Korean Journal of Acupuncture

Society for Meridian and Acupoint (경락경혈학회)
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Study on Clinical Research Methodologies for Acupuncture: Based on Review of Clinical Studies on Back Pain

침 임상연구방법론 연구: 요통 임상연구 사례를 중심으로

  • Park, Yu Lee (Global Center, The Association of Korean Medicine, Institute of Korean Medicine Education and Evaluation)
  • 박유리 (대한한의사협회 글로벌센터, 한의학교육평가원)
  • Received : 2014.12.17
  • Accepted : 2014.12.18
  • Published : 2014.12.27
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Abstract

Objectives : The results from randomized controlled trials on traditional medicine have been negative or ambiguous. The appropriateness of the research methodology started to be questioned. However, the research methodology appropriate for studying traditional medicine has not been well-established. This study aims to explore the appropriate research methodologies for clinical studies on acupuncture. Methods : Clinical researches evaluating the efficacy and effectiveness of acupuncture for back pain were systematically searched and evaluated focusing on research methodology. The acupuncture treatment protocol is evaluated by 9 items which is individual treatment based on diagnosis, combining proximal and distal acupoints, exact location of acupoint, De Qi, adequate stimulation, duration of acupuncture, treatment sessions, treatment interval, and establishing relationship between patients and doctors. Results : Systematic review of acupuncture researches on low back pain suggested that observational studies and pragmatic trials rather than explanatory studies could incorporate these elements. Qualitative studies also could help understanding complex characteristics of acupuncture treatment which could not be evaluated by quantitative studies. Conclusions : In designing clinical researches on acupuncture, various study designs, especially observational study and pragmatic study, should be considered according to research objectives and subjects. The efforts to incorporate the core characteristics of acupuncture practiced in everyday clinical setting are also essential.

