Efficacy of Anshen Jieyu Decoction for Sub-healthy People with Insomnia

[Objectives]To investigate the efficacy of Anshen Jieyu decoction for sub-healthy people with insomnia.[Methods]A total of 80 sub-healthy insomnia patients admitted to Taihe Hospital of Shiyan City from January,2020 to December,2020 were selected as the research objects.All the patients were divided into observation group and control group according to a random number table.The control group was treated with conventional Western medicine,and the observation group was treated with Anshen Jieyu decoction.The clinical treatment effect of the two groups was compared.[Results]Before the intervention,there was no significant difference in Pittsburgh sleep quality index between the two groups.After the intervention,the scores of time required to fall asleep[(1.2±0.3)points],sleep time[(1.2±0.4)points],sleep disorder[(1.2±0.2)points],sleep efficiency[(1.4±0.3 points)],sleep quality[(0.9±0.2)points]and daytime dysfunction[(0.9±0.4)points]of the observation group were significantly lower than those of the control group.There was no significant difference in life quality between the two groups before the intervention.The scores of physical function[(92.3±3.3)points],social function[(91.7±4.1)points],mental health[(92.3±4.1)points]and emotional role[(92.8±5.2)points]after the intervention were significantly higher than those before the intervention.Before the intervention,there was no significant difference in the severity of insomnia between the two groups.After the intervention,the score of insomnia severity index was(10.3±3.0)points in the observation group and was(12.2±2.9)points in the control group.In terms of safety,there were 23 cases of level 1,15 cases of level 2 and 2 cases of level 3 in the observation group,and there were 20 cases of level 1,16 cases of level 2 and 4 cases of level 3 in the control group.No significant difference was observed in treatment safety between the two groups.[Conclusions]Anshen Jieyu decoction is effective in treating sub-healthy insomnia and is worthy of promotion.

Effect of Chaishao Jieyu Decoction on postoperative colorectal cancer patients with liver depression and spleen deficiency

Objective:To study the effect of Chaishao Jieyu Decoction on the improvement of mental state、immune function and diarrhea of Liver Depression and Spleen Deficiency patients with colorectal cancer after operation.Methods:76 cases of colorectal cancer patients after operation,according to the method of random grouping would be divided into the chinese medicine treatment(CMT)group and the western medicine control(WMC)group,each group 38 cases.The WMC group were treated with montmorillonite.The CMT group accepted oral administration of Chaishao Jieyu Decoction.The levels of anxiety and depression score,quality of life,T lymphocyte subsets and TNF-α,and improvement of diarrhea were compared.Results:With the therapy ending,the standards of SAS and SDS in CMT group were reduced signficantly than the WMC group(P<0.05),The score of QOL was obviously higher than the WMC group(P<0.05),the treatment group's CD3+、CD4+subsets levels increased obviously than the WMC group(P<0.05),the CD8+subsets and Tumor necrosis factor-alpha-levels were obviously lower than the WMC group(P<0.05),the improvement of diarrhea of the CMT group was obviously better than the WMC group(P<0.05).Conclusion:Chaishao Jieyu Decoction can effectively improve the mental state and diarrhea symptoms of postoperative patients with colorectal cancer,and significantly improve the immune function of the body,the Chaishao Jieyu Decoction's effect is excellent.

Effect of Chaishao Jieyu Decoction combined with Pingxiao Capsule on the patients with luminal breast cancer after operation

Objective:To study the improvement of Chaishao Jieyu decoction combined with Pingxiao capsule on the mental state、immune function and endometrium of patients with luminal breast cancer undergoing endocrine therapy after operation.Methods:60 cases of luminal breast cancer patients after operation,according to the method of random grouping would be divided into the control group and the observation group,each group 30 cases.The control group were treated with tamoxifen.On the basis,the observation group accepted oral administration of Chaishao Jieyu Decoction and Pingxiao capsule.The levels of 5-HT、DA、T lymphocyte subsets、IGF-1 and endometrial thickness were compared.Results:At the end of treatment,the observation group's 5-HT、DA、CD3+、CD4+levels were obviously higher than the control group(P<0.05),the observation group's CD8+levels、IGF-1 levels and endometrial thickness were significantly lower than the control group(P<0.05).Conclusion:Chaishao Jieyu Decoction combined with Pingxiao capsule can significantly improve the mental state、immune function of patients with luminal breast cancer undergoing endocrine therapy after surgery,and inhibit their endometrial thickening,the effect is exact.

