Table of Contents Author Guidelines Submit a Manuscript
Evidence-Based Complementary and Alternative Medicine
Volume 2013, Article ID 708251, 12 pages
http://dx.doi.org/10.1155/2013/708251
Review Article

Blinding Measured: A Systematic Review of Randomized Controlled Trials of Acupuncture

1The Center for Musculoskeletal Care and Department of Rehabilitation Medicine, New York University School of Medicine, 333 East 38th Street, 5th Floor, Room 5-103, New York, NY 10016, USA
2Department of Neuroscience, Brown University, Providence, RI 02912, USA
3Division of Biostatistics, Department of Public Health Sciences, University of California-Davis, Davis, CA 95616, USA
4Asian Medicine and Acupuncture Research, Department of Physical Medicine and Rehabilitation, School of Medicine, University of North Carolina-Chapel Hill, Chapel Hill, NC 27514, USA
5Orofacial Pain Program, Regional Center for Neurosensory Disorders, School of Dentistry, University of North Carolina-Chapel Hill, Chapel Hill, NC 27599, USA

Received 17 October 2012; Revised 6 January 2013; Accepted 6 January 2013

Academic Editor: Gerhard Litscher

Copyright © 2013 Alex Moroz et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. Yeung and C. Albert, “New guidelines for trial reporting—CONSORT, 2010,” British Medical Journal, vol. 340, Article ID c332, 2010. View at Google Scholar
  2. A. J. Vickers, “Placebo controls in randomized trials of acupuncture,” Evaluation & the Health Professions, vol. 25, pp. 421–435, 2002. View at Google Scholar
  3. C. Vincent, “Credibility assessment in trials of acupuncture,” Complementary Medicine Research, vol. 4, pp. 8–11, 1990. View at Google Scholar
  4. R. Wood and G. Lewith, “The credibility of placebo controls in acupuncture studies,” Complementary Therapies in Medicine, vol. 6, no. 2, pp. 79–82, 1998. View at Publisher · View at Google Scholar · View at Scopus
  5. I. Boutron, D. Moher, D. G. Altman, K. F. Schulz, and P. Ravaud, “Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration,” Annals of Internal Medicine, vol. 148, no. 4, pp. 295–309, 2008. View at Google Scholar · View at Scopus
  6. P. Barlas, S. L. H. Ting, L. S. Chesterton, P. W. Jones, and J. Sim, “Effects of intensity of electroacupuncture upon experimental pain in healthy human volunteers: a randomized, double-blind, placebo-controlled study,” Pain, vol. 122, no. 1-2, pp. 81–89, 2006. View at Publisher · View at Google Scholar · View at Scopus
  7. A. Enblom, M. Hammar, G. Steineck, and S. Börjeson, “Can individuals identify if needling was performed with an acupuncture needle or a non-penetrating sham needle?” Complementary Therapies in Medicine, vol. 16, no. 5, pp. 288–294, 2008. View at Publisher · View at Google Scholar · View at Scopus
  8. M. Haake, H. H. Müller, C. Schade-Brittinger et al., “German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups,” Archives of Internal Medicine, vol. 167, no. 17, pp. 1892–1898, 2007. View at Publisher · View at Google Scholar · View at Scopus
  9. S. Kennedy, G. D. Baxter, D. P. Kerr, I. Bradbury, J. Park, and S. M. McDonough, “Acupuncture for acute non-specific low back pain: a pilot randomised non-penetrating sham controlled trial,” Complementary Therapies in Medicine, vol. 16, no. 3, pp. 139–146, 2008. View at Publisher · View at Google Scholar · View at Scopus
  10. T. Lundeberg, I. Lund, J. Näslund, and M. Thomas, “The Emperor's sham—wrong assumption that sham needling is sham,” Acupuncture in Medicine, vol. 26, no. 4, pp. 239–242, 2008. View at Publisher · View at Google Scholar · View at Scopus
  11. A. Moroz, “Issues in acupuncture research: the failure of quantitative methodologies and the possibilities for viable, alternative solutions,” American Journal of Acupuncture, vol. 27, no. 1-2, pp. 95–103, 1999. View at Google Scholar · View at Scopus
