Journal of Acupuncture Research

Korean Acupuncture & Moxibustion Medicine Society (대한침구의학회)
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Characteristics of Sham/Placebo Acupuncture Controlled Trials for Headache

두통에 대한 Sham/Placebo 침술 대조군 연구의 특성에 대한 연구

  • Jung, Su-Hyung (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Daegu Haany University) ;
  • Seo, Jung-Chul (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Daegu Haany University) ;
  • Yang, Angela (Division of Chinese Medicine, School of Health Science, RMIT University) ;
  • Xue, Charlie (Division of Chinese Medicine, School of Health Science, RMIT University)
  • 정수형 (대구한의대학교 한의과대학 침구학교실) ;
  • 서정철 (대구한의대학교 한의과대학 침구학교실) ;
  • ;
  • Published : 2009.02.20
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Abstract

목적 : 두통의 침술효과에 대한 연구가 꾸준히 이루어지고 있다. 하지만 많은 연구들에서 서로 상충되는 결과를 내놓고 있다. 이에 저자는 대조군 집단 시술의 역할과 시험의 특성에 대해 연구하는 데 있어 몇 가지 유형의 두통, 특히 긴장성 두통(Tension-type headache, TTH)과 편두통에 대한 침술의 대조군 시험에서 나타나는 일관성 없는 발견 사항들의 원인이 무엇인지에 대해 밝히려고 하였다. 방법 : 두통의 침술효과에 대해 보고하고 있는 11개의 임의대조군 시험(Randomized controlled trials, RCTs)을 대상으로 하여 위약 침술과 방법론적 특성 범주 III과 IV를 중심으로 위약 시술 분석, 비교를 실시하였다. 결과 : 임상적 유효성과의 상관관계에 있어 범주 III과 IV 사이에는 유의한 차이가 없었다. 표본 크기 계산, 표본 전체 크기, 진짜 집단과 위약 집단에 속한 피험자의 수에는 긍정적 결과와 중립적 결과 사이에 유의한 차이가 없었다. 결론 : 두통의 임의대조군 시험에 대한 다양한 유형의 위약 대조군과 침술의 방법론적 특성이 임상적 효과를 예측해 주는지의 여부에 대해 추가 연구가 이루어져야 하겠다.

