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

BACKGROUND: Several 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. METHODS: This 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. RESULTS: There 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. CONCLUSION: All 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 COMMITTEE: Federal University of Sergipe (UFS), number of approval: 47193015.5.0000.5546 TRIAL REGISTRATION: ensaiosclinicos.gov.br RBR-3w2p32 Registered in 28th January 2016.

Feasibility for Using Thermography Throughout an Exercise Program in Mastectomized Patients.

Introduction: Breast cancer is the most common in the female population. Physical training is safe and indicated after surgical treatment for breast cancer. During exercise, body temperature changes due to tissue metabolic activity; in this sense, infrared thermography is used to map the thermal patterns of the body surface. Objective: This study aimed to evaluate the feasibility of using thermography during a physical rehabilitation program in mastectomized patients by analyzing the change in body temperature caused by physical exercise in the breast region. Methodology: This is a simple and covert clinical trial, in which the sample was constituted for convenience. The women were submitted to a supervised physical exercise protocol, three times a week, for 20 sessions. They were evaluated in the first, tenth, and twentieth sessions in relation to changes in body temperature in the breast region (infrared thermography). Results: Twenty patients who underwent mastectomy surgery were recruited. No patient had drain infection, scar dehiscence, or lymphedema, and only one patient had seroma removed. The mean age was 50.45 ± 2.00 years, and the body mass index (BMI) was 28.95 ± 1.11 kg/m2. In the body thermography of the patients' breast region, no significant difference was observed when comparing the thermograms of the plastron region of the patients in the first, tenth, and twentieth sessions (p = 0.201). However, when comparing the plastron region with the control breast, a reduction in temperature was observed in the operated region in the first (p = 0.012) and tenth sessions (p = 0.004). Conclusion: Through this study, we can conclude that the use of infrared thermography is viable for the analysis of the body temperature of mastectomized patients during a supervised physical exercise protocol and, therefore, suggest that this instrument is increasingly used in the cancer public.