  12. J. Park and H. Bang, “Methodological advances needed in analysis and interpretation of sham acupuncture validation studies,” Acupuncture in Medicine, vol. 29, no. 3, pp. 168–169, 2011. View at Google Scholar
  13. J. Park, H. Bang, and I. Cañette, “Blinding in clinical trials, time to do it better,” Complementary Therapies in Medicine, vol. 16, no. 3, pp. 121–123, 2008. View at Publisher · View at Google Scholar · View at Scopus
  14. N. P. Assefi, K. J. Sherman, C. Jacobsen, J. Goldberg, W. R. Smith, and D. Buchwald, “A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia,” Annals of Internal Medicine, vol. 143, no. 1, pp. 10–19, 2005. View at Google Scholar · View at Scopus
  15. T. J. Kaptchuk, J. M. Kelley, L. A. Conboy et al., “Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome,” British Medical Journal, vol. 336, no. 7651, pp. 999–1003, 2008. View at Publisher · View at Google Scholar · View at Scopus
  16. G. Deng, V. Rusch, A. Vickers et al., “Randomized controlled trial of a special acupuncture technique for pain after thoracotomy,” Journal of Thoracic and Cardiovascular Surgery, vol. 136, no. 6, pp. 1464–1469, 2008. View at Publisher · View at Google Scholar · View at Scopus
  17. H. G. Endres, G. Böwing, H. C. Diener et al., “Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomised trial,” Journal of Headache and Pain, vol. 8, no. 5, pp. 306–314, 2007. View at Publisher · View at Google Scholar · View at Scopus
  18. R. E. Harris, J. K. Zubieta, D. J. Scott, V. Napadow, R. H. Gracely, and D. J. Clauw, “Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on μ-opioid receptors (MORs),” NeuroImage, vol. 47, no. 3, pp. 1077–1085, 2009. View at Publisher · View at Google Scholar · View at Scopus
  19. M. S. Shin, J. I. Kim, M. S. Lee et al., “Acupuncture for treating dry eye: a randomized placebo-controlled trial,” Acta Ophthalmologica, vol. 88, no. 8, pp. e328–e333, 2010. View at Publisher · View at Google Scholar · View at Scopus
  20. C. Zaslawski, C. Rogers, M. Garvey, D. Ryan, C. X. Yang, and S. P. Zhang, “Strategies to maintain the credibility of sham acupuncture used as a control treatment in clinical trials,” Journal of Alternative and Complementary Medicine, vol. 3, no. 3, pp. 257–266, 1997. View at Google Scholar · View at Scopus
  21. G. Deng, A. Vickers, S. Yeung, and B. Cassileth, “Randomized, controlled trial of acupuncture for the treatment of hot flashes in breast cancer patients,” Journal of Clinical Oncology, vol. 25, no. 35, pp. 5584–5590, 2007. View at Publisher · View at Google Scholar · View at Scopus
  22. R. W. Jubb, E. S. Tukmachi, P. W. Jones, E. Dempsey, L. Waterhouse, and S. Brailsford, “A blinded randomised trial of acupuncture (manual and electroacupuncture) compared with a non-penetrating sham for the symptoms of osteoarthritis of the knee,” Acupuncture in Medicine, vol. 26, no. 2, pp. 69–78, 2008. View at Google Scholar · View at Scopus
  23. J. Alecrim-Andrade, J. A. Maciel, X. C. Cladellas, H. R. Correa-Filho, and H. C. Machado, “Acupuncture in migraine prophylaxis: a randomized sham-controlled trial,” Cephalalgia, vol. 26, no. 5, pp. 520–529, 2006. View at Publisher · View at Google Scholar · View at Scopus
  24. B. M. Berman, L. Lao, P. Langenberg, W. L. Lee, A. M. K. Gilpin, and M. C. Hochberg, “Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee. A randomized, controlled trial,” Annals of Internal Medicine, vol. 141, no. 12, pp. 901–910, 2004. View at Google Scholar · View at Scopus
  25. B. Brinkhaus, C. M. Witt, S. Jena et al., “Acupuncture in patients with chronic low back pain: a randomized controlled trial,” Archives of Internal Medicine, vol. 166, no. 4, pp. 450–457, 2006. View at Publisher · View at Google Scholar · View at Scopus
