Abstract
Placebo effects are common in medicine. Randomised clinical trials help us to understand their magnitude in different therapies. There are particular problems with placebo effects in allergen immunotherapy (AIT) as it is difficult to blind the active treatment and the endpoints are largely subjective. This may explain why large placebo effects are often found in AIT trials. Patients receiving open label AIT get the benefit of the active and placebo components but it can be difficult to say how much benefit is due to the active component. The use of active placebos has been proposed but brings its own problems (ethical and scientific). An EAACI Task Force has been established to address these issues. Here we review the current literature on the placebo effect in general, with a special focus on AIT trials, and indicate what we believe to be important considerations and unmet needs in AIT trial design.
Highlights
Placebo effects are common in medicine and the underlying complex neuropharmacological and -anatomical mechanisms involved have mainly been investigated in the field of pain and Alzheimer’s disease [1]
The purpose of a current Task Force (TF) initiative is to review this phenomenon with a number of stakeholders in the field of allergen immunotherapy (AIT) comprising clinicians, methodologists, regulatory and patient representatives and to develop an EAACI Position Paper on this topic
The following review overviews the current literature on the placebo effect with a special focus on AIT trials, and indicates important considerations and unmet needs in the view of experts’ opinions
Summary
Placebo effects are common in medicine and the underlying complex neuropharmacological and -anatomical mechanisms involved have mainly been investigated in the field of pain and Alzheimer’s disease [1]. In trials on allergen immunotherapy (AIT) by both the sublingual (SLIT) and subcutaneous (SCIT) route, placebo effects of large magnitudes have been reported and several hypotheses for these effects have been suggested [3, 4]. Those factors undoubtedly have an important bearing on the design, execution and interpretation of results of clinical trials in AIT. The following review overviews the current literature on the placebo effect with a special focus on AIT trials, and indicates important considerations and unmet needs in the view of experts’ opinions
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