Nocebo in cerebellar ataxia: A systematic review and meta-analysis of placebo-controlled clinical trials

  • Jawwaria M. Alam
    Affiliations
    Academic Department of Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, UK

    Sheffield Institute for Translational Neuroscience, Sheffield, UK
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  • Marios Hadjivassiliou
    Affiliations
    Academic Department of Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, UK
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  • Panagiotis Zis
    Correspondence
    Corresponding author at: Academic Directorate of Neurosciences, Sheffield Teaching Hospitals NHS Trust, Royal Hallamshire Hospital, Glossop Rd, South Yorkshire S10 2JF, Sheffield, UK.
    Affiliations
    Academic Department of Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, UK

    Sheffield Institute for Translational Neuroscience, Sheffield, UK

    Medical School, University of Cyprus, Nicosia, Cyprus
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Published:April 30, 2019DOI:https://doi.org/10.1016/j.jns.2019.04.039

      Highlights

      • One in 7 placebo-treated patients with cerebellar ataxia (13.8%) report at least one adverse event (AE).
      • One in 20 placebo-treated patients with cerebellar ataxia (4.8%) discontinue treatment because of AEs.
      • Nocebo AE rate and dropout rate in cerebellar ataxia are amongst the lowest in neurological diseases.

      Abstract

      Introduction

      Nocebo, the negative counterpart of the placebo phenomenon results in the induction of adverse events (AEs) following the administration of an inert substance. Nocebo has been demonstrated to be associated with low treatment compliance in clinical trials, thus affecting treatment outcomes. This study sought to determine the prevalence of nocebo in cerebellar ataxia.

      Methods

      A systematic literature search was conducted on Pubmed for randomized controlled trials (RCTs) for cerebellar ataxia treatments. The number of drug-related AEs and the number of withdrawals due to drug intolerance in the placebo group were statistically analysed.

      Results

      The literature search identified 214 studies, of which 6 studies fulfilled the inclusion criteria. Approximately 1 in 20 (4.8%) placebo-treated patients withdrew treatment due to AEs and approximately 1 in 7 (13.8%) placebo-treated participants reported at least one AE. Participants in cerebellar ataxia trials reported similar AEs across both treatment groups (active and placebo).

      Conclusion

      Our results demonstrate that the nocebo effect in cerebellar ataxia is amongst the lowest in neurological diseases.
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