  26. A. Enblom, A. Johnsson, M. Hammar, G. Steineck, and S. Borjeson, “The nonpenetrating telescopic sham needle may blind patients with diferrent characteristics and experiences when treated by several therapists,” Evidence-Based Complementary and Alternative Medicine, vol. 2011, Article ID 185034, pp. 1–12, 2011. View at Publisher · View at Google Scholar
  27. M. Fink, C. Gutenbrunner, J. Rollnik, and M. Karst, “Credibility of a newly designed placebo needle for clinical trials in acupuncture research,” Forschende Komplementarmedizin und Klassische Naturheilkunde, vol. 8, no. 6, pp. 368–372, 2001. View at Publisher · View at Google Scholar · View at Scopus
  28. G. Goddard, Y. Shen, B. Steele, and N. Springer, “A controlled trial of placebo versus real acupuncture,” Journal of Pain, vol. 6, no. 4, pp. 237–242, 2005. View at Publisher · View at Google Scholar · View at Scopus
  29. R. H. Goldman, W. B. Stason, S. K. Park et al., “Acupuncture for treatment of persistent arm pain due to repetitive use: a randomized controlled clinical trial,” Clinical Journal of Pain, vol. 24, no. 3, pp. 211–218, 2008. View at Publisher · View at Google Scholar · View at Scopus
  30. K. Itoh, Y. Katsumi, S. Hirota, and H. Kitakoji, “Effects of trigger point acupuncture on chronic low back pain in elderly patients—a sham-controlled randomised trial,” Acupuncture in Medicine, vol. 24, no. 1, pp. 5–12, 2006. View at Google Scholar · View at Scopus
  31. K. Itoh, S. Hirota, Y. Katsumi, H. Ochi, and H. Kitakoji, “Trigger point acupuncture for treatment of knee osteoarthritis—a preliminary RCT for a pragmatic trial,” Acupuncture in Medicine, vol. 26, no. 1, pp. 17–26, 2008. View at Google Scholar · View at Scopus
  32. S. W. H. Lee, M. L. Liong, K. H. Yuen et al., “Acupuncture versus sham acupuncture for chronic prostatitis/chronic pelvic pain,” American Journal of Medicine, vol. 121, no. 1, pp. 79.e1–79.e7, 2008. View at Publisher · View at Google Scholar · View at Scopus
  33. S. W. H. Lee, M. L. Liong, K. H. Yuen, W. S. Leong, N. K. Khan, and J. N. Krieger, “Validation of a sham acupuncture procedure in a randomised, controlled clinical trial of chronic pelvic pain treatment,” Acupuncture in Medicine, vol. 29, no. 1, pp. 40–46, 2011. View at Publisher · View at Google Scholar · View at Scopus
  34. J. Park, A. White, C. Stevinson, E. Ernst, and M. James, “Validating a new non-penetrating sham acupuncture device: two randomised controlled trials,” Acupuncture in Medicine, vol. 20, no. 4, pp. 168–174, 2002. View at Google Scholar · View at Scopus
  35. J. Park, A. R. White, M. A. James et al., “Acupuncture for subacute stroke rehabilitation: a sham-controlled, subject- and assessor-blind, randomized trial,” Archives of Internal Medicine, vol. 165, no. 17, pp. 2026–2031, 2005. View at Publisher · View at Google Scholar · View at Scopus
  36. Y. F. Shen, J. Younger, G. Goddard, and S. Mackey, “Randomized clinical trial of acupuncture for myofascial pain of the jaw muscles,” Journal of Orofacial Pain, vol. 23, no. 4, pp. 353–359, 2009. View at Google Scholar · View at Scopus
  37. K. J. Sherman, C. J. Hogeboom, D. C. Cherkin, and R. A. Deyo, “Description and validation of a noninvasive placebo acupuncture procedure,” Journal of Alternative and Complementary Medicine, vol. 8, no. 1, pp. 11–19, 2002. View at Google Scholar · View at Scopus
  38. P. Smith, D. Mosscrop, S. Davies, P. Sloan, and Z. Al-Ani, “The efficacy of acupuncture in the treatment of temporomandibular joint myofascial pain: a randomised controlled trial,” Journal of Dentistry, vol. 35, no. 3, pp. 259–267, 2007. View at Publisher · View at Google Scholar · View at Scopus
