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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.
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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.
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<b>Objecti</b><b>ves:</b> 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.<BR><b>Methods:</b> 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.<BR><b>Results: </b>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.<BR><b>Conclusion:</b> 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.
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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.
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<b>Objective</b>: To propose the best pharmacovigilance plan in Japan by comparing post marketing safety studies in Japan and the U.S.<br><b>Method</b>: 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.<br><b>Result</b>: 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.<br><b>Conclusion</b>: 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)
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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.
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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.
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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.
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Humans , Biomedical Research , Methods , Education, Medical , History, 20th Century , History, 21st Century , History, Ancient , Japan , Medicine, Kampo , History , Medicine, Traditional , History , Models, BiologicalABSTRACT
The Fifth Session of the Sixth Executive Committee (EC), the Seventh General Assembly (GA), and the First Session of the Seventh EC and 2009 World Acupuncture Congress of the World Federation of Acupuncture-Moxibustion societies (WFAS) were held at European parliament in Strasbourg, France on 3-7 November 2009.<BR>New EC members for the year of 2009-2013were elected in the GA. The Seventh EC commenced and now consists of 49 members. Host countries for the future meetings were also approved.<BR>In the Seventh EC, the Japan Society of Acupuncture and Moxibustion (JSAM) made a proposal regarding WFAS administrative duties. It consisted of eight items, and among them, the request for making the minutes of EC meetings was most important because WFAS EC meeting minutes have never been sent to the EC members except once, for the Bali, Indonesia meeting in 2006.<BR>Papers regarding acupuncture education, legislation, traditional research and scientific research were also presented in the academic meeting.<BR>JSAM will continue to support the enhancement of the academic level of WFAS and make any necessary proposals toward the further development of WFAS.
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The Japan Society for Oriental Medicine (JSOM) began its second Special Committee for EBM (evidence- based medicine) project in 2005. Evidence Report Task Force (ER-TF) of the furthered the project on Evidence Reporting in Kampo Treatment initiated by the previous committee in 2001. The second Committee once again collected randomized control trial (RCT) literature only, to produce structured abstracts (SA). ors were then asked to make comments in these SA, as would be found in international EBM medical journals. There was concern, however, that their comments were reviewed negatively by authors of original article. Therefore a workshop entitled “How to Write Appropriate Comments” was held at the 58th Annual Meeting of JSOM in Hiroshima, on June 17, 2007. This workshop proved educational, and demonstrated ways to write more positive comments, including the so-called “sandwich technique” of writing first positive, then negative, then positive comments (PNP).
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Medicine, Kampo , NotificationABSTRACT
For the purpose of pharmacists to be able to be more involved clinically, the pharmacy education system in Japan was revised in April 2006 and the term length of pharmacy education was extended from 4 years to 6 years.<Br> The Japanese Society for Pharmacoepidemiology is deeply concerned about the new curriculum which will be adopted for the 6-year course, especially the handling of pharmacoepidemiology education. Two questionnaire surveys were sent to the dean of all schools of pharmacy to inquire whether they lecture pharmacoepidemiology and, if not, what study in pharmaceutical sciences would be most closely related to pharmacoepidemiology. The surveys were conducted just before and just after the introduction of the new system, in October 2005 and July 2007. The recovery of the first and second survey were 90% and 76%, respectively.<Br> In the first survey only 17 universities (31%) had lectures on pharmacoepidemiology but in the second survey 31 universities (57%) did, and in 55% of these 31 universities the lecture was required. The result indicates that the understanding of professors of pharmacy school regarding the lecture have been gradually promoted and they feel that pharmacoepidemiology is going to be considered to be one of the essential lectures in pharmacy education in Japan. However, many responders indicated that pharmacoepidemiology was still an immature field of study and there are few appropriate textbooks and no teaching experts, and therefore, the society should take these matters into reconsideration.
