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  4. The Special Committee for EBM
  5. Evidence Reports of Kampo Treatment
  6. 6. Relation to other projects

6. Relation to other projects

The relation of this project to some other projects is described below.

(1) Development in Japan and Korea of universal-style structured abstracts of RCTs in the fields of traditional medicine and complementary and alternative medicine

The first initiative to deliver SAs to people who require them was the ACP Journal Club in 1991. A further, similar initiative was taken by the Evidence-Based Medicine.

In the field of Complementary and Alternative Medicine (CAM), the quarterly journal FACT (Focus on Alternative and Complementary Therapies) was published from 1996 to 2016. For acupuncture articles, in particular, the Japanese translation project was started in 2001, with translation of articles published since 1996. As the total number of translated articles reached 150, they were compiled with comments of Japanese experts into a book published in 2009.

Hari no ebidensu: Shinkyu rinsho hyoka ronbun no abusutorakuto zokyo kaiteiban (Evidence for acupuncture: abstracts of articles on clinical evaluation of acupuncture. Enlarged and revised edition). Ido no Nippon, 2009.

Several other initiatives have followed in Japan that are modeled on the EKAT initiative. In terms of Oriental medicine, in 2012, the fiscal 2010-2011 Ministry of Health, Labour and Welfare (MHLW) scientific research grant project, entitled “Higashi Ajia Dento Igaku no Yukosei, Anzensei, Keizaisei no Shisutematic Rebu” (Systematic Review of the Effectiveness, Safety, and Economy of East Asian Traditional Medicine [Principal Researcher: Kiichiro Tsutani]), prepared reports entitled “Shinkyu Ebidensu Repoto 2011” (Evidence Reports of Japanese Acupuncture and Moxibustion 2011), “Anma Massagi Shiatsu (Amashi) Ebidensu Repoto 2011” (Evidence Reports of Anma-Massage-Shiatsu 2011), and “Kampoyaku no Keizaihyoukaryoiki no Ebidensu Repoto 2011” (Evidence Report of Economic Evaluation of Kampo Treatment 2011).

In Korea, the Special Committee for EBM of the Korean Oriental Medicine Society (KOMS), with which JSOM has established an exchange agreement in 2009, published the Korean translation (근거중심의 한방처방:임상 근거를 만들고, 전달하며, 사용하는) of Evidence Reports of Kampo Treatment 2010: 345 Randomized Controlled Trials (EKAT 2010) on 15 July 2011.

The Committee also used the same methods as for EKAT to prepare an evidence report on traditional Korean medicine, which was published on 20 January 2012 as근거중심의 한의치료. The Committee prepared SAs in Korean after gathering and selecting 306 papers (including 134 RCTs), which include trials using designs other than RCT designs and were found by searching The Cochrane Library (CENTRAL), PubMed, the Korea Institute of Oriental Medicine (KIOM) database, and the websites of 17 sub-committees in the field of traditional Korean medicine. The SAs for the 134 RCTs were translated into English in “Heisei 22-23 nendo Kosei Rodo Kagakukenkyu Chiikiiryo Kibankaihatsu Suishin Kenkyujigyo -Higashiajia Dentoigaku no Yukosei Anzensei Keizaisei no Shisutematikku Rebyu” (Systematic Review of the Effectiveness, Safety, and Economy of East Asian Traditional Medicine, a Research on Region Medical under the 2010/2011 Ministry of Health, Labour and Welfare Scientific Research grants) (Principal Researcher: Kiichiro Tsutani). The report is entitled “Evidence Reports of Korean Medicine Treatment 2010: 132 Randomized Clinical Trials (EKOM 2010)”. This evidence report contains 77 RCTs on acupuncture and moxibustion, 27 RCTS on herbal medicines, one RCT on both, and 27 RCTs on other traditional Korean medicine.

Of the above, SAs on Japanese acupuncture and moxibustion (in Japanese and English), Amashi (Japanese and English), traditional Korean medicine (English), economic evaluation of Kampo treatment (Japanese) can be accessed on the website of the Evidence Reports of Traditional East Asian Medicine (ETEAM).

Furthermore, SAs of evidence reports on acupuncture, moxibustion, and massage in sport were prepared in 2016, and also on yoga in 2017, and can be accessed on the website of the integrative medicine information project subsidized by the Ministry of Health, Labour and Welfare known as: Information site for evidence-based Japanese Integrative Medicine (eJIM)

(2) CONSORT Statement

With the aim of improving the quality of references of RCTs, the CONSORT statement was published in 1996 and revised in 2001 and 2010 (

The 2010 version consists of a total of 25 items, and authors are requested to attach a checklist showing on which page the information on each item can be found. They are also requested to attach a flowchart representing subject disposition in case results might differ depending on the analysis population. These requirements not only control the quality of RCT articles but also improve the quality RCT themselves. The JSOM has added the statement that “RCT papers shall conform to revised CONSORT statement (2001)” to the instructions to authors its March 2008 revision (Nihon Toyo Igaku Zasshi [Kampo Medicine] 2008; 59: 580-89). Use of the CONSORT statement 2010 has been required since 2010.

