Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Sep 2;11(9):e047099.
doi: 10.1136/bmjopen-2020-047099.

Expectation-induced enhancement of pain, itch and quality of life in psoriasis patients: study protocol of a randomised controlled trial

Stefanie Hölsken  1 , Frederik Krefting  2 , Manfred Schedlowski  1   3 , Wiebke Sondermann  4
Affiliations

Expectation-induced enhancement of pain, itch and quality of life in psoriasis patients: study protocol of a randomised controlled trial

Stefanie Hölsken et al. BMJ Open. .

Abstract

Introduction: Experimental and clinical data demonstrate that skin diseases like psoriasis are affected by psychological factors and can be modulated by interventions other than conventional drug therapy. The expectation of patients towards the benefit of a forthcoming treatment as well as treatment pre-experiences have been demonstrated as crucial factors mediating placebo responses in inflammatory skin diseases. However, it is unknown whether and to what extent treatment outcomes of psoriasis patients under therapy with monoclonal antibodies like secukinumab can be experimentally modulated at subjective and physiological levels by modifying the expectation of patients via verbal instruction or prior experience.

Methods and analysis: Treatment expectations will be modulated in patients with moderate-to-severe psoriasis undergoing treatment with the anti-interleukin-17A monoclonal antibody secukinumab. Patients with a Psoriasis Area and Severity Index (PASI) >12 will be randomly allocated to one of three groups (N=40 each). As a standard schedule, patients in the pharmacological control group (group 1) will be treated weekly with 300 mg secukinumab, while patients in groups 2 and 3 will receive only 75 mg secukinumab (75% dose reduction) during all treatment weeks. In addition to the injections, patients in group 3 will ingest a novel tasting drink, with a cover story explaining that previous studies showed additional beneficial effects of this combination (drug and drink). Patients will be assessed and treated at nine visits over a 16-week period, during which the severity of pain and itch symptoms, skin lesions and quality of life will be analysed with standardised questionnaires and the PASI.

Ethics and dissemination: This study was approved by the Ethics committee of the Medical Faculty of the University Duisburg-Essen. Study outcomes will be published in peer-reviewed scientific journals.

Keywords: dermatology; immunology; neurobiology; psoriasis.

PubMed Disclaimer

Conflict of interest statement

Competing interests: WS reports grants from medi Bayreuth, personal fees from Janssen, grants and personal fees from Novartis, personal fees from Lilly UCB, Almirall, LEO Pharma and Sanofi Genzyme, outside the submitted work. The other authors declare that they have no competing interests.

Figures

Figure 1
Figure 1
Schedule of enrolment, interventions and assessments. Adapted from the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 template.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Schedlowski M, Enck P, Rief W, et al. . Neuro-Bio-Behavioral mechanisms of placebo and nocebo responses: implications for clinical trials and clinical practice. Pharmacol Rev 2015;67:697–730. 10.1124/pr.114.009423 - DOI - PubMed
    1. Benedetti F. Placebo effects: from the neurobiological paradigm to translational implications. Neuron 2014;84:623–37. 10.1016/j.neuron.2014.10.023 - DOI - PubMed
    1. Ashar YK, Chang LJ, Wager TD. Brain mechanisms of the placebo effect: an affective appraisal account. Annu Rev Clin Psychol 2017;13:73–98. 10.1146/annurev-clinpsy-021815-093015 - DOI - PubMed
    1. Colloca L, Benedetti F. Placebos and painkillers: is mind as real as matter? Nat Rev Neurosci 2005;6:545–52. 10.1038/nrn1705 - DOI - PubMed
    1. Bingel U, Wanigasekera V, Wiech K, et al. . The effect of treatment expectation on drug efficacy: imaging the analgesic benefit of the opioid remifentanil. Sci Transl Med 2011;3:70ra14. 10.1126/scitranslmed.3001244 - DOI - PubMed

Publication types