Clinical Study On Modified Tiaogan Decoction Intervening In Insomnia Patients With The Type Of Liver Stagnation

Objective To study the clinical effect of the modified Tiaogan Decoction treating on 106 cases of insomnia with the type of liver stagnation, by evaluation of the efficacy of TCM in the treatment of insomnia and Pittsburgh sleep quality Index(PSQI).Methods A randomized controlled clinical trial was conducted in 108 cases of insomnia with the type of liver stagnation (control group 36 cases, treatment group 36 cases and combined group 36 cases).All the patients came from the Quzhou hospital of TCM during January 2015 to September 2015.After entering the group, control group and treatment group had 1 case loss each, the expulsion rate is 1.85%. Finally,106 patients were treated(control group was 35 cases,treatment group was 35 cases, and combined group was 36 cases).The control group was treated with Zolpidem Tartrate Tablets 10 mg,1 times a night.The treatment group was treated with the modified Tiaogan Decoction,200ml each time,2 times a day; on this basis, the combined group was given Zolpidem Tartrate Tablets also. Three groups were treated for 10 weeks. Observed the changes of insomnia syndrome of TCM efficacy evaluation questionnaire and evaluation PSQI indicators while 4,6,8,10 weeks after treatment and 30 days after discontinuation.Results 1. The clinical curative effect comparison:The healing rate of the control group was 54.29%, total effective rate was 80.00%.Show the healing rate was 51.43% in treatment group, the total effective rate was 82.86%.Combined group show the healing rate was 77.78%, total effective rate was 91.69%.After statistics analysis, reveals the healing rate and total effective of combined group were better than the treatment group and control group (P<0.05), while the treatment group compared with control group, there was no statistically significant difference (P>0.05).2.Pittsburgh sleep quality Index comparison:three groups of patients with PSQI scores were decreased after treatment.Compared with the control group in the same period, the combined group’s PSQI scores declined after 4 weeks,6 weeks,8 weeks and 10 weeks, the differences were statistically significant (P<0.05).Compared with treatment group at the same time, the combined group’s PSQI scores declined after 4 weeks,6 weeks,8 weeks and 10 weeks, the differences were statistically significant (P<0.05).30 days following the end of the treatment, the results showed that.Compared with the control group, the total score of PSQI in treatment group and combined group were significantly decreased, the difference was statistically significant (P<0.01). Compared with the treatment group, the total score of combined group was significantly decreased, the difference was statistically significant (P<0.01).3.Evaluation of the efficacy of TCM in the treatment of insomnia comparison:The insomnia syndrome scores of TCM efficacy evaluation questionnaire in all the groups were declined.Compared with the control group, treatment group, combined group in the treatment of 4 weeks,6 weeks,8 weeks,10 weeks after treatment, the difference was statistically significant (P<0.05).Compared with treatment group at the same time, the combined group’s total integral decline is not obvious, there was no statistically significant difference (P>0.05).30 days following the end of the treatment, the results showed that:compared with control group, treatment group and combined group Evaluation of the efficacy of TCM in the treatment of insomnia had significantly lower, the difference was statistically significant (P<0.01);Compared with the treatment group, combined group Evaluation of the efficacy of TCM in the treatment of insomnia decline is not obvious, there was no statistically significant difference (P>0.05).4.Safety comparison:the three patients with the test of the safety index were not significantly abnormal changes. The control group has 1 cases of dizziness,1 cases of adverse reactions of dry mouth. The adverse reaction rate was 5.7%.Conclusion 1.The modified Tiaogan Decoction can improve the symptoms of insomnia patients with the type of liver stagnation, enhance the quality of sleep, play good clinical effect.2. The curative effect of the modified Tiaogan Decoction and Western medicine in combination is better than single use of traditional Chinese medicine or western medicine, and less adverse reactions, the recurrence rate is lower, and effective duration is more sustainable.