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Executive Summary

The Special Committee for Evidence Based Medicine (EBM), established in June 2001 by the Japan Society for Oriental Medicine (JSOM), issued the “EBM in Kampo 2002, Interim Report” (Nihon Toyo Igaku Zasshi [Japanese Journal of Oriental Medicine] 2002: 53 (5), supplementary issue) in 2002, followed by “Evidence Reports of Kampo Treatment” (Nihon Toyo Igaku Zasshi [Kampo Medicine] 2005: 56, EBM supplementary issue) in 2005. These publications were intended to present the evidence from “good” studies, including randomized controlled trials (RCTs), of Kampo products published between 1986 and 2002. However, those studies had several methodological limitations, such as lack of clear inclusion/exclusion criteria. Thus, questions were raised by readers such as why particular existing articles had or had not been included.

Accordingly, the improvements listed below were included in the JSOM Task Force for Evidence Report (ER-TF), the second phase of the EBM Special Committee, starting in 2005. These improvements were continued in the Task Force for Evidence Reports / Clinical Practice Guidelines (ER/CPG-TF), the third phase of the EBM Special Committee (changed to EBM Committee in June 2012), starting in 2009, and the fourth phase of the EBM Committee starting in 2013.

  1. (1) RCT articles with high levels of evidence were exhaustively included for review.
  2. (2) The methods for literature search and review processes were specified to enhance accuracy and transparency.
  3. (3)  The reports were presented in the form of structured abstracts consisting of 8 items in accordance with world standards, i.e., “objectives,” “design,” “setting,” “participants,” “intervention,” “main outcome measures,” “main results,” and “conclusions,” and four additional items, i.e., “from Kampo medicine perspective,” “safety assessment in the article,” “abstractor’s comments,” and “abstractor’s name and date.”
  4. (4)  Excluded references were listed along with the reasons for their exclusion.
  5. (5)  Partly because of establishement of the Task Force for Clinical Practice Guidelines in 2005, “recommendations” included in the first report compilations were excluded.
  6. (6) A system to enable feedback from readers through the internet and other media on the current reports was established.
  7. (7) To enhance transparency and accountability, conflicts of interests (COI) among persons concerned were disclosed.
  8. (8) A search function was added to the website (http://www.jsom.or.jp/medical/ebm/ index.html). Links to the web pages on which references are published were provided.

The inclusion criteria were RCT articles using Kampo formulations (extract and pills) approved for manufacture and sale in Japan that were published between 1986, when the quality of Kampo formulations reached present levels, and the first half of 2012. Studies of in-house formulations such as decoctions were excluded, as in the report compilations in the first phase. The phase 2 report included only RCTs of Kampo products (extract granules, tablets, and capsules, or pills, approved for sale as Kampo formulations for prescription in Japan). It excluded studies of in-house formulations such as decoctions, since no quality control criteria have been established.

The data sources of searches were (1) the Cochrane Library (CENTRAL), (2) Igaku Chuo Zasshi (Japana Centra Revuo Medicana [JCRM], Ichushi) web, and (3) the database offered by the Japan Kampo Medicines Manufacturers Association (JKMA).

Structured abstracts were arranged in the order used in the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD10).

Finally, out of 494 references, 402 RCTs and 1 meta-analysis were prepared as structured abstracts. The 159 references not satisfying the inclusion criteria were listed as excluded references along with their bibliographic items and the reason for exclusion.

We would appreciate your comments on compilation method, the contents of the structured abstracts, information on references not included in the report compilations, if any, and other matters. Please send your comments to ebm-er@jsom.or.jp

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