Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2007, Vol. 5 ›› Issue (1): 1-4.doi: 10.3736/jcim20070101

Special Issue: Traditional Chinese Medicine

• Editorial •     Next Articles

Administration and quality control of large-scale clinical trials of traditional Chinese medicine

Hong-cai Shang1,2, Jun-hua Zhang1, Guo-hua Dai1, Hong-bo Cao1, Ming Ren1,Yao-zu Xiang1, Yang Wang1, Bo-li Zhang1, You-ping Li2,3   

  1. 1. Clinical Research Assessment Centre, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
    2. Clinical Medicine Post-doctoral Flow Station of Sichuan University, Chengdu, Sichuan Province 610041, China
    3. China Evidence-Based Medicine Centre, Chengdu, Sichuan Province 610041, China
  • Online:2007-01-31 Published:2007-01-21

Large-scale clinical trial is an important measure of clinical evaluation on drugs. This paperintroduces the concept and features of large-scale clinical trial, the possibility and necessity of large-scale clinical trial of traditional Chinese medicine, as well as its administration and quality control, with Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine (MISPS-TCM), a National Program Subject, as an example.

Key words: Chinese herbal drugs, clinical trials, administration, quality control

CLC Number: 

  • R285.6
[1] 王文, 刘力生, 龚兰生 , 等. 我国大样本随机临床试验治疗心脑血管病的效价评估[J]. 中华心血管病杂志, 2003,31(1):24-28
Wang W, Liu LS, Gong LS , et al. Assessment of cost-effectiveness of treatment for cardio-cerebrovascular diseases from large-sample randomized clinical trials in China[J]. Zhonghua Xin Xue Guan Bing Za Zhi, 2003,31(1):24-28
[2] 刘建平 . 循证中医药临床研究方法学(第1版)[M]. 北京: 人民卫生出版社, 2006,( 第1版):7
Liu JP. Clinical research methodology for evidence-based Chinese medicine(1st ed)[M]. Beijing: People's Medical Publishing House, 2006,( 1st ed):7
[3] 王杰松, 张俊虎, 胡慧渊 , 等. 三七总皂苷和复方丹参注射液治疗脑梗死的Meta分析[J]. 中国医院药学杂志, 2006,26(3):317-319
Wang JS, Zhang JH, Hu HY , et al. Meta-analysis of notoginseng saponin and compound Salviae miltiorrhizae injection for treatment of cerebral infarction[J]. Zhongguo Yi Yuan Yao Xue Za Zhi, 2006,26(3):317-319
[4] 王丽平, 解越 . 针灸治疗卒中后吞咽困难的系统评价[J]. 中国针灸, 2006,26(2):141-146
Wang LP, Xie Y . Systematic review on acupuncture and moxibustion for treatment of dysphagia after stroke[J]. Zhongguo Zhen Jiu, 2006,26(2):141-146
[5] 刘建平 , Manbeimer E, 施毅, 等. 中西医结合治疗SARS的系统评价与Meta-分析[J]. 中国中西医结合杂志, 2005,25(12):1082-1088
Liu JP, Manheimer E, Shi Y , et al. Systematic review and meta-analysis on the integrative traditional Chinese and Western medicine in treating SARS[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2005,25(12):1082-1088
[6] 黄峻, 王文 . 脑血管疾病大型临床试验(第1版)[M]. 南京: 江苏科学技术出版社, 1998,( 第1版):1
Huang J, Wang W . Large-scale clinical trials of cardio-cerebrovascular diseases(1st ed)[M]. Nanjing: Jiangsu Scientific and Technical Publishers, 1998,( 1st ed):1
[7] 王文, 刘力生 . 心血管药大样本临床试验的质量控制[J]. 中华心血管病杂志, 1999,27(2):153-154
Wang W, Liu LS . Quality control of large-scale clinical trial for cardiovascular drugs[J]. Zhonghua Xin Xue Guan Bing Za Zhi, 1999,27(2):153-154
[8] 吴泰相, 李幼平, 李静 , 等. 中国临床试验注册和发表机制及实施说明[J]. 中西医结合学报, 2006,4(4):333-334
Wu TX, Li YP, Li J , et al. Statement for Chinese clinical trial registration and publishing system[J]. Zhong Xi Yi Jie He Xue Bao, 2006,4(4):333-334
[9] 刘建平 . 中医药临床试验的方法学问题与挑战: 循证医学的观点[J]. 中西医结合学报, 2006,4(1):1-6
Liu JP . Methodological quality assessment of clinical trials in traditional Chinese medicine: the principles of evidence-based medicine[J]. Zhong Xi Yi Jie He Xue Bao, 2006,4(1):1-6
[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] Min Yee Lim, Jian Huang, Bai-xiao Zhao, Hui-qin Zou, Yong-hong Yan. Influence of storage duration and processing on chromatic attributes and flavonoid content of moxa floss. Journal of Integrative Medicine, 2016, 14(1): 69-76.
[5] Yan-bin Shi, Hui-li Li, Hai-qin Wang, Yan-biao Yang, Xiao-yun Zhang, Hui Wang, Zong-jie Zhu, Zhi-ye Zhang, Cheng-an Zhang. Simultaneous determination of five anthraquinones in a Chinese traditional preparation by RP-HPLC using an improved extraction procedure. Journal of Integrative Medicine, 2014, 12(5): 455-462.
[6] 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.
[7] Qing-hui Zhou . Assessment of research papers in medical university staff evaluation. Journal of Chinese Integrative Medicine, 2012, 10(6): 707-711.
[8] 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.
[9] Thomas Efferth, Henry Johannes Greten. The European directive on traditional herbal medicinal products: friend or foe for plant-based therapies?. Journal of Chinese Integrative Medicine, 2012, 10(4): 357-361.
[10] 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.
[11] 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.
[12] 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.
[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.
Viewed
Full text


