Clinical Research Of Baile Mian Capsule In Treating The Insomnia Which Type Is Stagnation Of Liver Qi And Yin Deficiency

Objective:To observe the clinical effect of Baile Mian Capsule In Treating the Insomnia which type is Stagnation of liver qi and yin deficiency,evaluating the Baile Mian treatment superiority and safety.Methods:72patients with stagnation of liver yin deficiency insomnia were randomly divided into the treatment group and control group with each group of32.Both groups were treated with a placebo one week. Patients in treatment group were treated with Baile Mian every four,two times a day and Tian wang bu xin Dan simulant a pill every time,two times a day.Patients in control group were treated with Tian wang bu xin Dan a pill every time,two times a day and Baile Mian simulant every four,two times a day.The treatment lasted four weeks. Before the treatment, Hamilton Anxiety Scale(HAMA) and Hamilton Depression Rating Scale(HAMD) were used to evaluate. Pittsburgh Sleep Quality Index Scale were used evaluate before treatment and in the2nd week. The TCM Syndromes Scale and Epworth Sleepiness Scale were used evaluate before treatment in the2nd week and in the4nd week. At the same time,side effects were monitored.All of these,to evaluate by the changes of the scores.Results:1.The changes of the Pittsburgh Sleep Quality score,Scores of two groups were decreased after four weeks treatment,both were significant differences compared with those before treatmen(P<0.01);Both Pittsburgh Sleep Quality scores were significant differences after four weeks treatment(P<0.01), the treatment group was better than the control group.2. To evaluate the effect by TCM Syndromes Scale, The treatment group:5cases(13.89%) were cured,12cases(33.33%) were significantly effective,15cases(41.67%) were advancd and4cases(11.11%) were invalid, with a total effective rate of88.89%. As to the control group,the dates were0(0%),3(8.33%),21(58.33%),12(33.33%) respectively,and the total cure rate was66.67%. There were no significant differences between the two groups (P>0.05).3. The changes of TCM Syndromes, Scores of two groups were decreased after one weeks treatment,scores of the treatment group after treatment were significant differences compared with before treatment(P<0.01),scores of the control group were no significant differences.The scores of both groups after two weeks treatment were significant differences compared with before treatment(P<0.05), Both TCM Syndromes scores were significant differences after two weeks treatment(P<0.01), the treatment group was better than the control group. The scores of both groups after four weeks treatment were significant differences compared with before treatment(P<0.01), Both TCM Syndromes scores were significant differences after four weeks treatment(P<0.01), the treatment group was better than the control group. The treatment group in improving poor sleep, fitfully or wake up early, heavy dreams, fatigue, red tongue project has the advantage, and the difference was statistically significant (P<0.05).4. The changes of ESS, Scores of two groups were decreased after one weeks treatment,there were no significant differences. Scores of the treatment group after two weeks treatment were significant differences compared with before treatment(P<0.05),scores of the control group were no significant differences(P>0.05). Scores of the treatment group after four weeks treatment were significant differences compared with before treatment(P<0.05),scores of the control group were no significant differences(P>0.05).5.Assessment of adverse events:there were no adverse events in two groups.Conclusion:. Baile Mian is effective in the treatment of Insomnia which type is Stagnation of liver qi and yin deficiency.It can significantly improve the syndromes of poor sleep, fitfully or wake up early, heavy dreams, fatigue, red tongue, and it has a rapid onset without side effect. So it was worthy to be popularized.