Journal of Acupuncture and Meridian Studies
Volume 1, Issue 1 , Pages 36-41, September 2008

Creating an Instrument for a Successful Double-blind Acupuncture Placebo

  • Sungchul Kim

      Affiliations

    • Wonkwang University, Iksan, South Korea
    • Wonkwang University Oriental Medicine Hospital, Gwangju, South Korea
    • Corresponding Author InformationCorresponding author. Wonkwang University Oriental Medicine Hospital, 543–8 Juwoldong Namgu, Gwangju City, South Korea

Received 1 February 2008; accepted 4 June 2008.

Article Outline

Abstract 

Due to the lack of an appropriate placebo, the general scientific community has questioned studies on the effects of acupuncture. The double-blind placebo-controlled clinical trial is said to be the gold standard for showing that a treatment has a specific effect over placebo. But acupuncture treatments undoubtedly involve placebo effects. In order to aid the study of the effects of acupuncture and to give more credibility to acupuncture studies in the eyes of the general scientific community using evidence based medicine, a thoroughly tested double-blind placebo for acupuncture needs to be developed. Investigations on a sham endermic acupuncture needle were performed. Experienced subjects were tested for an ability to distinguish real acupuncture from sham acupuncture in appearance and skin sensation. From receiving real or sham acupuncture treatment, experienced subjects from the public correctly identified 55.8% of treatments from appearance and 56.7% from skin sensation. Acupuncturists identified 45% of treatments from appearance and 55% from skin sensation. When experienced subjects of acupuncture treatment from the public received both real and sham treatment side-by-side in each hand, they were able to identify 60% with appearance and sensation and 66.7% with only skin sensation. It is possible that this sham acupuncture could be used as the placebo for further research on the effects of acupuncture.

Key Words:  double blind , placebo acupuncture needle , random allocation , real acupuncture , sham acupuncture , single blind

 

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1. Introduction 

Since the inception of clinical research into acupuncture, the dilemma of how to create an appropriate placebo has hindered progress. There has been no good method of managing all confounding variables, particularly the implementation of a double-blind protocol into experiments. Thus far, research on the effects of acupuncture have used no proven methods of achieving a double-blind study and have been either single-blind or without any blinding. Research on medical drugs has been advancing strongly as a placebo is very easy to implement, however acupuncture treatment holds a unique position in the medical research community, in that most believe that it cannot be administered in a way in which both acupuncturist and subject do not know whether the subject is receiving real or sham treatment. This study was designed to test an instrument invented by the author to prove whether or not it has an effect like that of a placebo pill in medical drug research.

The subject receiving the placebo treatment should believe that they are receiving the real treatment [1], which entails giving the treatment without actually performing any sort of legitimate operation but still being impossible to distinguish from the real treatment. Presently there are several sham acupuncture needles that have been invented. Some methods used for the placebo have included pricking the wrong positions [2, 3] which is out of the traditional acupuncture point or meridian and superficially stabbing at inappropriate acupoints without manipulation [4]. However, these minimal acupunctures are inadequate placebos because they can have physiological effects [5, 6] such as Diffuse Noxious Inhibitory Controls on the patient. Sham transcutaneous electrical nerve stimulation [7, 8], sham tablets [9] and inoperative laser acupuncture [10] have been used as control groups, however their effects cannot be appropriately identified as truly a placebo effect [11] as afterwards the participants were comparing their treatment to the real acupuncture group and finding differences causing non-placebo psychological effects. Another inadequate method for the placebo was to simply poke the subject with the fingernail [12], without breaking the skin, and then tell them that they were receiving real acupuncture treatment. Another attempted method was only stimulating with the acupuncture pipe [13] on the skin and lightly pricking with a real acupuncture needle on the superficial skin [14]. One method was to only let the acupuncture needle enter to the plastic stopple at the edge of the acupuncture pipe [15] and because the edge of the needle was flat, it did not puncture the skin but only pressed it [16]. In addition, Streitberg's method was designed using a blunted needle inserted into a prop to give the appearance that acupuncture was being administered through the skin when it was not [17]. By using this method for a placebo in an experiment on the clinical treatment of rotator cuff tendonitis, results were acquired favoring real acupuncture over sham acupuncture [18]. However, the key problem with these results was that the experiment did not successfully achieve a double blind design because the acupuncturist knows about the sham acupuncture needle.

