Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (10): 906-910.doi: 10.3736/jcim20101001

• Review • Previous Articles     Next Articles

Placebo control and clinical trial of Chinese medicine

J Wu   

  1. Department of Gastroenterology, Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing 210029, Jiangsu Province, China
  • Received:2010-04-08 Accepted:2010-06-23 Online:2010-10-20 Published:2010-10-15

World Health Organization aims to develop safe, effective and practical traditional medicine. Traditional Chinese medicine (TCM) and other complementary and alternative medicine are being recognized in the whole world nowadays. However, the definite effect of Chinese medicine is still in need of scientific research proof. Placebo control is of equal importance to active control and blank control in clinical trial of TCM. This article briefly reviewed the importance of placebo control and commented on its present situation in clinical trial of TCM. This article also brought up the preliminary proposals of placebo application in TCM clinical trial. We should emphasize scientific placebo preparation and good design of placebo-controlled trial, which are directed by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. A good clinical trial project will avoid unnecessary wastes and provide safe and effective treatment for people.

Key words: Clinical trials, Placebos, Drugs, Chinese herbal

[1] Steve Bunk . Is integrative medicine the future? Relman-Weil debate focuses on scientific evidence issues[J]. Scientist, 1999,13(10):1
[2] Walach H . The efficacy paradox in randomized controlled trials of CAM and elsewhere: beware of the placebo trap[J]. J Altern Complement Med, 2001,7(3):213-218
doi: 10.1089/107555301300328070
[3] Steurer-Stey C, Russi EW, Steurer J . Complementary and alternative medicine in asthma: do they work?[J]. Swiss Med Wkly, 2002,132(25-26):338-344
pmid: 12422290
[4] Food and Drug Administration. Guidance for industry: botanical drug products. 2004: 9-10
[5] Zhu GG. Guidance for industry: botanical drug products[M]. Beijing: China Medical Science and Technology Press,2006: 10
祝国光 . 植物药生产指南[M]. 北京: 中国医药科技出版社,2006: 10
[6] Bian ZX, Moher D, Dagenais S, Li YP, Liu L, Wu TX, Miao JX . Improving the quality of randomized controlled trials in Chinese herbal medicine, part Ⅱ: control group design[J]. J Chin Integr Med, 2006,4(2):130-136
卞兆祥, Moher D, Dagenais S, 李幼平, 刘良, 吴泰相, 缪江霞 .提高中草药随机对照试验的质量Ⅱ:对照组设计[J]. 中西医结合学报, 2006,4(2):130-136
[7] Liu JP, Zhang M, Wang WY, Grimsgaard S .Chinese herbal medicines for type 2 diabetes mellitus[J].Cochrane Database Syst Rev, 2004,( 3):CD003642
doi: 10.1002/14651858.CD003642 pmid: 15266492
[8] Fu JJ, Wang G, Mao B . The assessment of scientificalness and ethic of placebo-controlled trials in traditional Chinese medicine[J]. Zhongguo Xun Zheng Yi Xue Za Zhi, 2008,8(9):781-785
doi: 10.3969/j.issn.1672-2531.2008.09.021
付娟娟, 王刚, 毛兵 . 中医药随机对照试验中安慰剂应用科学性与伦理性评价[J]. 中国循证医学杂志, 2008,8(9):781-785
doi: 10.3969/j.issn.1672-2531.2008.09.021
[9] Barrett BP, Brown RL, Locken K, Maberry R, Bobula JA, D’Alessio D .Treatment of the common cold with unrefined echinacea. A randomized, double-blind, placebo-controlled trial[J]. Ann Intern Med, 2002,137(12):939-946
doi: 10.7326/0003-4819-137-12-200212170-00006
[10] Barrett B . Echinacea for the common cold[J]. Ann Intern Med, 2003,139(7):601
doi: 10.7326/0003-4819-139-7-200310070-00018 pmid: 14530237
