Takakura Nobuari, et al.. Japanese Acupuncture and Moxibustion, 2010; Vol.1(1): 80-91

The 2 nd JSAM International Symposium on Evidence-based Acupuncture

A possible double-blind (practitioner-patient masking)acupuncture needle.
TAKAKURA Nobuari, TAKAYAMA Miho, KAWASE Akiko, YAJIMA Hiroyoshi
Department of Acupuncture and Moxibustion, Faculty of Health Sciences,
Tokyo Ariake University of Medical and Health Sciences, The Educational Foundation of Hanada Gakuen
Second Department of Physiology, Showa University School of Medicine
The Foundation for Oriental Medicine Research
Japan School of Acupuncture, Moxibustion and Physiotherapy, The Educational Foundation ofHanada Gakuen
Abstract
Background: The double-blind (practitioner-patient masking) placebo acupuncture needles have been consideredalmost impossible to develop until now.
Methods: We designed a double-blind non-penetrating placebo needle, the needle tip of which simply presses
against the skin, and a matched penetrating needle. Validation test 1: To validate the masking effect for the practitioner, well-experienced 10 acupuncturists each applied 23 non-penetrating needles and 17 penetrating needles tothe LI-4 point. After removing each needle, they judged whether the needle was 'penetrating,' 'non-penetrating' or'unidentifiable.' Validation test 2: An acupuncturist who was pre-informed he will apply penetrating or nonpenetrating needle applied penetrating/penetrating needle pairs at bilateral TE-5 points in 30 healthy volunteers.
The acupuncturist guessed whether or not the needle was penetrating after removal of each needle. The acupuncturist provided clues to the needle's authenticity and rated his confidence in identification on a visual analog scale.
Validation test 3: For the validation of uninformed patient masking, an acupuncturist randomly applied a nonpenetrating/penetrating needle pair to the bilateral TE-5 points in 60 subjects. When both applications were completed, we asked them to write down anything that they noticed regarding the needle application and associatedsensations. Validation test 4: For the validation of informed patient masking, an acupuncturist applied one of thefollowing needle pairs －penetrating/non-penetrating, non-penetrating/non-penetrating, penetrating/penetrating－randomly at bilateral TE-5 points in 114 subjects who were informed that they would receive either a nonpenetrating or a penetrating needle. After the application of a pair of needles the subjects reported whether they
identified the needle to be non-penetrating or penetrating for each arm.
Results: Validation test 1: The mean ± SD of correct/unidentifiable/incorrect answers given by the 10 acupuncturists were 17.0 ± 4.1/6.4 ± 3.6/16.6 ± 3.0, respectively. Validation test 2: Of 60 needles, 44 were incorrectly identified by the acupuncturist. Most identifications were made based on the "feeling of needle insertion." Validation test
3: Regarding uninformed patient masking, none of the subjects commented in the questionnaire that they had received a non-penetrating needle. Validation test 4: Of the 114 non-penetrating needle applications, the informed
subjects identified 64 incorrectly and 50 correctly. Most interestingly, the subjects identified 36 (32%) of 114 penetrating needle.applications incorrectly
Conclusion: These needles have the potential to mask both practitioners and patients from the type of needle usedin acupuncture research.
Key words: acupuncture, double-blind, placebo.
Corresponding author: Takakura Nobuari
Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, 2-9-1 Ariake, Koto-ku, Tokyo 135-0063, Japan
E-mail: takakura@t-ariake.ac.jp

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Introduction

Methods

The double-blind study design is generally employed
as a methodological safeguard to satisfy the current criterion of minimizing bias in medical science1-5). However, in acupuncture trials the single-blind design had been
only possible because practitioner masking in acupuncture studies has been considered as almost infeasible4-11).
Therefore, randomized single-blind (patient masking)placebo controlled studies12-17) have been acknowledged
as the most rigorous methods in clinical acupuncturescience. That is, the strongest evidence supporting theefficacy of acupuncture has been obtained using singleblind approaches12-17) that fail to meet the methodological standards for study blinding in current medical science1-5).
Several investigators recently invented and validated apatient masking, single-blind needle which to the patient
looks and feels like a real needle8-11). These recently
designed sham/placebo devices, which overcome theinadequacies of previous control procedures, provide
enhanced evidence in acupuncture studies when it is
impossible to blind the practitioner to the intervention 4-8).
However, with studies in which only patients are blinded(single-blind studies), the specific effects of acupuncture
beyond placebo cannot be fully clarified because thestudy subjects/patients may have been biased due topresence of unmasked practitioners1-6,18-23). As a result,the effectiveness of acupuncture has remained controversial, even though studies of the highest possible
quality have been published in leading medical journals5).
Thus, there has been a call for a methodological advancebeyond single-blind studies, despite the inherent difficulties in masking the practitioner in acupuncture studies4-8).
Double-blind trials using placebo needles are criticallyimportant to ensure that acupuncture research meets themethodological standards of medical science to provide
stronger evidence of the effectiveness of acupuncture
treatment using needles1-6). Only then will acupuncture
be incorporated into generally accepted practice1-6,19-21).
To solve this methodological conundrum of practitioner masking in acupuncture research x4-8), we havedesigned a double-blind non-penetrating placebo needle
and a matched penetrating needle24-30). Here, we report
the design of double-blind (practitioner-patient masking)needles with a statistical evaluation of the masking effectof these needles24-30).

