Efficacy and safety of Guipi Decoction combined with conventional Western medicine in the treatment of insomnia with deficiency of heart and spleen:a meta-analysis

Objective:To systematically evaluate the efficacy and safety of Guipi Decoction combined with Western medicine in the treatment of insomnia with deficiency of heart and spleen.Methods:English databases(PubMed,Web of Science,The Cochrane Library,EMBASE)and Chinese databases(CNKI,Wanfang database,China Biomedical Literature Service System,VIP database)were searched by computer.Randomized controlled trials of Guipi Decoction on insomnia with deficiency of heart and spleen were searched from the database construction to November 2021.After the first and second authors independently screened the literature,extracted the data and evaluated the risk of bias in the included studies,meta-analysis was performed using RevMan5.3 software.Results:A total of 9 RCTS were included after screening,including 914 patients.Meta-analysis results showed that:Total effective rate[RR=1.22,95%CI(1.16,1.30),P<0.00001],total PSQI score[MD=-3.05,95%CI(-3.96,-2.14),P=0.008],number of night awakening times[[MD=-1.18,95%CI(-1.42,-0.94),P<0.00001],adverse reaction rate[RR=0.32,95%CI(0.21,0.51),P<0.00001]were better than the control group,and the differences were statistically significant.Conclusion:The current evidence shows that,compared with pure using conventional western medicine,belongs to the spleen decoction combined western medicine therapy,cases both deficiency type of insomnia in the total effective rate,reducing the total PSQI score(improve sleep quality,sleep efficiency,sleep disorder,daytime function,etc.),reducing frequency of nighttime awakening,security,have more advantages.However,due to the limitation of the quality and quantity of articles included in the study,more randomized,double-blind,large-sample clinical studies are needed to confirm the above conclusions.

Clinical Observation on the Treatment of Insomnia in Germany with Deficiency of Heart and Spleen by the Ear Bean Therapy

Objective: To observe the effect of insomnia patients with deficiency of heart and spleen in Germany by the therapy of ear points pressing with bean. Methods: A total of 80 cases of insomnia with deficiency of heart and spleen in Germany were divided into the observation group and the control group, with 40 cases in each group. The patients in the control group were treated with oral modified Guipi Decoction(归脾汤), while the patients in the observation group were treated with oral traditional Chinese medicine(TCM) and the therapy of ear points pressing with bean. The efficacy, sleep quality, the TCM syndromes score and the incidence of adverse reactions were compared between the two groups. Results: The effective rate in the observation group was higher than that in the control group, and there was statistical difference between the two group(P<0.05). After treatment, the Pittsburgh sleep quality index scale(PSQI) score, insomnia severity index(ISI) score and the TCM syndromes score in the two groups were decreased sharply(P<0.01), and those scores in the observation group were lower than that in the control group(P<0.05). There was no adverse reaction between the two groups. Conclusion: The therapy of ear points pressing with bean is effective on insomnia in Germany, which is worth further study and promotion.

ACUPUNCTURE TREATMENT FOR 100 CASES WITH INSOMNIA OF THE TYPE OF THE HEART AND SPLEEN DEFICIENCY

cases of insomnia of the type of heart and spleen deficiency were treated by acupuncture.Results indicated that 95 cases were cured,accounting for 95%;3 cases were markedly effective,accounting for 3% and the 2 cases were ineffective,accounting for 2%,the total effective rate was 98%.

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).