[11] Xie ZW. National collection of Chinese herbs(2nd ed)[M]. Beijing: People’s Medical Publishing House,1996,(2nd ed) 332, 952
谢宗万 . 全国中草药汇编(第二版)[M]. 北京: 人民卫生出版社,1996,(第二版): 332, 952
[12] Zhao WS, Zhang YQ, Ren LJ, Zhang L, Yang J . Immunopotentiating effects of polysaccharides isolated from Medicago sativa L[J]. Zhongguo Yao Li Xue Bao, 1993,14(3):273-276
赵武述, 张玉琴, 任丽娟, 张岚, 杨健 . 苜蓿多糖的免疫增强效应[J]. 中国药理学报, 1993,14(3):273-276
[13] Dong XF, Gao WW, Tong JM, Jia HQ, Sa RN, Zhang Q . Effect of polysavone(alfalfa extract) on abdominal fat deposition and immunity in broiler chickens[J]. Poult Sci, 2007,86(9):1955-1959
doi: 10.1093/ps/86.9.1955
[14] Jiangsu New Medical College . Dictionary of Chinese materia medica[M]. Shanghai: Shanghai Scientific and Technical Publishers,1986: 1305
江苏新医学院. 中药大辞典[M]. 上海: 上海科学技术出版社,1986: 1305
[15] Linde K, Barrett B, Wölkart K, Bauer R, Melchart D .Echinacea for preventing and treating the common cold[J].Cochrane Database Syst Rev, 2006, 25(1):CD000530
[16] Wang XF, Dong D, Liu F, Li J, Lu Y . Preliminary study of placebo making in clinical trial of Chinese medicine[J]. Liaoning Zhong Yi Za Zhi, 2003,30(12):966-967
doi: 10.3969/j.issn.1000-1719.2003.12.007
王雪峰, 董丹, 刘芳, 李杰, 鲁瑛 . 中药临床试验研究安慰剂制作初探[J]. 辽宁中医杂志, 2003,30(12):966-967
doi: 10.3969/j.issn.1000-1719.2003.12.007
[17] Tang XD, Bian LQ, Gao R, Guan SJ . Exploration into the preparation of placebos used in Chinese medicinal clinical trial[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2009,29(7):656-658
唐旭东, 卞立群, 高蕊, 官仕杰 . 中药临床试验安慰剂制作探讨[J]. 中国中西医结合杂志, 2009,29(7):656-658
[18] Dube A, Manthata LN, Syce JA . The design and evaluation of placebo material for crude herbals: Artemisia a?fra herb as a model[J]. Phytother Res, 2007,21(5):448-451
doi: 10.1002/ptr.2084 pmid: 17262891
[19] Podczeck F, Jones BE. Pharmaceutical capsules(2nd ed)[M]. London: Pharmaceutical Press, 2004,( 2nd ed):92
[20] Liu JP . Setting of control and blinded methods in clinical trial of Chinese medical study[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2003,23(10):789-791
doi: 10.7661/CJIM.2003.10.789
刘建平 . 中医药临床试验的对照与盲法设置[J]. 中国中西医结合杂志, 2003,23(10):789-791
doi: 10.7661/CJIM.2003.10.789
[21] Bu QY, Xiong NN, Wu J . International ethical guidelines for the choice of control in clinical trials[J]. Zhongguo Lin Chuang Yao Li Xue Yu Zhi Liao Xue, 2003,8(2):215-218
doi: 10.3969/j.issn.1009-2501.2003.02.029
卜擎燕, 熊宁宁, 吴静 . 临床试验中对照选择的国际伦理要求[J]. 中国临床药理学与治疗学, 2003,8(2):215-218
doi: 10.3969/j.issn.1009-2501.2003.02.029
[22] Seeff LB, Lindsay KL, Bacon BR, Kresina TF, Hoofnagle JH . Complementary and alternative medicine in chronic liver disease[J]. Hepatology, 2001,34(3):595-603
doi: 10.1007/s11894-005-0068-z pmid: 15701301
[23] Angell M, Kassirer JP . Alternative medicine — the risks of untested and unregulated remedies[J]. N Engl J Med, 1998,339(12):839-841
doi: 10.1056/NEJM199809173391210 pmid: 9738094
[1] Rui-jin Qiu, Min Li, Jia-yuan Hu, Jing Chen, Hong-cai Shang. Methods for development of a core outcome set for clinical trials integrating traditional Chinese medicine and Western medicine. Journal of Integrative Medicine, 2021, 19(5): 389-394.
[2] Arthur Yin Fan, Hui Ouyang, Xinru Qian, Hui Wei, David Dehui Wang, Deguang He, Haihe Tian, Changzhen Gong, Amy Matecki, Sarah Faggert Alemi. Discussions on real-world acupuncture treatments for chronic low-back pain in older adults. Journal of Integrative Medicine, 2019, 17(2): 71-76.