Participants
We recruited well-experienced and licensed acupuncturists on the teaching staff and healthy volunteers who
were familiar with receiving acupuncture as experimental subjects, and were familiar with the different sensations of needle penetration and de qifrom Japan Schoolof Acupuncture, Moxibustion and Physiotherapy. Before
the study, the purpose and format were explained and theparticipants provided written consent. The Showa University Ethics Committee gave its approval.
Design of double-blind needles24-30)
We designed a double-blind (practitioner-patient) nonpenetrating placebo needle, the tip of which presses
against the skin but cannot penetrate it, and a matchedpenetrating needle with a specified insertion depth to be
used in acupuncture research. The non-penetrating needle is identical to the penetrating needle except for being
shorter in the needle body and having a blunt tip. The
appearance and feel of the non-penetrating and penetrating needles were indistinguishable from one another(Figure 1).
Validation test 1 for practitioner masking25,26)
Ten highly experienced, licensed acupuncture practitioners (mean ± SD age: 41.7 ± 8.8 years; all men) witha mean ± SD duration of acupuncture experience of 12.4
± 7.8 years participated in this study (Table 1). Forty
needles consisted of 23 non-penetrating and 17 penetrating needles (10 mm insertion depth31)) were used. Before
the trial began, the practitioners were informed of possible use of both non-penetrating and penetrating needles.
Each acupuncturist consecutively applied 40 needles atthe LI-4 point31), using the alternating twirling technique(alternating between rotating the needle clockwise andcounterclockwise). Each needle was inserted and pulled
out after the stopper had made contact with the top of theguide tube. Immediately after the removal of each needle,
the practitioner recorded his judgment of the needle tobe 'penetrating,' 'non-penetrating' or 'unidentifiable.'
Validation test 2 for practitioner masking27)
We used 30 penetrating/penetrating needle (10 mm insertion depth31)) pairs in this study (Figure 1). However,the subjects and the acupuncturist were informed that the

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non-penetrating needle would be used in addition to thepenetrating needle before the trial to perform this study
under double-blind conditions.
An acupuncturist with 28 years of experience applied
the pair of needles at bilateral TE-5 points, one needleon each side, in the 30 subjects (31.0± 9.8 years; 24 men,
6 women) using the alternating twirling technique. Afterremoval of each needle the acupuncturist recorded
whether he judged the needle to be penetrating or nonpenetrating. He then reported clues that led to his identification of authenticity of the needle; these were "facial
expression," "body movement," and "bleeding," in addition to the "feeling of needle insertion," "verval expression," "no bleeding," and "feeling of needle removal."

He also rated his confidence in identification of the needle authenticity (i.e., the degree of certainty about his
answer) on a visual analog scale (VAS), the end-pointsof which were 0 for no con fidence and 100 for complete
confidence.
We asked the subjects to guess the authenticity of theneedle and to rate skin penetration/penetration-like painand deep dull sensation (de qi), that is considered essential for a successful acupuncture treatment31) on a VAS
after each removal of the needle. The VAS corresponded
to a numerical scale of 0-100, where 0 represented nopain or de qi sensation and 100 the most intense skinpenetration pain or de qi ever experienced during needle
insertion.

