DOI QR코드

DOI QR Code

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

침구임상시험 가이드라인 개발과정에서 IRB의 윤리적·과학적 지적사항 사례 조사 연구

  • Leem, Jung Tae (Korean Medicine Clinical Trial Center, Kyung Hee University) ;
  • Lee, Seung Hoon (Department of Acupuncture and Moxibustion Medicine, Kyung Hee University) ;
  • Han, Ga Jin (Korean Medicine Clinical Trial Center, Kyung Hee University) ;
  • Kim, Eun Jung (Department of Acupuncture and Moxibustion Medicine, Dongguk University) ;
  • Seo, Byung Kwan (Department of Acupuncture and Moxibustion Medicine, Kyung Hee University) ;
  • Kim, Tae Hun (Korean Medicine Clinical Trial Center, Kyung Hee University) ;
  • Lee, Seung Deok (Department of Acupuncture and Moxibustion Medicine, Dongguk University) ;
  • Kim, Jong Uk (Department of Acupuncture and Moxibustion Medicine, Woosuk University) ;
  • Yu, A Mi (Korean Medicine Clinical Trial Center, Kyung Hee University) ;
  • Nam, Dong Woo (Korean Medicine Clinical Trial Center, Kyung Hee University) ;
  • Lee, Jun Hee (Korean Medicine Clinical Trial Center, Kyung Hee University)
  • 임정태 (경희대학교 한의약임상시험센터) ;
  • 이승훈 (경희대학교 침구의학과) ;
  • 한가진 (경희대학교 한의약임상시험센터) ;
  • 김은정 (동국대학교 침구의학과) ;
  • 서병관 (경희대학교 침구의학과) ;
  • 김태훈 (경희대학교 한의약임상시험센터) ;
  • 이승덕 (동국대학교 침구의학과) ;
  • 김종욱 (우석대학교 침구의학과) ;
  • 유아미 (경희대학교 한의약임상시험센터) ;
  • 남동우 (경희대학교 한의약임상시험센터) ;
  • 이준희 (경희대학교 한의약임상시험센터)
  • Received : 2015.04.06
  • Accepted : 2015.04.22
  • Published : 2015.06.20

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.

Keywords

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. doi : 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. https://doi.org/10.1089/1075553041323911
  3. Shuai P, Zhou X-H, Lao L, Li X. Issues of design and statistical analysis in controlled clinical acupuncture trials: an analysis of Englishlanguage reports from western journals. Stat Med. 2012 ; 31(7) : 606-18. https://doi.org/10.1002/sim.4034
  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. doi : 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. doi : 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. https://doi.org/10.7326/0003-4819-144-5-200603070-00013
  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, Gotzsche 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. https://doi.org/10.1136/bmj.39335.541782.AD
  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. https://doi.org/10.2105/AJPH.94.3.361
  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. https://doi.org/10.1016/S0140-6736(99)04149-5
  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. https://doi.org/10.1016/0197-2456(95)00134-4
  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. https://doi.org/10.1093/ecam/nen055
  22. Hammerschlag R. Methodological and ethical issues in clinical trials of acupuncture. J Altern Complement Med. 1998 ; 4(2) : 159-71. https://doi.org/10.1089/acm.1998.4.159
  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. https://doi.org/10.1054/ctim.2001.0489
  24. Sherman KJ, Cherkin DC. Challenges of acupuncture research: study design considerations. Clin Acupunct Orient Med. 2002 ; 3(4) : 200-6. https://doi.org/10.1016/S1461-1449(02)00043-9
  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. doi : 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 tensiontype headache. Cochrane Database Syst Rev. 2009 ; (1) : CD007587. doi : 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. doi : 10.1002/14651858.CD001218.pub2.
  31. Hopwood V, Lewith G. Acupuncture trials and methodological considerations. Clin Acupunct Orient Med. 2003 ; 3(4) : 192-9. https://doi.org/10.1016/S1461-1449(02)00042-7
  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. doi :10.1089/107555304323062374.

Cited by

  1. Current Status of Institutional Review Boards in Dental Hospitals in Korea: A Survey vol.44, pp.2, 2015, https://doi.org/10.17779/kaomp.2020.44.2.001