[3] Shahnaz Karkon Varnosfaderani, Fataneh Hashem-Dabaghian, Gholamreza Amin, Mahbubeh Bozorgi, Ghazaleh Heydarirad, Esmaeil Nazem, Mohsen Nasiri Toosi, Seyed Hamdollah Mosavat. Efficacy and safety of Amla (Phyllanthus emblica L.) in non-erosive reflux disease: A double-blind, randomized, placebo-controlled clinical trial. Journal of Integrative Medicine, 2018, 16(2): 126-131.
[4] May To, Caroline Alexander. The effects of Park sham needles: A pilot study. Journal of Integrative Medicine, 2015, 13(1): 20-24.
[5] Subhranil Saha​, Munmun Koley​, Subhasish Ganguly​, Prasanta Rath​, Pulak Roy Chowdhury, Seikh Intaj Hossain. Developing the criteria for evaluating quality of individualization in homeopathic clinical trialreporting: A preliminary study. Journal of Integrative Medicine, 2014, 12(1): 13-19.
[6] Jian Liu, Chuan-bing Huang, Yuan Wang, Gui-qin Xu, Yuan-yuan Cheng, Yun-xia Feng, Lei Liu, Ya-jun Qi. Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis: Study protocol of a multicenter randomized controlled trial. Journal of Chinese Integrative Medicine, 2013, 11(6): 428-434.
[7] Christoph A. Doenitz, Ana Anjos, Thomas Efferth , Tobias Greten, Henry J. Greten. Can heat and cold be parameterized? Clinical data of a preliminary study. Journal of Chinese Integrative Medicine, 2012, 10(5): 532-537.
[8] Li Min, Yang Ming-hui, Liu Yi. Effects of Chinese herbal medicine Bushen Huoxue Granule on quality of life of patients with Parkinson disease: a randomized, double-blinded and placebo-controlled trial. Journal of Chinese Integrative Medicine, 2012, 10(3): 310-317.
[9] Dong-tao Li, Jian Wang , Hong-yang Jiang , Feng-lei Shi , Fu-yu Li , Ji-hong Liu , Yong-mei Cheng , Nan Yan , Ai-hua Hu, Mei-zeng Zhang , Jie Li, Ling-bo Wei , Rong-qin Jiang. Quantitative evaluation of the degrees of traditional Chinese medicine qualitative syndromes of osteoporosis. Journal of Chinese Integrative Medicine, 2012, 10(11): 1254-1262.
[10] Ping Wang , Xu-dong Tang , Bao-yan Liu , Ming-jie Zi . Development of a patient-reported outcome instrument for chronic gastrointestinal diseases: Item selection. Journal of Chinese Integrative Medicine, 2012, 10(10): 1092-1098.
[11] Yu Huang, Xing Zeng, Wei Zhu, Sha-sha Li, Dan Zhou, Chuan-jian Lu. Correlation between T lymphocyte subsets and different syndrome types in patients with influenza A (H1N1): A retrospective study. Journal of Chinese Integrative Medicine, 2011, 9(2): 143-147.
[12] Qi-lin Fu, Yi-yang Hu, Qin Feng, Xiao-ning Wang, Jing-hua Peng, Tuan Cui. Analysis of major herbs in Chinese herbal formula Jianpi Huoxue Decoction for improving intestinal permeability based on uniform design. Journal of Chinese Integrative Medicine, 2011, 9(11): 1234-1241.
[13] Hugh MacPherson , Douglas G Altman , Richard Hammerschlag , Youping Li , Taixiang Wu , Adrian White, David Moher . Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT statement (Chinese version). Journal of Chinese Integrative Medicine, 2010, 8(9): 804-818.
[14] MacPherson H. Towards better reporting of interventions in clinical trials of acupuncture. Journal of Chinese Integrative Medicine, 2010, 8(9): 801-803.
[15] David Moher, Sally Hopewell, Kenneth F Schulz, Victor Montori, Peter C Gtzsche, P J Devereaux, Diana Elbourne, Matthias Egger, Douglas G Altman. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials (Chinese version). Journal of Chinese Integrative Medicine, 2010, 8(8): 701-741.
Full text



