Aldo Liguori, MD1-2; Jacob Juel, MD3; Stefano Liguori, MD1; MassimilianoValeriani, MD, PhD4, Carina Graversen, MSc, PhD3;Søren S. Olesen, MD, PhD3; Asbjørn M. Drewes, MD, PhD, DMSc3-4

1Istituto Paracelso, Rome, Italy; 2Department of Anatomic, Histologic, Forensic Medicine and Locomotor System Sciences, Faculty of Pharmacy and Medicine, Sapienza University;3Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; 4Department of Neurology, Paediatric Hospital Bambino Gesù, Rome, Italy;  4Center for Sensory-Motor Interaction, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark

Objective. Acupuncture is increasingly used as an alternative to medical therapy for various pain conditions. To studythe effect of acupuncture in experimental and clinicalstudies, a control condition with sham acupuncture isneeded. However, as such models have not been establishedin assessment of acupuncture effect against visceral pain,this study aimed to validate a new method for blinded shamacupuncture in experimental rectal pain.

Materials and methods. Fifteen subjects underwent a sequence of eithersham or real acupuncture in randomized order. In the shamarm, a hollow inner tube with a sharp tip was fitted into anouter tube and subjects were blinded to the stimulations.Before and after the intervention, pain was induced by rectalstimulation with an inflatable balloon distended until thesubjects’ pain threshold was reached. The resting electroencephalogram (EEG) was quantified by spectral power analysisto explore the central nervous system effects objectively.Additionally, after the second study day, the subject wasasked to indicate the sequence of interventions.

Results. A significant increase in rectal balloon volume wasobserved after sham 12±21 mL (P=0.049) and real acupuncture17±30 mL (P=0.046). However, the change in volume wasnot different between groups (P = 0.6). No differences in EEGspectral power distributions between sham and real acupuncturewere seen (all P>0.6). The correct sequence of sham andacupuncture was indicated by 36% of the subjects (P=0.4).

Conclusions. The presented sham procedure provides avalid method for blinding of “sham acupuncture” and maybe used in future blinded controlled trials of acupuncture forvisceral pain.

Key Words: acupuncture, sham-controlled, sham acupuncture, experimental visceral pain, abdominal pain, EEG,spectral power analysis.

假针灸控制实验性内脏痛的新方法——随机单盲研究

奥尔多利古力医学博士，雅各布尤尔医学博士，斯蒂法诺医学博士，马西米利亚诺·瓦列里安尼医学博士，卡瑞娜格拉弗森理学硕士、博士，索伦S·奥尔森医学博士，豪格M.德鲁斯医学博士

目的：目前，针灸越来越多地被用来替代治疗各种疼痛的药物。 为了研究针灸在实验和临床研究中的作用，我们需要假针刺的对照条件。 然而，由于这种模型尚未建立针灸内脏痛的评估方法，本研究旨在验证盲法假针灸治疗实验性直肠痛的新方法。

材料和方法：15名受试者按照随机顺序进行假针灸或真针灸。在假手臂中，将具有尖锐尖端的中空内管装入外管中，受试者对刺激不知情。 在干预之前和之后，直肠刺激引起疼痛，是由可膨胀球囊膨胀引起，并扩张直至达到受试者的疼痛阈值。通过光谱功率分析对静息脑电图（EEG）进行量化分析，客观地探究中枢神经系统的效应。此外，在研究的二天后，我们要求受试者指出干预的顺序。

结果：假针灸12±21 mL（P = 0.049）和真针灸17±30 mL（P = 0.046）后观察到直肠球囊体积明显增加。但是，各组之间的体积变化没有差异（P = 0.6）。在假针灸与真针灸之间，脑电光谱功率分布没有差异（所有P> 0.6）。36％的受试者指出了假针灸的正确顺序（P = 0.4）。

结论：我们所提出的假疗法为“假针灸”的盲法提供了一种有效的方法，并可用于未来对针灸内脏疼痛的盲法对照试验。

关键词：针灸，假对照实验，假针灸，实验性内脏痛，腹痛，脑电图，光谱功率分析