Over its history, medicine has vacillated between acknowledging placebo effects as important and trying to overcome them. Placebos are controversial, in part, because they appear to challenge a ...biocentric view of the scientific basis of medical practice. At the very least, research should distinguish between the effects of placebos on subjective and objective endpoints. Theoretically, placebos are of interest because they underscore the other side of the mind-body problem: how mental states can affect physical conditions.
Placebos being prescribed with full honesty and disclosure (i.e., open-label placebo OLP) have been shown to reduce symptom burden in a variety of conditions. With regard to allergic rhinitis, ...previous research provided inconclusive evidence for the effects of OLP, possibly related to a separate focus on either symptom severity or symptom frequency. Overcoming this limitation of previous research, the present study aimed to examine the effects of OLP on both the severity and frequency of allergic symptoms.
In a randomized-controlled trial, patients with allergic rhinitis ( N = 74) were randomized to OLP or treatment as usual (TAU). Because of the COVID-19 pandemic, OLP was administered remotely in a virtual clinical encounter. Participants took placebo tablets for 14 days. The primary outcomes were the severity and frequency of allergic symptoms. The secondary end point was allergy-related impairment.
OLP did not significantly improve symptom severity over TAU ( F (1,71) = 3.280, p = .074, η2 = 0.044) but did reduce symptom frequency ( F (1,71) = 7.272, p = .009, η2 = 0.093) and allergy-related impairment more than TAU ( F (1,71) = 6.445, p = .013, η2 = 0.083), reflecting medium to large effects. The use of other antiallergic medication did not influence the results.
Although OLP was able to lower the frequency of allergic symptoms and allergy-related impairment substantially, its effects on symptom severity were weaker. The remote provision of OLP suggests that physical contact between patients and providers might not be necessary for OLP to work.
Placebo Effects in Medicine Kaptchuk, Ted J; Miller, Franklin G
The New England journal of medicine,
07/2015, Letnik:
373, Številka:
1
Journal Article
Recenzirano
Research has revealed placebo effects to be genuine biopsychosocial phenomena representing more than simply spontaneous remission or normal symptom fluctuations. How can this understanding be used to ...benefit patients?
Placebo effects are often considered the effects of an “inert substance,” but that characterization is misleading. In a broad sense, placebo effects are improvements in patients' symptoms that are attributable to their participation in the therapeutic encounter, with its rituals, symbols, and interactions. These effects are distinct from those of discrete therapies and are precipitated by the contextual or environmental cues that surround medical interventions, both those that are fake and lacking in inherent therapeutic power and those with demonstrated efficacy. This diverse collection of signs and behaviors includes identifiable health care paraphernalia and settings, emotional and cognitive engagement with . . .
To evaluate the efficacy of adalimumab in the healing of draining fistulas in patients with active Crohn's disease (CD).
A phase III, multicentre, randomised, double-blind, placebo controlled study ...with an open-label extension was conducted in 92 sites.
A subgroup of adults with moderate to severely active CD (CD activity index 220-450) for >or=4 months who had draining fistulas at baseline.
All patients received initial open-label adalimumab induction therapy (80 mg/40 mg at weeks 0/2). At week 4, all patients were randomly assigned to receive double-blind placebo or adalimumab 40 mg every other week or weekly to week 56 (irrespective of fistula status). Patients completing week 56 of therapy were then eligible to enroll in an open-label extension.
Complete fistula healing/closure (assessed at every visit) was defined as no drainage, either spontaneous or with gentle compression.
Of 854 patients enrolled, 117 had draining fistulas at both screening and baseline (70 randomly assigned to adalimumab and 47 to placebo). The mean number of draining fistulas per day was significantly decreased in adalimumab-treated patients compared with placebo-treated patients during the double-blind treatment period. Of all patients with healed fistulas at week 56 (both adalimumab and placebo groups), 90% (28/31) maintained healing following 1 year of open-label adalimumab therapy (observed analysis).
In patients with active CD, adalimumab therapy was more effective than placebo for inducing fistula healing. Complete fistula healing was sustained for up to 2 years by most patients in an open-label extension trial.
Placebo effect refers to beneficial changes induced by the use of inert treatment, such as placebo-induced relief of physical pain and attenuation of negative affect. To date,we know little about ...whether placebo treatment could facilitate social functioning, a crucial aspect for well-being of a social species. In the present study, we develop and validate a paradigm to induce placebo effects on social trust and approach behavior (social placebo effect), and show robust evidence that placebo treatment promotes trust in others and increases preference for a closer interpersonal distance. We further examine placebo effects in real-life social interaction and show that placebo treatment makes single, but not pair-bonded, males keep closer to an attractive first-met female and perceive less social anxiety in the female. Finally,we show evidence that the effects of placebo treatment on social trust and approach behavior can be as strong as the effect of intranasal administration of oxytocin, a neuropeptide known for its function in facilitating social cognition and behavior. The finding of the social placebo effect extends our understanding of placebo effects on improvement of physical, mental, and social well-being and suggests clinical potentials in the treatment of social dysfunction.
