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

Vase L, Baram S, Takakura N, Takayama M, Yajima H, Kawase A, Schuster L, Kaptchuk TJ, Schou S, Jensen TS, Zachariae R, Svensson P - PLoS ONE (2015)

Bottom Line: 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.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.Still, the non-penetrating needle is the only needle that allows some degree of practitioner blinding.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark; Danish Pain Research Center, Aarhus University Hospital, Aarhus, Denmark.

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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Related in: MedlinePlus

Study design.Patients who developed pain levels of ≥ 3 (0–10) up to 4 hours following surgical removal of one mandibular third molar were randomized to receive active acupuncture (AA) or placebo acupuncture (PA) for 30 minutes. Pain levels were measured at pretreatment, halfway through the session, and at the end of the session. Needles were rotated during insertion, halfway through the session, and at the end of the session right before they were removed. The patients and the acupuncturist were asked about the experience of de qi right after insertion of the needle and at the end of the study, respectively. Both the patients and the acupuncturist reported perceived treatment allocation at the end of the study.
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pone.0119612.g003: Study design.Patients who developed pain levels of ≥ 3 (0–10) up to 4 hours following surgical removal of one mandibular third molar were randomized to receive active acupuncture (AA) or placebo acupuncture (PA) for 30 minutes. Pain levels were measured at pretreatment, halfway through the session, and at the end of the session. Needles were rotated during insertion, halfway through the session, and at the end of the session right before they were removed. The patients and the acupuncturist were asked about the experience of de qi right after insertion of the needle and at the end of the study, respectively. Both the patients and the acupuncturist reported perceived treatment allocation at the end of the study.

Mentions: The acupuncturists introduced him- or herself to the patients, established rapport, and invited the patients to lie down comfortably in a horizontal dental chair. The research assistant then asked the patients about their current acute pain intensity. Next, the acupuncturist palpated the patients, applied the needles in the designated points and rotated the needles manually for approximately 10 seconds. Immediately after the needles had been applied and the acupuncturist had left the room, the patients were asked if they felt de qi. Halfway through the session and at the end of the session, the research assistant again asked the patients about their current acute pain intensity and subsequently the acupuncturist rotated the needles manually. Immediately after the needles were removed, the acupuncturist left the room and answered whether they experienced de qi or not. Also, both the patients and the acupuncturists were asked which treatment they believed they had received/administered (active or placebo acupuncture) as well as their level of confidence in the answer (Fig. 3). The acupuncturists were only in the examination room at the onset, halfway through, and at the end of the study.


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

Vase L, Baram S, Takakura N, Takayama M, Yajima H, Kawase A, Schuster L, Kaptchuk TJ, Schou S, Jensen TS, Zachariae R, Svensson P - PLoS ONE (2015)

Study design.Patients who developed pain levels of ≥ 3 (0–10) up to 4 hours following surgical removal of one mandibular third molar were randomized to receive active acupuncture (AA) or placebo acupuncture (PA) for 30 minutes. Pain levels were measured at pretreatment, halfway through the session, and at the end of the session. Needles were rotated during insertion, halfway through the session, and at the end of the session right before they were removed. The patients and the acupuncturist were asked about the experience of de qi right after insertion of the needle and at the end of the study, respectively. Both the patients and the acupuncturist reported perceived treatment allocation at the end of the study.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4352029&req=5

pone.0119612.g003: Study design.Patients who developed pain levels of ≥ 3 (0–10) up to 4 hours following surgical removal of one mandibular third molar were randomized to receive active acupuncture (AA) or placebo acupuncture (PA) for 30 minutes. Pain levels were measured at pretreatment, halfway through the session, and at the end of the session. Needles were rotated during insertion, halfway through the session, and at the end of the session right before they were removed. The patients and the acupuncturist were asked about the experience of de qi right after insertion of the needle and at the end of the study, respectively. Both the patients and the acupuncturist reported perceived treatment allocation at the end of the study.
Mentions: The acupuncturists introduced him- or herself to the patients, established rapport, and invited the patients to lie down comfortably in a horizontal dental chair. The research assistant then asked the patients about their current acute pain intensity. Next, the acupuncturist palpated the patients, applied the needles in the designated points and rotated the needles manually for approximately 10 seconds. Immediately after the needles had been applied and the acupuncturist had left the room, the patients were asked if they felt de qi. Halfway through the session and at the end of the session, the research assistant again asked the patients about their current acute pain intensity and subsequently the acupuncturist rotated the needles manually. Immediately after the needles were removed, the acupuncturist left the room and answered whether they experienced de qi or not. Also, both the patients and the acupuncturists were asked which treatment they believed they had received/administered (active or placebo acupuncture) as well as their level of confidence in the answer (Fig. 3). The acupuncturists were only in the examination room at the onset, halfway through, and at the end of the study.

Bottom Line: 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.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.Still, the non-penetrating needle is the only needle that allows some degree of practitioner blinding.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark; Danish Pain Research Center, Aarhus University Hospital, Aarhus, Denmark.

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.

Show MeSH
Related in: MedlinePlus