Druart Leo, Graham Longsworth SaraEve, Rolland Carole, Dolgopoloff Maïa, Terrisse Hugo, Bosson Jean-Luc, Pinsault Nicolas
Physiotherapy Department, University Grenoble Alpes, 38000 Grenoble, France.
Techniques pour l'Évaluation et la Modélisation des Actions de Santé (ThEMAS), Techniques de l'Ingénierie Médicale et de la Complexité (TIMC), Unité Mixte de Recherche (UMR), Centre National de la Recherche Scientifique (CNRS) 5525, Université Grenoble-Alpes, 38000 Grenoble, France.
Medicines (Basel). 2020 Jan 2;7(1):3. doi: 10.3390/medicines7010003.
Placebo has been studied for many years and is ever-present in healthcare. In clinical practice, its use is limited by ethical issues raised by the deception entailed by its administration. To investigate whether, when given detailed information about pain and underlying placebo mechanisms, subjects will have a response similar to that of those subjected to a procedure in which they receive a conventional placebo treatment. The study is designed as a non-inferiority randomized, parallel with a nested crossover trial. In addition, 126 subjects without any known pathology will be included. They will be randomized into two groups. Each subject will undergo three Cold Pressor Tests (CPT): calibration, condition of interest (deceptive placebo or educated placebo), and control. Our main judgment criterion will be the comparison in pain intensity experienced on the visual analog scale between the two CPTs with placebo conditions. This study will allow us to rule on the non-inferiority of an "educated" placebo compared to a deceptive placebo in the context of an acute painful stimulation. It is another step towards the understanding of open-label placebo and its use in clinical practice. This study has been approved by the ethics committee in France (2017-A01643-50) and registered on ClinicalTrials.gov (NCT03934138).
安慰剂已被研究多年，且在医疗保健中一直存在。在临床实践中，其使用受到给药时所涉及的欺骗行为引发的伦理问题的限制。为了研究当给予受试者关于疼痛和潜在安慰剂机制的详细信息时，他们的反应是否会与接受传统安慰剂治疗程序的受试者相似。该研究设计为非劣效性随机平行试验，并嵌套交叉试验。此外，将纳入126名无任何已知病理状况的受试者。他们将被随机分为两组。每个受试者将接受三次冷加压试验（CPT）：校准、感兴趣的条件（欺骗性安慰剂或知情安慰剂）和对照。我们的主要判断标准将是比较在两种安慰剂条件下的CPT中视觉模拟量表上所经历的疼痛强度。这项研究将使我们能够判定在急性疼痛刺激的背景下，“知情”安慰剂相对于欺骗性安慰剂的非劣效性。这是朝着理解开放标签安慰剂及其在临床实践中的应用迈出的又一步。这项研究已获得法国伦理委员会批准（2017 - A01643 - 50）并在ClinicalTrials.gov上注册（NCT03934138）。
