PMID- 30896060
OWN - NLM
STAT- MEDLINE
DCOM- 20210208
LR  - 20220210
IS  - 1525-1403 (Electronic)
IS  - 1094-7159 (Linking)
VI  - 23
IP  - 3
DP  - 2020 Apr
TI  - Safety, Tolerability, and Nocebo Phenomena During Transcranial Magnetic 
      Stimulation: A Systematic Review and Meta-Analysis of Placebo-Controlled Clinical 
      Trials.
PG  - 291-300
LID - 10.1111/ner.12946 [doi]
AB  - BACKGROUND: The methodology used for the application of repetitive transcranial 
      magnetic stimulation (TMS) is such that it may induce a placebo effect. 
      Respectively, adverse events (AEs) can occur when using a placebo, a phenomenon 
      called nocebo. The primary aim of our meta-analysis is to establish the nocebo 
      phenomena during TMS. Safety and tolerability of TMS were also studied. METHODS: 
      After a systematic Medline search for TMS randomized controlled trials (RCTs), we 
      assessed the number of patients reporting at least one AE and the number of 
      discontinuations because of AE in active and sham TMS groups. RESULTS: Data were 
      extracted from 93 RCTs. The overall pooled estimate of active TMS and placebo 
      treated patients who discontinued treatment because of AEs was 2.5% (95% CI 
      1.9%-3.2%) and 2.7% (95% CI 2.0%-3.5%), respectively. The pooled estimate of 
      active TMS and placebo treated patients experiencing at least one AE was 29.3% 
      (95% CI 19.0%-22.6%) and 13.6% (95% CI 11.6%-15.8%), respectively, suggesting 
      that the odds of experiencing an AE is 2.60 times higher (95% CI 1.75-3.86) in 
      the active treatment group compared to placebo (p < 0.00001). The most common AE 
      was headache, followed by dizziness. Secondary meta-analyses in depression and 
      psychotic disorders showed that the odds of experiencing an AE is 3.98 times 
      higher (95% CI 2.14-7.40) and 2.93 times higher (95% CI 1.41-6.07), respectively, 
      in the active treatment groups compared to placebo. CONCLUSIONS: TMS is a safe 
      and well-tolerated intervention. Nocebo phenomena do occur during TMS treatment 
      and should be acknowledged during clinical trial design and daily clinical 
      practice.
CI  - (c) 2019 International Neuromodulation Society.
FAU - Zis, Panagiotis
AU  - Zis P
AUID- ORCID: 0000-0001-8567-3092
AD  - Academic Department of Neurosciences, Sheffield Teaching Hospitals NHS Foundation 
      Trust, Sheffield, UK.
AD  - Medical School, University of Cyprus, Nicosia, Cyprus.
FAU - Shafique, Faiza
AU  - Shafique F
AD  - Academic Department of Neurosciences, Sheffield Teaching Hospitals NHS Foundation 
      Trust, Sheffield, UK.
FAU - Hadjivassiliou, Marios
AU  - Hadjivassiliou M
AD  - Academic Department of Neurosciences, Sheffield Teaching Hospitals NHS Foundation 
      Trust, Sheffield, UK.
FAU - Blackburn, Daniel
AU  - Blackburn D
AD  - Sheffield Institute for Translational Neuroscience, Sheffield, UK.
FAU - Venneri, Annalena
AU  - Venneri A
AD  - Sheffield Institute for Translational Neuroscience, Sheffield, UK.
FAU - Iliodromiti, Stamatina
AU  - Iliodromiti S
AD  - School of Medicine, University of Glasgow, Glasgow, UK.
FAU - Mitsikostas, Dimos-Dimitrios
AU  - Mitsikostas DD
AD  - 1st Neurology Department, Aeginition Hospital, National and Kapodistrian 
      University, Athens, Greece.
FAU - Sarrigiannis, Ptolemaios G
AU  - Sarrigiannis PG
AD  - Academic Department of Neurosciences, Sheffield Teaching Hospitals NHS Foundation 
      Trust, Sheffield, UK.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20190321
PL  - United States
TA  - Neuromodulation
JT  - Neuromodulation : journal of the International Neuromodulation Society
JID - 9804159
SB  - IM
MH  - Female
MH  - Humans
MH  - Male
MH  - *Nocebo Effect
MH  - Transcranial Magnetic Stimulation/*adverse effects
OTO - NOTNLM
OT  - adverse events
OT  - nocebo
OT  - placebo
OT  - transcranial magnetic stimulation
OT  - trial design
EDAT- 2019/03/22 06:00
MHDA- 2021/02/09 06:00
CRDT- 2019/03/22 06:00
PHST- 2018/07/17 00:00 [received]
PHST- 2018/12/28 00:00 [revised]
PHST- 2019/01/23 00:00 [accepted]
PHST- 2019/03/22 06:00 [pubmed]
PHST- 2021/02/09 06:00 [medline]
PHST- 2019/03/22 06:00 [entrez]
AID - S1094-7159(21)02116-4 [pii]
AID - 10.1111/ner.12946 [doi]
PST - ppublish
SO  - Neuromodulation. 2020 Apr;23(3):291-300. doi: 10.1111/ner.12946. Epub 2019 Mar 
      21.