Two herbal extensions of the CONSORT statement have been published:

Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, et al. Reporting randomized controlled trials of herbal interventions: An elaborated CONSORT statement. Annals of Internal Medicine 2006; 144(5): 364-7. (Available in Japanese: Okabe T, Tsutani K [trans], Habu kainyu no randamuka hikakusiken hokoku: shosai na CONSORT seimei. In: Nakayama T, Tsutani K [supervise-eds] Rinshokenkyu to Ekigakukenkyu notameno Kokusairuru-shu (International Rulebook for Clinical and Epidemiological Studies. Tokyo: Life Science Publishing Co., Ltd.; 2008: 156-63).

Chen CW, et,al CONSORT-CHM Formulas 2017 Group.CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med, 167 (2), 112-21

The former extension applies to single herbs, while the latter to Chinese herbal formulas. These extensions explain in detail how to describe the “intervention”, taking into consideration the nature of crude drugs. The latter extension also gives consideration to the diagnostic system used in Chinese traditional medicine and the number of years of clinical experience. Following the 2006 and 2007 editions and laborious efforts over 11 years, as the edition known as the “CONSORT Extension for Chinese Herbal Medicine Formulas” was released in 2017.

In the third phase of the Special Committee for EBM starting 2009, the Task Force for KCONSORT (KC-TF) was established. A survey of the references compiled as structured abstracts in EKAT 2009 for compliance with the CONSORT statement demonstrated that few were good in quality. Particularly, the following defects were commonly noted: no indication that the study is an RCT in title/abstract; no indication of the study site or period; no indication of the name of the manufacturer of Kampo formulation or the daily dosing frequency; no indication of the methods and assurance of randomization; unclear numbers of enrolled patients, assigned patients, and analyzed patients; no indication of adverse events in the control group. In the future, Kampo RCTs will also be required to be reported in compliance with the CONSORT statement. These findings were presented in the following meeting and published in Nihon Toyo Igaku Zasshi (Kampo Medicine) as study results.

Okabe T, Arai I, Tsutani K. Ebidensu repoto purojekuto: autorain to Kampo RCT no shitsu hyoka (Evidence Report Project [1] Outline and evaluation of Kampo RCTs). The Japan Society for Oriental Medicine 60th Annual Meeting Forum “Kampo no ebidensu wo tsutaeru (Transfer Kampo evidence),” 21 Jun. 2009, Tokyo. Nihon Toyo Igaku Zasshi (Kampo Medicine) 2009; 60 suppl.: 160 (in Japanese).

While it is recommended that RCTs be published in accordance with the CONSORT statement, the existing CONSORT statement and its extensions made it clear that it was not possible to correctly describe Kampo formulation interventions. To resolve that problem and to enable completion of the necessary information in the RCT paper methods field without needing to have a high degree of familiarity with Kampo formulations, the KCONSORT webpage was published in English in August 2011 by the Department of Pharmacognosy, Phytochemistry and Narcotics (DPPN), National Institute of Health Sciences (NIHS) of Japan, and the Research Center for Medicinal Plant Resources (RCMPR), National Institute of Biomedical Innovation (NIBIO) of Japan under work collaboration of KC-TF and Japan Kampo Medicines Manufacturers Association (JKMA). The website is intended to replace the need for authors writing RCTs on Kampo preparations to complete detailed information in their papers relating to the Kampo preparations used in research, by including the web address of this website, which contains detailed information on Kampo preparations. KCONSORT was then renamed STORK in May 2017, in part because it employs only one of the 25-item CONSORT Checklist, i.e., “Interventions”. STORK is available at the link below.

  STORK (Standards of Reporting Kampo Products)

The CONSORT statement was extended to include various study designs such as epidemiological studies and systematic reviews, and further studies on above-mentioned complementary and alternative medicine (CAM). In this context, the “Equator Network” was established in June 2008 to cover the publication guidelines for all these studies for enhanced accessibility and to help prepare such guidelines in future.

The Japanese version of these guidelines is included in the following:

Nakayama T, Tsutani K (eds). Rinsho kenkyu to ekigaku kenkyu notameno kokusai ruru-shu (International Rulebook for Clinical and Epidemiological Studies). Tokyo: Life Science Publishing Co., Ltd.; 2008 (in Japanese).