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The purpose of this study was to systematically review non-randomized controlled trials of balneotherapy effects on locomotorium diseases in order to assess their quality and organize the evidence.<br> We searched the databases of PubMed, CINAHL, Web of Science, JDream ll, and lchushi-Web forpapers published from 1990 to December 2, 2008. Eligible studies were non-randomized controlled trials in which balneotherapy exclusive of underwater exercise was the primary intervention. There was no limitation on the language in which the paper was written.<br> We found only 4 papers (2 in English, 1 in Croatian, and 1 in Japanese) that fulfilled the eligibility criteria. These papers differed in the type of diseases studied, so a meta-analysis could not be applied. Their individual results showed that hot springs treatment in combination with a comprehensive fitness class was more effective than hot springs treatment alone, and that balneotherapy had therapeutic effects on arthrosis deformans, psoriatic arthritis, and lumbago. However, it was difficult to accurately interpret the effects because these papers were deficient in providing descriptions of important details of the studies.<br> To improve the quality of future investigations performed with non-randomized controlled trials, we suggest that investigators design a study based on various checklists, implement interventions, conduct evaluations, finally write papers summarizing their findings.
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WFAS Executive Committee meeting was held on 6 November 2008 in Beijing, China. Firstly, WFAS secretary reported what they have achieved since last meeting in 2007. Then some important issues such as revision of membership certificate and revision of WFAS constitution were proposed and discussed. The 7th WFAS World Congress of Acupuncture had been decided to be held in Korea in 2009, but it was cancelled because of the recent economic crisis. The alternative venue for the next congress was not decided but France and/or Germany could be the candidate. In addition, Dr. Tsutani made a suggestion about the WFAS ethic codes on the WFAS website and it was approved.
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WHO Congress on Traditional Medicine was held in Beijing, China from 7 to10 November 2008. Dr. Margaret Chan, Secretary General of WHO addressed a speech at the opening ceremony, emphasizing the role of traditional medicine (TM) /complementary and alternative medicine (CAM) in primary health care and preventive medicine. During the congress, the Beijing Declaration was adopted. The Declaration affirms the importance of government action to promote the integration of TM /CAM into their health care system.<BR>In addition, there were four satellite symposia, including the symposium of the World Federation of Acupuncture and Moxibustion Societies (WFAS). In line with the principle of the congress, a session regarding the present status of legislation, education and research in each member country was presented. In the executive committee meeting of WFAS, revision of the constitution and other issues were discussed. The university cooperation working committee of WFAS proposed a project editing an international textbook on acupuncture and moxibustion.
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The purpose of this study was to review several kinds of checklists and statements of studies in human subjects, and to examine reporting methods in order to improve the quality of studies concerning hot springs.<br>For randomized controlled trials (RCTs), “the CONSORT Statement” (Moher et al. <i>JAMA</i> 2001) consisting of 22 terms is the most well known checklist. In addition, different versions and new checklists have been developed depending upon the content of the studies (such as intervention methods) or field of the studies. There is also “the QUOROM Statement” (Moher et al. <i>Lancet</i> 1999) for a systematic review (SR) of RCTs, “the TREND Statement” (Jarlais et al. <i>Am J Public Health</i> 2004) for nonrandomized controlled trials, “the STROBE Statement” (Elm et al. <i>Ann Inter Med</i> 2007) for observational studies, and “the MOOSE Checklist” (Stroup et al. <i>JAMA</i> 2000) as a SR of observational studies. With regard to studies on hot springs, however, terms in the checklists and the statements described above are insufficient or inappropriate because of difficulties in performing such studies in a blinded manner, and the diversity of intervention methods, such as the quellen charakter.<br>Improvement of the quality of reports is important for validation of evidence. In order to improve the quality of assessments and reports of studies on hot springs, it may be necessary to develop a unique checklist based on the above-described statements and checklists.