Endermic acupuncture is pertinent to the search for an acupuncture placebo because its small needle and patch are easy to imitate. Kim Sham Acupuncture (Figure 1, Figure 2) uses an endermic acupuncture needle with a blunt tip that cannot pierce the skin to induce a medical effect but can also not be easily identified by acupuncturists or experienced subjects of acupuncture treatment, either from examining it or feeling it on the skin. The author wanted to see if this Kim Sham Acupuncture could be properly utilized as a placebo, for the scientific benefit of the many frequent patients who partake in the acupuncture culture, by using a patch that feels similar to real endermic acupuncture, but does not actually puncture the skin because of its stumpy shape that feels a bit sore when pressed. To investigate the possibility of the application of sham acupuncture, we examined how well subjects who are accustomed to acupuncture treatment could distinguish real acupuncture from sham acupuncture.

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2. Methods 

2.1. Participants 

Prior to participating in the study, subjects were given a consent form. Subjects were selected for being familiar with receiving acupuncture treatment and included hospital patients, acupuncture assistants and acupuncturists working at the Hospital of Korean Medicine at Won Kwang University in South Korea. The study targeted 220 people who agreed to participate. Among those 220 people, 40 were acupuncturists, 180 were from the public, 81 were male and 139 were female. Their age ranged from 17 to 84 with the average age being 44.9 years old.

2.2. Real acupuncture needle 

Real acupuncture uses the type T endermic acupuncture needle which is for clinical use with the public and is 0.2 mm thick, 1.5 mm long with a circle of the needle 2 mm in diameter attaching the needle to the patch. The specific Type T model is the H-607, named after the Haelim Seowon Medical Company that manufactures them in South Korea.

2.3. Sham acupuncture needle 

Kim Sham Acupuncture needles use the exact same manufacturing machines as the real type T H-607′s and are made to the exact same dimensions. The only difference is that the sham acupuncture needle tip is not sharpened but perfectly flat. The patch consists of 3 layers, with the first and second film layer securing the needle to the patch and the third layer possessing the adhesive that attaches the needle to the patient's skin. The needle is still 1.5 mm long and is secured to the patch to make a vertical 90° contact with the skin.

2.4. Procedure details 

Group A: The first 60 of the subjects drawn from the public (no acupuncturists) and 20 of the acupuncturists were randomly allocated by a computer and were shown real or sham acupuncture. After judging the needles, real or sham, they were then treated with the needles in the LI4 acupoint and asked again (Table 1).

Table 1. Results from the public and acupuncturists in correctly distinguishing real and sham acupuncture treatment
Order of exposure Group AGroup B
Level of experiencePublic (n =60)Acupuncturists (n =20)p*Public (n =60)Acupuncturists (n =20)p*
From appearance63.3%25.0%0.003†48.3%65.5%0.196
From sensation50.0%45.0%0.69863.3%65.0%0.893

* Pearson chi-square test between the rates of correct identification by those who received real treatment and those who received sham treatment in the given groups (public and acupuncturists);

† statistically significant.

Group B: The second 60 subjects from the public and 20 more acupuncturists were then randomly allocated to receive real or sham acupuncture treatment in the LI4 acupoint and then asked to judge whether the treatment was real or sham. After judging the treatment they were then shown the needles and asked again (Table 1). The difference between Group A and Group B investigated whether subjects thought the needle was real or sham when they were shown it before and after acupuncture treatment.

Group C: The final 60 subjects drawn from the public were randomly allocated, shown real and sham acupuncture in the same double-blind method as the other groups to their left and right hands in varying orders, always in the LI4 acupoint. Thirty were randomly chosen to be shown the needle first, and the other 30 never saw the needle. After receiving treatment in both hands, the acupuncturist asked the subjects which hand received the real acupuncture. Whether the needle was placed on the right or the left hand was randomized to eliminate potential bias. The spread of the conditions of Group C were: (C-1) right-real-left-sham, (C-2) right-sham-left-real, (C-3) left-real-right-sham and (C-4) left-sham-right-real, all given to 15 participants. Those who could not distinguish between the two needles after treatment were recorded as “wrong answers” (Table 2).

