Review of Ethical and Scientific Aspects of Acupuncture Clinical Trials Pointed Out by Institutional Review Board a Part of Development Process of the Acupuncture and Moxibustion Clinical Research Guideline

Jung Tae Leem; Seung Hoon Lee; Ga Jin Han; Eun Jung Kim; Byung Kwan Seo; Tae Hun Kim; Seung Deok Lee; Jong Uk Kim; A Mi Yu; Dong Woo Nam; Jun Hee Lee

doi:10.13045/acupunct.2015016

J Acupunct Res > Volume 32(2); 2015 > Article

Leem, Lee, Han, Kim, Seo, Kim, Lee, Kim, Yu, Nam, and Lee: Review of Ethical and Scientific Aspects of Acupuncture Clinical Trials Pointed Out by Institutional Review Board a Part of Development Process of the Acupuncture and Moxibustion Clinical Research Guideline※

Original Article

Acupuncture 2015; 32(2): 11-21.

DOI: https://doi.org/10.13045/acupunct.2015016

Review of Ethical and Scientific Aspects of Acupuncture Clinical Trials Pointed Out by Institutional Review Board a Part of Development Process of the Acupuncture and Moxibustion Clinical Research Guideline※

Jung Tae Leem^1,², Seung Hoon Lee³, Ga Jin Han^1,⁴, Eun Jung Kim⁵, Byung Kwan Seo³, Tae Hun Kim^1,², Seung Deok Lee⁵, Jong Uk Kim⁶, A Mi Yu¹, Dong Woo Nam^1,^3,^*, Jun Hee Lee^1,^7,^*

¹Korean Medicine Clinical Trial Center, Kyung Hee University

²Department of Clinical Research of Korean Medicine, Kyung Hee University

³Department of Acupuncture and Moxibustion Medicine, Kyung Hee University

⁴Department of Gastroenterology, Kyung Hee University

⁵Department of Acupuncture and Moxibustion Medicine, Dongguk University

⁶Department of Acupuncture and Moxibustion Medicine, Woosuk University

⁷Department of Sasang Constitutional Medicine, Kyung Hee University

^*Corresponding author: Dong Woo Nam: Korean Medicine Clinical Trial Center, College of Korean Medicine, Kyung Hee University, 23, Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-872, Republic of Korea,
Tel: +82-2-958-9202, E-mail: hanisanam@hanamil.net; Jun Hee Lee: Korean Medicine Clinical Trial Center, College of Korean Medicine, Kyung Hee University, 23, Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-872, Republic of Korea,
Tel: +82-2-958-9280, E-mail: ssljh@hanmail.net

Received April 06, 2015 Revised April 16, 2015 Accepted April 22, 2015

See the Original "".

Abstract

Objectives:

To improve quality of clinical research for acupuncture and moxibustion, a guideline for clinical research protocol is needed. While developing a guideline for acupuncture and moxibustion clinical research, we reviewed the ethical and scientific aspects of protocols pointed out by the institutional review board. This will offer practical assistance to the researchers.

Methods:

Ethical and scientific aspects of acupuncture and moxibustion research protocols reviewed by Kyung Hee University Korean Medicine Hospital Institutional Review Board were gathered and reviewed.

Results:

Ethical and scientific aspects of protocol review was reported.

Conclusions:

The example of review will be helpful for new researchers when developing acupuncture and moxibustion clinical research protocol.

Key Words: Institutional review board(IRB); Clinical reserach guideline; Acupuncture; Moxibustion; Protocol; Ethical and scientific.

Notes

This study was supported by the Traditional Korean Medicine R&D program funded by the Ministry of Health and Welfare through the Korean Health Industry Development Institute(KHIDI)(No. HI13C0700)

VII.

References

1. Gu J, Zhao Y, Wang X, Jiang J, Tian J, Yang K. Registration quality assessment of acupuncture clinical trials. PLoS ONE. 2013;8(3):e59506, PMID: 10.1371/journal.pone.0059506.

2. Birch S. Clinical research on acupuncture: Part 2. Controlled clinical trials, an overview of their methods. J Altern Complement Med. 2004;10(3):481–98.

3. Shuai P, Zhou X-H, Lao L, Li X. Issues of design and statistical analysis in controlled clinical acupuncture trials: an analysis of English-language reports from western journals. Stat Med. 2012;31(7):606–18.

4. Kim JE, Kang KW, Kim TH, et al. A systematic review and meta-analysis of acupuncture trials in republic of Korea that used sham acupuncture as a control group the acupuncture. The Acupuncture. 2011;28(6):1–17.

5. Jang JY, Kim SJ, Kim NS, Nam SS, Kim YS. Review and analysis of sham acupuncture in acupuncture clinical trials. The Acupuncture. 2011;28(5):29–38.

6. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332, PMID: 10.1136/bmj.c332.

