Can acupuncture treatment be double-blinded? An evaluation of double-blind acupuncture treatment of postoperative pain

PLoS One. 2015 Mar 6;10(3):e0119612. doi: 10.1371/journal.pone.0119612. eCollection 2015.

Abstract

Blinding protects against bias but the success of blinding is seldom assessed and reported in clinical trials including studies of acupuncture where blinding represents a major challenge. Recently, needles with the potential for double-blinding were developed, so we tested if acupuncture can be double-blinded in a randomized study of sixty-seven patients with acute pain ≥ 3 (0-10 scale following third molar removal) who received active acupuncture with a penetrating needle or placebo acupuncture with a non-penetrating needle. To test if acupuncture was administered double-blind, patients and acupuncturists were asked about perceived treatment allocation at the end of the study. To test if there were clues which led to identification of the treatment, deep dull pain associated with needle application and rotation (termed "de qi" in East Asian medicine), and patients' pain levels were assessed. Perceived treatment allocation depended on actual group allocation (p < 0.015) for both patients and acupuncturists, indicating that the needles were not successful in double-blinding. Up to 68% of patients and 83% of acupuncturists correctly identified the treatment, but for patients the distribution was not far from 50/50. Also, there was a significant interaction between actual or perceived treatment and the experience of de qi (p = 0.027), suggesting that the experience of de qi and possible non-verbal clues contributed to correct identification of the treatment. Yet, of the patients who perceived the treatment as active or placebo, 50% and 23%, respectively, reported de qi. Patients' acute pain levels did not influence the perceived treatment. In conclusion, acupuncture treatment was not fully double-blinded which is similar to observations in pharmacological studies. Still, the non-penetrating needle is the only needle that allows some degree of practitioner blinding. The study raises questions about alternatives to double-blind randomized clinical trials in the assessment of acupuncture treatment.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acupuncture Analgesia / instrumentation*
  • Acupuncture Analgesia / methods*
  • Adult
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Pain Management / instrumentation*
  • Pain Management / methods*
  • Pain, Postoperative / therapy*
  • Tooth Extraction / adverse effects

Grants and funding

Lene Vase is part of the Europain Collaboration, which has received support from the Innovative Medicines Initiative Joint Undertaking, under grant agreement no. 115007, the resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007–2013) and EFPIA companies’ kind contribution, www.imi.europa.eu. The funding source had the possibility to comment on the design and the reporting of the study, but had no role in the collection, analysis, and interpretation of the data and the decision to submit for publication.