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Validation test 3 for uninformed patient masking 25,26)
Sixty healthy volunteers (29.7 ± 7.5 years, 35 men, 25
women) were recruited. Before the trial began, the experimental procedure was explained to the subjects asfollows: 'We will apply two needles, which may or may
not differ in type, at bilateral TE-5 points31).'
The acupuncturist applied a pair of penetrating/ nonpenetrating needles (10 mm insertion depth31)) to each of
the 60 subjects at the bilateral TE-5 points, one needle in
the right arm and the other in the left, using the alternating twirling technique. After each application, the subjects reported whether they felt a skin penetration sensation and de qi for each arm and wrote down anythingthat came to their notice. The practitioner guessed theauthenticity of the needle after its removal.
Validation test 4 for informed patient masking28,30)
We recruited a well-experienced and licensed acupuncturist and 114 healthy volunteers (30.3±7.9 years;
73 men, 41 women). Before the trial, the subjects andthe practitioner were informed that penetrating / penetrating, non-penetrating / non- penetrating, and penetrating/non-penetrating needle pairs would be used and that
we would ask them about the nature of each needle after
it had been removed. We prepared 38 pairs of each ofthese needle combinations. The insertion depth of thepenetrating needle was 5 mm8).
An acupuncturist with 8 years experience inserted apair of needles, randomly taken from the shuffled 114
pairs, at bilateral TE- 5 points in the subjects and stimulated them using the alternating twirling technique. Aftereach needle application, the subjects guessed the type ofthe needles. They also rated skin penetration/penetration-like pain and de qi on the VAS ranging
from 0 to 108,27). The practitioner was also asked toguess the type of needle after each needle removal25,27).
Data Analysis25,27,28)
The chi-squared goodness-of-fit test was used to determine whether the number of correctly and incorrectly
identified needles fits a probability of 0.5. Statisticalcomparisons of practitioner's confidence scores between
correct and incorrect identifications and of the needle
groups for VAS scores for skin penetration/penetrationlike pain and de qi were made using Mann-Whitney's U
test. Pearson's corre lation coefficient was used to indicate the relationship between the practitioner's confidence and skin penetration pain, and between the practitioner's confidence and de qi. All statistical analyses
were performed using SPSS, version 15.0 J (SPSS Inc,
Chicago, IL). The true identity of the needle was notrevealed until after the results had been tabulated.
Results
Validation test 1 for practitioner masking25,26)
The number of correct/unidentifiable/incorrect answers given by the 10 acupuncturists had a mean± SD of
17.0 ± 4.1/6.4 ± 3.6/16.6 ± 3.0, respectively. Overall, the170 correct and 166 incorrect identifications fitted aprobability of 0.5 (χ2 = 0.048, p = 0.827), excluding the64 unidentifiable needles. Furthermore, 107 correctly

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identified non-penetrating needles and 94 incorrectly
identified non-penetrating needles (χ2 = 0.841, p =0.359), and 63 correctly identified penetrating needles
and 72 incorrectly identified penetrating needles (χ2 =
0.600, p = 0.439) fitted a probability of 0.5 (Table 1).
Validation test 2 for practitioner masking27)
Of the 60 penetrating needles, 16 (27%) were correctly and 44 (73%) were incorrectly identified by thepractitioner; these numbers did not fit a probability of
0.5 (χ2 = 13.1, p < 0.001) (Figure 2). On the VAS, themean confidence of the practitioner in identification ofneedle authenticity was 50.0 ± 19.7 for correctly identified needles, 73.6 ± 13.7 for incorrectly identified needles, and 67.3 ± 18.6 for all needles. Confidence in incorrect identification was significantly greater than thatin correct identification (p < 0.001).
The practitioner guessed the authenticity of the needle
principally depending on the "feeling of needle inser-

tion" (Table 2). The second most frequently used determinant was "facial expression."
Of all the needles that were correctly and incorrectly
identified by the practitioner, approximately 90% elicited skin penetration/penetration-like pain and/or de qi inthe subjects (Table 3). The skin penetration/penetrationlike pain and de qi scores for incorrectly identified needles were not significantly lower than those for correctly
identified needles (skin penetration/penetration-like pain,
p = 0.09; de qi, p = 0.13) (Figure 3). Further, no significant correlation between the VAS score of practitioner's
confidence in identification and skin penetration/penetration-like pain or between the VAS score andde qi was observed for 16 correctly (skin penetration/penetration-like pain, r = 0.45, p = 0.08; de qi, r =0.20, p = 0.47) and 44 incorrectly (skin penetration/penetration-like pain, r = 0.24, p = 0.12; de qi, r =0.08, p = 0.63) identified needles.
Of the 60 needles, 40 (67%) were correctly and 20

