The Clinical Research Of Self Designed Jieyu Anshen Decoction Treating Insomnia With Liver Depression And Qi Stagnation Syndrome

Objectives:To investigate the efficiency and safty of self-designed Jieyu anshen decoction treating the insomnia (liver depression and qi stagnation syndrome) patients by a self-controlled study about the patients with insomnia,which making a prepartion for further randomized double blind trial.Methods:By using the self-control design, the patients with insomnia(liver depression and qi stagnation syndrome)who conforming to the test standard were enrolled from Neurology clinics of the Chinese Medicine hospital of Jiangsu Provience From May 2015 to December 2015.And they volunteer to take the self designed Jieyuanshen decoction.Then the researcher evaluates the Pittsburgh Sleep Quality Index(PSQI)、Insomnia Severity Index (ISI)and TCM score as clinical evaluation by comparing the scores before and after treatment. Statistics by SPSS 17.0 statistical analysis, are compared difference that whether have significant difference before and after the treatment. The researcher evaluated the safety by observing adverse reaction after the decoction.Results:There are 40 patients conforming to the inclusion criteria at first, but 4 cases were lost to follow-up after 28 days treatment,.According to the result of the analysis on the date of remaining 36 patients, time for falling asleep and sleep are obviously improved in the before and after treatment,and the difference is statistically significant (P<0.05). the Pittsburgh Sleep Quality Index(PSQI)、Insomnia Severity Index (ISI)and TCM score are also obviously improved in the before and after treatment,and the difference is also statistically significant (P<0.05). The effective rate of criteria set by is the 70% or higher.There is no headache, heart palpitations and other adverse reactions and bad record during the period of the medicine.Conclusions:The preliminary results show that self-designed Jieyu anshen decoction is effective for treating the patients with insomnia (liver depression and qi stagnation syndrome) and no obvious side effects, which provides the basis for the further randomized double-blind controlled study.