title: The comparative clinical study of efficacy of Gamisoyo-San (Jiaweixiaoyaosan) on generalized anxiety disorder according to differently manufactured preparations: multicenter, randomized, double blind, placebo controlled trial.
abstract: BACKGROUND
  Gamisoyo-San (GSS) is a well-known Traditional Korean Medicine shown to be effective on mood disorders.
  
  
  OBJECTIVE
  The purpose of this research is to examine the effect of Gamisoyo-San on generalized anxiety disorder by its differently manufactured preparations.
  
  
  METHODS
  Multicenter, randomized, double-blinded, placebo-controlled study was set for 147 patients with generalized anxiety disorder recruited from November 1st 2009 to December 16th 2010. They were given Gamisoyo-San individual extract mixture (extraction done for each crude materia medica separately) or Gamisoyo-San multi-compound extract (extraction done for whole materia medica at once) or controlled medication. Hamilton Rating Scale for Anxiety (HAM-A), Korean State-Trait Anxiety Inventory (K-STAI), Penn State Worry Questionnaire (PSWQ), Korean Beck Depression Inventroy (K-BDI), Symptom Checklist-90-Revised (SCL-90-R), and Korean WHO Quality of Life Scale Abbreviated Version (WHOQOL-BREF) were evaluated. We also applied Pattern Identification tool for 'JingJi and ZhengChong (, Traditional Korean Medicine term which correlates with generalized anxiety disorder)' to patients to evaluate different responses among 9 patterns.
  
  
  RESULTS
  HAM-A scores of Gamisoyo-San multi-compound extract group showed greater decrease compared to Gamisoyo-San individual extract mixture group and placebo group, but the difference was insignificant. WHOQOL-BREF scores of Gamisoyo-San multi-compound extract group showed significant increase compared to Gamisoyo-San individual extract mixture group and placebo group. In Heart blood deficiency pattern, the Gamisoyo-San multi-compound extract group showed significant decrease in K-BDI compared to the Gamisoyo-San individual extract mixture group.
  
  
  CONCLUSIONS
  Gamisoyo-San did not improve anxiety level of GAD patients. However, it can be useful to improve quality of life, and reduce depressive, obsessive-compulsive, somatic symptoms of generalized anxiety disorder. Gamisoyo-San multi-compound seemed more effective than Gamisoyo-San individual extract mixture, especially in Heart blood deficiency pattern.
authors.affiliation: Department of Psychiatry, Oriental Medical College of Daejeon University, 96-3 Yongwun-dong, Daejeon 300-716, Republic of Korea.
authors.forename: Dae-Myung
authors.initials: DM
authors.lastname: Park
authors.affiliation: Department of Psychiatry, Oriental Medical College of Daejeon University, 96-3 Yongwun-dong, Daejeon 300-716, Republic of Korea.
authors.forename: Seok-Hwan
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Oriental Medical College of Daejeon University, 96-3 Yongwun-dong, Daejeon 300-716, Republic of Korea.
authors.forename: Yang-Chun
authors.initials: YC
authors.lastname: Park
authors.affiliation: Department of Business Information Statistics, College of Business Ministration, Daejeon University, 96-3 Yongwun-dong, Daejeon 300-716, Republic of Korea.
authors.forename: Wee-Chang
authors.initials: WC
authors.lastname: Kang
authors.affiliation: Department of Psychiatry, Oriental Medical College of Daejeon University, 96-3 Yongwun-dong, Daejeon 300-716, Republic of Korea.
authors.forename: Sang-Ryong
authors.initials: SR
authors.lastname: Lee
authors.affiliation: Department of Psychiatry, Oriental Medical College of Daejeon University, 96-3 Yongwun-dong, Daejeon 300-716, Republic of Korea. Electronic address: npjeong@dju.kr.
authors.forename: In-Chul
authors.initials: IC
authors.lastname: Jung
mesh_terms: D000328:Adult; D014151:Anti-Anxiety Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D055670:Medicine, Korean Traditional; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D014151:Anti-Anxiety Agents; D004365:Drugs, Chinese Herbal; C103354:kamisyoyo san
keywords: Clinical trial; Gamisoyo-San; Generalized anxiety disorder; Multicenter; Pattern identification