The Challenges of Nonpharmacological Trials: Blinding and Other Issues Using Acupuncture Research as an Example



To discuss some of the methodological challenges of nonpharmacological trials using acupuncture as an example.


Challenges in nonpharmacological trials are plenty. In acupuncture trials, choosing the most credible blinding technique and selecting the appropriate treatment parameters are some of the many difficulties facing clinicians. There is no consensus about the most appropriate type of sham acupuncture. The parameters to be considered in the sham group are the location of the points (wrong points, same spinal segment as the actual points of interest, outside the spinal segment of the actual points of interest), depth of needle insertion (no insertion, superficial insertion, or regular insertion), amount of stimulation to the needles (no stimulation, minimal stimulation, or regular stimulation), or a combination of these parameters. In a review, the average number of acupuncture treatments used was six. The average frequency of treatments per week was two. The duration of treatment was between 4 to 30 minutes with the mean at 20 minutes. About an equal number of studies used electrical or manual needle stimulation. Deep needle insertions were used in the studies that reported depth of insertion. The depth was either reported as deep or between 10 to 30 mm. On average, five needles were used during treatment sessions. “De qi” was elicited in only five of the studies. It appeared that most of these high-quality trials for musculoskeletal problems used combinations of segmental and nonsegmental point locations.

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  1. 1.

    Ezzo J, Berman B, Hadhazy VA, et al. Is acupuncture effective for the treatment of chronic pain? A systematic review. Pain. 2000;86:217–225.

    CAS  Article  Google Scholar 

  2. 2.

    Godfrey CM, Morgan PA: A controlled trial of the theory of acupuncture in musculoskeletal pain. J Rheumatol. 1978;5:124

    Google Scholar 

  3. 3.

    Korpan MI, Dezu Y, Schneider TH, et al. Acupuncture in the treatment of posttraumatic pain syndrome. Acta Orthop Belg. 1999;65:197–201.

    CAS  PubMed  Google Scholar 

  4. 4.

    Molsberger A, Hille E. The analgesic effect of acupuncture in chronic tennis elbow pain. Br J Rheumatology. 1994;33:1162–1165.

    CAS  Article  Google Scholar 

  5. 5.

    Ballegaard S, Jensen G, Pedersen F, et al. Acupuncture in severe, stable angina pectoris: A randomized trial. Acta Med Scand. 1986;220:307–313.

    CAS  Article  Google Scholar 

  6. 6.

    David J, Townsend S, Sathanathan R, et al. The effect of acupuncture on patients with rheumatoid arthritis: A randomized, placebo-controlled cross-over study. Rheumatology. 1999;38:864–869.

    CAS  Article  Google Scholar 

  7. 7.

    Deluze C, Bosia L, Zirbs A, et al. Electroacupuncture in fibromyalgia: Results of a controlled trial. Br Med J. 1992;305:1249–1252.

    CAS  Article  Google Scholar 

  8. 8.

    Emery P, Lythgoe S. The effect of acupuncture on ankylosing spondylitis (letter). Br J Rheumatology. 1986;25:132–133.

    CAS  Article  Google Scholar 

  9. 9.

    Trinh KV. The efficacy of acupuncture in acute nonspecific low back pain and sciatica: a randomized controlled trial in primary care. Master Thesis Dissertation. McMaster University; 2000.

    Google Scholar 

  10. 10.

    White AR, Eddleston C, Hardie R, et al. A pilot study of acupuncture for tension headache, using a novel placebo. Acupuncture Med. 1996;14:11–15.

    Article  Google Scholar 

  11. 11.

    Lao L, Bergman S, Hamilton GR, Langenberg P, Berman B. Evaluation of acupuncture for pain control after oral surgery. Arch Otolaryngol Head Neck Surg. 1999;125:567–572.

    CAS  Article  Google Scholar 

  12. 12.

    Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. The Lancet. 1998;352:364–365.

    CAS  Article  Google Scholar 

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Correspondence to Kien Vinh Trinh MD, MSc.

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Trinh, K.V. The Challenges of Nonpharmacological Trials: Blinding and Other Issues Using Acupuncture Research as an Example. Ther Innov Regul Sci 36, 509–511 (2002).

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Key Words

  • Acupuncture
  • Blinding
  • Treatment parameters
  • Pain
  • Systematic review