PMID- 38247265
OWN - NLM
STAT- MEDLINE
DCOM- 20240807
LR  - 20240814
IS  - 1531-8257 (Electronic)
IS  - 0885-3185 (Linking)
VI  - 39
IP  - 3
DP  - 2024 Mar
TI  - Placebo and Nocebo Responses in Pharmacological Trials of Tic Disorders: A 
      Meta-Analysis.
PG  - 585-595
LID - 10.1002/mds.29714 [doi]
AB  - BACKGROUND: Clinical trials of new drugs for tic disorders (TD) often fail to 
      yield positive results. Placebo and nocebo responses play a vital role in 
      interpreting the outcomes of randomized controlled trials (RCTs), yet these 
      responses in RCTs of TD remain unexplored. OBJECTIVE: The aim was to assess the 
      magnitude of placebo and nocebo responses in RCTs of pharmacological 
      interventions for TD and identify influencing factors. METHODS: A systematic 
      search of the Embase, Medline, Cochrane Central Register of Controlled Trials, 
      and PsycINFO databases was conducted. Eligible studies were RCTs that compared 
      active pharmacological agents with placebos. Placebo response was defined as the 
      change from baseline in TD symptom severity in the placebo group, and nocebo 
      response as the proportion experiencing adverse events (AEs) in this group. 
      Subgroup analysis and meta-regression were performed to explore modifying 
      factors. RESULTS: Twenty-four trials involving 2222 participants were included in 
      this study. A substantial placebo response in TD symptom severity was identified, 
      with a pooled effect size of -0.79 (95% confidence interval [CI] -0.99 to -0.59; 
      I(2) = 67%). Forty-four percent (95% CI 27% to 63%; I(2) = 92%) of patients 
      experienced AEs while taking inert pills. Sample size, study design, and 
      randomization ratio were correlated with changes in placebo and nocebo responses. 
      CONCLUSION: There were considerable placebo and nocebo responses in TD clinical 
      trials. These results are of great relevance for the design of future trials and 
      for clinical practice in TD. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 
      registration ID CRD42023388397. (c) 2024 The Authors. Movement Disorders published 
      by Wiley Periodicals LLC on behalf of International Parkinson and Movement 
      Disorder Society.
CI  - (c) 2024 The Authors. Movement Disorders published by Wiley Periodicals LLC on 
      behalf of International Parkinson and Movement Disorder Society.
FAU - Wang, Simeng
AU  - Wang S
AD  - Department of Pediatrics, Guang'anmen Hospital, China Academy of Chinese Medical 
      Sciences, Beijing, China.
FAU - Xiong, Zhiyi
AU  - Xiong Z
AD  - School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese 
      Medicine, Beijing, China.
FAU - Cui, Yuehua
AU  - Cui Y
AD  - Department of Pediatrics, Guang'anmen Hospital, China Academy of Chinese Medical 
      Sciences, Beijing, China.
FAU - Fan, Fei
AU  - Fan F
AD  - Department of Pediatrics, Guang'anmen Hospital, China Academy of Chinese Medical 
      Sciences, Beijing, China.
FAU - Zhang, Si
AU  - Zhang S
AD  - Department of Pediatrics, Guang'anmen Hospital, China Academy of Chinese Medical 
      Sciences, Beijing, China.
FAU - Jia, Ru
AU  - Jia R
AD  - Department of Pediatrics, Guang'anmen Hospital, China Academy of Chinese Medical 
      Sciences, Beijing, China.
FAU - Hu, Yuchen
AU  - Hu Y
AD  - Department of Pediatrics, Guang'anmen Hospital, China Academy of Chinese Medical 
      Sciences, Beijing, China.
FAU - Li, Liang
AU  - Li L
AD  - Department of Traditional Chinese Medicine, Children's Hospital of Soochow 
      University, Soochow, China.
FAU - Zhang, Xuan
AU  - Zhang X
AD  - Chinese EQUATOR Center, Hong Kong Chinese Medicine Clinical Study Center, Chinese 
      Clinical Trial Registry (Hong Kong), School of Chinese Medicine, Hong Kong 
      Baptist University, Kowloon, Hong Kong SAR, China.
FAU - Han, Fei
AU  - Han F
AUID- ORCID: 0000-0002-8072-9701
AD  - Department of Pediatrics, Guang'anmen Hospital, China Academy of Chinese Medical 
      Sciences, Beijing, China.
LA  - eng
GR  - CI2021A02506/The Science and Technology Innovation Project of China Academy of 
      Chinese Medical Sciences/
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20240121
PL  - United States
TA  - Mov Disord
JT  - Movement disorders : official journal of the Movement Disorder Society
JID - 8610688
MH  - Humans
MH  - *Nocebo Effect
MH  - *Placebo Effect
MH  - Randomized Controlled Trials as Topic
MH  - *Tic Disorders/drug therapy
OTO - NOTNLM
OT  - Tourette syndrome
OT  - meta-analysis
OT  - nocebo response
OT  - placebo response
OT  - tic disorders
EDAT- 2024/01/22 06:42
MHDA- 2024/03/26 06:45
CRDT- 2024/01/22 02:23
PHST- 2023/12/20 00:00 [revised]
PHST- 2023/09/30 00:00 [received]
PHST- 2023/12/22 00:00 [accepted]
PHST- 2024/03/26 06:45 [medline]
PHST- 2024/01/22 06:42 [pubmed]
PHST- 2024/01/22 02:23 [entrez]
AID - 10.1002/mds.29714 [doi]
PST - ppublish
SO  - Mov Disord. 2024 Mar;39(3):585-595. doi: 10.1002/mds.29714. Epub 2024 Jan 21.