What is STORK ?

DPPN of NIHS and RCMPR of NIBIOHN

(ver.1.0, 10 Oct 2011) ver. 5.2, 17 Nov 2023

STORK (Standards of Reporting Kampo Products) is the website for Kampo products, formerly called as KCONSORT. The CONSORT Statement is “an evidence-based, minimum set of recommendations for reporting randomized controlled trials (RCTs). It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation” ( http://www.consort-statement. org/ ). Its first edition was developed in 1996 and has been revised in 2002 and 2010. The CONSORT Statement 2010 comprises a 25-item checklist and a flow diagram.

From the analysis of “Evidence Reports of Kampo Treatment”, which contains structured abstracts of RCTs of ethical Kampo drugs ( http://www.jsom.or.jp/medical/ebm/ere/index.html ), it was observed that characteristics of Kampo drug as intervention have been reported in various styles. It varies from Kampo formula name only to detailed description including “fingerprint” using HPLC. It might be the reflection of different ‘Instruction to Authors’ in different journals. Kampo drugs in Japan are manufactured by Kampo drug companies under the regulation of Japanese Pharmaceutical Affairs Law, including Japanese Pharmacopeia and relevant notification such as GMP and others. Therefore, for Japanese readers of the articles of RCT using Kampo drugs, identification of the Kampo drug is easy. For international readers, however, correct identification is not easy because the access to the relevant information is limited.

The website of STORK provides information of characteristics of 148 ethical Kampo drugs marketed in Japan. This corresponds to Item 5 (Intervention) of the CONSORT Statement 2010. Thus, reporters of RCT and other type of clinical research of Kampo drugs are recommended to write the correct URL of STORK to describe characteristics for each Kampo drug involved in the study in the manuscript, such as (anchusan, see http://mpdb.nibiohn.go.jp/stork/). In addition, dose, usage and other elements of intervention should be reported separately in the Intervention section.

For Kampo diagnostic system used in RCT, it would be mainly reported in Item 4a of the CONSORT statement (Eligibility criteria, including inclusion criteria or exclusion criteria) or item 5 (Intervention).

KCONSORT Task Force, Special Committee for Evidence-based Medicine (EBM), the Japanese Society for Oriental Medicine (JSOM) was set up in June 2009 to develop KCONSORT website. In June 2011, the project was shifted from JSOM to Division of Pharmacognosy, Phytochemistry and Narcotics (DPPN), National Institute of Health Sciences (NIHS) of Japan, and Research Center for Medicinal Plant Resources (RCMPR), National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN) of Japan, as a part of the large project of “Systematic review of efficacy, safety, cost-effectiveness of traditional east Asian medicine” funded by Ministry of Health, Labor and Welfare (MHLW) of Japan 2010-2011 (H22-Iryo-Ippan-011). KCONSORT original version of website was released as ver.1.0 on 10 October 2011. It was re-named as STORK in 24 December 2016. It has been maintained jointly by DPPN of NIHS and RCMPR of NIBIOHN, in cooperation with STORK Task Force, Committee for EBM (re-named in June 2012), JSOM, and Japan Kampo Medicines Manufacturers Association (JKMA).