Preliminary remarks<\/strong><\/p>\n\n\n\n This text is rather academic. The train of thought is interesting for all.<\/p>\n\n\n\n This is not about empathy, but only about ‘the sugar pill that works.’<\/p>\n\n\n\n A much-cited definition of placebo<\/strong><\/p>\n\n\n\n from Shapiro and Shapiro: \u201cany therapy (or that component of any therapy) that is intentionally or knowingly used for its nonspecific, psychological, or psychophysiological, therapeutic effect, or that is used for a presumed specific therapeutic effect on a patient, symptom, or illness but is without specific activity for the condition being treated.\u201d [The powerful placebo: From ancient priest to modern physician<\/em>, 1997]<\/p>\n\n\n\n \u2018Open placebo\u2019 (or \u2018open-label placebo\u2019)<\/strong><\/p>\n\n\n\n is used as a concept to denote a placebo being given openly together with the information that it is a placebo towards, for example, the diminishment of pain. Open placebo research shows positive clinical effects in such situations. [see: 1 \u2192 5]<\/p>\n\n\n\n A truly open-label placebo (OLP) would be nice. We could straightforwardly use its power while being ethically safe and scientifically on solid ground.<\/p>\n\n\n\n However<\/strong><\/p>\n\n\n\n Please read [see: RG: \u201cFrom Placebo to \u2018Open-Label Placebo\u2019 to Open Altogether<\/a>\u201c]. Using the term \u2018placebo\u2019 doesn\u2019t necessarily make something a non-deceptive placebo. For example, if a subject in a study doesn\u2019t believe or fully understand the administrator of the \u2018placebo,\u2019 then \u2013 depending only on the subject \u2013 it can still be deceptive. [1]<\/p>\n\n\n\n A person may consciously believe something, yet non-consciously be confident of the opposite. In that case, his non-conscious belief will most frequently gain the upper hand. In OLP studies, the openness is at the conscious level, but the non-conscious level (the non-conscious belief, therefore) engenders the placebogenic outcome. [see RG: “The Placebo Effect: How the Subconscious Fits in<\/a>“]<\/p>\n\n\n\n Also notably, in a systematic review of five OLP studies, the four who used accompanying verbal instructions with suggestive wordings showed a positive result. The one study without suggestive instructions didn\u2019t. [2]<\/p>\n\n\n\n Who deceives whom?<\/strong><\/p>\n\n\n\n In OLP administration, nobody is really lying.<\/p>\n\n\n\n According to the conceptual definition of OLP, the truth is not being told to the study subjects at the non-conscious level. See the accompanying suggestions: “placebo effect is powerful; body can automatically respond; taking the pills faithfully is critical.” [2] These are no falsehoods by themselves, in isolation. Yet, in the specific setting, there is an implicit<\/em> deception involved behind the explicit<\/em> informative openness.<\/p>\n\n\n\n Is this enough for ethical purposes? Is non-conscious processing irrelevant to ethics? Is it not part of the total-person who \u2013 also legally \u2013 may be entitled to informed consent? Eventually, who (ego or total-person) should be informed, not being deceived?<\/p>\n\n\n\n In other words,<\/strong><\/p>\n\n\n\n in OLP, the make-belief lies in making the subjects believe that \u201calso in openness, it works.\u201d This is not the same, but the same kind of deception as with any placebo \u2015 only the object differs. In plain placebo, it\u2019s the pill; in OLP, it\u2019s the make-belief itself that functions as placebo.<\/p>\n\n\n\n In both cases, it\u2019s the patient or study subject who \u2018works,\u2019 more precisely not as an automaton but as a meaningful and meaning-processing being. [see: \u201cThe Non-Conscious is no Automaton<\/a>\u201d]<\/p>\n\n\n\n Is an open-label placebo ethically superior to a plain placebo?<\/strong><\/p>\n\n\n\n This is a profound question. One could utilize the answer to heighten the relevance of conscious versus non-conscious deception on many domains. This has to be taken well into consideration. Also, according to AMA guidelines of informed consent concerning placebo [4], this does not make OLP seem to conform. Patients do not give consent to the specific kind of deception involved.<\/p>\n\n\n\n It may be better not to use the term \u2018open-label placebo.\u2019 To me, anyway, it is a contradictio in terminis<\/em>, a conceptual non-possibility, yet an interesting one:<\/p>\n\n\n\n It shows the difficulty of accepting in-depth the human non-conscious.<\/strong><\/p>\n\n\n\n Talking about an \u2018open placebo effect\u2019<\/em> is one step in the right direction. Of course, there cannot literally be a \u2018placebo effect\u2019 without a placebo, but one can use the term to denote the actual effect of what is present using a placebo and may principally also be attained without the placebo.<\/p>\n\n\n\n