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References

  1. Haynes RB. What kind of evidence is it that Evidence-Based Medicine advocates want health care providers and consumers to pay attention to? BMC Health Services Research 2002 ; 2 : 3. https://doi.org/10.1186/1472-6963-2-3
  2. Evidence-Based Medicine Working Group. Evidence-Based Medicine: a new approach to teaching the practice of medicine. JAMA 1992 ; 268(17) : 2420-5. https://doi.org/10.1001/jama.1992.03490170092032
  3. Sehon SR, Stanley DE. A philosophical analysis of the evidence- based medicine debate. BMC Health Services Research 2003 ; 3 : 14. https://doi.org/10.1186/1472-6963-3-14
  4. Jackson S, Scambler G. Perceptions of evidence-based medicine: traditional acupuncturists in the UK and resistance to biomedical modes of evaluation. Sociology of Health & Illness 2007 ; 29(3) : 412-29. https://doi.org/10.1111/j.1467-9566.2007.00494.x
  5. Richardson J. The use of randomised control trials in complementary therapies: exploring the issues. J Adv Nurs 2000 ; 32(2) : 398-406. https://doi.org/10.1046/j.1365-2648.2000.01490.x
  6. Tonelli MR, Callahan TC. Why alternative medicine cannot be evidence-based. Academic Medicine 2001 ; 76(12) : 1213-20. https://doi.org/10.1097/00001888-200112000-00011
  7. Nahin RL, Straus SE. Research into complementary and alternative medicine: problems and potential. BMJ 2001 ; 322 : 161-4. https://doi.org/10.1136/bmj.322.7279.161
  8. Mason S, Tovey P, Long AF. Evaluating complementary medicine: methodological challenges of randomised controlled trials. BMJ 2002 ; 325 : 832-4. https://doi.org/10.1136/bmj.325.7368.832
  9. Walji R, Boon H. Redefining the randomized controlled trial in the context of acupuncture research. Complement Ther Clin Pract 2006 ; 12(2) : 91-6. https://doi.org/10.1016/j.ctcp.2005.10.001
  10. Coulter ID, Khorsan R. Is health service research the holy grail of complementary and alternative medicine research? Alternative Therapies in Medicine 2008 ; 14(4) : 40-5.
  11. Herman PM, D'Huyvetter K, Mohler MJ. Are health services research methods a match for CAM? Altern Ther Health Med 2006 ; 12(3) : 78-83.
  12. Ritenbaugh C, Verhoef M, Fleishman S, Boon H, Leis A. Whole Systems Research: a discipline for studying Complementary and Alternative Medicien. Altern Ther Health Med 2003 ; 9(4) : 32-6.
  13. Schwartz L. Evidence-Based Medicine and Traditional Chinese Medicine: Not Mutually Exclusive. Medical Acupuncture 2000 : 12(1).
  14. Walach H, Falkenberg T, Fonnebo V, Lewith G, Jonas WB. Circular instead of hierarchical : methodological principles for the evaluation of complex interventions. BMC Medical Research Methodology 2006 ; 6 : 29. https://doi.org/10.1186/1471-2288-6-29
  15. Eom SK, Kim SH, Choi WC. Study on modernization of traditional research methodologies of traditional Korean medicine. Journal of Medical History 2010 ; 23(2) : 89-105.
  16. MacPherson H, Thomas K. Self-help advice as a process integral to traditional acupuncture care: implications for trial design. Complement Ther Med 2008 ; 16(2) : 101-6. https://doi.org/10.1016/j.ctim.2008.02.010
  17. MacPherson H, Schroer S. Acupuncture as a complex intervention for depression: A consensus method for develop a standardised treatment protocol for a randomised controlled trial. Complement Ther Med 2007 ; 15 : 92-100. https://doi.org/10.1016/j.ctim.2006.09.006
  18. Yuan J, Kerr D, Park J, Liu XH, McDonough S. Treatment regimens of acupuncture for low back pain-A systemic review. Complement Ther Med 2008 ; 16 : 295-304. https://doi.org/10.1016/j.ctim.2008.04.006
  19. Gartlehner G, Hansen RA, Nissman D, Lohr KN, Carey TS. A simple and valid tool distinguished efficacy from effectiveness studies. J Clin Epidemiol 2006 ; 59(10) : 1040-8. https://doi.org/10.1016/j.jclinepi.2006.01.011
  20. Linde K, Scholz M, Melchart D, Willich SN. Should systematic reviews include non-randomized and uncontrolled studies? The case of acupuncture for chronic headache. J Clin Epidemiol 2002 ; 55(1) : 77-85. https://doi.org/10.1016/S0895-4356(01)00422-X
  21. Zaringhalam J, Manaheji H, Rastqar A, Zaringhalam M. Reduction of chronic non-specific low back pain : a randomised controlled clinical trial on acupuncture and baclofen. Chin Med 2010 ; 5 : 15. https://doi.org/10.1186/1749-8546-5-15
