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

Lene Vase; Sara Baram; Nobuari Takakura; Miho Takayama; Hiroyoshi Yajima; Akiko Kawase; Lars Schuster; Ted J Kaptchuk; Søren Schou; Troels Staehelin Jensen; Robert Zachariae; Peter Svensson

doi:10.1371/journal.pone.0119612

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

Lene Vase, Sara Baram, Nobuari Takakura, Miho Takayama, Hiroyoshi Yajima, Akiko Kawase, Lars Schuster, Ted J Kaptchuk, Søren Schou, Troels Staehelin Jensen, Robert Zachariae, Peter Svensson

32 Citations (Scopus)

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.

Original language	English
Journal	P L o S One
Volume	10
Issue number	3
Pages (from-to)	e0119612
ISSN	1932-6203
DOIs	https://doi.org/10.1371/journal.pone.0119612
Publication status	Published - 6 Mar 2015
Externally published	Yes

Keywords

Acupuncture Analgesia
Adult
Double-Blind Method
Female
Humans
Male
Pain Management
Pain, Postoperative
Tooth Extraction
Journal Article
Randomized Controlled Trial

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title = "Can acupuncture treatment be double-blinded?: An evaluation of double-blind acupuncture treatment of postoperative pain",

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.",

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AU - Vase, Lene

AU - Baram, Sara

AU - Takakura, Nobuari

AU - Takayama, Miho

AU - Yajima, Hiroyoshi

AU - Kawase, Akiko

AU - Schuster, Lars

AU - Kaptchuk, Ted J

AU - Schou, Søren

AU - Jensen, Troels Staehelin

AU - Zachariae, Robert

AU - Svensson, Peter

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AB - 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.

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KW - Humans

KW - Male

KW - Pain Management

KW - Pain, Postoperative

KW - Tooth Extraction

KW - Journal Article

KW - Randomized Controlled Trial

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DO - 10.1371/journal.pone.0119612

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SN - 1932-6203

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JO - PLoS Computational Biology

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ER -

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

Abstract

Keywords

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