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

Authors Park, Dae-Myung; Kim, Seok-Hwan; Park, Yang-Chun; Kang, Wee-Chang; Lee, Sang-Ryong; Jung, In-Chul

Journal JOURNAL OF ETHNOPHARMACOLOGY , DEC 2 2014,:158

DOI 10.1016/j.jep.2014.10.024 PubMed 25456420

Abstract Ethnopharmacological relevance: Gamisoyo-San (GSS) is a well-known Traditional Korean Medicine shown to be effective on mood disorders. Aim of the study: The purpose of this research is to examine the effect of Gamisoyo-San on generalized anxiety disorder by its differently manufactured preparations.Materials and 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.Conclusion: 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. (C) 2014 Elsevier Ireland Ltd. All rights reserved.