Table 2. Results of Group C where each patient received two treatments: one sham and one real (n =60)
Rate of correct identification for those who were shown the needle and then treated (n = 30)Rate of identification for those who were only treated with each (n =30)p*
60%66.7%0.592

* p values are from a Pearson's Chi-squared test.

2.5. Blind acupuncture performer 

All treatments were performed by one acupuncturist who was blinded to the patch and the discrete needle, while one clinical researcher used a computer to give the acupuncturist randomized real and sham needles.

2.6. Statistics 

The analysis of the data used SPSS 10.0 for Microsoft Windows and the analysis of the statistics were done with a chi-square test which produced a statistically significant result at the p < 0.05 level.

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3. Results 

The first set from the public (n = 60) was able to correctly identify whether the needle was real or sham from appearance 63.3% of the time and then after receiving treatment to the LI4 acupoint were able to correctly identify their needle 50% of the time. The first set of acupuncturists (n = 20) was able to correctly identify whether the needle was real or sham from appearance 25% of the time and then after receiving treatment they could distinguish properly 45% of the time. After doing statistical tests between the judgment derived from the needle's appearance of regular patients and acupuncturists it was found that there was a significant difference favoring the judgment of the patients over the acupuncturists. However, from the feeling of the treatment there was no statistically significant difference even though the public had a higher statistic.

Because there is the possibility that the subjects' answer to whether they thought the needle was real or sham when they were shown it may have had an effect on their answer after they were treated, the second set of 60 patients and 20 acupuncturists would receive acupuncture first and then be shown it. The second set of 60 patients correctly identified whether their treatment was real or sham 63.3% of the time and then when shown the needle were able to correctly identify it 48.3% of the time. The second group of 20 acupuncturists was able to properly distinguish between the real and sham treatment 65% of the time and when shown the needles they were still able to identify the needles 65.5% of the time. The public and the acupuncturists were not found to have a statistically significant difference in their abilities to judge whether the needle was real or sham from both the treatment and the appearance.

While the first two parts of the experiment involved acupuncture being performed on the LI4 acupoint located on the hand, the final part would examine the possibilities between the differences of judgment between real and sham acupuncture when administered side-by-side to the LI4 acupoint on the left and right hand. The possibility of an increased ability for patients to distinguish between real and sham needles when compared side-by-side made an examination of this variable relevant. To minimize any variability caused by which hand received real or sham acupuncture, and in which order, the final group of 60 subjects from the public were randomly allocated evenly into right-real-left-sham, right-sham-left-real, left-real-right-sham and left-sham-right-real treatments. After they were assigned to the 4 treatments, 30 of them were randomly selected to be shown the real and sham needle side-by-side and then treated with their allocated method. These subjects correctly identified the needles 66.7% of the time. The other 30 were simply treated in their hands and then asked to judge which needle was real and which was sham. These subjects correctly identified the needles 60% of the time. There was no statistically significant difference in judgment between those who were shown the needles and those who were not.

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4. Discussion 

Modern acupuncture needles evolved from the healing stone needles, an ancient form of acupuncture started in East Asia.

It stemmed into classical acupuncture theory working through the intradermal acupoint. The acupuncture treatment adjusts the patient's Yin & Yang condition, activates their meridian and its branches, and makes their Qi energy and blood flow smoothly. While the clinical research of acupuncture is proceeding, in order to really prove the effects of acupuncture, the scientific community needs to create a control group with a plausible effect.

