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Abstract Objective Given the findings of central effects of erenumab in the literature, we aimed to conduct a rigorous placebo-controlled, double-blind, randomized study to elucidate whether the observed changes are directly attributable to the drug. Methods We recruited 44 patients with migraine, randomly assigning them to either the erenumab 70 mg or the placebo group. 40 patients underwent fMRI scanning using a trigeminal nociceptive paradigm both, pre- and four weeks post-treatment. Participants kept a headache diary throughout the whole study period of two months in total. A clinical response was defined as a ≥30% reduction in headache frequency at follow-up. Details of this study have been preregistered in the open science framework: https://osf.io/ygf3t . Results Seven participants of the verum group (n=33.33%) and 4 of the placebo group (21.05%) experienced improvements in migraine activity, characterized by a minimum of 30% reduction in monthly headache frequency compared to baseline. The imaging data show an interaction between the verum medication and the response. Whilst numbers were too small for individual analyses (Verum vs. Placebo and Responder vs. Non-Responder), the variance-weighted analysis (Verum vs Placebo, scan before vs after weighted for response) revealed specific decrease in thalamic, opercular and putamen activity. Interpretation The central effects of erenumab could be reproduced in a placebo randomized design, further confirming its central role in migraine modulation. The mechanism, whether direct or secondary to peripheral mode of action, needs further exploration. It is important to note that the response rate to erenumab 70mg in this study was not as substantial as anticipated in 2019, when this study was planned. This resulted in a too small sample size for a subgroup analysis based on the responder status was associated with both the verum drug and the relative reduction in headache days.

In humans, placebo effect can be produced by giving verbal information and also by conditioning when, after repeated administration of an active substance, an inactive compound that just looks like the drug administered before, can produce the effect of the active substance. Conditioned placebo effect has been reported in rodents, however, the dog ( Canis familiaris ) may also provide a promising model species. In our study dogs’ behaviour was observed while they were repeatedly separated from their owners in the same unfamiliar room. First, subjects did not receive any pre-treatment (Baseline trial), then they participated in either of two different conditioning contexts: after having received either sedative drug (Conditioned group) or non-sedating vitamin (Control group) treatment, subjects participated in 3 conditioning trials on consecutive days. Finally, in the ‘Test trial’, both groups were separated from their owners after receiving placebo (non-sedating vitamin). Results show significant effect of the sedative drug conditioning; when comparing the change from Baseline to Test trials in the Conditioned and the Control groups, conditioned subjects showed less active signs of distress ( U (26) = 48, p = 0.021) and more passive behaviours ( U (26) = 50, p = 0.027). We also investigated the association between dogs’ susceptibility to conditioned placebo effect and their expectancy bias towards positive outcomes and found a positive correlation ( r (12) = 0.697, p = 0.008), suggesting that dogs with more positive expectations are more responsive to placebo treatment. Considering previous human findings about stronger responsiveness to placebo in optimistic people, our results support the validity of the application of a dog model towards a better understanding of some aspects of the placebo phenomena in humans. [ABSTRACT FROM AUTHOR]

The authors intend to examine the relationship between the use of pharmaceutical agents and non-drug alternatives to alter one or more biological processes within the brain. There exist several means, including music therapy, meditation, placebo, or the therapeutic context, and other environmental factors by which therapists may utilize the brain's intrinsic plasticity to influence mental health. This paper contains an exploration of the subjective effects, physiological changes, and specific brain mechanisms involved in music therapy, meditation, and placebo effects. The many neurotransmitter systems involved in neuropathology and the somatization of stress are explored in the context of non-drug therapies. This paper provides a brief introduction to "autointrinsogens"--endogenous chemicals working in synchrony to respond to environmental and mental state adaptations in ways similar to prescription chemical substances. Autointrinsogens have long been a fundamental component of patient response to therapy and recovery but until recently, scientific medicine has focused primarily on exogenous chemical means for treating mental disorders. Promoting further clinical and laboratory research will allow advances in clinically-relevant supplementation of autointrinsogens in patient care. [ABSTRACT FROM AUTHOR]

The author formulates the main topical theoretical issues of psychosomatics. It provides an overview of psychosomatogenesis models. It gives the hypothesis of the author about psycho-biological nature of cancer and mechanism of the placebo effect. It formulates a general model of psychosomatic work. It provides a brief overview of psychotherapeutic techniques used in the work with the somatic diseases, where the main attention is paid to the procedure and hypnotherapeutic techniques. Description of the author's techniques. It discusses the question of the integration of psychosomatics and somatic medicine.

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Copyright of Stimulus is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)