title: Efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder: a randomized, double-blind, controlled trial.
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 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.
  
  
  CONCLUSIONS
  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.
authors.forename: Qing
authors.initials: Q
authors.lastname: Ye
authors.forename: Jie
authors.initials: J
authors.lastname: Zhou
authors.forename: Xiaolei
authors.initials: X
authors.lastname: Yuan
authors.forename: Canxing
authors.initials: C
authors.lastname: Yuan
authors.forename: Xuming
authors.initials: X
authors.lastname: Yang
mesh_terms: D000328:Adult; D000368:Aged; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage*; D005260:Female; D005704:Gallbladder / Q000187:drug effects* / Q000503:physiopathology; D006321:Heart / Q000187:drug effects* / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D019413:Qi; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal