Study on the Current Situation and Issues for Clinical Research in Korean Medicine worldwide - Future Clinical Research Strategy I -

한의 임상 연구에 대한 국내외 현황 및 논쟁에 관한 고찰 - 미래 임상 연구 전략 I -

  • Jung, Ki Yong (Department of Internal Medicine, College of Korean Medicine, Gachon University) ;
  • Go, Ho Yeon (Department of Internal Medicine, College of Korean Medicine, SeMyung University) ;
  • Sun, Seung Ho (Department of Internal Medicine, College of Korean Medicine, Sangji University) ;
  • Jeong, Jong Jin (Department of Internal Medicine, College of Korean Medicine, Sangji University) ;
  • Park, Jeong Su (Department of Internal Medicine, College of Korean Medicine, Gachon University) ;
  • Song, Yun Kyung (Department of Rehabilitation Medicine, College of Korean Medicine, Gachon University) ;
  • Kim, Tae Hoon (Department of Diagnostic & Biofunctional Medicine, College of Korean Medicine, Gachon University) ;
  • Hong, Sung In (Department of Diagnostic & Biofunctional Medicine, College of Korean Medicine, Gachon University) ;
  • Choi, You Kyung (Department of Internal Medicine, College of Korean Medicine, Gachon University) ;
  • Go, Seong Gyu (Department of Preventive Medicine, College of Korean Medicine, KyungHee University) ;
  • Lim, Eun Mee (Department of Gynecology, College of Korean Medicine, Gachon University) ;
  • Lee, Choong Yeol (Department of Physiology, College of Korean Medicine, Gachon University) ;
  • Park, Jong Hyeong (Department of Internal Medicine, College of Korean Medicine, Gachon University) ;
  • Jeon, Chan Yong (Department of Internal Medicine, College of Korean Medicine, Gachon University)
  • 정기용 (가천대학교 한의과대학 내과학교실) ;
  • 고호연 (세명대학교 한의과대학 내과학교실) ;
  • 선승호 (상지대학교 한의과대학 내과학교실) ;
  • 정종진 (상지대학교 한의과대학 내과학교실) ;
  • 박정수 (가천대학교 한의과대학 내과학교실) ;
  • 송윤경 (가천대학교 한의과대학 재활의학교실) ;
  • 김태훈 (가천대학교 한의과대학 진단학교실) ;
  • 홍성인 (가천대학교 한의과대학 진단학교실) ;
  • 최유경 (가천대학교 한의과대학 내과학교실) ;
  • 고성규 (경희대학교 한의과대학 예방의학교실) ;
  • 임은미 (가천대학교 한의과대학 부인과교실) ;
  • 이충열 (가천대학교 한의과대학 생리학교실) ;
  • 박종형 (가천대학교 한의과대학 내과학교실) ;
  • 전찬용 (가천대학교 한의과대학 내과학교실)
  • Received : 2014.03.27
  • Accepted : 2014.04.10
  • Published : 2014.04.25

Abstract

The purpose of this paper is to explore the strategy of future Korean medicine(KM) clinical research through the study on the current situation and issues for KM clinical research worldwide. In this study, the papers published in English through Pubmed were investigated mainly. And we analyzed the methodological issues from the clinical research reports in the KM fields. As a result of examining the current situation of the RCTs(Randomized Controlled Trials) studies in KM, the sample size for most studies was small and the overall methodological quality appeared to be low. And there was a discussion about whether or not to apply RCTs method to the KM clinical research. The majority of studies have argued the use of RCTs method for KM clinical research. In addition, we could find some problems through the analysis of KM clinical studies. First, the majority of RCTs in KM were of low quality. Second, RCTs method was applied to the KM clinical studies according to the Western medicine methods only. Third, the actual KM diagnosis was not used in the KM studies and inadequate outcomes measurement methods were utilized without considering the characteristics of KM practice. The methodological issues in the KM clinical research were caused by the conflict between the characteristics of KM practice and clinical research method based on the western medicine.

Keywords

References

  1. Shea, J.L. Applying evidence-based medicine to traditional chinese medicine: debate and strategy. J Altern Complement Med. 12(3):255-263, 2006.
  2. Verhoef, M.J., Casebeer, A.L., Hilsden, RJ. Assessing efficacy of complementary medicine: adding qualitative research methods to the "Gold Standard". J Altern Complement Med. 8(3):275-281, 2002. https://doi.org/10.1089/10755530260127961
  3. Carter, B. Methodological issues and complementary therapies: researching intangibles?. Complement Ther Nurs Midwifery. 9(3):133-139, 2003. https://doi.org/10.1016/S1353-6117(03)00042-8
  4. Critchley, J.A., Zhang, Y., Suthisisang, C.C., Chan, T.Y., Tomlinson, B. Alternative therapies and medical science: designing clinical trials of alternative/complementary medicines--is evidence-based traditional Chinese medicine attainable?. J Clin Pharmacol. 40(5):462-467, 2000. https://doi.org/10.1177/00912700022009224
  5. Fonnebo, V., Grimsgaard, S., Walach, H., Ritenbaugh, C., Norheim, A.J., MacPherson, H., Lewith, G., Launsø, L., Koithan, M., Falkenberg, T., Boon, H., Aickin, M. Researching complementary and alternative treatments--the gatekeepers are not at home. BMC Med Res Methodol. 11:7:7, 2007.
  6. 대한한의학회. 근거중심의 한의치료. 서울, 군자출판사, pp 4-33, 2012.
  7. Watanabe, K., Matsuura, K., Gao, P., Hottenbacher, L., Tokunaga, H., Nishimura, K., Imazu, Y., Reissenweber, H., Witt, C.M. Traditional Japanese Kampo Medicine: Clinical Research between Modernity and Traditional Medicine-The State of Research and Methodological Suggestions for the Future. Evid Based Complement Alternat Med. 2011: 513842, 2011.
  8. Jiang, M., Yang, J., Zhang, C., Liu, B., Chan, K., Cao, H., Lu, A. Clinical studies with traditional Chinese medicine in the past decade and future research and development. Planta Med. 76(17):2048-2064, 2010. https://doi.org/10.1055/s-0030-1250456
  9. Wu, T., Li, Y., Bian, Z., Liu, G., Moher, D. Randomized trials published in some Chinese journals: how many are randomized?. Trials 10: 46, 2009. https://doi.org/10.1186/1745-6215-10-46
  10. 오래영, 설인찬, 손창규. 한약을 이용한 한국에서의 무작위 임상시험 개괄적 검토. 대한한의학회지 31(4):1-8, 2010.
  11. Normile, D. Asian medicine. The new face of traditional Chinese medicine. Science. 299(5604):188-190, 2003. https://doi.org/10.1126/science.299.5604.188
  12. Ernst, E. Methodological aspects of Traditional Chinese Medicine (TCM). Ann Acad Med Singapore. 35(11):773-774, 2006.
  13. Ioannidis, J.P., Evans, S.J., Gøtzsche, P.C., O'Neill, R.T., Altman, D.G., Schulz, K., Moher, D. CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 141(10):781-788, 2004. https://doi.org/10.7326/0003-4819-141-10-200411160-00009
  14. Tang, J.L., Leung, P.C. An efficacy-driven approach to the research and development of traditional Chinese medicine. Hong Kong Med J. 7(4):375-380, 2001.
  15. Tang, J.L. Research priorities in traditional Chinese medicine. BMJ. 333(7564): 391-394, 2006. https://doi.org/10.1136/bmj.333.7564.391
  16. Cardini, F., Wade, C., Regalia, A.L., Gui, S., Li, W., Raschetti, R., Kronenberg, F. Clinical research in traditional medicine: priorities and methods. Complement Ther Med. 14(4):282-287, 2006. https://doi.org/10.1016/j.ctim.2006.07.003
