Clinical Study On Modified Anshen Dingzhi Decoction Combined With Trazodone Hydrochloride Tablets In Treating

Objective: To observe the clinical efficacy and safety of modified Anshen Dingzhi Decoction combined with Trazodone Hydrochloride Tablets in the treatment of insomnia of spleen-stomach disharmony,as well as its influence on the mental state of patients during awakening period,and to explore new ideas and methods for the treatment of insomnia.Methods: A total of 60 patients with spleen-stomach disharmony insomnia who visited the Department of Encephalopathy of Hebei Provincial Hospital of Traditional Chinese Medicine from March 2017 to October 2018 were collected and randomly divided into 2 groups,30 cases in each group.The treatment group was given modified Anshen Dingzhi Decoction combined with Trazodone Hydrochloride Tablets.One dose of traditional Chinese medicine decoction is warm-taken daily,once in the morning and once in the evening,and Trazodone Hydrochloride Tablets were taken orally 50mg/ night.The control group was given Trazodone Hydrochloride Tablets 50mg/ night orally,and the treatment course and observation course of both groups were 4weeks.The insomnia severity index scale(ISI),Epworth sleepiness scale score(ESS)and pittsburgh sleep quality index(PSQI)of the two groups of patients were evaluated before treatment and the PSQI and ESS scales were evaluated by 4 week after treatment respectively.The changes of scale scores were observed.The therapeutic effects were calculated by sleep improvement criteria and PSQI reduction rate.The safety indexes of patients were tested before and after treatment respectively.Results:This study brings into 60 eligible patients totally,and there were no shedding cases.There was no difference in gender,age,course of disease,severity of insomnia,PSQI and ESS scores between the two groups before treatment.After 4 weeks of treatment,the PSQI and ESS scores in the twogroups were significantly lower than those before treatment(P<0.05).The scores of the treatment were lower than those of the control group in PSQI and ESS rating scale,and the differences were significant(P<0.05).The total effective rates of sleep improvement between the two groups were 96.7% and86.7%,respectively,with no significant difference(P>0.05).The total effective rates of sleep quality improvement in the two groups were 93.3% and83.3%,respectively,with statistically significant difference(P<0.05).No adverse reactions were found in the two groups during the observation period.Conclusion: Modified Anshen Dingzhi Decoction combined with Trazodone Hydrochloride Tablets is safe and effective in the treatment of spleen-stomach disharmony insomnia.The total effective rate of sleep condition and sleep quality improvement is better than that of Trazodone Hydrochloride Tablets alone,especially in improving sleep quality,and it has obvious improvement effect on patients' mental state during awakening period.Therefore,it is worthy of clinical large sample study and further clinical promotion.