Clinical Effect Observation of Jieyu Decoction in the Treatment of Generalized Anxiety Disorder

Objective:To observe the clinical effect of Jieyu decoction in treating generalized anxiety disorder with stagnation-heat in liver meridian type.Methods:There were 72 cases of generalized anxiety disorders outpatient and inpatient patients,and 36 in the control and treatment group.The control group was given oral Deanxit;the treatment group was given Jieyu decoction granules,and necessary psychological counseling was given to patients in both groups.Changes in traditional Chinese medicine syndrome scoring scale,Hamilton scale(HAMA),dynamic electrocardiogram heart rate variability and other indicators were recorded and compared between the two groups.Results:The total effective rate of the control group was 76.5%,and the total effective rate of the treatment group was 80.0%.The curative effect of the treatment group and the control group was significantly higher than that before treatment(P<0.05),and there was no significant difference in the overall curative effect between the two groups(P>0.05).The HAMA scale score of the two groups was significantly lower than that before treatment(P<0.05),and there was no significant difference in the reduction rate of HAMA score between the two groups(P>0.05).The traditional Chinese medicine syndrome scores of the two groups were significantly decreased compared with that before treatment(P<0.05).The traditional Chinese medicine syndrome scores of the treatment group were significantly different from that of the control group after 8 weeks of treatment(P<0.05).Two groups of heart rate variability in 24 h period of standard deviation between the average normal R-R(SDNN),24 h per 5 min normal R-R period between the standard deviation(SDANN),root mean square of phase difference between adjacent R-R(RMSSD)and the number of cardiac 50 ms accounted for the percentage of the total number of cardiac(PNN50)than before treatment significantly increased(P<0.05),8 weeks after treatment the SDNN,SDANN than the control group no significant difference(P>0.05),RMSSD,PNN50 significantly difference compared with control group(P<0.05).Conclusion:Jieyu decoction has good efficacy and high safety in the treatment of generalized anxiety disorder of the type of liver meridian and heat stagnation,which is suitable for clinical promotion and application.

Efficacy and Safety of Jianpi Jieyu Decoction for Patients with Mild-to-Moderate Depression of Xin(Heart)-Pi(Spleen)Deficiency Syndrome:A Multi-centre Randomized Controlled Study

Objective:To evaluate the efficacy and safety of Jianpi Jieyu Decoction(JJD)for treating patients with mild-to-moderate depression of Xin(Heart)-Pi(Spleen)deficiency(XPD)syndrome.Methods:In this multi-center,randomized,controlled study,140 patients with mild-to-moderate depression of XPD syndrome were included from Xiyuan Hospital of China Academy of Chinese Medical Sciences and Botou Hospital of Traditional Chinese Medicine from December 2017 to December 2019.They were randomly divided into JJD group and paroxetine group by using a random number table,with 70 cases in each group.The patients in the JJD group were given JJD one dose per day(twice daily at morning and evening,100 m L each time),and the patients in the paroxetine group were given paroxetine(10 mg/d in week 1;20 mg/d in weeks 2-6),both orally administration for a total of 6 weeks.The primary outcome was the change of 17-item Hamilton Depression Rating Scale(HAMD-17)score at week 6 from baseline.The secondary outcomes included the Hamilton Anxiety Scale(HAMA)score,Traditional Chinese Medicine Symptom Scale(TCMSS),and Clinlcal Global Impression(CGI)scores at the 2nd,4th,and 6th weekends of treatment,HAMD-17 response(defined as a reduction in score of>50%)and HAMD-17 remission(defined as a score of 7)at the end of the 6th week of treatment.Adverse events(AEs)were also recorded.Results:From baseline to week 6,the HAMD-17 scores decreased 10.2±4.0 and 9.1±4.9 points in the JJD and paroxetine groups,respectively(P=0.689).The HAMD-17 response occurred in 60%of patients in the JJD group and in 50%of those in the paroxetine group(P=0.292);HAMD-17 remission occurred in 45.7%and 30%of patients,respectively(P=0.128).The differences of CGI scores at the 6th week were not statistically significant(P>0.05).There were significant differences in HAMD-17 scores between the two groups at 2nd and 4th week(P=0.001 and P=0.014).The HAMA scores declined 8.1±3.0 and 6.9±4.3 points from baseline to week 6 in the JJD and paroxetine groups,respectively(P=0.905 between groups).At 4th week of treatment,there was a significant difference in HAMA between the two groups(P=0.037).TCMSS decreased 11.4±5.1,and 10.1±6.8 points in the JJD and paroxetine groups,respectively(P=0.080 between groups).At the 6th week,the incidence of AEs in the JJD group was significantly lower than that in the paroxetine group(7.14%vs.22.86%,P<0.05).Conclusion:Compared with paroxetine,JJD was associated with a significantly lower incidence of AEs in patients with mild-tomoderate depression of XPD syndrome,with no difference in efficacy at 6 weeks.(Trial registration No.Chi CTR2000040922).

