Progress in the design and quality control of placeboes for clinical trials of traditional Chinese medicine |
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| Institution: | 1. College of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;2. Engineering Research Center of Modern Preparation Technology of TCM of Ministry of Education, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;3. Department of Traditional Chinese Medicine, Beicai Community Health Service Center of Pudong New District, Shanghai 201204, China;1. Department of Radiology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;2. Department of Acupuncture & Moxibustion, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;1. Gastroenterology and Hepatology Research Center, Kerman University of Medical Sciences, Kerman 7716913555, Iran;2. Department of Traditional Medicine, School of Persian Medicine, Kerman University of Medical Sciences, Kerman 7716913555, Iran;3. Student Research Committee, Afzalipour Faculty of Medicine, Kerman University of Medical Sciences, Kerman 7716913555, Iran;4. Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman 7716913555, Iran;5. Department of Community Health Nursing, Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman 7716913555, Iran;1. School of Pharmacy, Faculty of Medicine and Health, the University of Sydney, Sydney, New South Wales 2006, Australia;2. The Australian Research Centre in Complementary and Integrative Medicine, School of Public Health, the University of Technology, Sydney, New South Wales 2007, Australia;3. Institute for Sustainable Futures, the University of Technology, Sydney, New South Wales 2007, Australia;4. The Woolcock Institute of Medical Research, the University of Sydney, Sydney, New South Wales 2037, Australia;5. Sydney Medical School, Faculty of Medicine and Health, the University of Sydney, Sydney, New South Wales 2006, Australia;6. Department of Respiratory & Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, New South Wales 2050, Australia;1. Department of Biomedical Engineering, Southwest State University, Kursk 305040, Russian Federation;2. Electrical Energy Department, Balqa Applied University, Amman 11937, Jordan;3. Civil Engineering Department, Zarqa University, Zarqa Governorate 13222, Jordan;4. Saint-Petersburg National Research University of Information Technologies, Mechanics and Optics, Saint-Petersburg 197101, Russian Federation;5. Pediatric Faculty, Kursk State Medical University, Kursk 305041, Russian Federation;1. Andalusian School of Public Health, 18011 Granada, Spain;2. Unit of Clinical Management of Preventive Medicine and Public Health and Occupational Medicine, Puerta del Mar University Hospital, 11009 Cádiz, Spain;3. Consortium for Networked Biomedical Research in Epidemiology and Public Health, 28029 Madrid, Spain;4. Institute for Biosanitary Research (ibs.GRANADA), 18012 Granada, Spain;1. Institute of Chemistry, São Paulo State University, Araraquara, São Paulo 14800-060, Brazil;2. Educational Foundation of the City of Assis, Assis, São Paulo 19807-130, Brazil;3. Department of Chemistry, School of Sciences, São Paulo State University, Bauru, São Paulo 17033-360, Brazil;4. Department of Biotechnology, School of Sciences, Humanities and Languages, São Paulo State University, Assis, São Paulo 19806-900, Brazil |
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| Abstract: | In recent years, new preparations of traditional Chinese medicines (TCMs) have been developed, increasing the need for their clinical trials. Using placeboes rather than control drugs is increasingly popular in clinical trials of TCMs, as the therapeutic effects of the tested TCMs can be more properly judged. The basic attributes of TCM placeboes include similarity, safety, applicability and controllability. In particular, it is necessary to have similarities in appearance, color, smell and taste between the tested TCMs and placeboes. This is quite difficult for some TCMs due to their distinctive smell and taste. On the other hand, according to the TCM theory on homology of medicine and food, many foods also have certain bioactivities, potentially further complicating the selection of materials for TCM placeboes. In this review, firstly, studies on the special smell and taste of TCMs were introduced. Then, the preparation quality evaluation processes for TCM placeboes were summarized and discussed, based on the relevant literature published in recent years and the research results from our own lab. This review will facilitate the further research and development of TCM placeboes. |
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| Keywords: | Traditional Chinese medicines Placebo Critical quality attributes Clinical trial Similarity |
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