Keywords

References

  1. Lipton RB, Bigal ME. Migraine : epidemiology, impact, and risk factors for progression. Headache. 2005 ; 45(Suppl 1) : S3-S13. https://doi.org/10.1111/j.1526-4610.2005.4501001.x
  2. Le Jeunne C, Gomez JP, Pradalier A, Titus I Albareda F, Joffroy A, Liano H et al. Comparative efficacy and safety of calcium carbasalate plus metoclopramide versus ergotamine tartrate plus caffeine in the treatment of acute migraine attacks. Eur Neurol. 1999 ; 41(1) : 37-43.
  3. Moore N. Forty years of ibuprofen use. Int J Clin Pract Suppl. 2003 ; 57(s135) : 28-31.
  4. Acupuncture. NIH Consens Statement. 1997 ; 15(5) : 1-34.
  5. Melchart D, Linde K, Fischer P, Berman B, White A, Vickers A, Allais G. Acupuncture for idiopathic headache. Cochrane Database Syst Rev. 2001 ; (1) : CD001218.
  6. Elorriaga Claraco A, Hanna SE, Fargas-Babjak A. Reporting of clinical details in randomized controlled trials of acupuncture for the treatment of migraine/headaches and nausea/vomiting. J Altern Complement Med. 2003 ; 9(1) : 151-9. https://doi.org/10.1089/107555303321223026
  7. Hansen PE, Hansen JH. Acupuncture treatment of chronic tension headache-a controlled crossover trial. Cephalalgia. 1985 ; 5(3) : 137-42. https://doi.org/10.1046/j.1468-2982.1985.0503137.x
  8. Karst M, Rollnik JD, Fink M, Reinhard M, Piepenbrock S. Pressure pain threshold and needle acupuncture in chronic tension-type headache-a double-blind placebo-controlled study. Pain. 2000 ; 88(2) : 199-203. https://doi.org/10.1016/S0304-3959(00)00315-8
  9. Karst M, Reinhard M, Thum P, Wiese B, Rollnik J, Fink M. Needle acupuncture in tension-type headache : a randomized, placebocontrolled study. Cephalalgia. 2001 ; 21(6) : 637-42. https://doi.org/10.1046/j.1468-2982.2001.00198.x
  10. Linde K, Streng A, Jurgens S, Hoppe A, Brinkhaus B, Witt C, et al. Acupuncture for patients with migraine : a randomized controlled trial. JAMA. 2005 ; 293(17) : 2118-25. https://doi.org/10.1001/jama.293.17.2118
  11. Linde M, Fjell A, Carlsson J, Dahlof C. Role of the needling per se in acupuncture as prophylaxis for menstrually related migraine : a randomized placebo-controlled study. Cephalalgia. 2005 ; 25(1) : 41-7. https://doi.org/10.1111/j.1468-2982.2004.00803.x
  12. Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, et al. Acupuncture in patients with tension-type headache : randomised controlled trial. BMJ. 2005 ; 331(7513) : 376-82. https://doi.org/10.1136/bmj.38512.405440.8F
  13. Tavola T, Gala C, Conte G, Invernizzi G. Traditional Chinese acupuncture in tension-type headache : A controlled study. Pain. 1992 ; 48(3) : 325-9. https://doi.org/10.1016/0304-3959(92)90080-U
  14. Vincent CA. A controlled trial of the treatment of migraine by acupuncture. Clin J Pain. 1989 ; 5(4) : 305-12. https://doi.org/10.1097/00002508-198912000-00006
  15. White AR, Eddleston C, Hardie R, Resch KL, Ernst E. A Pilot Study of Acupuncture for Tension Headache, Using a Novel placebo. Acupunct Med. 1996 ; 14(1) : 11-5. https://doi.org/10.1136/aim.14.1.11
  16. White AR, Resch KL, Chan JC, Norris CD, Modi SK, Patel JN, et al. Acupuncture for episodic tension-type headache : a multicentre randomized controlled trial. Cephalalgia. 2000 ; 20(7) : 632-7. https://doi.org/10.1046/j.1468-2982.2000.00097.x
  17. Xue CC, Dong L, Polus B, English RA, Zheng Z, Da Costa C et al. Electroacupuncture for tension-type headache on distal acupoints only : a randomized, controlled, crossover trial. Headache. 2004 ; 44(4) : 333-41. https://doi.org/10.1111/j.1526-4610.2004.04077.x
  18. Pintov S, Lahat E, Alstein M, Vogel Z, Barg J. Acupuncture and the opioid system : implications in management of migraine. Pediatr Neurol. 1997 ; 17(2) : 129-33. https://doi.org/10.1016/S0887-8994(97)00086-6
  19. Dincer F, Linde K. Sham interventions in randomized clinical trials of acupuncture--a review. Complement Ther Med. 2003 ; 11(4) : 235-42. https://doi.org/10.1016/S0965-2299(03)00124-9
  20. MacPherson H, White A, Cummings M, Jobst K, Rose K, Niemtzow R. Standards for reporting interventions in controlled trials of acupuncture : the STRICTA recommendations. Complement Ther Med. 2001 ; 9(4) : 246-9. https://doi.org/10.1054/ctim.2001.0488
  21. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials : is blinding necessary? Control Clin Trials. 1996 ; 17(1) : 1-12. https://doi.org/10.1016/0197-2456(95)00134-4
