Clinical Study Of Modified Sancai Fengsui Pill In The Treatment Of Type 2 Diabetic Insomnia With Deficiency Of Both Qi And Yin And Internal Disturbance Of Phase Fire

Objective: To observe the changes of related indexes of modified Sancai Fengsui Pill in the treatment of Qi and Yin deficiency and internal disturbance of phase fire type 2 diabetic patients with insomnia,and evaluate its clinical efficacy,so as to provide theoretical basis for for modified Sancai Fengsui Pill in the treatment of type 2 diabetes insomnia.Methods: From January 2020 to December 2020,82 patients who met the inclusion criteria and exclusion criteria were selected and randomly divided into a control group and a treatment group with 41 cases each.The control group was given basic treatment and Tianwang Buxin pill,the treatment group was given basic treatment an modified Sancai Fengsui pill for8 weeks.Fasting plasma glucose,2hours postprandial blood glucose,Glycated hemoglobin,Pittsburgh sleep quality index,Self-rating Anxiety Scale,Self-rating Depression Scale,TCM syndrome score were compared before and after treatment,and spss23.0 statistical software was used for data analysis.Results:(1)There was no significant difference in gender,age,course of type 2 diabetes and course of insomnia between the two groups,which were comparable(P>0.05).(2)Comparison of Fasting plasma glucose,2hours postprandial blood glucose,Glycate d hemoglobin.After treatment,fasting blood glucose in both groups decreased compared with before treatment,and the decrease rate in treatment group was better than that in control group(P<0.05).There were no significant changes in 2hours postprandial blood glucose and Glycated hemoglobin compared with before treatment,and there was no statistical significance between the two groups(P > 0.05).(3)Comparison of Pittsburgh sleep quality index score.After treatment,the total scores of the Pittsburgh sleep quality index scale score and the scores of each factor of the two groups of patients were lower than before treatment.The treatment group improved the total score and sleep quality,sleep disturbance,sleep time,time to fall asleep,and day dysfunction is better than that of control group(P < 0.05),there was no statistically significant difference in the improvement of other factors between the two groups(P>0.05).(4)Comparison of TCM syndrome score.After treatment,the total scores of TCM syndrome scores and single symptoms integral of the two groups of patients were lower than before treatment.The treatment group improved the total scores and the symptoms of difficulty falling asleep,dreaming and awakening,fatigue,shortness of breath,lazy speech,and irritability symptoms was better than that of control group(P < 0.05),there was no statistically significant difference in the improvement of other symptoms between the two groups(P>0.05).(5)Comparison of Self-rating Anxiety Scale and Self-rating Depression Scale scores.After treatment,the scores of the anxiety self-rating scale and depression self-rating scale of the two groups of patients decreased compared with those before the treatment,and the decrease rate of the treatment group was better than that of the control group(P<0.05).(6)Comparison of TCM syndrome efficacy and insomnia efficacy: the total effective rate of TCM syndrome efficacy in the treatment group was 92.31%,insomnia efficacy was 89.74%the total effective rate of TCM syndrome efficacy in the control group was 76.92%,insomnia efficacy was 82.05%,the treatment group was higher than the control group,the difference was statistically significant(P<0.05).Conclusions:Modified Sancai Fengsui Pill can improve the clinical symptoms and fasting blood glucose level of type 2 diabetes insomnia patients with deficiency of both qi and yin and internal disturbance of phase fire,improve the quality of life,the efficacy is better than Tianwang Buxin Dan,clinical safety and effectiveness.