A Clinical Research On The Efficacy Of Treating Perimenopausal Insomnia Of Heart And Kidney Disharmony Using Zishuiqingxin Particles

Objective:The objective of this clinical trial is to validate the clinical efficacy to treat peri-menopausal insomnia of Heart-Kidney disharmony using Zishuiqingxin Particles.determine the clinical efficacy of this prescription to provide a new method for the treatment of peri-menopausal.To provide new method to treat peri-menopausal insomnia.Methods : The clinical trial was randomized controlled trial,60 patients who coincidence inclusion criteria were randomly assigned to treatment group(n=30)and control group(n=30).The treatment group was given Zishuiqingxin Particles,and the control group was given Tianwangbuxin pill.The course of treatment were 4 weeks.To evaluate and record the Pittsburgh Sleep Quality Scale(PSQI)and insomnia in TCM symptom scale and the Kupperman scale score before and after the treatment.To conduct each score equilibrium test before treatment.After the treatment,all score were compared between groups and groups,and all the data were used to analyze by the statistical software SPSS17.0.To determine the clinical efficacy of Zishuiqingxin Particles to treate the peri-menopausal insomnia of Heart-Kidney disharmony.Results : Because the poor compliance of individual patients,there were cases shedding in the treatment period.Both treatment group and control group were 29 cases in end.After 4 weeks of treatment,evaluation of the efficacy of the two groups were given rank sum test,P<0.05,the effective rate of the treatment group was significantly better than that of the control group.In the treatment group,6 cases were clinical cure,which accounted for 20.69%;14 cases were markedly effective,which accountded for 48.28%;7 cases were effective,accounted for 24.14%;2 cases were invalid,accounted for 6.90%;the total clinical efficiency was 93.10%.In the control group,1 cases were clinical cure,which accounted for3.45%;7 cases were markedly effective,accounted for 24.1%;14 cases were effective,accounted for 48.28%;7 cases were invalid,accounted for 24.14%;the total efficiency was 75.86%.After the treatment,the two groups of PSQI total score and each score were improved.Zishuiqingxin particles and Tianwangbuxin pill have no statistical significance in the two groups of data of PSQI total scores and the scores were improved;The Zishuiqingxin particles and Tianwangbuxin pill have no statistical significance in improving sleep time,sleep efficiency and sleep disorder.But in theimprovement of PSQI score,sleep time,sleep quality and daytime dysfunction,P<0.05,the treatment group was significantly better than the control group that drug treatment group were better than those of the above symptoms in control group.After treatment,the two groups of the TCM syndrome score scale score were improved except the scant menses and amenorrhea.In the insomnia,palpitations,dizziness,tinnitus,five upset hot,hot flashes sweating,dry mouth and throat,P<0.05,the overal efficacy of the treatment group was better than the control group.The treatment group in the scant menses and amenorrhea were improvement and control group on the less amenorrhea was invalid.After treatment,the treatment group and the control group Kupperman score,P < 0.05,there was a significant difference between the two groups,the treatment group was better than control group in the Kupperman score.Conclusion : The clinical efficacy of Zishuiqingxin Particles was better than Tianwangbuxin pill.The curative effect of Zishuiqingxin Particles in improving the symptom of peri-menopausal insomnia of Heart-Kidney disharmony and the clinical symptom of peri-menopausal period is sure,safe,and non-toxic.The Zishuiqingxin Particles can improve the quality of life of patients.It has a high clinical value,worthy of promotion in clinical work in the day.