  22. He D, Hostmark AT, Veiersted KB, Medbo JI. Effect of intensive acupuncture on pain-related social and psychological variables for women with chronic neck and shoulder pain-an RCT with six month and three year follow up. Acupunct Med. 2005 ; 23(2) : 52-61. https://doi.org/10.1136/aim.23.2.52
  23. Ng DK, Chow PY, Ming SP, Hong SH, Lau S, Tse D, et al. A double-blind, randomized, placebo-controlled trial of acupuncture for the treatment of childhood persistent allergic rhinitis. Pediatrics. 2004 ; 114(5) : 1242-7. https://doi.org/10.1542/peds.2004-0744
  24. He D, Veiersted KB, Hostmark AT, Medbo JI. Effect of acupuncture treatment on chronic neck and shoulder pain in sedentary female workers : a 6-month and 3-year follow-up study. Pain. 2004 ; 109(3) : 299-307. https://doi.org/10.1016/j.pain.2004.01.018
  25. Engelhardt PF, Daha LK, Zils T, Simak R, Konig K, Pfluger H. Acupuncture in the treatment of psychogenic erectile dysfunction : first results of a prospective randomized placebocontrolled study. Int J Impot Res. 2003 ; 15(5) : 343-6. https://doi.org/10.1038/sj.ijir.3901021
  26. Ebneshahidi NS, Heshmatipour M, Moghaddami A, Eghtesadi-Araghi P. The effects of laser acupuncture on chronic tension headache-a randomised controlled trial. Acupunct Med. 2005 ; 23(1) : 13-8. https://doi.org/10.1136/aim.23.1.13
  27. Karakurum B, Karaalin O, Coskun O, Dora B, Ucler S, Inan L. The ‘dry-needle technique’ : intramuscular stimulation in tension-type headache. Cephalalgia. 2001 ; 21(8) : 813-7.
  28. Melchart D, Thormaehlen J, Hager S, Liao J, Linde K, Weidenhammer W. Acupuncture versus placebo versus sumatriptan for early treatment of migraine attacks : a randomized controlled trial. J Intern Med. 2003 ; 253(2) : 181-8. https://doi.org/10.1046/j.1365-2796.2003.01081.x
  29. Hesse J, Mogelvang B, Simonsen H. Acupuncture versus metoprolol in migraine prophylaxis : a randomized trial of trigger point inactivation. J Intern Med. 1994 ; 235(5) : 451-6. https://doi.org/10.1111/j.1365-2796.1994.tb01102.x
  30. Vincent CA. The treatment of tension headache by acupuncture : a controlled single case design with time series analysis. J Psychosom Res. 1990 ; 34(5) : 553-61. https://doi.org/10.1016/0022-3999(90)90030-8
  31. Gaus W, Hogel J. Studies on the efficacy of unconventional therapies. Problems and designs. Arzneimittelforschung. 1995 ; 45(1) : 88-92.
  32. Sherman KJ, Hogeboom CJ, Cherkin DC, Deyo RA. Description and validation of a noninvasive placebo acupuncture procedure. J Altern Complement Med. 2002 ; 8(1) : 11-9. https://doi.org/10.1089/107555302753507140
  33. Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet. 1998 ; 352(9125) : 364-5. https://doi.org/10.1016/S0140-6736(97)10471-8
  34. Park J, White A, Stevinson C, Ernst E, James M. Validating a new non-penetrating sham acupuncture device : two randomised controlled trials. Acupunct Med. 2002 ; 20(4) : 168-74. https://doi.org/10.1136/aim.20.4.168
  35. Goddard G, Shen Y, Steele B, Springer N. A controlled trial of placebo versus real acupuncture. J Pain. 2005 ; 6(4) : 237-42. https://doi.org/10.1016/j.jpain.2004.12.009
  36. Witt C, Brinkhaus B, Jena S, Linde K, Streng A, Wagenpfeil S, et al. Acupuncture in patients with osteoarthritis of the knee : a randomised trial. Lancet. 2005 ; 366(9480) : 136-43. https://doi.org/10.1016/S0140-6736(05)66871-7
  37. Xue CC, English R, Zhang JJ, Da Costa C, Li CG. Effect of acupuncture in the treatment of seasonal allergic rhinitis : a randomized controlled clinical trial. Am J Chin Med. 2002 ; 30(1) : 1-11. https://doi.org/10.1142/S0192415X0200020X
  38. Fink M, Gutenbrunner C, Rollnik J, Karst M. Credibility of a newly designed placebo needle for clinical trials in acupuncture research. Forsch Komplementarmed Klass Naturheilkd. 2001 ; 8(6) : 368-72. https://doi.org/10.1159/000057254
  39. Ernst E. Acupuncture research : where are the problems? Acupunct Med. 1994 ; 12(2) : 93-7. https://doi.org/10.1136/aim.12.2.93
  40. 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
  41. Kaptchuk TJ. Acupuncture : theory, efficacy, and practice. Ann Intern Med. 2002 ; 136(11) : 374-83.
  42. Kaptchuk TJ. The placebo effect in alternative medicine : can the performance of a healing ritual have clinical significance? Ann Intern Med. 2002 ; 136(11) : 817-25. https://doi.org/10.7326/0003-4819-136-11-200206040-00011
  43. Lewith G, Berman B, Cummings M, Filshie J, Fisher P, White A. Systematic review of systematic reviews of acupuncture published 1996-2005. Clin Med 2006 ; 6(4) : 381-6. https://doi.org/10.7861/clinmedicine.6-4-381