Dr. P. Rosted – M.D.
The main criticism in all acupuncture studies is the lack of, or insufficient placebo procedures. Unfortunately, no Gold Standard for placebo procedures exist in acupuncture. Many different attempts have been made but the different techniques have never been assessed against one another or against a standard procedure. Moreover a substantial number of techniques have been invasive.
The aim of this study is to compare the credibility of different placebo procedures with a standard procedure (superficial needling) and subsequent, on the basis of the results of this study, recommend the most credible placebo procedures as standard for future RCT involving acupuncture.
160 randomly selected patients who previously had tried acupuncture treatment took part in the study. Patients who were unable to to-operate due to age or patients where the selected point could have an inlluence on their treatment were excluded.
The patients were informed that a new technique was investigated where needles were inserted superficially on the back of the legs in either an acupuncture point or in a non acupuncture point. Moreover the patients were informed, that the stimulation might be a real stimulation on both sides, a real stimulation on one side and a placebo stimulation on the other side, or placebo stimulation on both sides. As reference for all tests, superficial needling was used in acupuncture point BL-57. The needles were inserted simultaneously on both sides. Hwato disposable stainless steel needles 0.30×30 mm in a guide tube were used. To investigate the variability between the individual techniques, the three most reliable techniques were tested against themselves.
The following test procedures were carried out: Superficial needling in a non acupuncture point, Blunt end of a needle technique, Guide tube technique, Cocktail stick technique and Cocktail stick in a guide tube technique.
After inserting of the needles the patients were asked the following questions:
1) Were you able to spot any difference between the stimulation on your right and on your left leg?
2) Do you believe the stimulation on your left/right side was:
a) A real stimulation,
b) A placebo stimulation
c) Are you unable to tell
Were the patient able to spot a difference?
|Reference stimulation||Test stimulation||Yes||No|
|Superficial acupuncture on an acupuncture site||Superficial acupuncture on a non acupuncture site||10||10|
|Superficial acupuncture on an acupuncture site||Blunt end of a needle technique||17||3|
|Superficial acupuncture on an acupuncture site||Guide tube technique||17||3|
|Superficial acupuncture on an acupuncture site||Cocktail stick technique||13||7|
|Superficial acupuncture on an acupuncture site||Cocktail stick and guide tube technique||12||8|
|Superficial acupuncture on an acupuncture site||Superficial acupuncture on an acupuncture site||9||11|
|Superficial acupuncture on a non acupuncture site||Superficial acupuncture on a non acupuncture site||11||9|
|Cocktail stick and guide tube technique||Cocktail stick and guide tube technique||8||12|
It appeals from this study that a cocktail stick in a guide tube is the most credible placebo procedure and I will propose that standards for acupuncture studies should include three arms.
1. A normal deep needling
2. A superficial needling in either an acupuncture site or a non acupuncture site.
3. A cocktail stick in a guide tube in either an acupuncture site or a non acupuncture site.
By using this model we are able to apply a real non invasive placebo procedure and I will propose this model as standard procedure for research in the future involving acupuncture.