Abstract:Objective:To observe the curative effect of the therapy of Shumian Capsules combined with Olanzapine on depression complicated with insomnia. Methods: A total of 70 patients with depression complicated with insomnia were selected and divided into the control group and the observation group according to different treatment methods,with 35 cases in each group. The control group was treated with Olanzapine,and the observation group was treated with Shumian Capsules combined with Olanzapine. The clinical effects and incidence of adverse reactions,and the changes of traditional Chinese medicine (TCM) syndrome scores,scores of Hamilton Depression Scale (HAMD) and World Health Organization Quality of Life: Brief Version (WHO-QOL-BREF) and sleep quality were compared before and after treatment between the two groups. Results: After eight weeks of treatment, the total clinical effective rate was 97.14% in the observation group and 71.43% in the control group, the difference being significant (P< 0.05). After treatment,the TCM syndrome scores in the two groups were decreased when compared with those before treatment (P<0.05),and the TCM syndrome score in the observation group was lower than that in the control group (P<0.05). After treatment,the HAMD scores in the two groups were decreased when compared with those before treatment (P<0.05),and the WHO-QOL-BREF scores were increased when compared with those before treatment (P<0.05); the HAMD score in the observation group was lower than that in the control group,and the WHO-QOL-BREF score was higher than that in the control group (P<0.05). The sleep latency in the observation group was shorter than that in the control group (P< 0.05),and the total sleep time was longer than that in the control group (P<0.05). The incidence of adverse reactions was 5.71% in the observation group and 28.57% in the control group, the difference being significant (P<0.05). Conclusion:The therapy of Shumian Capsules combined with Olanzapine can improve the clinical effect on patients with depression complicated with insomnia, mitigate such symptoms as depressed in mind,emotional upsets,dreaminess and multiple arousals,and insomnia and forgetfulness of patients, reduce the depression degree, and promote the improvement of sleep quality with great safety.