Comparison of the placebo effect between different non-penetrating acupuncture devices and real acupuncture in healthy subjects: a randomized clinical trial

Abstract

BackgroundSeveral studies have used placebo acupuncture methods in recent years as a way for blinding therapeutic effect of acupuncture, however placebo method selection has not followed enough methodological criteria to the point of stabilishing a consensus of what should be the best method to be used. This study aimed to evaluate the effectiveness of three different placebo acupuncture methods for blinding applied in healthy subjects.MethodsThis study was approved by the Ethics Committee of the Federal University of Sergipe with the number 47193015.5.0000.5546 and all individuals participating in the study signed a free and informed consent. For this study, 321 healthy volunteers were randomly divided into seven groups using the abdominal point stomach (ST) 25 and seven groups using the lumbar point bladder (Bl) 52 for stimulation. For real acupuncture procedure, three different methods of placebo acupuncture plus a mix between real acupuncture and placebo applied in the same individual, totaling fourteen groups in this study. Outcome assessments were performed before and immediately after applying the technique. Investigator who assessed variables had no knowledgement about the method was applied. Identification, weight and height were measured before puncture by using. At the end, subjects were asked if they believed they were receiving real or placebo acupuncture.ResultsThere was no significant difference between groups for the perception about the type o stimulation (wheter real or placebo puncture). Percentage of subjects who reported to have received real acupuncture in the abdominal point was 69.56% in real group, 86.95% in group Park Sham, 82.60% in needle + foam, 91.30% in insertion and removal, 78.26% in real + Park Sham, 86.36% in real + needle and foam, 86.95% in real + insertion and removal, and for the lumbar point was 86.36% in real group, 86.95% in group Park Sham, 69.56% in needle + foam, 72% in insertion and removal, 86.95% in real + Park Sham, 81.81% in real + needle and foam and 78.26% in real + insertion and removal.ConclusionAll placebo acupuncture methods proposed in this study were equally effective for bliding the study participants using either abdominal or lumbar acupoints, and none of the placebo methods presented benefit compared to the other to be used in future clinical trials.Ethics CommitteeFederal University of Sergipe (UFS), number of approval: 47193015.5.0000.5546Trial registrationensaiosclinicos.gov.br RBR-3w2p32 Registered in 28th January 2016.

Acupuncture versus sham acupuncture for simple obesity: a systematic review and meta-analysis

“…Previous systematic reviews indicated that acupuncture is a safe therapy for patients suffering from hypertension, primary dysmenorrhoea and even patients who take newer oral anticoagulants 37–40. But the effectiveness of acupuncture for obesity is controversial due to its lack of medical evidence, and some studies reported that acupuncture may be a placebo effect 41 42. Until now, there is no systematic review of acupuncture (without combining diet or exercise) versus sham acupuncture on the treatment of obesity.…”

Study on the Evaluation of Various Types of Sham Acupuncture Treatments in Hemiplegic Stroke Patients: The Protocol of a Randomized Clinical Trial

“…“ Discomfort Caused by Acupuncture Therapy ” Five Questions . On the basis of the results of a previous study [14] on sham acupuncture treatments in healthy individuals, five questions were used to evaluate the discomfort caused by acupuncture therapy. This questionnaire consists of questions on (1) the general perception of acupuncture, (2) discomfort at the moment of puncture, (3) the location of the feeling of puncture, (4) the intensity of discomfort, and (5) the duration of the puncture sensation.…”

“…In addition, there are other models using Streitberger's needle [11], a needle-foam device [12], and a toothpick [13]. Recently, the insertion and removal model [14] has also been introduced, which distinguishes between verum acupuncture and sham acupuncture, depending on the period of retention of the needle after skin penetration. Finally, the nonacupoint model [15], which focuses on nonacupoints, is also used for sham acupuncture in clinical studies, paying attention to the specificity of the effect on each acupoint.…”

“…In the background of the controversy related to the effects of verum acupuncture and sham acupuncture, which can be confirmed through the results of clinical research on various diseases, there is the question “Is the type of sham acupuncture used for each disease suitable for the patient with the disease?” Assessments of the various sham acupuncture treatments have already been conducted [14, 16]. However, these studies have definite limitations because they do not assess sham acupuncture in patients with a specific disease but in healthy individuals without disease.…”

The Construction of Sham Dry Needles and Their Validity

“…The subjects were also told that they would be asked the following three questions [ 12 ] after the procedure: (1) Did the needle puncture skin? (2) How painful is the penetration of the needle through the skin on a scale from 0 to 10, where 0 represents no pain and 10 the worst pain imaginable (numeric pain rating scale, NPRS[ 16 ])? (3) Is the needle pain sharp or dull?…”