PMID- 31075682 OWN - NLM STAT- MEDLINE DCOM- 20200720 LR - 20200720 IS - 1878-5883 (Electronic) IS - 0022-510X (Linking) VI - 401 DP - 2019 Jun 15 TI - Nocebo in cerebellar ataxia: A systematic review and meta-analysis of placebo-controlled clinical trials. PG - 112-117 LID - S0022-510X(19)30206-0 [pii] LID - 10.1016/j.jns.2019.04.039 [doi] AB - 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. CI - Copyright (c) 2019 Elsevier B.V. All rights reserved. FAU - Alam, Jawwaria M AU - Alam JM AD - Academic Department of Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, UK; Sheffield Institute for Translational Neuroscience, Sheffield, UK. Electronic address: jalam1@sheffield.ac.uk. FAU - Hadjivassiliou, Marios AU - Hadjivassiliou M AD - Academic Department of Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, UK. Electronic address: m.hadjivassiliou@sheffield.ac.uk. FAU - Zis, Panagiotis AU - Zis P AD - 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. Electronic address: takiszis@gmail.com. LA - eng PT - Journal Article PT - Meta-Analysis PT - Systematic Review DEP - 20190430 PL - Netherlands TA - J Neurol Sci JT - Journal of the neurological sciences JID - 0375403 SB - IM MH - Cerebellar Ataxia/*drug therapy MH - Humans MH - *Nocebo Effect MH - Randomized Controlled Trials as Topic MH - Treatment Outcome EDAT- 2019/05/11 06:00 MHDA- 2020/07/21 06:00 CRDT- 2019/05/11 06:00 PHST- 2019/03/05 00:00 [received] PHST- 2019/04/08 00:00 [revised] PHST- 2019/04/29 00:00 [accepted] PHST- 2019/05/11 06:00 [pubmed] PHST- 2020/07/21 06:00 [medline] PHST- 2019/05/11 06:00 [entrez] AID - S0022-510X(19)30206-0 [pii] AID - 10.1016/j.jns.2019.04.039 [doi] PST - ppublish SO - J Neurol Sci. 2019 Jun 15;401:112-117. doi: 10.1016/j.jns.2019.04.039. Epub 2019 Apr 30.