title: Use of Kampo diagnosis in randomized controlled trials of Kampo products in Japan: a systematic review.
abstract: BACKGROUND
  The Committee for Evidence-based Medicine (EBM) of the Japan Society for Oriental Medicine started compiling Evidence Reports of Kampo Treatment (EKAT) in 2007. EKAT is a compilation of structured abstracts of randomized controlled trials (RCTs), along with comments by a third party reviewer. As of 31 December, 2012, there were 378 RCTs of Kampo medicines in Japan. The primary research question of this study is "How frequently is Kampo diagnosis used in RCTs of Kampo medicines?" The secondary research question is "When is Kampo diagnosis used in RCTs?"
  
  
  METHODS
  The structured abstract (SA) of each RCT article was reviewed to examine how Kampo diagnosis was used in RCTs, especially how Kampo diagnosis was used in the randomization process.
  
  
  RESULTS
  Kampo diagnosis was used before randomization in 27 RCTs (7.1%), after randomization in 31 RCTs (8.2%), and not used in 320 RCTs (84.7%). Before randomization, Kampo diagnosis was used as a criterion for inclusion in 10 RCTs, criterion for exclusion in 9 RCTs, and criteria for both inclusion and exclusion in 2 RCTs. Kampo formulas were determined according to Kampo diagnosis in 7 RCTs. After randomization, subgroup analyses according to Kampo diagnosis were done in 27 RCTs, and grade of disease severity at Kampo diagnosis was used for analysis as an endpoint in 4 RCTs.
  
  
  CONCLUSIONS
  Kampo diagnosis was used before randomization only in approximately 15% of RCTs, and the number of RCT articles using Kampo diagnosis after randomization was almost the same as that before randomization. Further studies to determine the good RCTs conforming to CONSORT requirements and good systematic reviews conforming to PRISMA requirements are needed to clarify the significance of Kampo diagnosis.
authors.affiliation: Department of Medical Oncology, Kanazawa Medical University, Ishikawa, Japan.
authors.forename: Yoshiharu
authors.initials: Y
authors.lastname: Motoo
authors.affiliation: Department of Kampo Medicine, Nihon Pharmaceutical University, Saitama, Japan.
authors.forename: Ichiro
authors.initials: I
authors.lastname: Arai
authors.affiliation: Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.
authors.forename: Kiichiro
authors.initials: K
authors.lastname: Tsutani
mesh_terms: D019937:Diagnostic Techniques and Procedures; D004365:Drugs, Chinese Herbal / Q000494:pharmacology* / Q000592:standards; D019317:Evidence-Based Medicine / Q000379:methods*; D007564:Japan; D020835:Medicine, Kampo / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*
chemical_list: D004365:Drugs, Chinese Herbal