The author came to believe that one could create a type of sham acupuncture that would be identical to real acupuncture in structure, color and form but not break the skin because its edge, while appearing virtually identical to the real needle, is in fact stumpy. Because this sham acupuncture might be the best placebo for clinical studies on the effects of acupuncture, these experiments were performed on patients from the public with experience receiving acupuncture treatment, in addition to skilled acupuncturists with the type of sham acupuncture now known as Kim Sham Acupuncture, which is based on type T acupuncture. Type T acupuncture was ideally suited to be modified into a sham counterpart because its small needle (0.2 mm thick and 1.5 mm long) attached to plaster has a similar appearance to the stumpy needle and so perhaps the psychological effects might be the same because it is difficult for the performer and the patient to tell the difference before or during treatment. In the 2003 edition of Lee's paper [19], the placebo needles were manufactured type T needles that Lee cut down to 1 mm with scissors. This method however caused problems with irregularly shaped needles, some of which may have actually punctured the skin like a real needle. Kim Sham Acupuncture avoids this by using standardized mechanical manufacturing methods that create needles with the same length as real needles and that have edges that will not puncture the skin. In 2004, Menjo tried to test the possibility of a double blind for a sham 0.6 mm dermal acupuncture needle at the 1st J-K Workshop meeting in Chiba, Japan. This acupuncture needle is shorter than the mean depth (1.5 mm) of the adult dermis. It is very difficult to really prove the effects of acupuncture because the same real needle can't successfully stimulate the skin. Kim Sham Acupuncture avoids this problem by using 1.5 mm long needles. These experiments were also not successfully implemented in a double-blind manner. Kim Sham Acupuncture is the result of the combination of the use of an iron needle to perform subcutaneous stimulation and maintained acupuncture fixed to the skin with a form evolved from classical slight acupuncture to modern short acupuncture. Generally, during normal acupuncture, the acupoint is selected for its corresponding internal organ or for being a tender point, Posterior Referred Point, Limb Referred Point, or Ear Point chosen by meridian theory and the adaptation range is largely applied to chronic internal organ diseases and chronic multiple pains. Kim Sham Acupuncture gains several advantages from imitating endermic acupuncture. The simplicity of the puncturing method, the length of treatment (needles remain in for 2 to 3 days), and the uniformity of hand technique that causes standardization of procedure all make Kim Sham Acupuncture ideal for research into the effect of endermic acupuncture on pain.

In this study, regardless of whether the subject is an acupuncturist or a regular acupuncture patient, the order in which real and sham acupuncture are performed, or the exposure to the needle's appearance, the subjects' ability to distinguish between Kim Sham Acupuncture and real endermic acupuncture was never greater than 70%. Some sources of potential uncontained variability do pose problems. For example, the members of the public who were selected as having experience with acupuncture did not necessarily have experience with endermic acupuncture but with acupuncture treatment in general. This causes a potential problem as some patients actually did have experience with endermic acupuncture creating two groups that may differ in ability to judge endermic acupuncture in particular. However, it should be considered that Kim Sham Acupuncture could be used as an effective double-blind placebo group for future clinical research into the efficacy of acupuncture treatment.

Even with the results of this experiment, further research into the sensitivity of other acupoints around the body should be considered in order to see if Kim Sham Acupuncture really makes for an appropriate placebo group. Also further research should be considered into the physiological effects and the possibility of stimulation by the sham acupuncture even though it is not able to pierce through the skin.

In order to successfully research the effects of acupuncture, an effective double-blind control group will be needed in order to rule out that any change in health was due to the natural progress of the disease, the mutual belief between the patient and the acupuncturist, the attitude or expectation of the patient towards the acupuncture, or the expectation of success by the performer, but instead that recognizable health improvements were due to the real effect of acupuncture treatment.

In conclusion, examining the results of this experiment, the acupuncturists were unable to distinguish between real and sham acupuncture treatment from either appearance or sensation. It also may be inferred that the general public cannot distinguish from the sensation of the needle whether it was real or sham acupuncture treatment and that this may indicate that Kim Sham Acupuncture could be applied to the double-blind clinical study on the effects of acupuncture.

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Acknowledgments 

This study was supported by the Korea Institute of Oriental Medicine and the Won Institute of Graduate Studies in Philadelphia. The author wishes to thank Dr. Yuki Menjo for help in obtaining good information on double blind needles and also thanks Sunmi Choi, Dr. Mitchell B. Krause, Bokin Kim, Lynn Mitchell and Dr. Dajie Wang for their valuable time and cooperation in this long investigation.

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PII: S2005-2901(09)60005-4

doi:10.1016/S2005-2901(09)60005-4

Journal of Acupuncture and Meridian Studies
Volume 1, Issue 1 , Pages 36-41, September 2008

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