The Assessment of Scientificalness and Ethic of Placebo-controlled Trials in Traditional Chinese Medicine_Chinese Journal of Evidence-Based Medicine

Authors：

FU Juanjuan , WANG Gang ,  MAO Bin

Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

MAO Bin, Email: trapnest0711@163.com

Keywords：

Placebo; Randomized controlled trials; Traditional Chinese medicine; scientific alness; Ethic

DOI：

10.7507/1672-2531.20080175

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Objective　 To explore whether the placebo-controlled trials in traditional Chinese medicine (TCM) were scientific and ethical.
Method　 An electronic search concerned with placebo-controlled trials of TCM was performed at Chinese Journal Full-text Database, Chinese Scientific and Technological Periodical Database (VIP), Wanfang Database and Chinese Bio-medicine Database (CBM) from January 1979 to April 2008. In addition, we handsearched the trials in specialized journals of TCM. The trials were assessed regard with their scientificalness, ethic and traits of TCM of placebo-controlled trials.
Results　 A total of 231 trials were included, occupying about 2.09% of all the randomized controlled trials (RCTs) of TCM; among which there were 79 (34.20%) with sequence generation, 10 (4.33%) with allocation concealment, 129 (55.84%) with blind methods; 106 (45.89%)with basic intervention, 13 (5.63%) with criteria of intervention quality control, 139 (60.17%) with preparation of placebo, 10 (10.33%) with aggravating scheme, 70 (30.30%) with syndrome type of TCM, 48 (20.78%) with the outcome measurement of TCM. There were 48 RCTs (20.78%) were not scientific. There were 221 RCTs without institutional review board and 187 RCTs without informed consent.
Conclusion　 Placebo-controlled trials of TCM are not applied extensively, and some of them are not scientific. Most of than do not meet the ethical requirements.

Citation： FU Juanjuan,WANG Gang,MAO Bin. The Assessment of Scientificalness and Ethic of Placebo-controlled Trials in Traditional Chinese Medicine. Chinese Journal of Evidence-Based Medicine, 2008, 08(9): 781-785. doi: 10.7507/1672-2531.20080175 Copy

1.	王家良, 主编. 临床流行病学-临床科研设计、衡量和评价. 上海:上海科技出版社, 2001. 55, 61.
2.	Raymond ES. Placebo: Its Action and Place in Health Research Today – Summary and Conclusions. Science and Engineering Ethics, 2004, 10(1):189, 190, 191-192, 190-191.
3.	Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials: The CONSORT statement. JAMA, 1996, 276: 637-639.
4.	毛兵, 王刚, 陈小东, 等. 《中国中西医结合杂志》发表随机对照试验报告的质量评价. 中国循证医学杂志, 2006, 6(4): 300-302.
5.	Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Control Clin Trials, 1996, 17: 1-12.
6.	Wang G, Mao B, Xiong ZY, et al. The quality of reporting of randomized controlled trials of TCM: A survey of 13 randomly selected journals from mainland China. Clinical Therapeutics, 2007, 29(7): 1461-1465.
7.	Beecher HK. Powerful placebo. JAMA, 1955,159: 1602-1606.
8.	Lau JTF, Mao J, Woo J. Ethical issues related to the use of placebo in clinical trials. Hong Kong Med J, 2003, 9(2): 195-197.
9.	Ananda S. Prasad. Bl inding in Placebo-Controlled Trials. Ann Ital Med Int, 2001, 134(12): 1150.
10.	Rebecca L, Baba Shiv, Ziv Carmon, et al. Commercial Features of Placebo and Therapeutic Efficacy. JAMA, 2008, 299(9): 1016-1017.
11.	Baer N. Dabate about placebo point to issue surrounded by many shades of grey. CMAJ, 1996, 155(10): 1475-1476.
12.	Smoak R. Placebo: its action and place in health research today. Science and Engineering Ethics, 2004, 10(1): 11, 13.
13.	卜擎燕, 熊宁宁, 吴静, 等. 临床试验中对照选择的国际伦理要求.中国临床药理学与治疗学, 2003, 8(2): 217.
14.	王蕾, 王刚, 李廷谦, 等. 国外药品临床试验中的伦理学现状及思考. 中国新药与临床杂志, 2003, 22(10): 630.

1. 王家良, 主编. 临床流行病学-临床科研设计、衡量和评价. 上海:上海科技出版社, 2001. 55, 61.
2. Raymond ES. Placebo: Its Action and Place in Health Research Today – Summary and Conclusions. Science and Engineering Ethics, 2004, 10(1):189, 190, 191-192, 190-191.
3. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials: The CONSORT statement. JAMA, 1996, 276: 637-639.
4. 毛兵, 王刚, 陈小东, 等. 《中国中西医结合杂志》发表随机对照试验报告的质量评价. 中国循证医学杂志, 2006, 6(4): 300-302.
5. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Control Clin Trials, 1996, 17: 1-12.
6. Wang G, Mao B, Xiong ZY, et al. The quality of reporting of randomized controlled trials of TCM: A survey of 13 randomly selected journals from mainland China. Clinical Therapeutics, 2007, 29(7): 1461-1465.
7. Beecher HK. Powerful placebo. JAMA, 1955,159: 1602-1606.
8. Lau JTF, Mao J, Woo J. Ethical issues related to the use of placebo in clinical trials. Hong Kong Med J, 2003, 9(2): 195-197.
9. Ananda S. Prasad. Bl inding in Placebo-Controlled Trials. Ann Ital Med Int, 2001, 134(12): 1150.
10. Rebecca L, Baba Shiv, Ziv Carmon, et al. Commercial Features of Placebo and Therapeutic Efficacy. JAMA, 2008, 299(9): 1016-1017.
11. Baer N. Dabate about placebo point to issue surrounded by many shades of grey. CMAJ, 1996, 155(10): 1475-1476.
12. Smoak R. Placebo: its action and place in health research today. Science and Engineering Ethics, 2004, 10(1): 11, 13.
13. 卜擎燕, 熊宁宁, 吴静, 等. 临床试验中对照选择的国际伦理要求.中国临床药理学与治疗学, 2003, 8(2): 217.
14. 王蕾, 王刚, 李廷谦, 等. 国外药品临床试验中的伦理学现状及思考. 中国新药与临床杂志, 2003, 22(10): 630.

Previous Article
Dexmedetomidine in the General Anesthesia: A Meta-analysis of Randomized Controlled Trials
Next Article
Evidence for Use of Bone Morphogenetic Protein in Lumbar Spine Arthrodesis

Chinese Journal of Evidence-Based Medicine

The Assessment of Scientificalness and Ethic of Placebo-controlled Trials in Traditional Chinese Medicine

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content