  22. Cherkin DC, Eisenberg D, Sherman KJ, Barlow W, Kaptchuk TJ, Street J, et al. Randomized trial comparing traditional chinese medical acupuncture, therapeutic massage, and self-care education for chronic low back pain. Arch Intern Med 2001 ; 161(8) : 1081-8. https://doi.org/10.1001/archinte.161.8.1081
  23. Itoh K, Itoh S, Katsumi Y, Kitakoji H. A pilot study on using acupuncture and transcutaneous electrical nerve stimulation to treat chronic non-specific low back pain. Complement Ther Clin Pract 2009 ; 15(1) : 22-5. https://doi.org/10.1016/j.ctcp.2008.09.003
  24. Szczurko O, Cooley K, Busse JW, Seely D, Bernhardt B, Guyatt GH, et al. Naturopathic care for chronic low back pain : a randomized trial. PLoS One 2007 ; 2(9) : e919. https://doi.org/10.1371/journal.pone.0000919
  25. Brinkhaus B, Witt CM, Jena S, Linde K, Streng A, Wagenpfeil S, et al. Acupuncture in patients with chronic low back pain. Arch Intern Med 2006b ; 166(4) : 450-7.
  26. Itoh K, Katsumi Y, Kitakoji H. Trigger point acupuncture treatment of chronic low back pain in elderly patients-a blinded RCT. Acupunct Med 2004 ; 22(4) : 170-7. https://doi.org/10.1136/aim.22.4.170
  27. Tsui ML, Cheing GL. The effectiveness of electroacupuncture versus electrical heat acupuncture in the management of chronic low-back pain. J Altern Complement Med 2004 ; 10(5) : 803-9. https://doi.org/10.1089/acm.2004.10.803
  28. Kerr DP, Walsh DM, Baxter D. Acupuncture in the management of chronic low back pain: a blinded randomized controlled trial. Clin J Pain 2003 ; 19(6) : 364-70. https://doi.org/10.1097/00002508-200311000-00004
  29. Meng CF, Wang D, Ngeow J, Lao L, Peterson M, Paget S. Acupuncture for chronic low back pain in older patients: a randomized, controlled trial. Rheumatology 2003 ; 42 : 1508-17. https://doi.org/10.1093/rheumatology/keg405
  30. Yeung CK, Leung MC, Chow DH. The use of electro- acupuncture in conjunction with exercise for the treatment of chronic low-back pain. J Altern Complement Med 2003 ; 9(4) : 479-90. https://doi.org/10.1089/107555303322284767
  31. Leibing E, Leonhardt U, Koster G, Goerlitz A, Rosenfeldt JA, Hilgers R, Ramadori G. Acupuncture treatment of chronic low-back pain- a randomized, blinded, placebo-controlled trial with 9-month follow-up. Pain 2002 ; 96(1-2) : 189-96. https://doi.org/10.1016/S0304-3959(01)00444-4
  32. Molsberger AF, Mau J, Pawelec DB, Winkler J. Does acupuncture improve the orthopedic management of chronic low back pain- a randomized, blinded, controlled trial with 3 months follow up. Pain 2002 ; 99(3) : 579-87. https://doi.org/10.1016/S0304-3959(02)00269-5
  33. Carlsson CP, Sjolund BH. Acupuncture for chronic low back pain: a randomized placebo-controlled study with long-term follow-up. Clin J Pain 2001 ; 17(4) : 296-305. https://doi.org/10.1097/00002508-200112000-00003
  34. Witt CM, Jena S, Selim D, Brinkhaus B, Reinhold T, Wruck K, et al. Pragmatic randomized trial evaluating the clinical and economic effectiveness of acupuncture for chronic low back pain. Am J Epidemiol 2006 ; 164 : 487-96. https://doi.org/10.1093/aje/kwj224
  35. Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, et al. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med 2009 ; 169(9) : 858-66. https://doi.org/10.1001/archinternmed.2009.65
  36. Thomas KJ, MacPherson H, Thorpe L, Brazier J, Fitter M, Campbell MJ, et al. Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain. BMJ 2006 ; 333(7569) : 623. https://doi.org/10.1136/bmj.38878.907361.7C
  37. MacPherson H, Thorpe L, Thomas K. Beyond needling- therapeutic processes in acupuncture care: a qualitative study nested within a low-back pain trial. J Altern Complement Med 2006 ; 12(9) : 873-80. https://doi.org/10.1089/acm.2006.12.873
  38. Hsu C, BlueSpruce J, Sherman K, Cherkin D. Unanticipated benefits fo CAM therpaies for back pain: an exploration of patient experiences. J Altern Complement Med 2010 ; 16(2) : 157-63. https://doi.org/10.1089/acm.2009.0188
  39. MacPherson H. Pragmatic clinical trials. Complement Ther Med 2004 ; 12 : 136-40. https://doi.org/10.1016/j.ctim.2004.07.043
  40. Yuan J, Purepong N, Kerr DP, Park J, Bradbury I, McDonough S. Effectiveness of acupuncture for low back pain. Spine 2008b ; 33(23) : E887-E900. https://doi.org/10.1097/BRS.0b013e318186b276

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