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 8 weeks. The clinical efficacy was assessed by using Spiegel scale, Pittsburgh sleep quality index (PSQ) 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 was 46% in the treatment group and 27.7% in the control group at 4 weeks, and 80% and 53.2% at 8 weeks, 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.