[1] Jin-zhou Tian, Jing Shi, Xin-qing Zhang, Qi Bi, Xin Ma, Zhi-liang Wang, Xiao-bin Li, Shu-li Shen, Lin Li, Zhen-yun Wu, Li-yan Fang, Xiao-dong Zhao, Ying-chun Miao, Peng-wen Wang, Ying Ren, Jun-xiang Yin, Yong-yan Wang, Beijing United Study Group on MCI of the Capital Foundation of Medical Developments. An explanation on "guiding principles of clinical research on mild cognitive impairment (protocol)". Journal of Chinese Integrative Medicine, 2008, 6(1): 15-21
[2] Yi-ting He, Qing-lin Zha, Jian-ping Yu, Yong Tan, Cheng Lu, Ai-ping Lv. Principal factor analysis of symptoms of rheumatoid arthritis and their correlations with efficacy of traditional Chinese medicine and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 32-36
[3] Jun Cai, Hua Wang, Sheng Zhou, Bin Wu, Hua-rong Song, Zheng-rong Xuan. Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(1): 37-40
[4] Wei Zhang, Xiang-feng Lu, Xiao-mei Zhang, Jian-jun Wu, Liang-duo Jiang. A rat model of pulmonary fibrosis induced by infusing bleomycin quickly through tracheal intubation. Journal of Chinese Integrative Medicine, 2008, 6(1): 60-67
[5] A-gao Zhou, Yong Zhang, Gang Kui, De-Yun Kong, Hai-liang Ge, Qiu-hua Ren, Jia-rong Dong, Sheng Hong, Xu-ming Mao, Yin Wang, Hui-zheng Zhang, Shu-jun Wang. Influence of traditional Chinese compound recipes with different efficacy on body weight, tumor weight and immune function in H22 cancer-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 77-82
[6] Guo-hong Yuan, Xiao-jing Pang, He-chao Ma. Synergic effects of Danggui Buxue Decoction in reducing toxicity of cytoxan in tumor-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 83-88
[7] Li Zhou, Hong-xing Zhang, Ling-guang Liu, Wen-jun Wan. Effect of electro-acupuncture at Fenglong (GV 16) on nitric oxide and endothelin in rats with hyperlipidemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 89-92
[8] Jin-zhou Tian, Jing Shi, Xin-qing Zhang, Qi Bi, Xin Ma, Zhi-liang Wang, Xiao-bin Li, Shu-li Shen, Lin Li, Zhen-yun Wu, Li-yan Fang, Xiao-dong Zhao, Ying-chun Miao, Peng-wen Wang, Ying Ren, Jun-xiang Yin, Yong-yan Wang, Beijing United Study Group on MCI of the Capital Foundation of Medical Developments. Guiding principles of clinical research on mild cognitive impairment (protocol). Journal of Chinese Integrative Medicine, 2008, 6(1): 9-14
[9] Xin-jun Wang, Ling-ling Wang . A mechanism of endogenous opioid peptides for rapid onset of acupuncture effect in treatment of depression. Journal of Chinese Integrative Medicine, 2010, 8(11): 1014-1017
[10] Bo Wang , Wei Yan , Li-hui Hou, Xiao-ke Wu. Disorder of Tiangui (kidney essence) and reproductive dysfunction in patients with polycystic ovary syndrome. Journal of Chinese Integrative Medicine, 2010, 8(11): 1018-1022