The Clinical Research Of Bai He Ningshen Decoction In The Treatment Of Insomnia Caused By Fire Excess From Yin Deficiency

Objective:Based on the observation before and after the treatment of traditional Chinese medicine"Bai He Ningshen Decoction" on insomniac caused by Fire Excess from Yin Deficiency,this research aims at evaluating its curative effectiveness and safety.The change of the observation includes Pittsburgh sleep quality index(PSQI)score,clinical symptoms change and integral of traditional Chinese medicine syndrome.Methods:This research adopts the randomized controlled research method.A total of 62 Insomnia patients accord with enrollment criterion were enrolled in this study.They were randomly divided into two groups:one is treatment group and the other is control group.Every one contains 31 groups.The insomniac in the treatment group was provided with Bai He Ningshen Decoction,and the control group was offered Bai Le Mian Capsulesare.The cure of treatment for both two groups are four weeks.Curative effectiveness and safety of Hai He Ningshen Decoction are evaluated on the basis of changes in clinical symptom before and after,through accumulating points of TCM symptom and safety indexes such as blood routine examination,Liver and kidney function and electrocardiogram as well as statistical analysis.Results:1.In this research,62 patients are included,among which 61 patients finish the clinical observation and one drop in the control group;with the dropout rate being 1.61%.2.Before the treatment,there is no statistical significance in the gender,age,course of disease,PSQI scale,TCM symptom distribution and TCM symptom scores between the two groups.(P>0.05)3.The effective ratio of the treatment group is 87.1%,and 56.67%for the control group,which is significant different.(P<0.01).4.Patients in the both groups show apparent improvement in the clinical symptoms,but the changes of the treatment group's(43.25±13.44 to 25.61±9.99)accumulating points of TCM symptom score are much higher than that of the control group's(43.47± 10.71 to 30.06±9.00).The difference is significant(P<0.05).Also,the treatment group's(14.58±3.45 to 5.03±2.20)PSQI scale score changes are much better than control group's(14.20±3.68 to 7.13±2.32),the difference is significant(P<0.01).5.In the process of treatment,no adverse reaction occurred,and no obvious abnormal changes are seen in the test of blood routine examination,Liver and kidney function and electrocardiogram.There is no statistical significance before and after the treatment.(P>0.05)Conclusion:1.The curative effect of Bai He Ningshen Decoction is better than the control group on insomniacs for Insomnia caused by Fire Excess from Yin Deficiency.2.Bai He Ningshen Decoction shows no obvious untoward effective,and actually proves to be favorably safe.