Application and Analysis of Practical Randomized Controlled Trials in Clinical Research on Acupuncture_Chinese Journal of Evidence-Based Medicine

Authors：

 FUHong-wei ^1,2 , CHENBo ¹ ,  GUOYi ^1,2 , YANLi-juan ² , PANXing-fang ² , GUOYong-ming ²

1. Acupuncture Research Center, Tianjin University of Tradition Chinese Medicine, Tianjin 300193, China;
2. College of Acupuncture and Massage, Tianjin University of Tradition Chinese Medicine, Tianjin 300193, China;

Corresponding author：

GUOYi, Email: guoyi_168@163.com

Keywords：

Pragmatic randomized controlled trial; Acupuncture; Clinical trial

DOI：

10.7507/1672-2531.20150020

Video：

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To explore clinical design methods that suit the characteristics of acupuncture science, this article mainly analyzes the design features of pragmatic randomized controlled trials and the advantages and current problems in clinical research on acupuncture. We discuss the differences between pragmatic randomized controlled trials and explanatory randomized controlled trials and the application status of clinical research about acupuncture. We consider that pragmatic randomized controlled trials suit the characteristics of in clinical research on acupuncture with complicated interventions. Exploring the application of pragmatic randomized controlled trials clinical research on acupuncture is beneficial to exploring appropriate clinical research methods that suit the specific characteristics of acupuncture subject, and to objectively and comprehensively assessing clinical efficacy and safety of acupuncture.

Citation： FUHong-wei, CHENBo, GUOYi, YANLi-juan, PANXing-fang, GUOYong-ming. Application and Analysis of Practical Randomized Controlled Trials in Clinical Research on Acupuncture. Chinese Journal of Evidence-Based Medicine, 2015, 15(1): 116-119. doi: 10.7507/1672-2531.20150020 Copy

1.	Karanicolas PJ, Montori VM, Devereaux PJ, et al. A new "Mechanistic-Practical" framework for designing and interpreting randomized trials. J Clin Epidemiol, 2009, 62(5):479-484.
2.	Hallfors D, Cho H, Sanchez V, et al. Efficacy vs effectiveness trial results of an indicated "model" substance abuse program:implications for public health. Am J Public Health, 2006, 96(12):2254-2259.
3.	Godwin M, Ruhland L, Casson I, et al. Pragmatic controlled clinical trials in primary care:the struggle between external and internal validity. BMC Med Res Methodol, 2003, 3:28.
4.	Macpherson H. Pragmatic clinical trials. Complement Ther Med, 2004, 12(2-3):136-140.
5.	MacPherson H. Out of the laboratory and into the clinic:acupuncture research in the real world. Clin Acupunct Oriental Med, 2000, 1:97-100.
6.	Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutic trials. J Clin Epidemiol, 2009, 62(5):499-505.
7.	MacRae KD. Pragmatic versus explanatory trials. Int J Technol Assess Health Care, 1989, 5(3):333-339.
8.	Resch K. Pragmatic randomised controlled trials for complex therapies. Forsch Komplementarmed, 1998, 5:136-139.
9.	Zwarenstein M, Treweek S, Gagnier JJ, et al. Improving the reporting of pragmatic trials:an extension of the CONSORT statement. BMJ, 2008, 337:a2390.
10.	Roland M, Torgerson DJ. Understanding controlled trials:what are pragmatic trials? BMJ, 1998, 316(7127):285.
11.	Kaptchuk TJ. The placebo effect in alternative medicine:can the performance of a healing ritual have clinical significance? Ann Intern Med, 2002, 136(11):817-825.
12.	Linde K, Witt CM, Streng A, et al. The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain. Pain, 2007, 128(3):264-271.
13.	Streitberger K, Vickers A. Placebo in acupuncture trials. Pain, 2004, 109(1-2):195.
14.	Scharf HP, Mansmann U, Streitberger K, et al. Acupuncture and knee osteoarthritis:a three-armed randomized trial. Ann Intern Med, 2006, 145(1):12-20.
15.	Assefi NP, Sherman KI, Jacobsen C, et al. A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia. Ann Intern Med, 2005, 143(1):10-19.
16.	刘存志, 石广霞, 王麟鹏, 等. 实用性随机对照试验的设计特征及其在针刺研究中的应用. 2010年中国针灸学会脑病专业委员会/循证针灸专业委员会学术大会论文集, 2010:4-9.
17.	Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic explanatory continuum indicator summary (PRECIS):a tool to help trial designers. Journal of Clinical Epidemiology, 2009, 62:464-475.
18.	项燕, 李瑞. 国外SCI研究针刺的两种临床随机对照试验方法的特点分析及评价. 针灸临床杂志, 2012, 28(9):9-13.

1. Karanicolas PJ, Montori VM, Devereaux PJ, et al. A new "Mechanistic-Practical" framework for designing and interpreting randomized trials. J Clin Epidemiol, 2009, 62(5):479-484.
2. Hallfors D, Cho H, Sanchez V, et al. Efficacy vs effectiveness trial results of an indicated "model" substance abuse program:implications for public health. Am J Public Health, 2006, 96(12):2254-2259.
3. Godwin M, Ruhland L, Casson I, et al. Pragmatic controlled clinical trials in primary care:the struggle between external and internal validity. BMC Med Res Methodol, 2003, 3:28.
4. Macpherson H. Pragmatic clinical trials. Complement Ther Med, 2004, 12(2-3):136-140.
5. MacPherson H. Out of the laboratory and into the clinic:acupuncture research in the real world. Clin Acupunct Oriental Med, 2000, 1:97-100.
6. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutic trials. J Clin Epidemiol, 2009, 62(5):499-505.
7. MacRae KD. Pragmatic versus explanatory trials. Int J Technol Assess Health Care, 1989, 5(3):333-339.
8. Resch K. Pragmatic randomised controlled trials for complex therapies. Forsch Komplementarmed, 1998, 5:136-139.
9. Zwarenstein M, Treweek S, Gagnier JJ, et al. Improving the reporting of pragmatic trials:an extension of the CONSORT statement. BMJ, 2008, 337:a2390.
10. Roland M, Torgerson DJ. Understanding controlled trials:what are pragmatic trials? BMJ, 1998, 316(7127):285.
11. Kaptchuk TJ. The placebo effect in alternative medicine:can the performance of a healing ritual have clinical significance? Ann Intern Med, 2002, 136(11):817-825.
12. Linde K, Witt CM, Streng A, et al. The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain. Pain, 2007, 128(3):264-271.
13. Streitberger K, Vickers A. Placebo in acupuncture trials. Pain, 2004, 109(1-2):195.
14. Scharf HP, Mansmann U, Streitberger K, et al. Acupuncture and knee osteoarthritis:a three-armed randomized trial. Ann Intern Med, 2006, 145(1):12-20.
15. Assefi NP, Sherman KI, Jacobsen C, et al. A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia. Ann Intern Med, 2005, 143(1):10-19.
16. 刘存志, 石广霞, 王麟鹏, 等. 实用性随机对照试验的设计特征及其在针刺研究中的应用. 2010年中国针灸学会脑病专业委员会/循证针灸专业委员会学术大会论文集, 2010:4-9.
17. Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic explanatory continuum indicator summary (PRECIS):a tool to help trial designers. Journal of Clinical Epidemiology, 2009, 62:464-475.
18. 项燕, 李瑞. 国外SCI研究针刺的两种临床随机对照试验方法的特点分析及评价. 针灸临床杂志, 2012, 28(9):9-13.

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