Is it effective on group or individual?- Need for effective communication on efficacy of Oriental medicine.
10.3937/kampomed.48.569
- VernacularTitle:集団に効くことと個人に効くこと 「効き目」のコミュニケーション
- Author:
Kiichiro TSUTANI
- Publication Type:Journal Article
- Keywords:
WHO;
traditional medicine;
policy;
clinical trial;
evidence;
Kampo drug;
re-evaluation
- From:Kampo Medicine
1998;48(5):569-598
- CountryJapan
- Language:Japanese
-
Abstract:
This lecture was given on the occasion of the 1995th Award for Academic Encouragement of the Japan Society of Oriental Medicine (JSOM). It started by the author's experience and information he gained from various settings in different countries during his service as a Medical Officer for Traditional Medicine in the Western Pacific Regional Office of the World Health Organization (WHO). During that time, he was often caught in the controversy of promotion or assessment of traditional medicine. But even in China, where the government have had a strong policy in promoting Traditional Chinese Medicine (TCM), methods of clinical epidemiology has been introduced in TCM since the early 1990s. From the viewpoint of a clinical pharmacologist, the author described in this lecture, the current status of traditional medicine focusing on East Asia and proposed future plans. He discussed the relation between clinical pharmacology and clinical epidemiology and introduced basic concepts in these areas such as randomized controlled trial (RCT), placebo, bias and their prevention methods. He proposed the use of Evidence-based Oriental Medicine (EBOM) showing the strength of evidence according to study design including comparisons done before and after the study and discussed the cultural acceptability and practicability of clinical trials of oriental medicine as well as the use of RCT and the difference in the pattern of accumulation of information between classic Oriental medicine in olden times and modern Oriental medicine in the industrialized era. He stressed the difference in the meaning of efficacy on group and on individual using the concept of Number Needed to Treat (NNT) and the importance of using soft data as endpoints in evaluating oriental medicine. The applicability of evidence to the clinical setting was discussed and in the absence of strong evidence, the concept of Evidence-Biased Medicine (EBM) is recommended. The Ministry of Health and Welfare (MHW) of Japan initiated a review of the reevaluation of Kampo drugs in 1989 in line with current world trends in the evaluation of herbal medicine conducted by WHO and other organizations. In this review, disclosure of information from government sectors in areas such as clinical trials of Kampo medicine and adverse event (AE)/adverse drug reaction (ADR) was stressed. Methods of single case study (N of 1 trial) was introduced and future plans and actions by the JSOM on the evaluation of Kampoo drug were proposed.