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Takakura Nobuari, et al.. Japanese Acupuncture and Moxibustion, 2010; Vol.6(1): 80-91(33%) were incorrectly identified by the subjects (Table4). For the skin penetration/penetration-like pain and deqi scores, there was no significant difference between
the 20 needles that were incorrectly and the 40 that werecorrectly identified (skin penetration/penetration-like
pain, p = 0.162; de qi, p = 0.153).
Validation test 3 for uninformed patient masking25,26)
None of the subjects commented in the questionnairethat they had received a non-penetrating needle.
Of the 120 needles, the practitioner identified 65(54.2%) correctly (penetrating needle = 35, nonpenetrating needle = 30) and 55 (45.8%) incorrectly(penetrating needle = 25, non-penetrating needle = 30),
which fits a probability of 0.5 (χ2 = 0.833, p = 0.361).
Validation test 4 for informed patient masking28,30)
Of the total 228 needles applied, the subjects identified 128 (56.1%) needles correctly (non-penetrating = 50,
penetrating = 78) and 100 (43.9%) needles incorrectly(non-penetrating = 64, penetrating = 36), fitting theprobability of 0.5 (χ2 = 3.439, p = 0.064).
With regard to the ratings of the skin penetration/
penetration-like pain and de qi, no significant differenceswere found in subjective intensity between the 114 nonpenetrating and 114 penetrating needles (Table 5). Of

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the 114 penetrating needles, 72 (63.2%, 54 correctly and
18 incorrectly identified) elicited skin penetration/penetration-like pain and 40 (35.1%) elicited de qi.
Interestingly, 21.1% of the penetrating needles elicitedneither response. Of the 114 non-penetrating needles, 72(63.2%, 20 correctly and 52 incorrectly identified) elicited skin penetration/penetration-like pain and 30(26.3%) elicited de qi.
The distribution of the non-penetrating needles depicted according to the intensity of skin penetration/penetration-like pain or de qi was similar to that ofthe penetrating needles (Figure 4). Moreover, the frequencies that needle sensations were elicited in the caseof the 114 non-penetrating needles were similar to those

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in the case of the 114 penetrating needles (Table 6).
Furthermore, the frequencies that needle sensations wereelicited in the case of non-penetrating needles that wereincorrectly and correctly identified were quite similar to
those in the case of the penetrating needles that werecorrectly and incorrectly identified (Table 6).
Of the total 228 needles, the practitioner identified 97(42.5%) needles correctly (non-penetrating = 54, penetrating = 43) and 122 (53.5%) needles incorrectly (nonpenetrating = 54, penetrating = 68), fitting the probability of 0.5 (χ2 = 2.854, p = 0.091). Nine (4%) needles
were indistinguishable.
Discussion
Practitioner masking
The practitioners failed to distinguish between thepenetrating and non-penetrating needles, regardless of
their practical experience. The appearance and feel ofthe non-penetrating placebo and penetrating needles inthis study were virtually identical, such that the needles
caused well-experienced practitioners much difficulty in
identifying the true nature of each needle. The fact thatthe practitioners made incorrect identifications approximately half of the times excluding the unidentifiable
needles in the validation test 1, 3 and 4 shows that theseneedles are useful for masking even with a highly experienced acupuncturist. Further, the highly experienced
acupuncturist failed to identify a large proportion of thetotal number of needles with the finding that a large
proportion of needles were identified from the "feelingof needle insertion" in the validation test 2. This indicates that the non-penetrating needle and the penetratingneedle were virtually indistinguishable in appearance
and feel.

For the incorrectly identified needles in the validation
test 2, the subjects' reactions were not expected to reveal
the authenticity of the needle. Seven percent of all needles were identified by "body movement" with "facial
expression," and all of these were correctly identified.
However, for these needles, the practitioner's VAS
scores of confidence in identification ranged from 40%
to 80%. Thus, although these correctly identified needles
were assumed to elicit penetration pain, withdrawal reactions suggesting the authenticity of the needles were
obscure. We believe that the penetration pain elicited byan acupuncture needle is relatively weak, the authenticity of needles could not be revealed with 100% confidence. "Facial expression" gave the practitioner little
clue about the needle authenticity because approximately
two-thirds of needle identification from "facial expression" alone, together with other clues, were incorrect. In
addition, the mean VAS score for the practitioner's confidence in identification of needles identified only from"facial expression" (86% of which were correctly identified) was only 40. Further, there was no significant positive correlation between the in tensity of skin penetration
pain or de qi and the degree of the practitioner's confidence in correct identification of the penetrating needles,
and a negative correlation for incorrectly identified
penetrating needles. It is unlikely that the practitioner's
identification was influenced by the subjects' reactions to
the insertion of the needle. Considering that more than
90% of the needles correctly as well as incorrectly identified by the practitioner elicited non-significant different
skin penetration/penetration-like pain and de qi, there
were very few needles whose authenticity was revealedby the subject's reactions on needle insertion.

