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Nocebo effects and psychotropic drug action.
Expert Rev Clin Pharmacol. 2015 Mar; 8(2):159-61.ER

Abstract

The role of psychosocial context around patient and therapy can be studied through randomized clinical trials. The analysis of the results of clinical trials, and considering the adverse events (AEs) in the placebo groups, provides an important perspective of study for this phenomenon. In double-blind, randomized clinical trials, the side effects reported in placebo-treated groups are not associated with pharmacological treatment, but other factors should be taken into account to explain these symptoms. This phenomenon may be conceptualized as 'nocebo effects' relating to negative expectations for treatment outcome, even though a role of prior learning in the form of conditioning with active treatments cannot be excluded. This approach makes it possible to observe how associating the placebo groups with a particular drug can cause specific AEs that are consistent with those observed in the active group. This phenomenon was described in a systematic review that examined placebo AEs in tricyclic antidepressant randomized clinical trials. The authors depicted nocebo effects in antidepressant placebos similar to the AE profiles of the real drugs, which they were matched with. These key findings contrast with the belief that nocebo effects were simply nonspecific. Moreover, they emphasize the need to develop standardized procedures for collecting information about AEs in randomized, double-blind, placebo-controlled trials determining drug efficacy.

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    Authors+Show Affiliations

    Amanzio M
    Department of Psychology, University of Turin, National Institute of Turin (NIT), Turin, Italy.

    MeSH

    Antidepressive AgentsHumansNocebo EffectPsychotropic DrugsRandomized Controlled Trials as TopicTreatment Outcome

    Pub Type(s)

    Editorial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    25494811

    Citation

    Amanzio, Martina. "Nocebo Effects and Psychotropic Drug Action." Expert Review of Clinical Pharmacology, vol. 8, no. 2, 2015, pp. 159-61.
    Amanzio M. Nocebo effects and psychotropic drug action. Expert Rev Clin Pharmacol. 2015;8(2):159-61.
    Amanzio, M. (2015). Nocebo effects and psychotropic drug action. Expert Review of Clinical Pharmacology, 8(2), 159-61. https://doi.org/10.1586/17512433.2015.992877
    Amanzio M. Nocebo Effects and Psychotropic Drug Action. Expert Rev Clin Pharmacol. 2015;8(2):159-61. PubMed PMID: 25494811.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Nocebo effects and psychotropic drug action. A1 - Amanzio,Martina, Y1 - 2014/12/12/ PY - 2014/12/16/entrez PY - 2014/12/17/pubmed PY - 2015/9/29/medline KW - adverse events KW - expectancy theory KW - nocebo effect KW - placebo groups KW - randomized controlled trials SP - 159 EP - 61 JF - Expert review of clinical pharmacology JO - Expert Rev Clin Pharmacol VL - 8 IS - 2 N2 - The role of psychosocial context around patient and therapy can be studied through randomized clinical trials. The analysis of the results of clinical trials, and considering the adverse events (AEs) in the placebo groups, provides an important perspective of study for this phenomenon. In double-blind, randomized clinical trials, the side effects reported in placebo-treated groups are not associated with pharmacological treatment, but other factors should be taken into account to explain these symptoms. This phenomenon may be conceptualized as 'nocebo effects' relating to negative expectations for treatment outcome, even though a role of prior learning in the form of conditioning with active treatments cannot be excluded. This approach makes it possible to observe how associating the placebo groups with a particular drug can cause specific AEs that are consistent with those observed in the active group. This phenomenon was described in a systematic review that examined placebo AEs in tricyclic antidepressant randomized clinical trials. The authors depicted nocebo effects in antidepressant placebos similar to the AE profiles of the real drugs, which they were matched with. These key findings contrast with the belief that nocebo effects were simply nonspecific. Moreover, they emphasize the need to develop standardized procedures for collecting information about AEs in randomized, double-blind, placebo-controlled trials determining drug efficacy. SN - 1751-2441 UR - https://www.unboundmedicine.com/medline/citation/25494811/Nocebo_effects_and_psychotropic_drug_action_ L2 - http://www.tandfonline.com/doi/full/10.1586/17512433.2015.992877 DB - PRIME DP - Unbound Medicine ER -