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Acupuncture for Dyspnea on Exertion in Chronic Obstructive Pulmonary Disease: No Blindness—Reply

Acupuncture for Dyspnea on Exertion in Chronic Obstructive Pulmonary Disease: No Blindness—Reply In reply In clinical trials of the efficacy of manual treatments like surgery or acupuncture, control groups are commonly given “sham” procedures, which is supposed to be indistinguishable from the real treatment and inactive. Among various options of sham procedures such as needling off point or needling at a minimal depth, mechanical telescopic needle with blunt tip is the most ideal device because it appears to be penetrating skin while causing a similar sensation to that of real needling.1,2 In our clinical trial, since we informed the participants that both procedures (penetrating and nonpenetrating needling) could cause some kind of sensation such as pricking or poking (it actually does), it is not surprising that most of them answered the question as “don't know,” and we have no doubt of their honesty. Although the therapist asked the patients if they felt a numb, dull, or heavy sensation (which is considered to be de qi) and those in the real acupuncture group answered “yes,” it could not necessarily be a clue to distinguish real needling from the sham procedure because the therapist did not inform the patients that the sensation is peculiar to acupuncture needling. In fact, even among patients who had experienced acupuncture prior to registration of our study (n = 10), 3 made the wrong judgment, while 3 answered correctly, of which the percentage of correct answers was no greater than that which occurs by coincidence and is comparable to the results of previous studies.3,4 Of 30 patients who were treated with real acupuncture, 5 had temporary bruising, but the reaction was found not by the patient but by the therapist because most of the bruising occurred on their backs, and all of the patients who had bruises answered that they did not know whether the needles penetrated their skin. Taken together, in the setting that a participant received either of sham or real needling, but not both, and was informed of the possible sensation caused by both procedures, it is highly possible that most of the subjects had no idea to distinguish the real procedure from the well-designed nonpenetrating, needlelike Park sham device. Back to top Article Information Correspondence: Dr Suzuki, Department of Clinical Acupuncture and Moxibustion, Meiji University of Integrative Medicine, Hiyoshi-cho, Kyoto 6290392, Japan (masuzuki@meiji-u.ac.jp). Conflict of Interest Disclosures: None reported. References 1. Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet. 1998;352(9125):364-3659717924PubMedGoogle ScholarCrossref 2. Park J, White A, Stevinson C, Ernst E, James M. Validating a new non-penetrating sham acupuncture device: two randomised controlled trials. Acupunct Med. 2002;20(4):168-17412512790PubMedGoogle ScholarCrossref 3. Tsukayama H, Yamashita H, Kimura T, Otsuki K. Factors that influence the applicability of sham needle in acupuncture trials: two randomized, single-blind, crossover trials with acupuncture-experienced subjects. Clin J Pain. 2006;22(4):346-34916691086PubMedGoogle ScholarCrossref 4. Lee H, Bang H, Kim Y, et al. Non-penetrating sham needle, is it an adequate sham control in acupuncture research? Complement Ther Med. 2011;19:(suppl 1) S41-S4821195294PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Internal Medicine American Medical Association

Acupuncture for Dyspnea on Exertion in Chronic Obstructive Pulmonary Disease: No Blindness—Reply

Archives of Internal Medicine , Volume 172 (22) – Dec 10, 2012

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Publisher
American Medical Association
Copyright
Copyright © 2012 American Medical Association. All Rights Reserved.
ISSN
0003-9926
eISSN
1538-3679
DOI
10.1001/jamainternmed.2013.1285
Publisher site
See Article on Publisher Site

Abstract

In reply In clinical trials of the efficacy of manual treatments like surgery or acupuncture, control groups are commonly given “sham” procedures, which is supposed to be indistinguishable from the real treatment and inactive. Among various options of sham procedures such as needling off point or needling at a minimal depth, mechanical telescopic needle with blunt tip is the most ideal device because it appears to be penetrating skin while causing a similar sensation to that of real needling.1,2 In our clinical trial, since we informed the participants that both procedures (penetrating and nonpenetrating needling) could cause some kind of sensation such as pricking or poking (it actually does), it is not surprising that most of them answered the question as “don't know,” and we have no doubt of their honesty. Although the therapist asked the patients if they felt a numb, dull, or heavy sensation (which is considered to be de qi) and those in the real acupuncture group answered “yes,” it could not necessarily be a clue to distinguish real needling from the sham procedure because the therapist did not inform the patients that the sensation is peculiar to acupuncture needling. In fact, even among patients who had experienced acupuncture prior to registration of our study (n = 10), 3 made the wrong judgment, while 3 answered correctly, of which the percentage of correct answers was no greater than that which occurs by coincidence and is comparable to the results of previous studies.3,4 Of 30 patients who were treated with real acupuncture, 5 had temporary bruising, but the reaction was found not by the patient but by the therapist because most of the bruising occurred on their backs, and all of the patients who had bruises answered that they did not know whether the needles penetrated their skin. Taken together, in the setting that a participant received either of sham or real needling, but not both, and was informed of the possible sensation caused by both procedures, it is highly possible that most of the subjects had no idea to distinguish the real procedure from the well-designed nonpenetrating, needlelike Park sham device. Back to top Article Information Correspondence: Dr Suzuki, Department of Clinical Acupuncture and Moxibustion, Meiji University of Integrative Medicine, Hiyoshi-cho, Kyoto 6290392, Japan (masuzuki@meiji-u.ac.jp). Conflict of Interest Disclosures: None reported. References 1. Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet. 1998;352(9125):364-3659717924PubMedGoogle ScholarCrossref 2. Park J, White A, Stevinson C, Ernst E, James M. Validating a new non-penetrating sham acupuncture device: two randomised controlled trials. Acupunct Med. 2002;20(4):168-17412512790PubMedGoogle ScholarCrossref 3. Tsukayama H, Yamashita H, Kimura T, Otsuki K. Factors that influence the applicability of sham needle in acupuncture trials: two randomized, single-blind, crossover trials with acupuncture-experienced subjects. Clin J Pain. 2006;22(4):346-34916691086PubMedGoogle ScholarCrossref 4. Lee H, Bang H, Kim Y, et al. Non-penetrating sham needle, is it an adequate sham control in acupuncture research? Complement Ther Med. 2011;19:(suppl 1) S41-S4821195294PubMedGoogle ScholarCrossref

Journal

Archives of Internal MedicineAmerican Medical Association

Published: Dec 10, 2012

Keywords: chronic obstructive airway disease,acupuncture therapy discipline,blindness,exertional dyspnea,acupuncture procedure

References