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  6. 2. Background

2. Background

In an effort to disseminate evidence-based medicine (EBM) in oriental medicine, the Japan Society for Oriental Medicine (JSOM) established the Special Committee for Evidence Based medicine (EBM) in June 2001. In the Committee, led by Chairman Tetsuo Akiba, experts worked to organize clinical evidence of Kampo treatment. The achievements were the “EBM in Kampo 2002, Interim Report” (Nihon Toyo Igaku Zasshi [Japanese Journal of Oriental Medicine] 2002: 53(5), supplementary issue) issued in 2002, and “Evidence Reports of Kampo Treatment” (Nihon Toyo Igaku Zasshi [Kampo Medicine] 2005: 56, EMB supplementary issue) in 2005 (in Japanese).

These reports covered the studies of Kampo formulations for prescription satisfying the new standards for Kampo formulations implemented in 1986, using the same prescription from the start through the end of the observation period in at least 10 subjects, and published between 1986 and 2002, including not only controlled trials but also case series (including records of academic or study meetings). References that satisfied the above criteria were selected from among the original database gathered and enumerated by the Japan Kampo Medicines Manufacturers Association (JKMA) and offered by the JKMA. In the final report, “Evidence Reports of Kampo Treatment,” 93 of 905 references offered by the JKMA were selected by the EBM Special Committee and compiled as structured abstracts consisting of five items, as follows: “participants,” “design (methods, period, and others),” “main results,” “from Kampo medicine perspective,” and “safety assessment in the article.” In addition, reference appraisal and recommendation ratings were made.

Preparation of this report was an epoch-making activity at that time, in terms of its basic procedures. However, some defects were pointed out; for example, whether a certain reference was not included because it was not found or because it was excluded in the selection process could not be distinguished

Okabe T. How much has the Kampo evidence been established to date? - the current state and future challenges based on the Evidence Reports. Nihon Toyo Igaku Zasshi [Kampo Medicine] -2007; 58(3): 435-41 [in Japanese].

Taking over predecessors' achievements, the second phase of the JSOM EBM Special Committee, starting in 2005, adopted the systematic review approach, focusing on exhaustibility and transparency, to prepare structured abstracts limited to randomized controlled trials (RCTs) published in or after 1986 in accordance with worldwide standards.

Furthermore, in consideration of how the results could best be utilized, the results were to be published on the Japan Society for Oriental Medicine (JSOM) web site to improve accessibility, for the following reasons:

In a flood of medical information, it is not easy to make a right decision on which information would profit the patient. Dissemination of evidence-based medicine usually involves our steps, as follows: step 1, identification of issues; step 2, information gathering; step 3, information review; and step 4, administration to patients. For busy clinicians, however, it is difficult to search various databases for available references, review all these references, and decide which reliable and appropriate medicines are. Especially for physicians not specialized in Kampo, it is even more difficult to judge which Kampo medicine should be used based on a search of general databases such as Medline.

In this context, it is desirable to develop a system to entrust the step 2 and step 3 procedures to a third party in advance so that information may be gathered and reviewed exhaustively and offered in an easy, accessible manner. Therefore, it was decided that the second phase of this activity would clearly focus on pre-appraisal and utilization of IT technology.

The outcomes of the activities after the second phase were sequentially published on the Society’s website (http://www.jsom.or.jp/medical/ebm/er/index.html) according to version, as shown on page 2. The summary of the activities during the first 4-year period was reported in the Japan Society for Oriental Medicine 60th Annual Meeting (Tokyo) Forum “Transfer Kampo evidence,” along with the activities of the Task Force for Clinical Practice Guidelines (CPG-TF) and the Task Force for Best Cases (BC-TF) (Abstracts of the Speeches in the Japan Society for Oriental Medicine 60th Annual Meeting, Nihon Toyo Igaku Zasshi [Kampo Medicine] 2009; 60 suppl.: 157-72) (in Japanese).

The slides used by all ten speakers in the Forum were all published in book form along with the above abstracts of the speeches, and on the Society's website:http://www.jsom.or.jp/medical/ebm/doc/Forum2009.htm

Chaired by Kiichiro Tsutani MD, PhD, the third and fourth phases of the Committee for EBM (changed from Special Committee for EBM in June 2012), from April 2009 on, took over the activities of the previous phases. The second phase of the Task Force for Evidence Reports (ER-TF) and the Task Force for Clinical Practice Guidelines (CPG-TF) had activities and outcomes strongly associated with each other in nature, and were therefore combined in 2009 into the Task Force for Evidence Reports / Clinical Practice Guidelines (ER/CPG-TF) to carry on updating of the Evidence Reports and their English versions.

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