Nakayama T, Tsutani K (eds). Rinsho kenkyu to ekigaku kenkyu notameno kokusai ruru-shu Part 2 (International Rulebook for Clinical and Epidemiological Studies Part 2). Tokyo: Life Science Publishing Co., Ltd.; 2016 (in Japanese)

The above and other related publications are also available at the link below:

  Reporting guidelines at JPT Online

(3) Clinical trial registry

In the Declaration of Helsinki revised in October 2008, a sentence “Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject” was added in section 19. However, this requirement is not well known. Therefore, the discussion here includes the historical background underlying the implementation of this requirement.

Awareness of the clinical trial registry (CTR) has increased since the 1990s, when evidence-based medicine (EBM) emerged. In particular, the problems became clearer after the Cochrane Collaboration, which plays a role in the EBM information infrastructure, was established in 1992 to fully implement systematic review (SR). SR is almost synonymous with meta-analysis (MA).

However, no matter how exhaustive the survey or search, how careful the assessment of quality, and how sophisticated the statistical method used for data consolidation, a problem of bias ("publication bias") arises when studies are not reported. This leads to flaws in decision making by health care providers, policy makers, medical consumers, etc. As a result, ineffective therapies, hazardous therapies, and therapies with poor cost-effectiveness are “used”.

Table 5 gives an example of publication bias in the area of acupuncture. Search for papers with an abstract published between 1966 and 1995 by the Medline identified 108 of 109 papers published in China (99%) that have shown favorable results, that is, demonstrated the efficacy of acupuncture compared with control. The efficacy rate was 75% in England and similar to that in China in other countries including Japan. This has been attributed to failure to publish studies that do not show efficacy.

Table 5

Vickers A, et al. Do certain countries produce only positive results? A systematic review of controlled trials. Controlled Clinical Trials 1998; 19: 159-66

This situation was widely acknowledged by those involved in systematic review of these studies. Although some measures might avoid this bias, such as encouraging researchers to publish all studies, passing legislation mandating registry of all trials, and establishing a website to register planned or ongoing clinical trials, no specific measures were fully established.

In 2003, the National Library of Medicine (NLM) of the National Institutes of Health (NIH) established "Clinical" ( with the aim of encouraging patients to access information on clinical trials of new drugs (therapies) intended for life-threatening disease. This is also an aim of the 1997 US-FDA Modernization Act. This system was not intended to avoid publication bias, but partially did a limited number of diseases including cancer, AIDS, and Alzheimer's disease.

The Glaxo SmithKline fraud scandal reported on the front page of the New York Times dated 3 June 2004 triggered a worldwide reaction. In a clinical trial of an anti-depressant in children, the company failed to properly report attempted suicide as an adverse event. The scandal prompted worldwide support for legislation requiring clinical trial registration and raised ethical issues such as the risk adverse events in similar clinical trials and abuse of the altruistic goodwill of participants.

In September 2004, the International Committee of Medical Journal Editors (ICMJE) issued a statement that no manuscript would be accepted in advance of registration of the clinical trial. Trials already in progress were given additional time to comply. The Cochran Colloquium in October 2004 issued the "Ottawa Statement." The WHO also supported these statements by holding the “WHO Technical Consultation on Clinical Trial Registration Standard Meeting” in its headquarters in Geneva in April 2005 to determine 20 items to be registered, etc.

This trend continued between 2004 and 2005 as indicated below:

(1) Rinshoshiken no toroku to kekka no kokai (Clinical trial registry and publication of the results [regardless of whether or not results are positive or negative]). The 25th Annual Meeting of the Japanese Society of Clinical Pharmacology and Therapeutics Symposium 12 (18 Sept. 2004, Shizuoka). Rinsho Iyaku (Journal of Clinical Therapeutics Medicine) 2005; 21(1): 3-62 (in Japanese).

(2) Rinshoshiken toroku nikansuru “Otawa seimei” to “Junebu kaigi” no doko (“Trend toward clinical trial registry as advocated by the "Ottawa Statement" and "Geneva Conference."). Yakuri to Chiryo (Japanese Pharmacology & Therapeutics) 2005; 33(6): 543-66 (in Japanese).

