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1 , JSAM JSAM KAMS KOMS) JSAM) KOMS JSAM,, Kawakita Kenji, Department of Physiology, Meiji University of Oriental Medicine, Hiyoshi-cho, Nantan City, Kyoto, Japan
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12 PMS PMS 5 PMS 6 PMS RCT n-of-1 trial n-of-1 trial RCT 1) Todman J,B. et al. Single-case and small-n experimental designs, Lawrence Erlbaum Assoc. Publishers, Mahwah, NJ, London (ISBN ). 2) Kawakita K et al. A proposal for a simple and useful research design for evaluating the efficacy of acupuncture: multiple, randomized n- of-1 trials. Japanese Acupuncture and Moxibustion (JAM). 2005: 1; ) Jaded AR et al. Meta-analysis to evaluate analgesic interventions: asystemtaic qualitative review of their methodology. J Clin Epidemiol 1996: 49; ) MacPherson H. Pragmatic clinical trials, Comp Ther Med, 2004: 12; ) Lee SH et al. Review of pragmatic clinical trials on acupuncture, J Korean Acupunct & Mox Soc, 2005: 22; ) Endicott J, Nee J, Harrison W. Daily Record of Severity of Problems (DRSP): reliability and validity. Arch Women Ment Health Jan; 9(1):
13 Workshop Clinical Trials in Japan and Korea - The Present State and Issues to be Solved - TAKAHASHI Norihito 1), SUMIYA Eiji 1), LEE Sang-Hoon 2), KIM Sung-Chul 3), TSUTANI Kiichiro 1), KIM Yong-Suk 2), KAWAKITA Kenji 1) 1 EBM Working Group, The Japan Society of Acupuncture and Moxibustion 2 Kyung Hee University 3 Won Kwang University Abstract The purpose of this workshop was to discuss on various issues for the development of a protocol for the Japan-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. Randomized n-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. On the 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. Zen Nippon Shinkyu Gakkai Zasshi (Journal of the Japan Society of Acupuncture and Moxibustion: JJSAM). 2006; 56(2): Key words: individualized acupuncture therapy, randomized n-of-1 trials, pragmatic clinical trials, pollinosis, premenstrul syndrome
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