Painkiller administration lowers pain empathy, but whether this also reduces prosocial behavior is unknown. In this preregistered study, we investigated whether inducing analgesia through a placebo ...painkiller reduced effortful helping. When given the opportunity to reduce the pain of another person, individuals experiencing placebo analgesia (n = 45 adults from Austria; 21 male, 24 female) made fewer prosocial choices at the lowest helping level and exerted less physical effort when helping, compared with controls whose pain sensitivity was unaltered (n = 45; 21 male, 24 female). Self-reported empathic unpleasantness positively correlated with prosocial choices across the whole sample. While not replicating group differences in empathy, a mediation analysis revealed that the level of unpleasantness to other people’s pain fully mediated the effect of placebo analgesia on prosocial choices. Given the importance of prosociality for social cohesion, these findings have broad potential implications both for individuals under the influence of painkillers and for society at large.
The doctor‐patient relationship is built on an implicit covenant of trust, yet it was not until the post‐World War Two era that respect for patient autonomy emerged as an article of mainstream ...medical ethics. Unlike their medical forebears, physicians today are expected to furnish patients with adequate information about diagnoses, prognoses and treatments. Against these dicta there has been ongoing debate over whether placebos pose a threat to patient autonomy. A key premise underlying medical ethics discussion is the notion that the placebo effect necessitates patient deception. Indeed, the American Medical Association guidelines imply that placebo treatment necessary entails a form of deception. As a consequence of this assumption, the fulcrum of debate on the use of placebo treatment has hinged on whether that deception is ever justified. Recently performed experiments with open‐label transparently prescribed placebos have begun to challenge the notion that deception is necessary in eliciting the placebo effect and such effects necessarily involve a binary distinction between autonomy and beneficence. In this article we focus on the content of disclosures in distinctive open‐label, transparently disclosed placebo studies and inquire whether they might be said to invoke deception in clinical contexts, and if so, whether the deception is unethical. We find that open placebos may be said to involve equivocation over how placebos work. However, drawing on surveys of patient attitudes we suggest that this equivocation appears to be acceptable to patients. We conclude that open placebos fulfil current American Medical Association guidelines for placebo use, and propose future research directions for harnessing the placebo effect ethically.
Open-label placebo (OLP) treatment seems to be effective in several medical conditions but has not yet been investigated in insomnia. Furthermore, it needs to be evaluated whether providing a ...plausible treatment rationale is essential to obtain OLP effects.
In two consecutive nights, the sleep of patients with primary insomnia (n = 45) was assessed via subjective and objective measures. Before the second night, they received a single OLP pill that was randomly provided either with a treatment rationale (OLP+) or without (OLP−). When (M)ANOVAs did not reveal differential effects between the two OLP groups, the OLP+ group was compared post-hoc to a formerly assessed no pill control sample (NPC; n = 23).
Neither the MANOVAs nor the ANOVAs revealed significant interaction effects of treatment group and assessment night. The OLP+ condition was superior neither to OLP− nor to NPC in improving the patients' sleep.
Our findings do neither confirm the general efficacy of OLP in primary insomnia nor differential effects depending on the treatment rationale. Possible explanations lie in the dosing scheme (i.e., single OLP application), the provision of the OLP rationale by video and the experimental instead of therapeutic character of our investigation. Trials with larger samples and longer-term OLP treatment in insomnia are needed. Providing the rationale face-to-face and in a clinical setting might be additionally beneficial.
•This is the first experimental trial of open-label placebo (OLP) in primary insomnia•OLP with a prerecorded treatment rationale did not improve the patients' sleep•Longer-term OLP treatment instead of a single application may be needed•Providing the rationale face-to-face and in a clinical setting may be beneficial
Passing the driving school test can be very challenging, especially in big cities, where up to 52% of all students fail this test. Consequently, many learner drivers experience stress and anxiety. ...For some learner drivers these feelings can be extreme and negatively affect the performance in the driving test. Different strategies to face anxiety and stress are known, including, for example, psychological or pharmacological approaches and even placebo pills. Recent intriguing findings have also demonstrated that placebos without deception, so-called open-label placebos, successfully reduce anxiety. Here we aimed to test effects of this novel treatment for learner drivers. We investigated whether open-label placebos affect test performance and feelings of anxiety in learner drivers. Sixty-eight healthy participants (mean age 21.94 years, 26 females) were randomized into two groups. The open-label placebo group received placebo pills two weeks before the driving test (two pills each day). The control group received no treatment. Results revealed that the open-label placebo group experienced significantly less anxiety than the control group before the test (measured with the State-Trait-Anxiety-Inventory, STAI-S, and the German Test Anxiety Inventory, PAF). Moreover, in the open-label placebo group less learner drivers failed the driving test (29.41% vs. 52.95%). The results suggest that open-label placebos may provide an ethical unproblematic way to experience less anxiety and might also enhance the probability to pass the driving test. We discuss possible mechanisms of open-label placebos and limitations of our findings.
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