(3) UMIN Clinical Trial Registry System Symposium (2 Feb. 2005)

In Japan, the University hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) (June 2005-), the Japan Pharmaceutical Information Center Clinical Trials Information (JAPIC-CTI) (July 2005-), and Japan Medical Association Center for Clinical Trials (JMA CCT) system (December 2005-) were launched. In April 2007, interventional clinical studies supported by Health and Labour Sciences Research Grants were required to be registered. Registration is also required for clinical trials by the “Ethical Guidelines for Clinical Research” issued by the Ministry of Health, Labour, and Welfare in April 2009, and also for specific clinical trials by the Clinical Trials Act (Act No. 16 of 2017). On the basis of this Act, the Japan Registry of Clinical Trials (jRCT) was created.

Since 2008, these data have been sent through the Japan Primary Registries Network (JPRN) (since October 2008) of the National Institute of Public Health to the WHO International Clinical Trials Registry Platform (ICTRP), and one-click access to the data is available worldwide. Currently, all clinical trials registered in Japan, including those on Kampo, can be searched at this website.

(4) The Cochrane Library (CENTRAL)

The Cochrane Library (CENTRAL) is a global RCT database platform, but includes only 67 of the 345 RCTs on Kampo formulations in EKAT 2010. The Center for Integrative Medicine, University of Maryland Medical School manages the compilation of RCTs on complementary therapies in CENTRAL. We have made contact with the Center and negotiated for the RCT papers compiled in EKAT to be added to CENTRAL. As a result, the Kampo RCT papers in EKAT 2010 will be included in CENTRAL, and it will have links to the English versions of JSOM’s EKAT SAs. When CENTRAL was updated in October 2011, additional EKAT papers were included. However, due to copyright issues, there are no links from the RCT papers on Kampo formulations that were originally included in CENTRAL. Nevertheless, it is now possible to access RCTs of 352 Kampo formulations from the Cochrane Library (CENTRAL), the worldwide database of RCTs. When evidence-based clinical practice guidelines (CPG) are produced, CENTRAL will be used most often to search for RCT papers. It is expected that this will facilitate Kampo formulation RCT searches, and that there will be no gaps in the evaluation of Kampo formulations for such CPGs.

The following paper describes the above in detail.

Wieland LS, Manheimer E, Sampson M, et al. Bibliometric and content analysis of the Cochrane Complementary Medicine Field specialized register of controlled trials. Systematic Reviews 2013, 2: 51

(5) Clinical practice guidelines

Traditional medicines are already international commodities. From this perspective, Japan’s Kampo formulations have fallen a little behind. If high quality SAs are prepared for Chinese and Korean traditional medicines, then it may become possible to reduce confusion in the debate through the publication of clinical practice guidelines (CPG) for traditional medicines, something that the WHO Office for the Western Pacific (WPRO) attempted to do in 2005 and 2006.

Motoo Y, Arai I, Hyodo I, Tsutani K. Current status of Kampo (Japanese herbal) medicines in Japanese clinical practice guidelines. Complementary Therapies in Medicine 2009; 17: 147-54.

Motoo Y, Tsutani K. Dento Igaku no Gurobaru Shinryo Gaidorain wa Kano ka? (Is it Possible to Realize Global Clinical Guidelines for Traditional Medicines?) Nihon Toyo Igaku Zasshi [Kampo Medicine] 2006; 57 (4): 465-75 (in Japanese).

Furthermore, the WHO/WPRO traditional medicine CPG project was discontinued at the 5th meeting in Hong Kong (2007) due to strong opposition from Japan and others. However, work was continued in China and the following three volumes were published in 2011.

China Academy of Chinese Medical Sciences ed. Chinese medicine evidence-based clinical practice guidelines: TCM Internal Medicine (Chinese Edition) (中医循証臨床実践指南 - 中医内科). Beijing. China Press of Traditional Chinese Medicine, 2011

China Academy of Chinese Medical Sciences ed. Chinese medicine evidence-based clinical practice guidelines: Special disease (Chinese Edition) (中医循証臨床実践指南 - 専科専病), Beijing. China Press of Traditional Chinese Medicine, 2011

China Academy of Chinese Medical Sciences ed. Chinese medicine evidence-based clinical practice guidelines: Acupuncture (Chinese Edition) (中医循証臨床実践指南 -鍼灸). Beijing. China Press of Traditional Chinese Medicine, 2011

The following paper includes details of the above.

Yanagawa T, Tsutani K. Chuyaku no Kokusaika to Hyojunka ni Kansuru Chugoku no Seisaku. Dai 5 kai Chui Shinryo ni Kansuru Gyokai Hyojun to Shinryo Gaidorain. (Chinese Policies on Internationalization and Standardization of Chinese Medicines. 5th Industry Standard and Clinical Practice Guidelines for Traditional Chinese Medicine Therapy) Wakan’yaku 2013; No.720: 3-10 (in Japanese).


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