Abstract

Cited

  Shared   
  Discussed   
[1] Jin-rong Fu. Establishment of multivariate diagnosis and treatment system of modern gynecology of traditional Chinese medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 22-24
[2] Hao Li, Ming-jiang Yao, Wen-ming Zhao, Jie Guan, Lin-lin Cai, Ling Cui. A randomized, controlled, double-blind trial of Huannao Yicong capsule in senile patients with mild cognitive impairment. Journal of Chinese Integrative Medicine, 2008, 6(1): 25-31
[3] Zhi-chun Jin. Problems in establishing clinical guideline for integrated traditional Chinese and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 5-8
[4] SUN Ming-yu, ZUO Jian, DUAN Ji-feng, HAN Jun, FAN Shi-ming, ZHANG Wei, ZHU Li-fang, YAO Ming-hui. Antitumor activities of kushen flavonoids in vivo and in vitro. Journal of Chinese Integrative Medicine, 2008, 6(1): 51-59
[5] Min Cheng, Qiong Feng, Shu-wen Qian, Hui Gao, Cui-qing Zhu. Preliminary assay of p-amyloid binding elements in heart-beneficial recipe. Journal of Chinese Integrative Medicine, 2008, 6(1): 68-72
[6] Ning-qun Wang, Liang-duo Jiang, Zong-xing Li. Research progress in asthma-related quality of life. Journal of Chinese Integrative Medicine, 2008, 6(1): 93-97
[7] Jing-yuan Mao, Chang-xiao Liu, Heng-he Wang, Guang-li Wei , Zhen-peng Zhang, Jie Xing, Wang Xian liang , Ying-fei Bi . Effects of Shenmai Injection on serum concentration and pharmacokinetics of digoxin in dogs with heart failure. Journal of Chinese Integrative Medicine, 2010, 8(11): 1070-1074
[8] Zhi-mei Wang, Bin Zhang. A study on translation of ellipses in Huangdi Neijing from perspective of hermeneutic theory. Journal of Chinese Integrative Medicine, 2010, 8(11): 1097-1100
[9] Gui Yu, Jie Wang. Thinking on building the network cardiovasology of Chinese medicine. Journal of Chinese Integrative Medicine, 2012, 10(11): 1206-1210
[10] Pedro Saganha João, Doenitz Christoph, Greten Tobias, Efferth Thomas, J. Greten Henry. Qigong therapy for physiotherapists suffering from burnout: a preliminary study. Journal of Chinese Integrative Medicine, 2012, 10(11): 1233-1239