia were analyzed,and the kidney deficiency and fire exuberance were summarized.Ziyin anshen is an important treatment for perimenopausal insomnia.At the same time,the pharmacological effects of several single drugs in Tianwang Buxin Recipe have also been sorted out.It provides a theoretical basis for Tianwang Buxindan to treat perimenopausal insomnia.2.Experimental Study:(1)13 perimenopausal insomnia patients were obtained from the Hubei provincial hospital of TCM,Hubei University of Chinese Medicine and Wuhan hospital of Traditional Chinese Medicine.The feces of Tianwang Buxin Granules and their non-insomnia spouses before and after treatment were collected,and the intestinal flora composition of each group was detected by metagenomic sequencing.(2)A total of 100 insomnia cases were collected from the above three hospital,and the patients were randomly divided into two groups: Tianwang Buxin slices group and Tianwang Buxin granule group with 50 cases each,and treated with Tianwang Buxin slices and Tianwang Buxin granule respectively.The clinical effective rates of the two groups were also observed.Among them,there were 13 perimenopausal insomnia female patients in the Tianwang Buxin granule group.On the basis of the above experiments,we evaluated the efficacy of Tianwang Buxin granule on PSQI,TCM Syndrome Score,AIS,ISI,HAMD and HAMA before and after treatment.Results1.Relationship between perimenopausal insomnia and intestinal flora.Analysis of the basic information of intestinal flora in the perimenopausal insomnia group and its non-insomnia spouse control group showed that there were 1884 species in the perimenopausal insomnia group,1659 species in the control group,and a total of 1336 species in the two groups.Each sample can be stably annotated at the seven classification levels of boundary,phylum,class,order,family,genus and species,and the annotation degree is similar among samples.There were compositional abnormalities between the control group and the perimenopausal insomnia group,such as Roseburiafaecis,Ruminococcus,Prevotellacopri,Fusicatenibacter saccharivorans,Bacteroides,Fecal bacteroidetes,Faecalibacterium prausnitzii,etc.Among them,Roseburiafaecis,Ruminococcus,Prevotellacopri,Fusicatenibacter saccharivorans accounted for more in the perimenopausal insomnia group than in the control group,while Bacteroides,Fecal bacteroidetes,and Faecalibacterium prausnitzii accounted for less.2.Equivalence of Tianwang Buxin granule and Tianwang Buxin slices and Efficacy of Tianwang Buxin granule on insomnia in perimenopausal women A total of 100 cases were completed in this study.There were 50 cases in the Tianwang Buxin granule group and 50 cases in the Tianwang Buxin slices group,including 13 perimenopausal women with insomnia in the Tianwang Buxin granule group.In the clinical study of 100 insomnia patients treated with Tianwang Buxin granules/slices,we first analyzed the gender,age,height,weight,BMI of the two groups separately,and the results showed that there was no significant difference in age,height,weight,BMI between the two groups(P > 0.05),suggesting that the general situation between the two groups is balanced and comparable.We then observed the clinical efficacy of Tianwang Buxin granules and Tianwang Buxin slices.The results showed that the clinical effectiveness rate of Tianwang Buxin granule group was 76%,while the clinical effectiveness rate of Tianwang Buxin slices group was 78%.There was no significant difference in clinical effectiveness between the two gorup(P>0.05).In the study of Tianwang Buxin Granules intervention for patients with perimenopausal insomnia,the results show that Tianwang Buxin granules can significantly reduce patients’ PSQI,TCM syndrome score,AIS,ISI,HAMA and HAMD score(P < 0.05)。3.Effects of Tianwang Buxin granule on intestinal flora composition in perimenopausal insomnia patients Tianwangbuxin granules contained 1884 species before and after the treatment of perimenopausal insomnia.There was no significant difference between the two groups.Compared with the before treatment group,the abundance of Bacteroides,Fecal bacteroidetes,and Faecalibacterium prausnitzii increased after treatment,and the abundance of Roseburiafaecis,Ruminococcus,Prevotellacopri,Fusicatenibacter saccharivorans decreased.However,there was still a certain gap in the abundance of related flora in the treatment group compared with the control group.Conclusion4.The efficacy of Tianwang Buxin decoction pieces and Tianwang Buxin granules is equivalent.5.Tianwang Buxin granules can effectively treat perimenopausal insomnia.6.Perimenopausal insomnia is related to intestinal flora disorders,and the major species of change are Bacteroides,Fecal bacteroidetes,Faecalibacterium prausnitzii,Roseburiafaecis,Ruminococcus,Prevotellacopri,Fusicatenibacter saccharivorans.7.Tianwang Buxin granules exert its clinical effect by regulating the disordered intestinal flora in perimenopausal women with insomnia.