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Nocebo in Biosimilars and Generics in Neurology: A Systematic Review
Background: Nocebo refers to adverse events related to patients’ negative expectations and previous experiences, mediated by several neurobiological pathways within the brain. It is common among neurological patients and affects adherence and treatment outcomes, representing a real clinical challeng...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Frontiers Media S.A.
2019
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6667943/ https://www.ncbi.nlm.nih.gov/pubmed/31396084 http://dx.doi.org/10.3389/fphar.2019.00809 |
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author | Spanou, Ioanna Mavridis, Theodoros Mitsikostas, Dimos D. |
author_facet | Spanou, Ioanna Mavridis, Theodoros Mitsikostas, Dimos D. |
author_sort | Spanou, Ioanna |
collection | PubMed |
description | Background: Nocebo refers to adverse events related to patients’ negative expectations and previous experiences, mediated by several neurobiological pathways within the brain. It is common among neurological patients and affects adherence and treatment outcomes, representing a real clinical challenge. Methods: We conducted a systematic search based on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines in MEDLINE database, using several keywords for studies that can be processed to investigate the magnitude of nocebo in generics and biosimilars used in the most common neurological diseases. The aim was to estimate its size and suggest strategies to minimize its prevalence in clinical trials and practice. Results: Of a total of 2,606 identified articles, after criteria-based selection, 35 studies were included for analysis. Overall, there was vast heterogeneity across the studies concerning population, study design, and outcomes. Nocebo response could be estimated only in one double-blind randomized trial of generic glatiramer acetate in relapsing remitting multiple sclerosis that included a placebo arm. In this trial, no significant differences observed between the three arms (innovator, bioequivalent, and placebo) in favorable and unfavorable outcomes. In the open-label phase of the trial, an increased withdrawal rate was recorded in patients switched from placebo to bioequivalent (8.4%) that may be related to nocebo. In other open-label and real-world studies evaluating biosimilars or generics for brain disorders, a similar indirect nocebo effect is assuming by several investigators. Also, knowledge gaps between health-care providers and patients exist towards generics and biosimilars. Conclusions: Despite its presence, the true burden of the nocebo response and effect cannot be accurately estimated in existing studies with generics and biosimilars in neurological diseases. Targeted strategies for clinical trials’ design are needed in order to measure the exact nocebo’s size. |
format | Online Article Text |
id | pubmed-6667943 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-66679432019-08-08 Nocebo in Biosimilars and Generics in Neurology: A Systematic Review Spanou, Ioanna Mavridis, Theodoros Mitsikostas, Dimos D. Front Pharmacol Pharmacology Background: Nocebo refers to adverse events related to patients’ negative expectations and previous experiences, mediated by several neurobiological pathways within the brain. It is common among neurological patients and affects adherence and treatment outcomes, representing a real clinical challenge. Methods: We conducted a systematic search based on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines in MEDLINE database, using several keywords for studies that can be processed to investigate the magnitude of nocebo in generics and biosimilars used in the most common neurological diseases. The aim was to estimate its size and suggest strategies to minimize its prevalence in clinical trials and practice. Results: Of a total of 2,606 identified articles, after criteria-based selection, 35 studies were included for analysis. Overall, there was vast heterogeneity across the studies concerning population, study design, and outcomes. Nocebo response could be estimated only in one double-blind randomized trial of generic glatiramer acetate in relapsing remitting multiple sclerosis that included a placebo arm. In this trial, no significant differences observed between the three arms (innovator, bioequivalent, and placebo) in favorable and unfavorable outcomes. In the open-label phase of the trial, an increased withdrawal rate was recorded in patients switched from placebo to bioequivalent (8.4%) that may be related to nocebo. In other open-label and real-world studies evaluating biosimilars or generics for brain disorders, a similar indirect nocebo effect is assuming by several investigators. Also, knowledge gaps between health-care providers and patients exist towards generics and biosimilars. Conclusions: Despite its presence, the true burden of the nocebo response and effect cannot be accurately estimated in existing studies with generics and biosimilars in neurological diseases. Targeted strategies for clinical trials’ design are needed in order to measure the exact nocebo’s size. Frontiers Media S.A. 2019-07-24 /pmc/articles/PMC6667943/ /pubmed/31396084 http://dx.doi.org/10.3389/fphar.2019.00809 Text en Copyright © 2019 Spanou, Mavridis and Mitsikostas http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Pharmacology Spanou, Ioanna Mavridis, Theodoros Mitsikostas, Dimos D. Nocebo in Biosimilars and Generics in Neurology: A Systematic Review |
title | Nocebo in Biosimilars and Generics in Neurology: A Systematic Review |
title_full | Nocebo in Biosimilars and Generics in Neurology: A Systematic Review |
title_fullStr | Nocebo in Biosimilars and Generics in Neurology: A Systematic Review |
title_full_unstemmed | Nocebo in Biosimilars and Generics in Neurology: A Systematic Review |
title_short | Nocebo in Biosimilars and Generics in Neurology: A Systematic Review |
title_sort | nocebo in biosimilars and generics in neurology: a systematic review |
topic | Pharmacology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6667943/ https://www.ncbi.nlm.nih.gov/pubmed/31396084 http://dx.doi.org/10.3389/fphar.2019.00809 |
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