  39. E. So, E. Ng, Y. Wong, W. Yeung, and P. Ho, “A randomized double blind comparison of real and placebo acupuncture in IVF treatment,” Human Reproduction, vol. 24, pp. 341–348, 2009. View at Google Scholar
  40. K. Streitberger and J. Kleinhenz, “Introducing a placebo needle into acupuncture research,” The Lancet, vol. 352, no. 9125, pp. 364–365, 1998. View at Publisher · View at Google Scholar · View at Scopus
  41. K. Streitberger, M. Diefenbacher, A. Bauer et al., “Acupuncture compared to placebo-acupuncture for postoperative nausea and vomiting prophylaxis: a randomised placebo-controlled patient and observer blind trial,” Anaesthesia, vol. 59, no. 2, pp. 142–149, 2004. View at Publisher · View at Google Scholar · View at Scopus
  42. Y. Tong, H. Guo, and B. Han, “Fifteen-day acupuncture treatment relieves diabetic peripheral neuropathy,” Journal of Acupuncture and Meridian Studies, vol. 3, no. 2, pp. 95–103, 2010. View at Publisher · View at Google Scholar · View at Scopus
  43. E. A. Tough, A. R. White, S. H. Richards, B. Lord, and J. L. Campbell, “Developing and validating a sham acupuncture needle,” Acupuncture in Medicine, vol. 27, no. 3, pp. 118–122, 2009. View at Publisher · View at Google Scholar · View at Scopus
  44. L. Venzke, J. F. Calvert, and B. Gilbertson, “A randomized trial of acupuncture for vasomotor symptoms in post-menopausal women,” Complementary Therapies in Medicine, vol. 18, no. 2, pp. 59–66, 2010. View at Publisher · View at Google Scholar · View at Scopus
  45. A. R. White, C. Eddleston, R. Hardie, K. L. Resch, and E. Ernst, “A pilot study of acupuncture for tension headache, using a novel placebo,” Acupuncture in Medicine, vol. 14, no. 1, pp. 11–15, 1996. View at Google Scholar · View at Scopus
  46. A. R. White, K. L. Resch, J. C. K. Chan et al., “Acupuncture for episodic tension-type headache: a multicentre randomized controlled trial,” Cephalalgia, vol. 20, no. 7, pp. 632–637, 2000. View at Publisher · View at Google Scholar · View at Scopus
  47. P. White, G. Lewith, and P. Prescott, “Should we recruit patients or healthy volunteers for acupuncture studies of chronic pain?” Clinical Journal of Pain, vol. 23, no. 8, pp. 714–719, 2007. View at Publisher · View at Google Scholar · View at Scopus
  48. J. Alecrim-Andrade, J. A. Maciel-Júnior, X. Carnè, G. M. Severino Vasconcelos, and H. R. Correa-Filho, “Acupuncture in migraine prevention: a randomized sham controlled study with 6-months posttreatment follow-up,” Clinical Journal of Pain, vol. 24, no. 2, pp. 98–105, 2008. View at Publisher · View at Google Scholar · View at Scopus
  49. R. E. Harris, X. Tian, D. A. Williams et al., “Treatment of fibromyalgia with formula acupuncture: investigation of needle placement, needle stimulation, and treatment frequency,” Journal of Alternative and Complementary Medicine, vol. 11, no. 4, pp. 663–671, 2005. View at Publisher · View at Google Scholar · View at Scopus
  50. L. Lao, S. Bergman, G. R. Hamilton, P. Langenberg, and B. Berman, “Evaluation of acupuncture for pain control after oral surgery: a placebo-controlled trial,” Archives of Otolaryngology, vol. 125, no. 5, pp. 567–572, 1999. View at Google Scholar · View at Scopus
  51. K. Linde, A. Streng, S. Jürgens et al., “Acupuncture for patients with migraine: a randomized controlled trial,” Journal of the American Medical Association, vol. 293, no. 17, pp. 2118–2125, 2005. View at Publisher · View at Google Scholar · View at Scopus
  52. T. Nabeta and K. Kawakita, “Relief of chronic neck and shoulder pain by manual acupuncture to tender points—a sham-controlled randomized trial,” Complementary Therapies in Medicine, vol. 10, no. 4, pp. 217–222, 2002. View at Publisher · View at Google Scholar · View at Scopus