Effects of Kaixin Jieyu Decoction(开心解郁汤)on Behavior, Monoamine Neurotransmitter Levels, and Serotonin Receptor Subtype Expression in the Brain of A Rat Depression Model

Objective： To determine the mechanisms underlying the anti-depressant effects of Kaixin JieyuDecoction （开心解郁汤, KJD） by investigating the effects of KJD on behavior, monoamine neurotransmitterlevels, and serotonin （5-HT） receptor subtype expression in the brain in a rat model of depression. Methods：The rat depression model was established using chronic unpredictable mild stress （CUMS）. Forty-eight SpragueDawley rats were randomly divided into control, depression model （CUMS）, CUMS＋KJD （7.7 g/kgl-d1 ofcrude drug）, and CUMS＋fluoxetine （2.4 mg/kgl.d1） groups （n=12 in each group）, and the treatments lastedfor 21 days. We regularly evaluated body weight, sucrose consumption, and horizontal and vertical activityscores in open-field tests. The content of the monoamine neurotransmitters 5-HT, norepinephrine （NE）, anddopamine （DA） and the DA metabolite homovanillic acid in the cerebral cortex, and 5-HT1A and 5-HT2A receptormRNA in the cerebral cortex and the hippocampus, were determined respectively by high-performance liquidchromatography-coularray electrochemical detector and real-time polymerase chain reaction. Results： Comparedwith the control group, CUMS rats showed a variety of depression-like behavioral changes, including a significantreduction in body weight, sucrose consumption, and horizontal and vertical activity scores in open-field tests（P〈0.05 or ,P〈0.01）, and a significant decrease in 5-HT and NE levels and 5-HT2A receptor mRNA expression.In contrast, they showed a significant increase in 5-HT1A receptor mRNA expression in the cerebral cortex. Inthe hippocampus, 5-HT1A receptor mRNA expression was lower whereas 5-HT2A receptor mRNA expressionwas higher than in the control group （P〈0.05 or P〈0.01）. Treatment with KJD or fluoxetine partially attenuatedthese changes （,P〈0.05 or ,P〈0.01）. Conclusion： KJD could normalize the levels of 5-HT and NE and adjust thebalance of 5-HT2A and 5-HT2A receptor expression in rat cerebrum, and this may be one of mechanisms ofantidepressant effects of KJD.

Effects of Kaixin Jieyu Decoction (开心解郁汤) on Behavior and Glial Fibrillary Acidic Protein Expression in Cerebral Hippocampus of A Rat Vascular Depression Model

Objective：To explore the effects and anti-depression mechanisms of Kaixin Jieyu Decoction（开心解郁汤,KJD）.Methods：The rat vascular depression（VD） model was established by ligation of bilateral common carotid arteries（LBCCA） combined with chronic unpredictable mild stress（CUMS）.Forty Wistar rats were randomly divided into sham,VD model,VD ＋ high-dose KJD[15.4 g/（kg·d） of crude drug],VD ＋ medium-dose KJD[7.7 g/（kg·d） of crude drug],and VD ＋ fluoxetine[2.4 mg/（kg·d）]groups（r〉=8 in each group）,and the treatments lasted for 21 days.Changes of behavior and hippocampus pathology were observed.The level of glial fibrillary acidic protein（GFAP）protein and mRNA in hippocampus was detected respectively by immunohistochemistry and real-time polymerase chain reaction.Results：Compared with the sham group,rats in model group showed a variety of behavioral obstacles,including a significant reduction in sucrose consumption percentage,horizontal and vertical activity scores in open-field tests（P〈0.05 or P〈0.01）,pathological damage like neuronal degeneration,necrosis,and a significant decrease of GFAP protein and mRNA in hippocampus（P〈0.01）;compared with the model group,rats in the high-dose KJD group,medium-dose KJD group and fluoxetine group obtained notable higher behavioral scores,and pathological injury lessened in hippocampus with a increased expression of GFAP protein and mRNA（P〈0.05 or P〈0.01）;compared with the medium-dose KJD group and fluoxetine group,GFAP mRNA in highdose KJD group expressed higer（P〈0.05）.Conclusion：LBCCA combined with CUMS may cause depression-like behavioral changes resulting in the VD model of rats whose depression state can be ameliorated by KJD,and the mechanism of cerebral protection is related possibly with promoting expression of GFAP in hippocampus.