Clinical Observation Of Qinggan Ningxin Granule On Insomnia Caused By Stagnation Of Liver And Fire

Background:Insomnia is characterized by complaints of difficulty in falling asleep,difficulty in maintaining sleep or waking fatigue affecting daytime life and work.25.3%of the people were unsatisfied with their sleep,29.9%reported insomnia symptoms,9.5%met the criteria of insomnia syndrome,long-term insomnia can cause potential psychiatric and physical diseases accompanied by a decline in quality of life.The understanding of insomnia in traditional Chinese medicine has a long history.Among the thirteen prescriptions of Neijing,there is a classic prescription of Banxia shumi tang for insomnia.With the continuous progress of social economy,the major causes of insomnia are emotional depression and unhealthy psychological factors caused by the increasing pressure of work and life.Liver depression transforming to fire become more and more common in clinical insomnia,and gradually form the academic viewpoint of treating insomnia from the liver.In the course of clinical treatment of patients with insomnia of stagnation of liver and fire,the tutor gradually formed the basic prescription of Qingganningxin Granule on the basis of Xiaochaihu Decoction,Chaihu Jialonggu Oyster Decoction and Suanzaoren Decoction,and combined with her own medication experience.Every good effect was achieved in clinical practice.Objective:To observe the clinical effect of Qingganningxin Granule on insomnia of stagnation of liver and fire type.Methods:60 patients were randomly divided into two groups by randomized controlled trial.The treatment group was given Qingganningxin Granule,1 dose a day,2 times a day.The control group and zopiclone were given medicine on demand,3-5 days a week,5-10 minutes before bedtime.The oral course of treatment was 4 weeks.By sorting out the scores of PSQI and TCM syndromes of Liver depression transforming to fire insomnia in each group before and after treatment,the data of treatment group and control group before and after treatment were analyzed by T test,non-parametric test and chi-square test.The sleep quality and TCM syndromes of the two groups were compared and observed,and the clinical efficacy was evaluated.The data of treatment group and control group after treatment were analyzed.To compare and observe the scores of Qingganningxin Granule in PSQI and TCM Syndrome Scale with Zopiclone,and to evaluate the clinical efficacy of Qingganningxin Granule in treating insomnia of Liver depression transforming to fire.Result:(1)Clinical efficacy evaluation:With the PSQI reduction rate as the evaluation index,there were 2 patients cured by Qingganingxin Granule,18 cases were markedly effective,6 cases were effective and 4 cases were ineffective,the total effective rate was 86.67%;3 cases were cured by Zopiclone,16 cases were markedly effective,9 cases were effective and 2 cases were ineffective,the total effective rate was 93.33%.There was no significant difference between the two groups(P>0.05).According to the score reduction rate of insomnia caused by Liver depression transforming to fire,there were 6 cases,12 cases were markedly effective,10 cases were effective,2 cases were ineffective,and the total effective rate was 93.33%.There were 0 cases,3 cases were markedly effective,8 cases were effective,19 cases were ineffective,and the total effective rate was 36.67%.There was statistical significance between them(P<0.05).(2)Comparison of PSQI component scores and total scores:Compared with before treatment,Qingganningxin Granule and Zopiclone could decrease the sleep quality,sleep time,sleep disorder,sleep efficiency,hypnotic drugs and daily function component scores and total scores of insomniacs(P<0.05).After treatment,there was no significant difference in the scores and total scores of each component of PSQI between the two treatments(P>0.05).(3)Comparison of the items and total scores of TCM Symptoms Scale for Insomnia of Liver depression transforming to fire Type:Compared with before treatment,Qingganningxin Granule can improve the symptoms of restlessness,irritability,chest distress,hypochondria,dreaminess,dizziness,tinnitus,dry mouth,constipation and yellow urine(P<0.05).After treatment with Zopiclone,the symptoms of restlessness of sleep in patients with liver depression were alleviated(P=0.014).There was no significant change in the total score of TCM symptom scale and symptoms such as irritability,chest distress and hypochondria,multiple dreams,dizziness and distention,tinnitus,dry mouth and bitter mouth,constipation and yellow urine before and after treatment(P>0.05).After treatment,the items and total scores of TCM Symptoms Scale for Insomnia of Liver depression transforming to fire Type were statistically significant(P<0.05).Conclusion:(1)Qingganningxin Granule can reduce the scores and total scores of PSQI.Compared with Zopiclone,Qingganningxin Granule has no difference in the effects of PSQI scores and total scores.Qingganningxin Granule has the same advantages as Zopiclone in improving sleep status of insomniacs.(2)Zopiclone can improve sleep disturbance in the TCM symptom scale of Liver depression transforming to fire insomnia,but has no effect on other items and total scores in the TCM symptom scale of liver-depression-fire insomnia.(3)Qinggannningxin Granule can improve the TCM syndromes of insomnia patients with Liver depression transforming to fire.(4)Qingganningxin Granule has more advantages than Zopiclone in improving sleep disturbance caused by Liver depression transforming to fire.