  17. Wilson, K., Mills, E. Closing comment: Evidence-based complementary and alternative medicine: is it a viable concept?. J Altern Complement Med. 8(6):875-876, 2002. https://doi.org/10.1089/10755530260511865
  18. Mason, S., Tovey, P., Long, A.F. Evaluating complementary medicine: methodological challenges of randomised controlled trials. BMJ. 325(7368):832-834, 2002. https://doi.org/10.1136/bmj.325.7368.832
  19. Verhoef, M.J., Lewith, G., Ritenbaugh, C., Boon, H, Fleishman, S., Leis, A. Complementary and alternative medicine whole systems research: beyond identification of inadequacies of the RCT. Complement Ther Med. 13(3):206-212, 2005. https://doi.org/10.1016/j.ctim.2005.05.001
  20. Nahin, R.L., Straus, S.E. Research into complementary and alternative medicine: problems and potential. BMJ. 322(7279):161-164, 2001. https://doi.org/10.1136/bmj.322.7279.161
  21. Fan, R.P. Modern Western science as a standard for traditional Chinese medicine: A critical appraisal. J Law Med Ethics. 31: 213-221, 2003. https://doi.org/10.1111/j.1748-720X.2003.tb00082.x
  22. Linde, K., Jonas, W.B., Melchart, D., Willich, S. The methodological quality of randomized controlled trials of homeopathy, herbal medicines and acupuncture. Int J Epidemiol. 30(3):526-531, 2001. https://doi.org/10.1093/ije/30.3.526
  23. Tang, J.L, Zhan, S.Y., Ernst, E. Review of randomised controlled trials of traditional Chinese medicine. BMJ. 319(7203):160-161, 1999. https://doi.org/10.1136/bmj.319.7203.160
  24. 김윤영, 유종향, 이수경, 이시우. 국내 한약 처방을 이용한 무 작위 배정 임상연구논문의 질 평가. 동의생리병리학회지 25(5):927-933, 2011.
  25. 장민기, 윤은혜, 정찬영, 김은정, 이승덕, 황민섭, 김갑성. 무작위대조군연구(RCT)를 중심으로 한 근.골격계 질환의 약침 치료에 관한 고찰. 대한침구학회지 26(3):143-163, 2009.
  26. 서병관, 백용현, 박동석. 중풍 후 강직의 침구치료에 대한 계통적 연구. 대한침구학회지 27(6):1-10, 2010.
  27. 한성수, 구창모, 홍권의, 박양춘, 최선미. 근거 중심 의학 (EBM)에 바탕을 둔 임상시험(Clinical Trial)에서 침 치료 문제점과 개선 방안에 대하여. 대한침구학회지 23(6):1-8, 2006.
  28. 문진석, 차민호, 윤유식, 최선미. 辨證을 위한 설문지 및 프로그램에 대한 특허정보 및 논문을 통한 연구 동향 분석. 한국 한의학연구원논문집 12(3):17-29, 2006.
  29. Long, A.F., Mercer, G., Hughes, K. Developing a tool to measure holistic practice: a missing dimension in outcomes measurement within complementary therapies. Complement Ther Med. 8(1):26-31, 2000. https://doi.org/10.1016/S0965-2299(00)90807-0
  30. Zhang, L., Zhang, J., Chen, J., Xing, D., Mu, W., Wang, J., Shang, H. Clinical Research of Traditional Chinese Medicine Needs to Develop Its Own System of Core Outcome Sets. Evid Based Complement Alternat Med. 2013: 202703, 2013.
  31. Zhang, J.H., Shang, H.C., Gao, X.M., Zhang, B.L., Xiang, Y.Z., Cao, H.B., Ren, M., Wang, H. Compound Salvia droplet pill, a traditional Chinese medicine, for the treatment of unstable angina pectoris: a systematic review. Med Sci Monit. 14(1):RA1-7, 2008.
  32. Junhua, Z., Menniti-Ippolito, F., Xiumei, G., Firenzuoli, F., Boli, Z., Massari, M., Hongcai, S., Yuhong, H., Ferrelli, R., Limin, H., Fauci, A., Guerra, R., Raschetti, R. Complex traditional Chinese medicine for poststroke motor dysfunction: a systematic review. Stroke. 40(8):2797-2804, 2009. https://doi.org/10.1161/STROKEAHA.109.555227