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Nocebo effect in myasthenia gravis: systematic review and meta-analysis of placebo-controlled clinical trials

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Abstract

Nocebo refers to the adverse events (AEs) experienced when taking a placebo drug and is believed to be a centrally mediated process. We sought to examine the AEs following placebo administration in Randomised Controlled Trials (RCTs) for Myasthenia Gravis (MG) patients. A systematic literature search was performed on Medline and Web of Science for RCTs for MG pharmacological treatments. We assessed the number of placebo-treated patients reporting at least one AE and the number of dropouts because of AEs. Data were extracted from six RCTs fulfilling the search criteria. Four out of five placebo-treated participants (80.1%) reported at least one AE and one in 40 (2.4%) discontinued placebo treatment because of AE. All patients participating in the MG trials reported similar AEs independent of the study arm to which they belonged (placebo or active treatment). This meta-analysis demonstrates a low nocebo dropout rate in MG compared to central nervous system disorders.

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Abbreviations

AEs:

Adverse events

CIDP:

Chronic inflammatory demyelinating polyneuropathy

GI:

Gastro-intestinal

MeSH:

Medical subject headings

MG:

Myasthenia gravis

PNS:

Peripheral nervous system

PRISMA:

Preferred reporting items for systematic reviews and meta-analyses

RCTs:

Randomised controlled trials

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Acknowledgements

We are sincerely thankful to Stamatina Iliodromiti for her contribution to the statistical analysis.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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Contributions

Study concept and supervision: PZ. Study design: AV, PZ. Data acquisition: AV. Data analysis: AV, PZ. Drafting and revision the manuscript: AV, PZ. Both authors edited and approved the final manuscript.

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Correspondence to Panagiotis Zis.

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Varma, A., Zis, P. Nocebo effect in myasthenia gravis: systematic review and meta-analysis of placebo-controlled clinical trials. Acta Neurol Belg 119, 257–264 (2019). https://doi.org/10.1007/s13760-019-01143-1

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  • DOI: https://doi.org/10.1007/s13760-019-01143-1

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