A long-standing point of contention to the validity of randomized, controlled acupuncture trials has been the inability of investigators to create and implement a true placebo, or "sham," acupuncture needle. The crux of this contention has been that patients know whether they are receiving acupuncture because they can see or feel a needle being inserted, which gives rise to the placebo effect and can skew the results of an otherwise sound study. A secondary point to this argument is that needles cause an effect on subjects whether being inserted at specific acupuncture points or not, and that this effect, though unintentional, may produce subjective data, lessening a study's credibility.
Over the years, scientists have tried various methods for mimicking the sensation of an acupuncture needle, including the sharp end of a pencil; a practitioner's fingernail; a needle guide tube - even the end of a cocktail swizzle stick - all without producing the desired effect. Researchers in Germany may have finally solved this problem with an experimental placebo needle used as part of a headache study, the results of which have been published in Forschende Komplement¼rmedizin und Klassiche Naturheilkunde (Research in Complementary and Classical Natural Medicine).1
Sixty-eight patients with a history of tension-type headache were chosen for the study. Half were assigned to an acupuncture group; the other half to a placebo group. Before being assigned, each patient was notified that they would receive one of two acupuncture treatments, and that it was not known which type was more effective. At the first treatment, patients were told that they might feel a pricking sensation from the needle, and that the de qi sensation could occur after the needle was inserted. Patients in the placebo group were further told that the needles would only be inserted gently and superficially, which would require the use of a small cube to keep them in place.
The placebo needle used in the study consisted of a real acupuncture needle (#16, 30 x 0.3 millimeters), with the tip removed and a new tip rounded off with a diamond polisher so as to touch, but not puncture, the skin. A cube-shaped block of sterilized foam was used as a holding device for the needle, with a ring of adhesive tape affixed to bottom of the foam to hold it in place on the skin. By inserting the needle through the foam, the view of the volunteers would be blocked such that they would not know whether the needle had actually penetrated the skin. In addition, once the needle touched the skin, it was gently twisted by the practitioner to enhance the illusion of treatment.
Patients in both groups received two treatments per week for five weeks, and received acupuncture bilaterally at the same points (GB20, LI4, LR3 and TW5). In the placebo group, needles were inserted, manipulated and left in place for 30 minutes, using a total of eight placebo needles per session. In the true acupuncture group, slightly different needles were used (#8, 0.3 x 0.3 millimeters or #2, 0.2 x 0.15 mm) and were also left in place for 30 minutes after insertion.
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