  53. Y. F. Shen and G. Goddard, “The short-term effects of acupuncture on myofascial pain patients after clenching,” Pain Practice, vol. 7, no. 3, pp. 256–264, 2007. View at Publisher · View at Google Scholar · View at Scopus
  54. K. Streitberger, J. Steppan, C. Maier, H. Hill, J. Backs, and K. Plaschke, “Effects of verum acupuncture compared to placebo acupuncture on quantitative EEG and heart rate variability in healthy volunteers,” Journal of Alternative and Complementary Medicine, vol. 14, no. 5, pp. 505–513, 2008. View at Publisher · View at Google Scholar · View at Scopus
  55. N. Takakura and H. Yajima, “A double-blind placebo needle for acupuncture research,” BMC Complementary and Alternative Medicine, vol. 7, article 31, 2007. View at Publisher · View at Google Scholar · View at Scopus
  56. N. Takakura and H. Yajima, “A placebo acupuncture needle with potential for double blinding—a validation study,” Acupuncture in Medicine, vol. 26, no. 4, pp. 224–230, 2008. View at Publisher · View at Google Scholar · View at Scopus
  57. C. W. Tan, L. Christie, V. St-Georges, and N. Telford, “Discrimination of real and sham acupuncture needles using the park sham device: a Preliminary Study,” Archives of Physical Medicine and Rehabilitation, vol. 90, no. 12, pp. 2141–2145, 2009. View at Publisher · View at Google Scholar · View at Scopus
  58. H. Tsukayama, H. Yamashita, T. Kimura, and K. Otsuki, “Factors that influence the applicability of sham needle in acupuncture trials: two randomized, single-blind, crossover trials with acupuncture—experienced subjects,” Clinical Journal of Pain, vol. 22, no. 4, pp. 346–349, 2006. View at Publisher · View at Google Scholar · View at Scopus
  59. A. D. Wasan, J. Kong, L. D. Pham, T. J. Kaptchuk, R. Edwards, and R. L. Gollub, “The impact of placebo, psychopathology, and expectations on the response to acupuncture needling in patients with chronic low back pain,” Journal of Pain, vol. 11, no. 6, pp. 555–563, 2010. View at Publisher · View at Google Scholar · View at Scopus
  60. Y. Chae, S. I. Um, S. H. Yi et al., “Comparison of biomechanical properties between acupuncture and non-penetrating sham needle,” Complementary Therapies in Medicine, vol. 19, no. 1, pp. S8–S12, 2011. View at Publisher · View at Google Scholar · View at Scopus
  61. M. Kreiner, A. Zaffaroni, R. Alvarez, and G. Clark, “Validation of a simplified sham acupuncture technique for its use in clinical research: a randomised, single blind, crossover study,” Acupuncture in Medicine, vol. 28, no. 1, pp. 33–36, 2010. View at Publisher · View at Google Scholar · View at Scopus
  62. P. M. Wayne, C. E. Kerr, R. N. Schnyer et al., “Japanese-style acupuncture for endometriosis-related pelvic pain in adolescents and young women: results of a randomized sham-controlled trial,” Journal of Pediatric and Adolescent Gynecology, vol. 21, no. 5, pp. 247–257, 2008. View at Publisher · View at Google Scholar · View at Scopus
  63. H. Bang, L. Ni, and C. E. Davis, “Assessment of blinding in clinical trials,” Controlled Clinical Trials, vol. 25, no. 2, pp. 143–156, 2004. View at Publisher · View at Google Scholar · View at Scopus
  64. H. Bang, S. P. Flaherty, J. Kolahi, and J. Park, “Blinding assessment in clinical trials: a review of statistical methods and a proposal of blinding assessment protocol,” Clinical Research and Regulatory Affairs, vol. 27, no. 2, pp. 42–51, 2010. View at Publisher · View at Google Scholar · View at Scopus
  65. J. Kolahi, H. Bang, and J. Park, “Towards a proposal for assessment of blinding success in clinical trials: up-to-date review,” Community Dentistry and Oral Epidemiology, vol. 37, no. 6, pp. 477–484, 2009. View at Publisher · View at Google Scholar · View at Scopus