title: [Clinical study on intervention of spleen-restoring decoction integrating with dormancy hygiene education on subhealthy insomnia of deficiency of both heart and spleen pattern].
abstract: OBJECTIVE
  To appraise the clinical efficacy, safety and compliance of the intervention of spleen-restoring decoction combined with dormancy hygiene education and the intervention of spleen-restoring decoction alone on sub-healthy insomnia of deficiency of both the heart and spleen pattern.
  
  
  METHODS
  Study design took multi-centers, blind and randomized control trial, 107 participants with sub-healthy insomnia of deficiency of both the heart and spleen pattern were assigned to A group (52 cases) which was treated with the intervention of spleen-restoring decoction combined with dormancy hygiene education and B group (55 cases) which was treated with the intervention of spleen-restoring decoction single, compared by efficacy, PSQI score, CGI score, WHOQOL-BREF score and security.
  
  
  RESULTS
  The efficacy of two group was 79.58%. There was no significant different between them. The PSQI scores before treatment was (11.80 +/- 2.08) and which afer treatment was (6.78 +/- 2.84) of A group. The PSQI scores before treatment was (11.61 +/- 2.00) and which afer treatment was (6.73 +/- 2.27) of B group. There was significant difference in PSQI scores both A group and B group after treatment (P < 0.01); the results of CGI score and WHOQOL-BREF score before and after measurement showed the same as PSQI. There were no significant difference between two groups in all scores after treatment and there was no interaction between time pots and treatment factors . Withdrawal reaction analysis: comparing CGI after withdraw 2 weeks and at the end of treatment course, there was no significant difference between two groups. The same result was in comparison among groups.
  
  
  CONCLUSIONS
  Both the intervention of spleen-restoring decoction integrating with dormancy hygiene education and spleen-restoring decoction had obvious clinical efficacy on treating subhealthy insomnia of deficiency of both the heart and spleen pattern, and had high compliance and safety. The intervention of spleen-restoring decoction integrating with dormancy hygiene education showed no better clinical efficacy than spleen-restoring decoction did.
authors.affiliation: The First Affiliated Hosptial of Wenzhou Medical College, Wenzhou 325000, China.
authors.forename: Ren
authors.initials: R
authors.lastname: Ye
authors.forename: Zhengzhong
authors.initials: Z
authors.lastname: Yuan
authors.forename: Chunxiu
authors.initials: C
authors.lastname: Dai
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.forename: Xiuhua
authors.initials: X
authors.lastname: Song
authors.forename: Zhiqing
authors.initials: Z
authors.lastname: Cheng
authors.forename: Wanhua
authors.initials: W
authors.lastname: Hu
authors.forename: Yan
authors.initials: Y
authors.lastname: Lin
authors.forename: Xiaoyun
authors.initials: X
authors.lastname: Wang
authors.forename: Shuchen
authors.initials: S
authors.lastname: Sun
authors.forename: Jincai
authors.initials: J
authors.lastname: He
mesh_terms: D000328:Adult; D005260:Female; D006266:Health Education; D006801:Humans; D006920:Hygiene; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy* / Q000503:physiopathology; D013158:Splenic Diseases / Q000188:drug therapy*