Acupunct Search

CLOSE


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※

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.

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.
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.
crossref pmid pmc
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.
crossref pmid
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.
crossref pmid pmc
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.
crossref pmid pmc
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.
crossref pmid pmc
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.
crossref pmid
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.
pmid
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.
crossref pmid pmc
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.
crossref pmid pmc
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.
crossref pmid
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.
crossref pmid
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.
crossref pmid pmc
22. Hammerschlag R. Methodological and ethical issues in clinical trials of acupuncture. J Altern Complement Med. 1998;4(2):159–71.
crossref pmid
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.
crossref pmid
24. Sherman KJ, Cherkin DC. Challenges of acupuncture research: study design considerations. Clin Acupunct Orient Med. 2002;3(4):200–6.
crossref
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.
crossref
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.
crossref pmid pmc
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.
crossref pmid pmc
31. Hopwood V, Lewith G. Acupuncture trials and methodological considerations. Clin Acupunct Orient Med. 2003;3(4):192–9.
crossref
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.
crossref pmid

Appendices

Appendix 1.

Ethical and Administrative Review Pointed Out by IRB
acupunct-32-2-11fa1.gif

Appendix 2.

Screview Review Pointed Out by IRB
acupunct-32-2-11fa2.gif
acupunct-32-2-11fa2a.gif
TOOLS
Share :
Facebook Twitter Linked In Google+
METRICS Graph View
  • 0 Crossref
  •    
  • 2,939 View
  • 38 Download
Related articles in JAR


Article and Issues
For this Journal
For Authors
Ethics
Submit Manuscript
Editorial Office
Gil Korean Medical Hospital, Gachon University
Keunumul-Ro, Chung-Ku, Inchoen 22138, Korea
Tel: +82-70-7606-6353,4    Fax: +82-32-232-3334    E-mail: jared@e-jar.org                

Copyright © 2019 by Korean Acupuncture & Moxibustion Medicine Society. All rights reserved.

Developed in M2community

Close layer
prev next