Objective:to evaluate the clinical efficacy, safety and compliance of Tianwang Buxin Decoction for Insomnia Patients (Yin Deficiency Fire Excess Syndrome) after ischemic cerebral stroke.Methods:With a design of randomized controlled trial,72 cases of patients with insomnia (Yin Deficiency Fire Excess Syndrome) after ischemic cerebral stroke are randomly divided into two sub-groups. One is the treatment group with 36 cases treated with Estazolam and Tianwang Buxin Decoction(the treatment group), and another is the control group with 36 cases treated with only Estazolam(the control group),observed 4 weeks.The PSQI grade, effective rate, WHOQOL-BREF grade and safety,compliance of both two sub-groups are compared.Results:The effective rate is 88.23% for the treatment group and 64.7% for the control group, and the difference between these two groups is statistically significant; For the treatment group, the PSQI scores before and after treatment are (12.91±2.16) and (6.92±2.86) respectively, and for control group it is (12.65±2.11) and (9.28±2.56), both two groups significantly (P<0.05) improved after treatment, and the between-group difference of PSQI grade after treatment is statistically significant(P<0.05); After treatment, the WHOQOL-BREF grade also improved for both two groups (P<0.05), and the the between-group difference of WHOQOL-BREF grade after treatment is statistically significant(P<0.05).Conclution:The intervention with combination of Estazolam and Tianwang Buxin Decoction and with only Estazolam both have significant effect on insomnia (Yin Deficiency Fire Excess Syndrome) after ischemic cerebral stroke.Both two groups also have high-security and high-compliance.But the clinical efficacy with combination of Estazolam and Tianwang Buxin Decoction is superior to the treatment with only Estazolam,and the former improve the patient’s quality of life better. |