OBJECTIVE: Although the use of complementary and alternative medicine (CAM) by the general population has been surveyed previously, the provision of CAM by Japanese physicians in private clinics has not been studied. Universal health insurance system was established in Japan in 1961, and most CAMs are not on the drug tariff. We aimed to clarify the current status of CAM provided by physicians at private clinics in Japan. METHODS: We conducted an internet survey on 400 directors/physicians of private clinics nationwide on the provision of CAM from February 6 to February 10, 2017. Survey items included attributes of subjects, presence/absence of sections or facilities for provision of CAM, proportions of health insurance coverage for medical practices, and source of information. Private clinic was defined as a clinic run by one physician, with less than 20 beds. RESULTS: Commonly provided CAMs were Kampo (traditional Japanese herbal) medicines (34.8%) and supplements/health foods (19.3%). CAMs on the drug tariff were provided in 46.5% of cases at the clinics, but only 16.5% of cases were provided CAMs which were not on the drug tariff, at different neighboring facilities. Among different specialties, Kampo medicines were prescribed at obstetrics/gynecology (54.0%), orthopedics (44.4%), and dermatology (43.0%). Clinics not providing any CAM accounted for 53.5%. With regard to health insurance coverage, 96.8% of the clinics provided only or mainly health services on the universal national health insurance tariff (29.8% and 67.0%, respectively). CONCLUSION Kampo medicines represent the most commonly used CAM in private clinics in Japan, and universal national health insurance coverage is considered to be the reason for the high rate of their use.

There had been no standardized rules for citing ethical Kampo products used in clinical trials in journal articles. Although the name of a Kampo manufacturer was described in 77.9% of research articles, the name and ratios of crude drug components of Kampo formulas were not described in 77.5% of these papers. Considering the importance of proper characterization of interventions in the Consolidated Standards of Reporting Trials (CONSORT) checklist, we hereby propose the use of the Standards of Reporting Kampo Products (STORK) website, http://mpdb.nibiohn.go.jp/stork, as a reference for Kampo products. This will provide an official source on the internet for verified information on individual Kampo formulations for citation purposes in clinical research articles.

Objectives: To assess the quality of study reports on spa therapy based on randomized controlled trials by the spa therapy and balneotherapy checklist (SPAC), and to show the relationship between SPAC score and the characteristics of publication. Methods: We searched the following databases from 1990 up to September 30, 2013: MEDLINE via PubMed, CINAHL, Web of Science, Ichushi Web, Global Health Library, the Western Pacific Region Index Medicus, Psyc INFO, and the Cochrane Database of Systematic Reviews. We used the SPAC to assess the quality of reports on spa therapy and balneotherapy trials (SPAC) that was developed using the Delphi consensus method. Results: Fifty-one studies met all inclusion criteria. Forty studies (78%) were about “Diseases of the musculoskeletal system and connective”. The total SPAC score (full-mark; 19pts) was 10.8±2.3pts (mean±SD). The items for which a description was lacking (very poor; ＜50%) in many studies were as follows: “locations of spa facility where the data were collected”; “pH”; “scale of bathtub”; “presence of other facility and exposure than bathing (sauna, steam bath, etc.)”; “qualification and experience of care provider”; “Instructions about daily life” and “adherence”. We clarified that there was no relationship between the publish period, languages, and the impact factor (IF) for the SPAC score. Conclusion: In order to prevent flawed description, SPAC could provide indispensable information for researchers who are going to design a research protocol according to each disease.

Objective: To propose the best pharmacovigilance plan in Japan by comparing post marketing safety studies in Japan and the U.S.
Method: Among all of the newly approved medicines in Japan in 2010, 12 marketed products in the U. S. are selected. First, to examine the U. S. system, post-marketing safety concerns over those drugs at the time of approval in the U. S. were collected as well as its postmarketing requirements (PMR) which are studies or clinical trials that sponsors are required to conduct under one or more statutes of regulations. Then, the same drugsʼ safety issues discussed as special cautions listed during the approval process in Japan and the corresponding postmarketing safety studies were reviewed.
Result: Both countries have many safety concerns in common, however, in Japan, ongoing studies are only conventional studies, such as post-marketing surveillance studies or all-cases studies, while the U. S. conducts studies to meet each individual requirement need. Ideal post-marketing safety study designs proposed by the task force, seemed beyond sponsors capabilities, particularly with regard to conduct studies with control group, and require involvement of academia external research organizations, or establishment of the national registry system for cancer and other major diseases.
Conclusion: In Japan, Risk Management Plan (RMP) will soon be implemented in 2013, and that is expected to secure patientsʼ safety by the scientific pharmacovigilance plan with the international standard. It is an urgent task to discuss what plan is feasible in Japan and how to make the corporation of industry-government-academia a reality. (Jpn J Pharmacoepidemiol 2012; 17 (1): 55-66)

We investigated the correlation between search terms in electronic databases and descriptors of Kampo medicine in English articles to consider what may the best expressions to search for Kampo medicine in English literature. First, we selected Kampo articles from CENTRAL of the Cochrane Library that were originally identified in Pubmed. “Medicine, Kampo” has been used as a Medical Subject Heading (MeSH) in PubMed since 2000. However, among the 53 Kampo articles published there since 2000, only 13 have been indexed with the MeSH descriptor “Medicine, Kampo”. Second, we searched for the keywords “Kampo” and “Japanese (medicine)” in the literature, and investigated the correlation between these terms and the same “Medicine, Kampo” descriptor. As a result, a literature search with “Medicine, Kampo” was highly correlated with the concurrent use of “Kampo” and “Japanese” in the articles. Hence, we advocate the use of terms such as “Kampo medicine (traditional Japanese medicine)” to include both the words “Kampo” and “Japanese” in future English literatures on Kampo medicine.

Duplicate publication has a negative influence on science and publishing communities. We found duplicate publication cases in the field of Kampo (traditional Japanese herbal medicine) while compiling the Evidence Reports of Kampo Treatment (EKAT) 2009 published by the Special Committee for Evidence-based Medicine (EBM), the Japan Society for Oriental Medicine (JSOM). Therefore, we checked the articles that appeared in the EKAT 2009 and analyzed how duplicate publication occurred.

Traditional Japanese medicine, Kampo, is used by over 80% of medical doctors in Japan. Owing to its high quality and safety, Kampo has been integrated into modern medicine, and there are 345 randomized controlled trials using Kampo in Japan as of 2010. Although there are a number of articles in top journals about basic science research, we can find only small numbers of high-quality clinical evidence. Since undergraduate education on Kampo has been established, integrative approach with the balanced combination of modern medicine and Kampo is expected to generate good clinical evidence in the near future.
Biomedical Research ; methods ; trends ; Education, Medical ; History, 20th Century ; History, 21st Century ; History, Ancient ; Humans ; Japan ; Medicine, Kampo ; history ; trends ; Medicine, Traditional ; history ; trends ; Models, Biological