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Patient masking
The fully informed subjects failed to correctly identify
the non-penetrating needles even though they had previously received acupuncture and were familiar with thedifferent sensations of needle penetration and de qi. The
reason for the successful subject masking with the nonpenetrating needle was that the sensations elicited by theneedle were similar in frequency and intensity to thoseexperienced with needle penetration to a 5 mm insertion
depth. Thus, subjects who were not informed of the potential use of non-penetrating needles did not suspectthat they received a non-penetrating needle in the validation test 3, and the fully informed subjects in the validation test 4 misjudged nearly half of the non-penetratingneedles. The difference in skin penetration/penetrationlike pain between non-penetrating and penetrating needles was too small to reveal the identity of the nonpenetrating needle, as reported in the single-blind study8).
The double-blind placebo needle with a blunt tip is apromising innovation that should allow double-blind
acupuncture studies to be undertaken in both non- andfully-informed subjects.
Although we expected it to be unlikely that a subject
would misjudge a penetrating needle to be a nonpenetrating one, surprisingly, 32% of 114 penetratingneedles with 5 mm insertion depth in the validation test
4 and 33% of 60 penetrating needles with 10 mm insertion depth in the validation test 2 were incorrectly identified by the subjects. The skin penetration pain elicited bythese needles was faint and nearly indistinguishable
from the sensation elicited by the skin pressure associated with the non-penetrating needle in the validation
test 4. Therefore, some penetrating needles were equally
misjudged to be non-penetrating when the subjects were
informed of the potential application of non-penetratingneedles. These incorrect identifications, even thoughsmall in proportion, suggest that penetrating needles
have some potential for double masking in study using
one needle per patient like acupuncture at only the PC-6
point32).
These results imply that this needle has the potential
for in double blinding, but we must be cautious when
extrapolating our results because of the following limitations of the study. These studies were not completed in aclinical setting with likely variables such as clinical improvement, adverse reactions and repeat treatments withmultiple needles or points, which would risk the practitioner and patient unmasking. Although few bleeding

occurred during this series of studies, slight bleeding andpatient reaction to strong pain elicited by real needle
insertion in a few instances could break the blind. We
used only one practitioner in the validation test 2, 3 and4, so inter-tester reliability should be tested. The subjects
were confined to healthy acupuncture students who had
previously experience that needle insertion or removal
are not necessarily accompanied by pain. We examined
only needle insertions to a 5 and 10 mm depth, using aneedle of diameter 0.16 mm, at only two acupoints. The
degree of manipulation of the depth or angle of the needle is restricted during needle insertion, although we
believe that needle insertion and advancement are themost important components of acupuncture. It is inevitable that any double-blind needle is an artificial device
for research that cannot fully reproduce all the conditions of real life acupuncture. It is not known for certain
whether this placebo needle has any therapeutic effect orwhether the action of acupuncture is point-specific, andthese uncertainties should be taken into account whencalling this needle placebo and designing studies with it
as placebo26,34,35).
Competing Interests
N.T. and The Educational Foundation of Hanada Gakuen hold US patent 6575992 B 1, Canadian patent CA
2339223, Korean patent 0478177, Taiwan patent 150135,
Chinese patent ZL 00800894.9 and Japanese patent
4061397 for the needles described in this article. N.T. isa salaried employee of The Educational Foundation ofHanada Gakuen and has received research funding fromThe Educational Foundation of Hanada Gakuen.
Authors' Contributions
N.T. designed the double-blind needles and the study,
performed the data collection and analysis, and wrote themanuscript. H.Y., M.T. and A.K. participated in the
study design, the data collection and analysis, and manuscript preparation. N.T. is the guarantor. All authors
have read and accepted the final version of the manuscript.
Acknowledgements
We thank Koji Sakurai (The Educational Foundationof Hanada Gakuen, Tokyo) and Professor Ikuo Homma(Second Department of Physiology, Showa University
School of Medicine, Tokyo) for their support. We also

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express our appreciation to all participants at The Educational Foundation of Hanada Gakuen.
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