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The purpose of this study was to review randomized controlled trials of the effects of treatment in spas, thereby clarifying therapeutic effects of these treatments on individual diseases, and its healthpromoting effects.<br>A review of the PubMed database for articles that fulfilled the following eligible criteria identified the studies that were chosen for this review. Key words were “randomized controlled trial” and “spa” or “balneotherapy”. Articles were published after 1990, and written in English. No criteria were set up concerning the number of subjects, the observation period, or the kind of disease studied. The quality of individual articles was evaluated on a 13-point modified PEDro scale that was constructed by adding three terms, representing the number of subjects, the observation period, and quellencharakter to the 10-point PEDro scale.<br>A total of 18 articles were chosen. Since two of them were essentially identical in content, these two articles were counted as one. As a result, a total of 17 articles were reviewed. Seven studies were conducted in France, 3 in Germany, 3 in Israel, 2 in the Netherlands, and 1 each in Italy and in Japan. Diseases studied in these articles were mostly disorders of the locomotorium, with pain as a main symptom; rheumatism in 6 articles, osteoarthritis in 4, lumbago in 3, and Parkinson's disease, varicosis, psoriasis, and health-promotion in one each. The mean score on the 13-point modified PEDro scale was 7.5 (SD, 2.3), with a minimum score of 2 points and a maximum score of 12 points.<br>The method of intervention in the spa varied widely from study to study. In addition to balneotherapy, exercise therapy, mud pack treatment, and douche massage were employed in numerous studies. Besides the intensity of pain and the amount of anodynes consumed by patients, emotional effects, QOL, physical working capacity, and even decreases in medical expenses were monitored as indicators for evaluation of the effect of the treatments in some studies. Improvements in the indicators were always more marked in balneotherapy intervention groups than in control groups, irrespective of the diseases studied. The improvements persisted for relatively long periods. In particular, a review of the high quality articles that reported effects of balneotherapy on patients with rheumatism, osteoarthritis, or lumbago showed that effects of intervention provided only once could be expected to persist for six months. With regard to the effect of quellencharakter on diseases, no definitive conclusion was obtained. On the basis of these results, we devised a “3-layer model of evidence to be accumulated in balneotherapy”
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The purpose of this workshop was to discuss on various issues for the development of a protocol for the Ja pan-Korea research collaboration. An important issue is to select/develop the experimental design of the clinical trial for individualized therapy done in Japan and Korea. Randomizedn-of-1 trial and randomization test were proposed as an possible candidate. A pilot study using randomized n-of-1 trial was done using intradermal acupuncture on pollinosis, and the methodological issues on the generalizability of randomized n-of-1 trial and the need of the selection of target disease were discussed. Onthe other hand, the literature survey has shown that the individualized acupuncture therapy is more effective than those of the standardized' fixed acupuncture therapy in usual RCTs. The diagnosis and selection of acupuncture point and method of manipulation were also shown to be an important factor. Further discussions will be required for the development of the adequate protocol for the individualized therapy.
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Since 2004, the World Health Organization Regional Office for the Western Pacific (WHO/WPRO) has been in the process of developing international clinical practice guidelines (CPU), for the use of traditional medicines. There are, however, major differences in the medical licensing, drug approval and health insurance systems among nations within this Region. Furthermore, there is yet not enough evidence to develop reliable CPU. It is highly possible that any such CPU could cause legal and administrative, as well as healthcare problems. Japan should approach this issue with caution.
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The Anatomical Therapeutic Chemical (ATC) classification system and the Defined Daily Dose (DDD) as a measuring unit was developed along with an increased concern about drug utilization studies in Europe in the 1960s. Its use was recommended by the WHO Regional Office of Europe on 1981, then by the WHO Headquarters in Geneva in 1996. It is maintained by the WHO Collaborating Centre on Drug Statistics Methodology in Olso (http://www.whocc.no/) and widely used in Europe. However, it is rarely used in other parts of the world. This paper aims to inform the Japanese public about the ATC/ DDD system towards a more rational use of drugs in Japan. It attempts to answer the five Ws on ATC/ DDD, i.e., “What is ATC/DDD?”; “Why is ATC/DDD used?”; “When was ATC/DDD established?”; “Who decide ATC/DDD and how?”; and “Where is ATC/DDD used?”
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The first Japan-Korea workshop on acupuncture and EBM was held on June 4, 2004 at Chiba in the 53rd annual scientific meeting of the JSAM. The purpose of this workshop was to exchange the experiences of clinical researches on acupuncture and moxibustion therapies, and to find out the issues and their solutions for developing the excellent clinical research to establish strong evidence. The final purpose was to develop aprotocol for the collaborative work between both countries.<BR>Drs. Kawakita (JSAM) and Jang (KAMS) chaired the workshop. Three speakers from Japan (Drs Takahashi, Nabeta, and Tsukayama) and three Korean speakers (Drs Seo, Lee and Moon) presented their data on the clinical researches of acupuncture, moxibustion and bee-venom injection. After their paper presentations, various issues were discussed on their research methodology for establishing more strong evidence of acupuncture.We got interesting new findings and understood various issues for conducting clinical researches especially RCT.<BR>Although we could not develop a protocol for the collaborative research in this workshop, it was very fruitful workshop as the first step for the future Japan-Korea collaborative clinical study. The most important product of this workshop was we could understand each other and we confirmed the necessity of the future collaborative clinical research on acupuncture.