Abstract: OBJECTIVE: To evaluate the clinical efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder.METHODS: We conducted a double-blind,randomized,controlled trial involving 100 patients with insomnia of Qi-deficiency of heart and gallbladder.Patients were randomly divided into the treatment group(n = 50) and the control group(n = 50) according to a random number table. The treatment group was given Zhenjingdingzhi decoction,while the control group was treated with Suanzaoren decoction. the pharmacological treatment lasted for 8weeks. The clinical efficacy was assessed by using Spiegel scale,Pittsburgh sleep quality index(PSQI)and Traditional Chinese Medicine(TCM) syndrome scores.RESULTS: Comparing Spiegel scores between the two groups at 4 and 8 weeks,the differences in curative effect between the two groups were both significant(both P < 0.05). The total effective rate was46% in the treatment group and 27.7% in the control group at 4 weeks,and 80% and 53.2% at 8weeks,respectively; After 8 weeks,PSQI scores showed that the total effective rates differed significantly between the two groups(P < 0.01): 84% in the treatment group and 59.6% in the control group; In improving sleep quality and sleep duration,the curative effect of the treatment group was better than that of the control group(P < 0.05).TCM syndrome,especially insomnia and palpitation,was improved better in the treatment group after 8 weeks as compared to that in the control group(P < 0.05). The total effective rate of the two groups was 84% and 66%,respectively.CONCLUSION: Zhenjingdingzhi decoction is effective and safe for the treatment of insomnia with Qi-deficiency of heart and gallbladder,especially for improving sleep quality and sleep duration.

Key words: Sleep initiation and maintenance disorders, Shyness, Heart Qi deficiency, Zhenjingdingzhi decoction, Randomized controlled trial, Double-blind method