7. MacPherson H, Altman DG, Hammerschlag R, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA): extending the CONSORT statement. PLoS Med. 2010;7(6):e1000261, PMID: 10.1371/journal.pmed.1000261.

8. Gagnier JJ, Boon H, Rochon P, et al. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med. 2006;144(5):364–7.

9. Lee HS, Cha SJ, Park HJ, Seo JC, Park JB, Lee HJ. Revised STandards for Reporting Intervetions in Clinical Trials of Acupuncture(STRICTA): extension the CONSORT statement. Korean Journal of Acupuncture. 2010;27(3):1–23.

10. Kim WY, Lee SD, Lim BM, Kim KS. The assessment of appropriatesness of acupuncture methodology based on STRICTA recommendations. The Acupuncture. 2007;24(5):151–70.

11. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. STROBE initiative. Strengthening the reporting of observational studies in epidemiology(STROBE) statement: guidelines for reporting observational studies. BMJ. 2007;335(7624):806–8.

12. Des Jarlais DC, Lyles C, Crepaz N. TREND group. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health. 2004;94(3):361–6.

13. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of reporting of meta analyses. Lancet. 1999;354(9193):1896–900.

14. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Controlled Clinical Trials. 1996;17(1):1–12.

15. Kim YY, Yoo JH, Lee SK, Lee SW. Quality assessment of randomized controlled trials using herbal remedies in Korea. Korean J Oriental Physiology & Pathology. 2007;25(5):927–33.

16. World Health Organization Regional Office for the Western Pacific. Guideline for clinical research on acupuncture. WHO Regional Publications. Western Pacific Series No. 15. 1995:

17. Kim KS, Yoon JH, Kim KH, Jang JH, Lee SD. Guideline for clinical reasearch on acupuncture. The Acupuncture. 2003;20(5):1–27.

18. MacPherson H, Hammerschlag R, Lewith GT, Schnyer RN. Acupuncture Research. Seoul: Elsevier Korea. 2009:

19. Lee SD. An assessment of statistical validity of articles published in the Journal of Korean Acupuncture & Moxibusition Society: from 1984 to 2002. The Acupuncture. 2004;21(1):176–88.

20. Kwon YK. Development of Korean medicine clinical study guideline. Health Industry Technology Trend. 2006;Summer;128–34.

21. Zaslawski C. Ethical considerations for acupuncture and chinese herbal medicine clinical trials: a cross-cultural perspective. Evid-Based Complement Altern Med. 2010;7(3):295–301.

22. Hammerschlag R. Methodological and ethical issues in clinical trials of acupuncture. J Altern Complement Med. 1998;4(2):159–71.

23. White AR, Filshie J, Cummings TM. International acupuncture research forum. Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding. Complement Ther Med. 2001;9(4):237–45.

24. Sherman KJ, Cherkin DC. Challenges of acupuncture research: study design considerations. Clin Acupunct Orient Med. 2002;3(4):200–6.

25. Gu J, Wang Q, Wang X, et al. Assessment of registration information on methodological design of acupuncture RCTs: a review of 453 registration records retrieved from WHO international clinical trials registry platform. Evid Based Complement Alternat Med. 2014;1–8. PMID: 10.1155/2014/614850.

26. Korea Food and Drug Administration Herbal Medicine Policy Division. Evaluation guideline of herbal medicine clinical trial: antitussive expectorant medicine. Korea Food and Drug Administration. Seoul. 2007;6.

27. Jung HJ, Park JE, Choi SM. Current status of institutional review boards and approvals of clinical research in oriental medical hospitals in Korea: a survey. J Korean Oriental Med. 2010;31(1):122–9.

28. Korea Food and Drug Administration Biopharmaceutical Policy Division. Guideline for biopharmaceutical clinical trial protocol writing: frequently, commonly indicated statistic improvoment point. Korea Food and Drug Administration Biopharmaceutical Policy Division. Seoul. 2013;12.

29. Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, White AR. Acupuncture for tension-type headache. Cochrane Database Syst Rev. 2009;(1):CD007587, PMID: 10.1002/14651858.CD007587.

30. Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, White AR. Acupuncture for migraine prophylaxis. Cochrane Database Syst Rev. 2009;(1):CD001218, PMID: 10.1002/14651858.CD001218.pub2.

31. Hopwood V, Lewith G. Acupuncture trials and methodological considerations. Clin Acupunct Orient Med. 2003;3(4):192–9.

32. Elizabeth AB, Robert JA. Institutional review board: management and function. 1st edition. Seoul: GCO Science. 2011:353–61.

33. Linde K, Dincer F. How informed is consent in sham-controlled trials of acupuncture? J Altern Complement Med. 2004;10(2):379–85. PMID: 10.1089/107555304323062374.

Appendices

Appendix 1.

Ethical and Administrative Review Pointed Out by IRB

Appendix 2.

Screview Review Pointed Out by IRB