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

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.