Non-penetrating sham needle – is it an adequate sham control for acupuncture research in Korean people?

Lee HS^1,2, Park J^2,3, Shim SY¹, Kim YJ¹, Lee JM¹, Lee H^2,4, Park HJ^2,4

¹College of Korean Medicine, Sangji University, Wonju, South Korea

²Acupuncture and Meridian Science Research Centre, Kyung Hee University, Seoul, South Korea

³Osher Institute, Harvard Medical School, Boston, USA

⁴College of Korean Medicine, Kyung Hee University, Seoul, South Korea

Objective

A newly developed non-penetrating sham needle was validated as an adequate sham control in English subjects, but is still to be assessed in other cultural population. This study aimed at assessing whether a non-penetrating sham needle is an adequate sham in Korean subjects.

Materials and methods

We conducted a randomised, subject-blind, sham controlled trial in both acupuncture-naïve and experienced healthy volunteers. Subjects were randomly allocated either to receive real acupuncture (n = 39) or non-penetrating sham acupuncture using the Park Sham Device (n = 40) at the hand (LI 4), abdomen (CV 12) and leg (ST 36) at the same time. The needles were left in place for 20 min after insertion, during which manipulation to elicit de qi sensation was performed for 30 s with a real needle or mimicking with a sham needle. Baseline data regarding age, gender, experience and knowledge of acupuncture were collected and analysed. Outcome measure was a 10-point scale of how they felt when they received acupuncture for items of acupuncture sensations. To assess the success of subject blinding, subjects were asked to guess which type of needle (real, sham or don’t know) they believed they were given for each acupuncture point.

Results

There was no significant difference between groups in age, gender, experience and knowledge of acupuncture. The sham needle produced significantly less penetrating (P = 0.002), hurting (P = 0.013) and soreness (P = 0.015) only at hand. The subjects discriminated real from sham at hand only (P = 0.05). People with more experience and knowledge of acupuncture were more likely to guess correctly the type of needle they received at leg (P = 0.021) but not at the other points.

Conclusion

Non-penetrating sham needles may produce a different needle sensation from real needles depending on acupuncture points, implying the need for a careful approach in their general use in clinical trials of acupuncture.

Acknowledgements

This study was partly supported by the SRC/ERC programme of MOST/KOSEF (R11-2005-014).

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